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Clinical Trial Results:
A Long-term, Open-Label Extension Study of Tofacitinib (CP-690,550) for the Treatment of Psoriatic Arthritis

Summary
EudraCT number	2011-002169-39
Trial protocol	BE HU CZ BG SK PL ES DE
Global end of trial date	20 May 2019

Results information
Results version number	v1(current)
This version publication date	22 May 2020
First version publication date	22 May 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

A3921092

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 May 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

20 May 2019

Was the trial ended prematurely?

Main objective of the trial

To evaluate the long term safety and tolerability of treatment with tofacitinib (5 mg twice daily [BID] and 10 mg BID) in adult subjects with active Psoriatic Arthritis (PsA) and to evaluate the long term efficacy of treatment with tofacitinib (5 mg BID and 10 mg BID) in adult subjects with active Psoriatic Arthritis (PsA)

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Feb 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 17

Country: Number of subjects enrolled

Brazil: 7

Country: Number of subjects enrolled

Bulgaria: 22

Country: Number of subjects enrolled

Canada: 2

Country: Number of subjects enrolled

Czech Republic: 18

Country: Number of subjects enrolled

Germany: 36

Country: Number of subjects enrolled

Hungary: 27

Country: Number of subjects enrolled

Mexico: 56

Country: Number of subjects enrolled

Poland: 196

Country: Number of subjects enrolled

Russian Federation: 63

Country: Number of subjects enrolled

Slovakia: 12

Country: Number of subjects enrolled

Spain: 31

Country: Number of subjects enrolled

Taiwan: 13

Country: Number of subjects enrolled

United Kingdom: 31

Country: Number of subjects enrolled

United States: 133

Country: Number of subjects enrolled

Australia: 22

Worldwide total number of subjects

686

EEA total number of subjects

390

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

625

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Eligible subjects (who had previously participated in randomized PsA clinical studies with tofacitinib) from qualifying studies A3921091 (NCT01877668) and A3921125 (NCT01882439) were enrolled into this current study A3921092 (NCT01976364).

Screening details

This main study was a long-term extension study, which also included a sub-study only for the purpose of efficacy, safety and tolerability of tofacitinib monotherapy as compared to tofacitinib combination therapy with methotrexate. Sub-study included eligible subjects from main study who consented to take part in sub-study.

Period 1 title

Main Study (36 Months)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Tofacitinib

Arm description

Subjects with active psoriatic arthritis (PsA) received tofacitinib 5 milligram (mg) oral tablet, twice daily (BID) with or without allowed concomitant disease-modifying anti-rheumatic drugs (DMARDs) examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib 5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tofacitinib 5 mg oral tablet, BID for 36 months.

Investigational medicinal product name

Tofacitinib 10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Two tablets of Tofacitinib 5 mg orally, BID for 36 months.

Number of subjects in period 1	Tofacitinib
Started	686
Completed	465
Not completed	221
Adverse event, serious fatal	5
Consent withdrawn by subject	69
Adverse event, non-fatal	63
Withdrawn due to pregnancy	5
No longer met eligibility criteria	2
Medication error	1
Unspecified	13
Lost to follow-up	10
Lack of efficacy	40
Protocol deviation	13

Period 2 title

Sub-study (12 Months)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Tofacitinib 5 mg BID + Methotrexate (MTX)

Arm description

Subjects from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib 5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tofacitinib 5 mg oral tablet BID for up to 12 months.

Investigational medicinal product name

Methotrexate (MTX)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

MTX capsules orally (dose range from 7.5 mg to 20 mg per week), for up to 12 months.

Tofacitinib 5 mg BID + Placebo

Arm description

Subjects from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib 5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tofacitinib 5 mg oral tablet BID for up to 12 months.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

MTX matched placebo capsules orally weekly for up to 12 months.

Number of subjects in period 2 ^[1]	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Started	89	90
Completed	83	85
Not completed	6	5
Consent withdrawn by subject	-	1
Adverse event, non-fatal	4	3
Lost to follow-up	1	-
Protocol deviation	1	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Subjects from main study who consented to take part in sub-study, continued into sub-study.

Baseline characteristics

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Reporting group title

Main Study (36 Months)

Reporting group description

Reporting group values	Main Study (36 Months)	Total
Number of subjects	686	686
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	625	625
From 65-84 years	61	61
85 years and over	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	48.8 ± 11.8	-
Sex: Female, Male
Units: Subjects
Female	370	370
Male	316	316
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0
Asian	21	21
Native Hawaiian or Other Pacific Islander	0	0
Black or African American	2	2
White	646	646
More than one race	17	17
Unknown or Not Reported	0	0

End points

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Reporting group title

Tofacitinib

Reporting group description

Reporting group title

Tofacitinib 5 mg BID + Methotrexate (MTX)

Reporting group description

Subjects from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.

Reporting group title

Tofacitinib 5 mg BID + Placebo

Reporting group description

Subjects from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.

Subject analysis set title

All Subjects

Subject analysis set type

Full analysis

Subject analysis set description

Main Study: Subjects with active psoriatic arthritis (PsA) received tofacitinib 5 milligram (mg) oral tablet, twice daily (BID) with or without allowed concomitant disease-modifying anti-rheumatic drugs (DMARDs) examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Subjects from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.

Primary: Percentage of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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End point title

Percentage of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) ^[1]

End point description

An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non -serious AEs. SAS included all subjects enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.

End point type

Primary

End point timeframe

Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analyzed for this endpoint.

End point values	All Subjects
Number of subjects analysed	686
Units: percentage of subjects
number (not applicable)
AEs	83.7
SAEs	16.8

No statistical analyses for this end point

Primary: Number of Adverse Events (AEs) by Severity

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End point title

Number of Adverse Events (AEs) by Severity ^[2]

End point description

An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with subject’s usual function), moderate AEs (interfered to some extent with subject’s usual function) and severe AEs (interfered significantly with subject’s usual function). SAS included all subjects enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.

End point type

Primary

End point timeframe

Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analyzed for this endpoint.

End point values	All Subjects
Number of subjects analysed	686
Units: adverse events
Number of adverse events: Mild	1632
Number of adverse events: Moderate	1045
Number of adverse events: Severe	136

No statistical analyses for this end point

Primary: Number of Subjects With Abnormal Clinical Laboratory Values

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End point title

Number of Subjects With Abnormal Clinical Laboratory Values ^[3]

End point description

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria. SAS was analyzed. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol. Number of Subjects Analyzed= Subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analyzed for this endpoint.

End point values	All Subjects
Number of subjects analysed	683
Units: subjects
number (not applicable)	646

No statistical analyses for this end point

Primary: Number of Subjects With Clinically Significant Change from Baseline in Clinical Laboratory Values

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End point title

Number of Subjects With Clinically Significant Change from Baseline in Clinical Laboratory Values ^[4]

End point description

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria. SAS was analyzed. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.

End point type

Primary

End point timeframe

Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analyzed for this endpoint.

End point values	All Subjects
Number of subjects analysed	686
Units: Subjects
number (not applicable)	9

No statistical analyses for this end point

Primary: Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6

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End point title

Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6

End point description

HAQ-DI assessed the degree of difficulty a subject had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities. Full analysis set (FAS) of sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Primary

End point timeframe

Sub-study: Baseline (Day 1), Month 6

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)	0.0174 ± 0.02775	0.0428 ± 0.02714

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least Square (LS) Mean difference

Point estimate

0.0255

Confidence interval

level

95%

sides

2-sided

lower limit

-0.0513

upper limit

0.1022

Primary: Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6

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End point title

Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6

End point description

PASDAS was composite PsA disease activity score that included following components:Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease. FAS of main study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Primary

End point timeframe

Sub-study: Baseline (Day 1), Month 6

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)	0.138 ± 0.0805	0.229 ± 0.0786

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Results are based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.091

Confidence interval

level

95%

sides

2-sided

lower limit

-0.131

upper limit

0.313

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response

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End point title

Main Study: Percentage of Subjects Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response

End point description

Subjects with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient’s global assessment of arthritis (PtGA), Physician’s global assessment of arthritis (PhyGA), subject's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: subject assessed health on VAS, 0 mm(very well) to 100 mm(worst health condition), higher score =worse condition. PhyGA: physician judged subjects' pain on VAS, 0(no pain) to 100 mm(extreme pain), higher score = more pain. Subject's assessment of arthritis pain: subject assessed pain on VAS, 0 mm(no pain) to 100 mm(most severe pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0(no difficulty) to 3(extreme difficulty),higher score implied more disability. FAS population for long-term extension (LTE) main study. n=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n = 673)	66.12 (62.55 to 69.70)
Month 3 (n =660)	68.79 (65.25 to 72.32)
Month 6 (n =634)	70.66 (67.12 to 74.21)
Month 9 (n =603)	71.48 (67.87 to 75.08)
Month 12 (n =581)	74.18 (70.62 to 77.74)
Month 15 (n =551)	78.04 (74.58 to 81.50)
Month 18 (n =537)	77.65 (74.13 to 81.18)
Month 21 (n =526)	77.00 (73.40 to 80.59)
Month 24 (n =511)	76.13 (72.43 to 79.82)
Month 27 (n =495)	78.18 (74.54 to 81.82)
Month 30 (n =479)	80.79 (77.27 to 84.32)
Month 33 (n =452)	77.88 (74.05 to 81.70)
Month 36 (n =383)	77.02 (72.81 to 81.24)

No statistical analyses for this end point

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response

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End point title

Main Study: Percentage of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response

End point description

Subjects with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, subject's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: subject assessed health on VAS, 0 mm(very well) to 100 mm(worst health condition), higher score =worse condition. PhyGA: physician judged subjects' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Subject's assessment of arthritis pain: subject assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score =more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. FAS population for LTE main study was analyzed. “n”=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =674)	45.70 (41.94 to 49.46)
Month 3 (n =661)	43.27 (39.49 to 47.04)
Month 6 (n =633)	47.08 (43.19 to 50.97)
Month 9 (n =605)	50.41 (46.43 to 54.40)
Month 12 (n =581)	50.26 (46.19 to 54.32)
Month 15 (n =554)	55.42 (51.28 to 59.55)
Month 18 (n =539)	55.10 (50.90 to 59.30)
Month 21 (n =527)	55.41 (51.16 to 59.65)
Month 24 (n =511)	57.34 (53.05 to 61.63)
Month 27 (n =496)	56.05 (51.68 to 60.42)
Month 30 (n =478)	60.46 (56.08 to 64.84)
Month 33 (n =452)	57.96 (53.41 to 62.52)
Month 36 (n =384)	58.85 (53.93 to 63.78)

No statistical analyses for this end point

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 70% (ACR70) Response

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End point title

Main Study: Percentage of Subjects Achieving an American College of Rheumatology 70% (ACR70) Response

End point description

Subjects with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, subject's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: subject assessed health on VAS, 0 mm(very well) to 100 mm(worst health condition), higher score =worse condition. PhyGA: physician judged subjects' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Subject's assessment of arthritis pain: subject assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score =more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. FAS population for LTE main study was analyzed. “n”=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: percentage of participants
number (confidence interval 95%)
Month 1 (n =676)	24.85 (21.59 to 28.11)
Month 3 (n =662)	26.13 (22.79 to 29.48)
Month 6 (n =636)	30.50 (26.92 to 34.08)
Month 9 (n =607)	30.81 (27.13 to 34.48)
Month 12 (n =582)	32.13 (28.34 to 35.92)
Month 15 (n =555)	33.87 (29.94 to 37.81)
Month 18 (n =538)	36.25 (32.18 to 40.31)
Month 21 (n =527)	34.35 (30.29 to 38.40)
Month 24 (n =512)	35.94 (31.78 to 40.09)
Month 27 (n =496)	38.10 (33.83 to 42.38)
Month 30 (n =476)	41.60 (37.17 to 46.02)
Month 33 (n =453)	38.19 (33.72 to 42.66)
Month 36 (n =384)	37.76 (32.91 to 42.61)

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicate more difficulty while performing daily living activities. FAS population for LTE main study was analyzed. “n”=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =675)	-0.4373 ± 0.55677
Change at Month 3 (n =661)	-0.4559 ± 0.55104
Change at Month 6 (n =636)	-0.4755 ± 0.57468
Change at Month 9 (n =605)	-0.4841 ± 0.58294
Change at Month 12 (n =582)	-0.4782 ± 0.60163
Change at Month 15 (n =554)	-0.5108 ± 0.58277
Change at Month 18 (n =539)	-0.5116 ± 0.59401
Change at Month 21 (n =528)	-0.5211 ± 0.59568
Change at Month 24 (n =511)	-0.5068 ± 0.62016
Change at Month 27 (n =496)	-0.5219 ± 0.60833
Change at Month 30 (n =478)	-0.5356 ± 0.61316
Change at Month 33 (n =453)	-0.5276 ± 0.63803
Change at Month 36 (n =386)	-0.5476 ± 0.65226

No statistical analyses for this end point

Secondary: Main Study: Percentage of Subjects Achieving Psoriatic Arthritis Response Criteria (PsARC)

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End point title

Main Study: Percentage of Subjects Achieving Psoriatic Arthritis Response Criteria (PsARC)

End point description

PsARC was comprised of 4 clinical improvement criteria: greater than or equal to (>=) 20% improvement in PhyGA (VAS), >=20% improvement in patient’s global assessment of arthritis (PtGA); and >=30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: subject assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged subjects' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the subject must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen. FAS population for LTE main study was analyzed. “n”= subjects evaluable for this outcome measure at specified time points.

End point type

Secondary

End point timeframe

Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =669)	68.46 (64.94 to 71.98)
Month 3 (n =657)	69.56 (66.04 to 73.08)
Month 6 (n =633)	73.14 (69.69 to 76.60)
Month 9 (n =599)	74.46 (70.97 to 77.95)
Month 12 (n =577)	76.08 (72.60 to 79.56)
Month 15 (n =547)	79.52 (76.14 to 82.91)
Month 18 (n =534)	80.15 (76.77 to 83.53)
Month 21 (n =522)	79.50 (76.04 to 82.96)
Month 24 (n =507)	77.51 (73.88 to 81.15)
Month 27 (n =494)	80.16 (76.65 to 83.68)
Month 30 (n =475)	82.11 (78.66 to 85.55)
Month 33 (n =449)	80.85 (77.21 to 84.49)
Month 36 (n =381)	77.17 (72.95 to 81.38)

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Score (For Subjects with Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Score (For Subjects with Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe). Analysis population included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline PGA-PsO score >0. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	660
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =649)	-1.1 ± 1.04
Change at Month 3 (n =636)	-1.1 ± 1.04
Change at Month 6 (n =610)	-1.2 ± 1.03
Change at Month 9 (n =578)	-1.2 ± 1.06
Change at Month 12 (n =559)	-1.1 ± 1.06
Change at Month 15 (n =532)	-1.2 ± 1.07
Change at Month 18 (n =516)	-1.2 ± 1.05
Change at Month 21 (n =506)	-1.2 ± 1.06
Change at Month 24 (n =488)	-1.3 ± 1.02
Change at Month 27 (n =478)	-1.3 ± 1.02
Change at Month 30 (n =462)	-1.3 ± 1.05
Change at Month 33 (n =434)	-1.3 ± 1.02
Change at Month 36 (n =372)	-1.2 ± 1.02

No statistical analyses for this end point

Secondary: Main Study: Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Subjects With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Subjects With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

PASI:combined assessment of lesion severity and body area affected into single score;range=0(no disease)-72(maximal disease).Higher score represented greater severity of psoriasis. PASI was composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0 4: 0=none,1=slight,2=moderate,3=marked,4=very marked.Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75: >= 75% reduction in PASI relative to Baseline. FAS of main study with baseline: BSA>=3%, PASI score > 0. n=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	474
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =465)	55.05 (50.53 to 59.58)
Month 3 (n =452)	57.96 (53.41 to 62.52)
Month 6 (n =433)	60.74 (56.14 to 65.34)
Month 9 (n =411)	61.07 (56.36 to 65.78)
Month 12 (n =399)	63.16 (58.42 to 67.89)
Month 15 (n =382)	65.71 (60.95 to 70.47)
Month 18 (n =368)	65.22 (60.35 to 70.08)
Month 21 (n =360)	69.72 (64.98 to 74.47)
Month 24 (n =347)	71.47 (66.72 to 76.22)
Month 27 (n =343)	70.85 (66.04 to 75.66)
Month 30 (n =331)	68.58 (63.58 to 73.58)
Month 33 (n =311)	70.10 (65.01 to 75.18)
Month 36 (n =260)	68.08 (62.41 to 73.74)

No statistical analyses for this end point

Secondary: Main Study: Percent Change From Baseline in PASI Composite Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Percent Change From Baseline in PASI Composite Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score represented greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). FAS of main study with baseline: BSA>=3%, PASI score >0. n =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	474
Units: percent change
arithmetic mean (standard deviation)
At Month 1 (n =465)	-64.09 ± 57.473
At Month 3 (n =452)	-66.98 ± 43.647
At Month 6 (n =433)	-68.58 ± 44.568
At Month 9 (n =411)	-70.42 ± 40.617
At Month 12 (n =399)	-71.58 ± 42.515
At Month 15 (n =382	-73.13 ± 43.653
At Month 18 (n =368)	-73.51 ± 40.527
At Month 21 (n =360)	-75.15 ± 44.182
At Month 24 (n =347)	-78.36 ± 34.808
At Month 27 (n =343)	-78.37 ± 34.405
At Month 30 (n =331)	-78.28 ± 30.270
At Month 33 (n =311)	-77.47 ± 43.952
At Month 36 (n =260)	-76.85 ± 31.973

No statistical analyses for this end point

Secondary: Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI was a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). Analysis population included FAS of main study with baseline BSA>=3%, baseline PASI score >0. n=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	474
Units: percent change
arithmetic mean (standard deviation)
Induration: At Month 1 (n =456)	-62.60 ± 62.288
Induration: At Month 3 (n =442)	-66.92 ± 46.898
Induration: At Month 6 (n =423)	-68.63 ± 46.644
Induration: At Month 9 (n =402)	-70.33 ± 41.960
Induration: At Month 12 (n =390)	-70.81 ± 48.439
Induration: At Month 15 (n =373)	-72.49 ± 48.644
Induration: At Month 18 (n =359)	-73.16 ± 40.801
Induration: At Month 21 (n =352)	-74.34 ± 47.617
Induration: At Month 24 (n =338)	-78.45 ± 36.534
Induration: At Month 27 (n =335)	-77.85 ± 34.297
Induration: At Month 30 (n =322)	-78.55 ± 31.187
Induration: At Month 33 (n =303)	-77.09 ± 42.305
Induration: At Month 36 (n =256)	-76.11 ± 35.000
Erythema: At Month 1 (n =464)	-63.60 ± 67.818
Erythema: At Month 3 (n =451)	-66.69 ± 43.013
Erythema: At Month 6 (n =432)	-67.17 ± 46.756
Erythema: At Month 9 (n =410)	-69.75 ± 42.882
Erythema: At Month 12 (n =398)	-70.45 ± 46.575
Erythema: At Month 15 (n =381)	-71.55 ± 50.406
Erythema: At Month 18 (n =367)	-73.12 ± 45.194
Erythema: At Month 21 (n =359)	-75.06 ± 45.993
Erythema: At Month 24 (n =346)	-77.40 ± 38.093
Erythema: At Month 27 (n =342)	-77.83 ± 33.877
Erythema: At Month 30 (n =330)	-77.04 ± 33.478
Erythema: At Month 33 (n =310)	-75.17 ± 53.782
Erythema: At Month 36 (n =259)	-75.72 ± 34.823
Scaling: At Month 1 (n =453)	-64.26 ± 55.848
Scaling: At Month 3 (n =439)	-66.15 ± 52.568
Scaling: At Month 6 (n =420)	-68.66 ± 49.145
Scaling: At Month 9 (n =399)	-69.09 ± 48.506
Scaling: At Month 12 (n =387)	-72.48 ± 45.755
Scaling: At Month 15 (n =370)	-73.83 ± 42.528
Scaling: At Month 18 (n =356)	-74.62 ± 39.708
Scaling: At Month 21 (n =348)	-75.11 ± 44.570
Scaling: At Month 24 (n =336)	-77.86 ± 38.041
Scaling: At Month 27 (n =332)	-79.34 ± 31.825
Scaling: At Month 30 (n =322)	-77.23 ± 37.819
Scaling: At Month 33 (n =302)	-77.94 ± 41.688
Scaling: At Month 36 (n =253)	-78.10 ± 30.391

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Subjects With Baseline DSS greater than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Subjects With Baseline DSS greater than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	366
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =360)	-6.7 ± 7.65
Change at Month 3 (n =352)	-6.8 ± 7.71
Change at Month 6 (n =335)	-7.2 ± 7.89
Change at Month 9 (n =313)	-7.4 ± 7.29
Change at Month 12 (n =305)	-7.6 ± 7.70
Change at Month 15 (n =290)	-7.7 ± 7.44
Change at Month 18 (n =282)	-7.7 ± 7.50
Change at Month 21 (n =275)	-7.8 ± 7.89
Change at Month 24 (n =269)	-7.9 ± 7.76
Change at Month 27 (n =265)	-8.1 ± 7.59
Change at Month 30 (n =257)	-8.0 ± 7.65
Change at Month 33 (n =250)	-8.1 ± 7.75
Change at Month 36 (n =212)	-7.7 ± 7.88

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Subjects With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Subjects With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis. Analysis population included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline LEI >0. "n" =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	458
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =449)	-1.5 ± 1.88
Change at Month 3 (n =437)	-1.6 ± 1.79
Change at Month 6 (n =418)	-1.7 ± 1.78
Change at Month 9 (n =398)	-1.8 ± 1.80
Change at Month 12 (n =380)	-1.7 ± 1.82
Change at Month 15 (n =364)	-2.0 ± 1.76
Change at Month 18 (n =347)	-1.9 ± 1.79
Change at Month 21 (n =340)	-1.9 ± 1.81
Change at Month 24 (n =327)	-2.0 ± 1.72
Change at Month 27 (n =317)	-2.0 ± 1.73
Change at Month 30 (n =306)	-2.0 ± 1.76
Change at Month 33 (n =288)	-2.0 ± 1.75
Change at Month 36 (n =253)	-2.1 ± 1.76

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Subjects with baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Subjects with baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis. Analysis population included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline SPARCC enthesitis index >0. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	525
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =517)	-2.8 ± 3.60
Change at Month 3 (n =504)	-3.0 ± 3.61
Change at Month 6 (n =481)	-3.2 ± 3.72
Change at Month 9 (n =457)	-3.4 ± 3.69
Change at Month 12 (n =438)	-3.5 ± 3.46
Change at Month 15 (n =415)	-3.7 ± 3.55
Change at Month 18 (n =400)	-3.5 ± 3.45
Change at Month 21 (n =394)	-3.6 ± 3.60
Change at Month 24 (n =379)	-3.7 ± 3.62
Change at Month 27 (n =369)	-3.7 ± 3.56
Change at Month 30 (n =359)	-3.8 ± 3.49
Change at Month 33 (n =340)	-3.9 ± 3.39
Change at Month 36 (n =290)	-3.9 ± 3.69

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects with Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects with Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

BASDAI was a validated self-assessment tool used to determine disease activity in subjects with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) subjects answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity. Analysis population included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 with presence of spondylitis at screening and baseline BASDAI Score >0 cm. n =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	124
Units: centimeter
arithmetic mean (standard deviation)
Change at Month 1 (n =124)	-2.26 ± 2.367
Change at Month 3 (n =121)	-2.10 ± 2.278
Change at Month 6 (n =116)	-2.40 ± 2.371
Change at Month 9 (n =106)	-2.35 ± 2.254
Change at Month 12 (n =105)	-2.41 ± 2.371
Change at Month 15 (n =99)	-2.35 ± 2.547
Change at Month 18 (n =95)	-2.41 ± 2.640
Change at Month 21 (n =89)	-2.28 ± 2.582
Change at Month 24 (n =85)	-2.47 ± 2.640
Change at Month 27 (n =83)	-2.65 ± 2.658
Change at Month 30 (n =82)	-2.95 ± 2.672
Change at Month 33 (n =80)	-2.85 ± 2.671
Change at Month 36 (n =71)	-2.88 ± 2.521

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

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End point title

Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point description

BASDAI was a validated self-assessment tool used to determine disease activity in subjects with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) subjects answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity. Analysis population included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with presence of spondylitis at screening and baseline BASDAI score >=4 cm. n =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

End point values	Tofacitinib
Number of subjects analysed	106
Units: centimeter
arithmetic mean (standard deviation)
Change at Month 1 (n =106)	-2.59 ± 2.324
Change at Month 3 (n =103)	-2.41 ± 2.227
Change at Month 6 (n =98)	-2.74 ± 2.350
Change at Month 9 (n =93)	-2.63 ± 2.175
Change at Month 12 (n =92)	-2.65 ± 2.364
Change at Month 15 (n =87)	-2.65 ± 2.487
Change at Month 18 (n =84)	-2.65 ± 2.652
Change at Month 21 (n =80)	-2.47 ± 2.602
Change at Month 24 (n =76)	-2.72 ± 2.616
Change at Month 27 (n =74)	-2.90 ± 2.640
Change at Month 30 (n =73)	-3.27 ± 2.596
Change at Month 33 (n =71)	-3.17 ± 2.589
Change at Month 36 (n =65)	-3.08 ± 2.459

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =668)	6.44 ± 8.285
Change at Month 6 (n =630)	6.71 ± 8.496
Change at Month 12 (n =578)	7.23 ± 8.257
Change at Month 18 (n =534)	7.44 ± 8.729
Change at Month 24 (n =502)	7.79 ± 9.055
Change at Month 30 (n =471)	8.06 ± 8.899
Change at Month 36 (n =384)	7.77 ± 9.074

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =668)	4.72 ± 10.480
Change at Month 6 (n =630)	4.98 ± 11.052
Change at Month 12 (n =578)	5.25 ± 11.072
Change at Month 18 (n =534)	5.53 ± 11.055
Change at Month 24 (n =502)	5.79 ± 11.122
Change at Month 30 (n =471)	5.82 ± 11.726
Change at Month 36 (n =384)	6.18 ± 11.284

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning. FAS of main study was analyzed. "n" =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	6.06 ± 9.425
Change at Month 6 (n =635)	6.44 ± 9.834
Change at Month 12 (n =582)	7.00 ± 9.472
Change at Month 18 (n =536)	7.31 ± 9.891
Change at Month 24 (n =505)	7.69 ± 10.280
Change at Month 30 (n =472)	7.96 ± 10.146
Change at Month 36 (n =386)	7.80 ± 10.703

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning. FAS of main study was analyzed. "n" =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =669)	6.19 ± 9.545
Change at Month 6 (n =631)	6.56 ± 9.650
Change at Month 12 (n =579)	6.61 ± 9.293
Change at Month 18 (n =534)	7.07 ± 10.050
Change at Month 24 (n =503)	7.46 ± 10.094
Change at Month 30 (n =473)	7.64 ± 10.041
Change at Month 36 (n =384)	7.40 ± 9.996

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =673)	8.36 ± 9.797
Change at Month 6 (n =636)	8.52 ± 10.033
Change at Month 12 (n =582)	9.29 ± 9.777
Change at Month 18 (n =536)	9.70 ± 10.271
Change at Month 24 (n =504)	9.95 ± 10.980
Change at Month 30 (n =473)	10.21 ± 10.645
Change at Month 36 (n =386)	10.45 ± 10.627

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	3.89 ± 8.033
Change at Month 6 (n =636)	4.09 ± 8.640
Change at Month 12 (n =582)	4.68 ± 8.652
Change at Month 18 (n =536)	4.76 ± 8.386
Change at Month 24 (n =504)	4.89 ± 8.608
Change at Month 30 (n =473)	4.81 ± 8.590
Change at Month 36 (n =386)	4.36 ± 8.847

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represents better vitality. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	5.92 ± 10.160
Change at Month 6 (n =636)	6.03 ± 10.546
Change at Month 12 (n =582)	6.72 ± 10.367
Change at Month 18 (n =536)	6.67 ± 10.147
Change at Month 24 (n =504)	7.10 ± 10.828
Change at Month 30 (n =474)	7.62 ± 10.808
Change at Month 36 (n =386)	7.65 ± 10.403

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. "n" =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	6.08 ± 11.028
Change at Month 6 (n =636)	6.51 ± 10.923
Change at Month 12 (n =582)	7.16 ± 10.932
Change at Month 18 (n =536)	6.76 ± 11.272
Change at Month 24 (n =504)	7.28 ± 11.487
Change at Month 30 (n =473)	7.64 ± 11.597
Change at Month 36 (n =386)	7.83 ± 11.977

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. "n" =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =668)	5.40 ± 11.962
Change at Month 6 (n =632)	5.39 ± 12.445
Change at Month 12 (n =578)	5.73 ± 12.235
Change at Month 18 (n =534)	6.71 ± 12.647
Change at Month 24 (n =502)	6.82 ± 12.154
Change at Month 30 (n =473)	6.54 ± 12.843
Change at Month 36 (n =384)	6.95 ± 12.859

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

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End point title

Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	4.85 ± 10.306
Change at Month 6 (n =636)	5.39 ± 10.893
Change at Month 12 (n =582)	5.56 ± 10.781
Change at Month 18 (n =536)	5.82 ± 10.730
Change at Month 24 (n =504)	6.09 ± 11.247
Change at Month 30 (n =474)	6.18 ± 11.278
Change at Month 36 (n =386)	6.37 ± 11.199

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this outcome measure. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	-0.24 ± 0.529
Change at Month 6 (n =635)	-0.30 ± 0.540
Change at Month 12 (n =582)	-0.28 ± 0.511
Change at Month 18 (n =536)	-0.30 ± 0.538
Change at Month 24 (n =505)	-0.31 ± 0.545
Change at Month 30 (n =474)	-0.30 ± 0.526
Change at Month 36 (n =386)	-0.32 ± 0.555

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this outcome measure. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. "n" =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =673)	-0.19 ± 0.547
Change at Month 6 (n =633)	-0.20 ± 0.530
Change at Month 12 (n =581)	-0.19 ± 0.532
Change at Month 18 (n =535)	-0.21 ± 0.522
Change at Month 24 (n =503)	-0.21 ± 0.534
Change at Month 30 (n =473)	-0.23 ± 0.533
Change at Month 36 (n =385)	-0.24 ± 0.589

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. "n" =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	-0.27 ± 0.588
Change at Month 6 (n =635)	-0.30 ± 0.539
Change at Month 12 (n =582)	-0.33 ± 0.547
Change at Month 18 (n =536)	-0.32 ± 0.579
Change at Month 24 (n =505)	-0.36 ± 0.547
Change at Month 30 (n =474)	-0.34 ± 0.571
Change at Month 36 (n =386)	-0.35 ± 0.594

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this endpoint. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	-0.31 ± 0.557
Change at Month 6 (n =635)	-0.32 ± 0.570
Change at Month 12 (n =582)	-0.36 ± 0.568
Change at Month 18 (n =536)	-0.40 ± 0.584
Change at Month 24 (n =505)	-0.41 ± 0.602
Change at Month 30 (n =474)	-0.41 ± 0.601
Change at Month 36 (n =386)	-0.40 ± 0.613

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this endpoint. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	-0.23 ± 0.600
Change at Month 6 (n =635)	-0.26 ± 0.623
Change at Month 12 (n =582)	-0.25 ± 0.594
Change at Month 18 (n =536)	-0.26 ± 0.604
Change at Month 24 (n =505)	-0.29 ± 0.605
Change at Month 30 (n =473)	-0.31 ± 0.608
Change at Month 36 (n =386)	-0.29 ± 0.651

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36

End point description

The EQ VAS recorded the subject's self-rated health on a vertical VAS as standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. “n” =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: millimeter
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	14.12 ± 24.928
Change at Month 6 (n =636)	15.71 ± 25.871
Change at Month 12 (n =582)	16.00 ± 24.896
Change at Month 18 (n =535)	16.68 ± 24.746
Change at Month 24 (n =505)	17.43 ± 25.226
Change at Month 30 (n =473)	17.87 ± 25.363
Change at Month 36 (n =386)	18.07 ± 25.185

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36

End point description

FACIT-F:13-item questionnaire, each item scaled on 0(not at all) to 4(very much).3 endpoints derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing usual activities,frustrated by being too tired to do things wanted to do,had to limit social activity because tired);3)change in FACIT-F total score(0-52)= Summing 13 items,higher score indicated lower level of fatigue, better subject status.All responses added with equal weight to get total score.FAS.n=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	7.0 ± 9.78
Change at Month 6 (n =636)	7.7 ± 10.13
Change at Month 12 (n =582)	7.8 ± 9.70
Change at Month 18 (n =536)	8.1 ± 10.06
Change at Month 24 (n =506)	8.3 ± 10.61
Change at Month 30 (n =474)	8.7 ± 10.93
Change at Month 36 (n =386)	9.1 ± 11.05

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36

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End point title

Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36

End point description

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =674)	3.1 ± 4.47
Change at Month 6 (n =636)	3.4 ± 4.61
Change at Month 12 (n =582)	3.5 ± 4.48
Change at Month 18 (n =536)	3.6 ± 4.63
Change at Month 24 (n =506)	3.7 ± 4.93
Change at Month 30 (n =474)	3.9 ± 5.02
Change at Month 36 (n =386)	4.0 ± 4.90

No statistical analyses for this end point

Secondary: Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Top of page

End point title

Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

End point description

FACIT-F:13-item questionnaire, each item scaled on 0(not at all) to 4(very much).3 endpoints derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing usual activities,frustrated by being too tired to do things wanted to do,had to limit social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue,better subject status)=summing 13 items,all responses added with equal weight to get total score.FAS. n=subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

End point values	Tofacitinib
Number of subjects analysed	686
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n= 674)	3.9 ± 5.98
Change at Month 6 (n= 636)	4.2 ± 6.19
Change at Month 12 (n= 582)	4.4 ± 5.88
Change at Month 18 (n= 536)	4.5 ± 6.05
Change at Month 24 (n= 506)	4.6 ± 6.34
Change at Month 30 (n= 474)	4.8 ± 6.46
Change at Month 36 (n= 386)	5.0 ± 6.77

No statistical analyses for this end point

Secondary: Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12

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End point title

Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12

End point description

HAQ-DI assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicate more difficulty while performing daily living activities. FAS for sub-study included all subjects who were randomized to the sub-study and received at least 1 dose of (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.0164 ± 0.02438	0.0322 ± 0.02411
Change at Month 3	0.0057 ± 0.02512	0.0381 ± 0.02474
Change at Month 9	0.0720 ± 0.03195	0.0663 ± 0.03125
Change at Month 12	0.0467 ± 0.02998	0.0563 ± 0.02941

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

0.0486

Confidence interval

level

95%

sides

2-sided

lower limit

-0.0192

upper limit

0.1163

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

0.0325

Confidence interval

level

95%

sides

2-sided

lower limit

-0.0372

upper limit

0.1021

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

-0.0058

Confidence interval

level

95%

sides

2-sided

lower limit

-0.0941

upper limit

0.0825

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

0.0096

Confidence interval

level

95%

sides

2-sided

lower limit

-0.0734

upper limit

0.0927

Secondary: Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12

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End point title

Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12

End point description

PASDAS was composite PsA disease activity score that included following components:Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in mm, swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), SF-36 physical component summary (norm-based domain score were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and RP in mg/L. PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease. FAS of sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.000 ± 0.0701	0.032 ± 0.0696
Change at Month 3	0.188 ± 0.0869	0.165 ± 0.0868
Change at Month 9	0.158 ± 0.0934	0.371 ± 0.0912
Change at Month 12	0.194 ± 0.0898	0.133 ± 0.0882

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

0.032

Confidence interval

level

95%

sides

2-sided

lower limit

-0.163

upper limit

0.227

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

-0.024

Confidence interval

level

95%

sides

2-sided

lower limit

-0.266

upper limit

0.219

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

0.213

Confidence interval

level

95%

sides

2-sided

lower limit

-0.045

upper limit

0.47

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS Mean Difference

Point estimate

-0.061

Confidence interval

level

95%

sides

2-sided

lower limit

-0.309

upper limit

0.188

Secondary: Sub-study: Percentage of Subjects Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12

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End point title

Sub-study: Percentage of Subjects Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12

End point description

PsARC was comprised of 4 clinical improvement criteria: >=20% improvement in PhyGA, >=20% improvement in PtGA; and >=30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: subject assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged subjects' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the subject must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: percentage of subjects
number (not applicable)
Month 1	12.36	12.22
Month 3	11.24	6.67
Month 6	12.36	6.67
Month 9	12.36	10.00
Month 12	13.48	3.33

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

-0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9.76

upper limit

9.48

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

Method

Parameter type

Difference in percentage of subjects

Point estimate

-4.57

Confidence interval

level

95%

sides

2-sided

lower limit

-12.91

upper limit

3.77

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

-5.69

Confidence interval

level

95%

sides

2-sided

lower limit

-14.26

upper limit

2.87

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

-2.36

Confidence interval

level

95%

sides

2-sided

lower limit

-11.59

upper limit

6.87

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

-10.15

Confidence interval

level

95%

sides

2-sided

lower limit

-18.16

upper limit

-2.14

Secondary: Sub-study: Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Score (For Subjects With Baseline PGA-PsO Score >0) at Months 1, 3, 6, 9 and 12

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End point title

Sub-study: Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Score (For Subjects With Baseline PGA-PsO Score >0) at Months 1, 3, 6, 9 and 12

End point description

The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe). Analysis population included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline PGA-PsO score >0.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	41	33
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.1 ± 0.10	0.2 ± 0.11
Change at Month 3	-0.1 ± 0.12	0.1 ± 0.14
Change at Month 6	-0.1 ± 0.11	0.2 ± 0.12
Change at Month 9	-0.3 ± 0.13	0.2 ± 0.13
Change at Month 12	0.0 ± 0.15	0.3 ± 0.15

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.5

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.8

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.7

Secondary: Sub-study: Percent Change from Baseline in Body Surface Area (BSA) (For Subjects With BSA >0%) With Psoriasis at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Percent Change from Baseline in Body Surface Area (BSA) (For Subjects With BSA >0%) With Psoriasis at Months 1, 3, 6, 9 and 12

End point description

Assessment of BSA with psoriasis was estimated by means of handprint method, where full palmar hand of subject (fully extended palm, fingers and thumb together) represented approximately 1% of total BSA. Body regions are assigned specific number of handprints with percentage (Head and neck = 10 handprints [1 handprint =10%], upper extremities = 20 handprints [1 handprint =5%], Trunk (including axillae and groin) = 30 handprints [1 handprint =3.33%], lower extremities (including buttocks) = 40 handprints [1 handprint =2.5%]. Number of handprints of psoriatic skin in a body region was used to determine extent (%) to which a body region was involved with psoriasis. Total BSA affected was summation of individual regions affected. Analysis population included all subjects who were randomized to sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline body surface Area >0. “n’’ =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	47	42
Units: percent change
least squares mean (standard error)
At Month 1 (n =44, 42)	28.47 ± 13.497	9.04 ± 13.972
At Month 3 (n =44, 41)	43.58 ± 18.679	13.47 ± 19.348
At Month 6 (n =42, 41)	41.51 ± 20.745	17.19 ± 21.157
At Month 9 (n =40, 40)	35.36 ± 17.309	23.72 ± 17.691
At Month 12 (n =39, 38)	34.74 ± 19.909	41.75 ± 20.333

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-19.43

Confidence interval

level

95%

sides

2-sided

lower limit

-58.06

upper limit

19.21

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-30.11

Confidence interval

level

95%

sides

2-sided

lower limit

-83.58

upper limit

23.37

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-24.33

Confidence interval

level

95%

sides

2-sided

lower limit

-83.35

upper limit

34.69

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-11.64

Confidence interval

level

95%

sides

2-sided

lower limit

-60.87

upper limit

37.58

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

7.02

Confidence interval

level

95%

sides

2-sided

lower limit

-49.73

upper limit

63.77

Secondary: Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Subjects with Baseline DSS >0) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Subjects with Baseline DSS >0) at Months 1, 3, 6, 9 and 12

End point description

Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a subject was 0-60. Higher score indicated greater degree of tenderness. Analysis population included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline DSS >0. 99999 =SD could not be estimated because only 1 subjects was analyzed. “n’’ =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	7	1
Units: units on a scale
arithmetic mean (standard deviation)
Change at Month 1 (n =7, 1)	-0.4 ± 0.79	0.0 ± 99999
Change at Month 3 (n =6, 1)	-0.3 ± 0.52	-1.0 ± 99999
Change at Month 6 (n =6, 1)	-0.3 ± 0.52	-1.0 ± 99999
Change at Month 9 (n =6, 1)	-0.3 ± 0.52	-1.0 ± 99999
Change at Month 12(n =6, 1)	-0.3 ± 0.52	-1.0 ± 99999

No statistical analyses for this end point

Secondary: Sub-study: Percentage of Subjects with Absence of Dactylitis (For Subjects With Baseline DSS >0) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Percentage of Subjects with Absence of Dactylitis (For Subjects With Baseline DSS >0) at Months 1, 3, 6, 9 and 12

End point description

End point type

Secondary

End point timeframe

Sub-study: Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	7	1
Units: percentage of subjects
number (not applicable)
Month 1	14.29	0.0
Month 3	14.29	0.0
Month 6	14.29	0.0
Month 9	14.29	0.0
Month 12	14.29	0.0

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

6.25

Confidence interval

level

95%

sides

2-sided

lower limit

-59.58

upper limit

72.08

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

6.25

Confidence interval

level

95%

sides

2-sided

lower limit

-59.58

upper limit

72.08

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

6.25

Confidence interval

level

95%

sides

2-sided

lower limit

-59.58

upper limit

72.08

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

6.25

Confidence interval

level

95%

sides

2-sided

lower limit

-59.58

upper limit

72.08

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

6.25

Confidence interval

level

95%

sides

2-sided

lower limit

-59.58

upper limit

72.08

Secondary: Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Subjects with Baseline LEI >0) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Subjects with Baseline LEI >0) at Months 1, 3, 6, 9 and 12

End point description

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis. Analysis population included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline Leeds enthesitis index >0. “n’’ =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	15	16
Units: units on a scale
least squares mean (standard error)
Change at Month 1 (n =15, 16)	-0.2 ± 0.25	-0.4 ± 0.24
Change at Month 3 (n =15, 15)	-0.3 ± 0.23	-0.5 ± 0.23
Change at Month 6 (n =15, 16)	-0.5 ± 0.29	-0.7 ± 0.28
Change at Month 9 (n =15, 16)	-0.3 ± 0.29	0.0 ± 0.28
Change at Month 12 (n =15, 15)	-0.5 ± 0.28	-0.3 ± 0.27

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.5

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.5

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

0.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

1.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

Secondary: Sub-study: Leeds Enthesitis Index (LEI) (For Subjects with Baseline LEI =0) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Leeds Enthesitis Index (LEI) (For Subjects with Baseline LEI =0) at Months 1, 3, 6, 9 and 12

End point description

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis. Analysis population included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline LEI =0. “n’’ =subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Sub-study: Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	74	74
Units: units on a scale
arithmetic mean (standard deviation)
Month 1 (n =72, 73)	0.2 ± 0.64	0.1 ± 0.58
Month 3 (n =71, 72)	0.2 ± 0.56	0.0 ± 0.24
Month 6 (n =69, 72)	0.2 ± 0.76	0.2 ± 0.82
Month 9 (n =68, 71)	0.1 ± 0.24	0.1 ± 0.46
Month 12 (n = 68, 70)	0.2 ± 0.67	0.1 ± 0.49

No statistical analyses for this end point

Secondary: Sub-study: Percentage of Subjects With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Subjects with Baseline LEI >0) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Percentage of Subjects With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Subjects with Baseline LEI >0) at Months 1, 3, 6, 9 and 12

End point description

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis. Analysis population included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline LEI >0.

End point type

Secondary

End point timeframe

Sub-study: Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	15	16
Units: percentage of subjects
number (not applicable)
Month 1	13.33	25.00
Month 3	13.33	43.75
Month 6	26.67	56.25
Month 9	13.33	37.50
Month 12	26.67	43.75

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

11.67

Confidence interval

level

95%

sides

2-sided

lower limit

-15.65

upper limit

38.98

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

30.42

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

60.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

29.58

Confidence interval

level

95%

sides

2-sided

lower limit

-3.46

upper limit

62.62

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

24.17

Confidence interval

level

95%

sides

2-sided

lower limit

-5.14

upper limit

53.47

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

17.08

Confidence interval

level

95%

sides

2-sided

lower limit

-15.96

upper limit

50.12

Secondary: Sub-study: Percentage of Subjects With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Percentage of Subjects With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12

End point description

A psoriatic arthritis subject was considered with MDA if subject had >= 5 of 7 criteria: 1) tender/painful joint count <=1; (2) swollen joint count <=1; (3) BSA <=3%; (4) Patient Assessment of Arthritis Pain (VAS) <=15 mm; (5) PtGA (VAS) <=20 mm; (6) HAQ-DI score <=0.5; (7) tender entheseal points (using LEI) <=1. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: Percentage of subjects
number (not applicable)
Month 1	50.56	55.56
Month 3	50.56	54.44
Month 6	46.07	48.89
Month 9	42.70	46.67
Month 12	41.57	44.44

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

4.99

Confidence interval

level

95%

sides

2-sided

lower limit

-9.61

upper limit

19.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

3.88

Confidence interval

level

95%

sides

2-sided

lower limit

-10.74

upper limit

18.5

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

2.82

Confidence interval

level

95%

sides

2-sided

lower limit

-11.8

upper limit

17.45

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

3.97

Confidence interval

level

95%

sides

2-sided

lower limit

-10.58

upper limit

18.52

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in percentage of subjects

Point estimate

2.87

Confidence interval

level

95%

sides

2-sided

lower limit

-11.63

upper limit

17.37

Secondary: Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12

End point description

68 joints were assessed to determine joints that are considered tender or painful. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints). The 68 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V). FAS for sub-study was analyzed.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: tender/painful joints
least squares mean (standard error)
Change at Month 1	0.7 ± 0.37	0.3 ± 0.37
Change at Month 3	1.3 ± 0.44	0.9 ± 0.44
Change at Month 6	0.5 ± 0.37	0.5 ± 0.37
Change at Month 9	0.4 ± 0.33	0.4 ± 0.32
Change at Month 12	0.3 ± 0.32	0.5 ± 0.32

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

0.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

0.8

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.9

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

1.1

Secondary: Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12

End point description

Joints were assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Sixty-six (66) joints were assessed for swelling. The 66 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V). FAS for sub-study was analyzed.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: swollen joints
least squares mean (standard error)
Change at Month 1	-0.1 ± 0.14	99999 ± 0.14
Change at Month 3	0.3 ± 0.21	0.3 ± 0.21
Change at Month 6	0.1 ± 0.16	0.1 ± 0.15
Change at Month 9	0.0 ± 0.17	0.2 ± 0.17
Change at Month 12	0.1 ± 0.14	0.0 ± 0.14

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

0.5

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

0.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

0.5

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

0.7

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

0.3

Secondary: Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12

End point description

The investigator or qualified assessor assessed how the subject’s overall arthritis appeared at the time of the visit. This was an evaluation based on the subject’s disease signs, functional capacity and physical examination, and independent of the PtGA and Patient Assessment of Arthritis Pain. The investigator’s response was recorded using a 100 mm VAS where 0 =PSA not active at all and 100 =PSA extremely active. Higher score indicated more PSA. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: millimeter
least squares mean (standard error)
Change at Month 1	-0.42 ± 0.992	-0.17 ± 0.981
Change at Month 3	1.98 ± 1.225	2.76 ± 1.216
Change at Month 6	1.18 ± 0.983	1.65 ± 0.966
Change at Month 9	1.18 ± 1.316	3.35 ± 1.287
Change at Month 12	0.86 ± 1.127	0.75 ± 1.111

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.26

Confidence interval

level

95%

sides

2-sided

lower limit

-2.51

upper limit

3.02

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-2.64

upper limit

4.18

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-2.26

upper limit

3.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

2.18

Confidence interval

level

95%

sides

2-sided

lower limit

-1.46

upper limit

5.81

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-3.25

upper limit

3.01

Secondary: Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12

End point description

Subjects answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Subject’s response were recorded using a 0 - 100 mm VAS where 0 =not affected at all and 100 =extremely affected. Higher score indicated worse condition due to PSA.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: millimeter
least squares mean (standard error)
Change at Month 1	1.35 ± 1.277	-0.68 ± 1.264
Change at Month 3	2.11 ± 1.537	1.68 ± 1.516
Change at Month	3.17 ± 1.725	4.45 ± 1.690
Change at Month 9	2.63 ± 1.691	3.27 ± 1.655
Change at Month 12	2.77 ± 1.629	2.65 ± 1.602

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-2.03

Confidence interval

level

95%

sides

2-sided

lower limit

-5.58

upper limit

1.52

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-4.69

upper limit

3.84

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

1.29

Confidence interval

level

95%

sides

2-sided

lower limit

-3.48

upper limit

6.06

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.64

Confidence interval

level

95%

sides

2-sided

lower limit

-4.03

upper limit

5.32

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-4.64

upper limit

4.38

Secondary: Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12

End point description

Subjects assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. Higher scores indicated more severe pain. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo). Higher scores indicated more severe pain.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: millimeter
least squares mean (standard error)
Change at Month 1	-0.05 ± 1.383	-1.16 ± 1.370
Change at Month 3	1.59 ± 1.394	0.36 ± 1.380
Change at Month 6	3.12 ± 1.709	4.07 ± 1.674
Change at Month 9	2.44 ± 1.780	4.45 ± 1.741
Change at Month 12	2.69 ± 1.692	3.35 ± 1.664

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.11

Confidence interval

level

95%

sides

2-sided

lower limit

-4.96

upper limit

2.74

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.23

Confidence interval

level

95%

sides

2-sided

lower limit

-5.11

upper limit

2.65

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.95

Confidence interval

level

95%

sides

2-sided

lower limit

-3.78

upper limit

5.69

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

2.01

Confidence interval

level

95%

sides

2-sided

lower limit

-2.92

upper limit

6.93

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.66

Confidence interval

level

95%

sides

2-sided

lower limit

-4.03

upper limit

5.35

Secondary: Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12

End point description

The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: mg/L
least squares mean (standard error)
Change at Month 1	-0.1171 ± 0.71654	-0.2706 ± 0.70892
Change at Month 3	-0.3625 ± 0.48088	-0.9285 ± 0.47675
Change at Month 6	0.5354 ± 0.79954	-0.2637 ± 0.78002
Change at Month 9	-0.3217 ± 0.59271	-0.2591 ± 0.57983
Change at Month 12	-0.1005 ± 0.78650	0.2667 ± 0.77230

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.1535

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1444

upper limit

1.8374

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.566

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9054

upper limit

0.7735

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.7991

Confidence interval

level

95%

sides

2-sided

lower limit

-3.0053

upper limit

1.4071

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.0626

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5767

upper limit

1.7018

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.3672

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8107

upper limit

2.545

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status. FAS of main study included all enrolled subjects who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.55 ± 0.424	-0.22 ± 0.419
Change at Month 3	-0.90 ± 0.492	-0.57 ± 0.487
Change at Month 6	-0.65 ± 0.480	-1.42 ± 0.466
Change at Month 9	-1.09 ± 0.607	-1.85 ± 0.593
Change at Month 12	-1.52 ± 0.533	-1.00 ± 0.523

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-0.85

upper limit

1.51

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-1.04

upper limit

1.69

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-2.09

upper limit

0.55

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-2.44

upper limit

0.91

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

-0.96

upper limit

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.35 ± 0.630	-0.11 ± 0.622
Change at Month 3	0.09 ± 0.642	-0.77 ± 0.634
Change at Month 6	-0.23 ± 0.733	-0.89 ± 0.713
Change at Month 9	-0.71 ± 0.749	0.06 ± 0.731
Change at Month 12	-0.38 ± 0.694	-0.47 ± 0.681

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-2.22

upper limit

1.29

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.86

Confidence interval

level

95%

sides

2-sided

lower limit

-2.65

upper limit

0.92

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.66

Confidence interval

level

95%

sides

2-sided

lower limit

-2.68

upper limit

1.36

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

-1.31

upper limit

2.83

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-2.01

upper limit

1.84

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12

End point description

SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.37 ± 0.472	-0.15 ± 0.467
Change at Month 3	-0.50 ± 0.562	-0.33 ± 0.556
Change at Month 6	-0.27 ± 0.586	-0.80 ± 0.571
Change at Month 9	-1.43 ± 0.657	-1.11 ± 0.643
Change at Month 12	-1.01 ± 0.676	-1.02 ± 0.664

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-1.09

upper limit

1.53

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-1.39

upper limit

1.73

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.53

Confidence interval

level

95%

sides

2-sided

lower limit

-2.15

upper limit

1.08

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.32

Confidence interval

level

95%

sides

2-sided

lower limit

-1.49

upper limit

2.13

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-1.89

upper limit

1.86

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 3, 6, 9 and 12

End point description

SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.27 ± 0.561	0.22 ± 0.555
Change at Month 3	-1.04 ± 0.626	0.21 ± 0.619
Change at Month 6	-1.57 ± 0.585	-0.87 ± 0.569
Change at Month 9	-0.64 ± 0.638	-0.44 ± 0.624
Change at Month 12	-1.85 ± 0.646	-0.12 ± 0.635

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.48

Confidence interval

level

95%

sides

2-sided

lower limit

-1.08

upper limit

2.05

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

1.25

Confidence interval

level

95%

sides

2-sided

lower limit

-0.49

upper limit

2.99

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.91

upper limit

2.31

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.57

upper limit

1.96

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

1.73

Confidence interval

level

95%

sides

2-sided

lower limit

-0.06

upper limit

3.52

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.77 ± 0.617	-0.06 ± 0.609
Change at Month 3	-1.59 ± 0.661	-1.24 ± 0.652
Change at Month 6	-0.61 ± 0.686	-2.42 ± 0.669
Change at Month 9	-1.29 ± 0.808	-3.05 ± 0.790
Change at Month 12	-1.69 ± 0.719	-1.99 ± 0.706

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.71

Confidence interval

level

95%

sides

2-sided

lower limit

-1.01

upper limit

2.42

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.34

Confidence interval

level

95%

sides

2-sided

lower limit

-1.49

upper limit

2.18

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.81

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

0.09

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.76

Confidence interval

level

95%

sides

2-sided

lower limit

-3.99

upper limit

0.48

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

1.69

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.20 ± 0.492	-0.48 ± 0.487
Change at Month 3	0.34 ± 0.516	-0.79 ± 0.511
Change at Month 6	0.24 ± 0.493	-0.57 ± 0.481
Change at Month 9	-0.48 ± 0.562	-0.46 ± 0.551
Change at Month 12	-0.32 ± 0.539	-0.29 ± 0.530

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.68

Confidence interval

level

95%

sides

2-sided

lower limit

-2.05

upper limit

0.69

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.13

Confidence interval

level

95%

sides

2-sided

lower limit

-2.57

upper limit

0.31

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.81

Confidence interval

level

95%

sides

2-sided

lower limit

-2.17

upper limit

0.56

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-1.54

upper limit

1.57

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-1.46

upper limit

1.53

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represented better vitality. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.04 ± 0.614	-0.39 ± 0.607
Change at Month 3	-0.26 ± 0.593	-1.12 ± 0.586
Change at Month 6	0.01 ± 0.705	-1.70 ± 0.687
Change at Month 9	-0.80 ± 0.645	-1.27 ± 0.632
Change at Month 12	-1.04 ± 0.640	-0.09 ± 0.629

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.36

Confidence interval

level

95%

sides

2-sided

lower limit

-2.06

upper limit

1.35

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.86

Confidence interval

level

95%

sides

2-sided

lower limit

-2.51

upper limit

0.79

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.71

Confidence interval

level

95%

sides

2-sided

lower limit

-3.66

upper limit

0.23

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-2.25

upper limit

1.32

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.95

Confidence interval

level

95%

sides

2-sided

lower limit

-0.82

upper limit

2.73

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.99 ± 0.734	-0.22 ± 0.726
Change at Month 3	-0.80 ± 0.750	-1.18 ± 0.740
Change at Month 6	-1.16 ± 0.776	-1.74 ± 0.757
Change at Month 9	-1.50 ± 0.753	-1.22 ± 0.737
Change at Month 12	-1.81 ± 0.758	-1.28 ± 0.746

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.78

Confidence interval

level

95%

sides

2-sided

lower limit

-1.27

upper limit

2.82

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.38

Confidence interval

level

95%

sides

2-sided

lower limit

-2.46

upper limit

1.71

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.57

Confidence interval

level

95%

sides

2-sided

lower limit

-2.72

upper limit

1.57

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-1.81

upper limit

2.36

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

-1.58

upper limit

2.63

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	1.14 ± 0.716	-0.53 ± 0.707
Change at Month 3	0.24 ± 0.807	-0.38 ± 0.797
Change at Month 6	-0.72 ± 0.788	-0.82 ± 0.769
Change at Month 9	-0.78 ± 0.803	-0.06 ± 0.782
Change at Month 12	-0.33 ± 0.835	-1.11 ± 0.820

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.67

Confidence interval

level

95%

sides

2-sided

lower limit

-3.67

upper limit

0.32

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.61

Confidence interval

level

95%

sides

2-sided

lower limit

-2.86

upper limit

1.63

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-2.27

upper limit

2.09

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.73

Confidence interval

level

95%

sides

2-sided

lower limit

-1.49

upper limit

2.95

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.79

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

1.53

Secondary: Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12

End point description

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.30 ± 0.676	0.63 ± 0.669
Change at Month 3	-0.42 ± 0.661	-0.31 ± 0.653
Change at Month 6	-0.01 ± 0.780	-0.26 ± 0.762
Change at Month 9	-0.72 ± 0.724	0.35 ± 0.710
Change at Month 12	-0.37 ± 0.723	0.01 ± 0.711

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

-0.95

upper limit

2.81

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-1.72

upper limit

1.95

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

1.9

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

1.07

Confidence interval

level

95%

sides

2-sided

lower limit

-0.93

upper limit

3.07

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.38

Confidence interval

level

95%

sides

2-sided

lower limit

-1.62

upper limit

2.38

Secondary: Sub-study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12

End point description

FACIT-F:13-item questionnaire,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better subject status. All responses were added with equal weight to get total score. FAS of sub-study.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-1.9 ± 0.61	-1.1 ± 0.61
Change at Month 3	-1.8 ± 0.59	-1.3 ± 0.58
Change at Month 6	-1.3 ± 0.61	-2.0 ± 0.60
Change at Month 9	-2.1 ± 0.65	-1.0 ± 0.64
Change at Month 12	-1.4 ± 0.66	-0.7 ± 0.64

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

2.5

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

2.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

2.9

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

2.6

Secondary: Sub-study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12

End point description

FACIT-F:13-item questionnaire, with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better subject status):calculated by summing 13 items,all responses were added with equal weight to get total score.FAS of sub-study was analyzed.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-0.9 ± 0.29	-0.5 ± 0.29
Change at Month 3	-0.8 ± 0.31	-0.9 ± 0.30
Change at Month 6	-0.5 ± 0.29	-1.3 ± 0.28
Change at Month 9	-0.7 ± 0.31	-0.8 ± 0.30
Change at Month 12	-0.5 ± 0.31	-0.5 ± 0.31

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

1.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

0.7

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.8

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.8

Secondary: Sub-study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12

End point description

FACIT-F:13-item questionnaire, with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better subject status):calculated by summing 13 items,all responses were added with equal weight to get total score.FAS of sub-study was analyzed.

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	-1.1 ± 0.39	-0.6 ± 0.39
Change at Month 3	-1.1 ± 0.35	-0.4 ± 0.35
Change at Month 6	-0.8 ± 0.41	-0.7 ± 0.40
Change at Month 9	-1.4 ± 0.42	-0.2 ± 0.41
Change at Month 12	-0.9 ± 0.40	-0.1 ± 0.40

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

1.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

1.7

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

1.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

2.3

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

1.9

Secondary: Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this measure. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.0 ± 0.04	0.0 ± 0.04
Change at Month 3	0.0 ± 0.04	0.0 ± 0.04
Change at Month 6	0.0 ± 0.04	0.1 ± 0.04
Change at Month 9	0.0 ± 0.04	0.1 ± 0.04
Change at Month 12	0.0 ± 0.04	0.1 ± 0.04

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.2

Secondary: Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.0 ± 0.03	0.0 ± 0.03
Change at Month 3	0.0 ± 0.03	0.0 ± 0.03
Change at Month 6	0.0 ± 0.04	0.0 ± 0.03
Change at Month 9	0.0 ± 0.04	0.0 ± 0.04
Change at Month 12	0.0 ± 0.04	0.1 ± 0.04

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.1

Secondary: Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.0 ± 0.04	0.0 ± 0.04
Change at Month 3	0.0 ± 0.04	0.0 ± 0.04
Change at Month 6	0.0 ± 0.04	0.1 ± 0.04
Change at Month 9	0.1 ± 0.04	0.1 ± 0.04
Change at Month 12	0.0 ± 0.04	0.0 ± 0.04

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Secondary: Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 3, 6, 9 and 12

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.1 ± 0.04	0.0 ± 0.04
Change at Month 3	0.1 ± 0.04	0.1 ± 0.04
Change at Month 6	0.1 ± 0.04	0.1 ± 0.04
Change at Month 9	0.1 ± 0.05	0.1 ± 0.05
Change at Month 12	0.1 ± 0.05	0.2 ± 0.05

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Secondary: Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12

End point description

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this endpoint. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: units on a scale
least squares mean (standard error)
Change at Month 1	0.1 ± 0.04	0.0 ± 0.04
Change at Month 3	0.0 ± 0.05	0.0 ± 0.04
Change at Month 6	0.1 ± 0.05	0.0 ± 0.05
Change at Month 9	0.1 ± 0.05	0.0 ± 0.05
Change at Month 12	0.1 ± 0.05	0.0 ± 0.05

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.1

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

Secondary: Sub-study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12

Top of page

End point title

Sub-study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12

End point description

The EQ VAS recorded the subject's self-rated health on a vertical VAS as standard verticle 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state. FAS for sub-study included all subjects who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

End point type

Secondary

End point timeframe

Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

End point values	Tofacitinib 5 mg BID + Methotrexate (MTX)	Tofacitinib 5 mg BID + Placebo
Number of subjects analysed	89	90
Units: millimeter
least squares mean (standard error)
Change at Month 1	2.0 ± 1.19	-0.9 ± 1.16
Change at Month 3	0.5 ± 1.54	-1.1 ± 1.52
Change at Month 6	4.4 ± 1.41	-1.9 ± 1.38
Change at Month 9	2.5 ± 1.59	-0.4 ± 1.56
Change at Month 12	3.0 ± 1.82	-1.9 ± 1.78

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.2

upper limit

0.4

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-5.8

upper limit

2.7

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-6.3

Confidence interval

level

95%

sides

2-sided

lower limit

-10.2

upper limit

-2.4

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-7.3

upper limit

1.6

Tofa 5 mg BID + Placebo vs Tofa 5 mg BID + MTX

Statistical analysis description

Comparison groups

Tofacitinib 5 mg BID + Methotrexate (MTX) v Tofacitinib 5 mg BID + Placebo

Number of subjects included in analysis

179

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-4.9

Confidence interval

level

95%

sides

2-sided

lower limit

-9.9

upper limit

0.2

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study

Adverse event reporting additional description

As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group in main study. For main study, analysis of safety data included cumulative data from main and sub-study as single group. Safety data collected in sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

22.0

Reporting group title

All Tofacitinib

Reporting group description

Main Study: Subjects with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Subjects from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.

Reporting group title

Tofacitinib 5 mg BID + Placebo

Reporting group description

Subjects from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.

Reporting group title

Tofacitinib 5 mg BID + Methotrexate (MTX)

Reporting group description

Subjects from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.

Serious adverse events	All Tofacitinib	Tofacitinib 5 mg BID + Placebo	Tofacitinib 5 mg BID + Methotrexate (MTX)
Total subjects affected by serious adverse events
subjects affected / exposed	115 / 686 (16.76%)	4 / 90 (4.44%)	3 / 89 (3.37%)
number of deaths (all causes)	6	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	1 / 686 (0.15%)	1 / 90 (1.11%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic myelomonocytic leukaemia
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Medullary thyroid cancer
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid neoplasm
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleomorphic adenoma
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post thrombotic syndrome
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion missed
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nodule
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Hypersensitivity
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Social circumstances
Miscarriage of partner
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast disorder female
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endometriosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Apnoea
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meconium aspiration syndrome
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Bipolar I disorder
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Product issues
Device loosening
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Heart rate decreased
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cartilage injury
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chemical poisoning
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Contusion
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint injury
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ligament injury
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 686 (0.15%)	1 / 90 (1.11%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	3 / 686 (0.44%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiovascular insufficiency
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prinzmetal angina
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Carotid artery stenosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 686 (0.15%)	1 / 90 (1.11%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Lymphadenitis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness neurosensory
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Chorioretinopathy
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Crohn’s disease
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	1 / 89 (1.12%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incarcerated umbilical hernia
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Melaena
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	1 / 89 (1.12%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Renal colic
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthritis
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	4 / 686 (0.58%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint swelling
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	7 / 686 (1.02%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	1 / 686 (0.15%)	1 / 90 (1.11%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertebral lateral recess stenosis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	1 / 89 (1.12%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epiglottitis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HIV infection
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neurosyphilis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 686 (0.29%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyoderma
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Serratia sepsis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia herpes viral
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	1 / 89 (1.12%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Cardiometabolic syndrome
subjects affected / exposed	1 / 686 (0.15%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	All Tofacitinib	Tofacitinib 5 mg BID + Placebo	Tofacitinib 5 mg BID + Methotrexate (MTX)
Total subjects affected by non serious adverse events
subjects affected / exposed	457 / 686 (66.62%)	24 / 90 (26.67%)	25 / 89 (28.09%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	34 / 686 (4.96%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	45	0	0
Aspartate aminotransferase increased
subjects affected / exposed	21 / 686 (3.06%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	23	0	0
Blood creatine phosphokinase increased
subjects affected / exposed	36 / 686 (5.25%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	44	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	22 / 686 (3.21%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	28	0	0
Hepatic enzyme increased
subjects affected / exposed	15 / 686 (2.19%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	19	0	0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	24 / 686 (3.50%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	24	0	0
Vascular disorders
Hypertension
subjects affected / exposed	50 / 686 (7.29%)	2 / 90 (2.22%)	2 / 89 (2.25%)
occurrences all number	52	2	2
Nervous system disorders
Dizziness
subjects affected / exposed	20 / 686 (2.92%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	22	0	0
Headache
subjects affected / exposed	32 / 686 (4.66%)	0 / 90 (0.00%)	2 / 89 (2.25%)
occurrences all number	45	0	2
Sciatica
subjects affected / exposed	19 / 686 (2.77%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	24	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	15 / 686 (2.19%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	15	0	0
General disorders and administration site conditions
Oedema peripheral
subjects affected / exposed	14 / 686 (2.04%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	14	0	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	25 / 686 (3.64%)	3 / 90 (3.33%)	0 / 89 (0.00%)
occurrences all number	35	4	0
Abdominal pain upper
subjects affected / exposed	17 / 686 (2.48%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	19	0	0
Dyspepsia
subjects affected / exposed	15 / 686 (2.19%)	0 / 90 (0.00%)	2 / 89 (2.25%)
occurrences all number	17	0	2
Nausea
subjects affected / exposed	27 / 686 (3.94%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	32	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	17 / 686 (2.48%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	22	0	0
Oropharyngeal pain
subjects affected / exposed	14 / 686 (2.04%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	16	0	0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	32 / 686 (4.66%)	1 / 90 (1.11%)	2 / 89 (2.25%)
occurrences all number	40	1	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	32 / 686 (4.66%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	44	0	0
Back pain
subjects affected / exposed	31 / 686 (4.52%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	39	0	0
Psoriatic arthropathy
subjects affected / exposed	44 / 686 (6.41%)	0 / 90 (0.00%)	3 / 89 (3.37%)
occurrences all number	51	0	3
Intervertebral disc disorder
subjects affected / exposed	0 / 686 (0.00%)	2 / 90 (2.22%)	0 / 89 (0.00%)
occurrences all number	0	2	0
Osteoporosis
subjects affected / exposed	0 / 686 (0.00%)	2 / 90 (2.22%)	0 / 89 (0.00%)
occurrences all number	0	2	0
Infections and infestations
Bronchitis
subjects affected / exposed	67 / 686 (9.77%)	3 / 90 (3.33%)	2 / 89 (2.25%)
occurrences all number	84	3	3
Gastroenteritis
subjects affected / exposed	19 / 686 (2.77%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	25	0	0
Nasopharyngitis
subjects affected / exposed	104 / 686 (15.16%)	3 / 90 (3.33%)	1 / 89 (1.12%)
occurrences all number	172	4	2
Pharyngitis
subjects affected / exposed	38 / 686 (5.54%)	3 / 90 (3.33%)	3 / 89 (3.37%)
occurrences all number	48	3	3
Respiratory tract infection
subjects affected / exposed	17 / 686 (2.48%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	32	0	0
Sinusitis
subjects affected / exposed	33 / 686 (4.81%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	44	0	0
Upper respiratory tract infection
subjects affected / exposed	124 / 686 (18.08%)	4 / 90 (4.44%)	6 / 89 (6.74%)
occurrences all number	190	4	6
Urinary tract infection
subjects affected / exposed	66 / 686 (9.62%)	4 / 90 (4.44%)	3 / 89 (3.37%)
occurrences all number	92	5	5
Herpes zoster
subjects affected / exposed	26 / 686 (3.79%)	1 / 90 (1.11%)	2 / 89 (2.25%)
occurrences all number	27	1	2
Influenza
subjects affected / exposed	19 / 686 (2.77%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	23	0	0
Oral herpes
subjects affected / exposed	19 / 686 (2.77%)	1 / 90 (1.11%)	2 / 89 (2.25%)
occurrences all number	37	2	4
Metabolism and nutrition disorders
Hypercholesterolaemia
subjects affected / exposed	14 / 686 (2.04%)	0 / 90 (0.00%)	0 / 89 (0.00%)
occurrences all number	14	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

12 Apr 2017

Protocol Summary updated to reflect new sub-study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Long-term, Open-Label Extension Study of Tofacitinib (CP-690,550) for the Treatment of Psoriatic Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary: Percentage of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary: Number of Adverse Events (AEs) by Severity

Primary: Number of Adverse Events (AEs) by Severity

Primary: Number of Subjects With Abnormal Clinical Laboratory Values

Primary: Number of Subjects With Abnormal Clinical Laboratory Values

Primary: Number of Subjects With Clinically Significant Change from Baseline in Clinical Laboratory Values

Primary: Number of Subjects With Clinically Significant Change from Baseline in Clinical Laboratory Values

Primary: Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6

Primary: Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6

Primary: Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6

Primary: Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 70% (ACR70) Response

Secondary: Main Study: Percentage of Subjects Achieving an American College of Rheumatology 70% (ACR70) Response

Secondary: Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Percentage of Subjects Achieving Psoriatic Arthritis Response Criteria (PsARC)

Secondary: Main Study: Percentage of Subjects Achieving Psoriatic Arthritis Response Criteria (PsARC)

Secondary: Main Study: Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Score (For Subjects with Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Score (For Subjects with Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Subjects With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Subjects With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Percent Change From Baseline in PASI Composite Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Percent Change From Baseline in PASI Composite Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Subjects With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Subjects With Baseline DSS greater than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Subjects With Baseline DSS greater than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Subjects With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Subjects With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Subjects with baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Subjects with baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects with Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects with Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Subjects With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36

Secondary: Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36

Secondary: Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36

Clinical Trial Results:
A Long-term, Open-Label Extension Study of Tofacitinib (CP-690,550) for the Treatment of Psoriatic Arthritis