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Clinical Trial Results:
A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

Summary
EudraCT number	2010-020002-15
Trial protocol	CZ DE GB NL FI ES DK SE BG SK HU AT GR BE
Global end of trial date	22 Jun 2016

Results information
Results version number	v1(current)
This version publication date	16 Jun 2017
First version publication date	16 Jun 2017
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

A3921061

ISRCTN number

US NCT number

NCT01163253

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer, Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, 110017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, 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

14 Apr 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

22 Jun 2016

Was the trial ended prematurely?

Main objective of the trial

To evaluate the long term safety and tolerability of treatment with tofacitinib (10 mg twice a day [BID] or variable dose 5 and 10 mg BID) in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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 Harmonization (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 Sep 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 19

Country: Number of subjects enrolled

Australia: 19

Country: Number of subjects enrolled

Austria: 3

Country: Number of subjects enrolled

Belgium: 5

Country: Number of subjects enrolled

Bosnia and Herzegovina: 12

Country: Number of subjects enrolled

Brazil: 7

Country: Number of subjects enrolled

Bulgaria: 56

Country: Number of subjects enrolled

Canada: 374

Country: Number of subjects enrolled

Chile: 171

Country: Number of subjects enrolled

Colombia: 74

Country: Number of subjects enrolled

Croatia: 7

Country: Number of subjects enrolled

Czech Republic: 41

Country: Number of subjects enrolled

Denmark: 30

Country: Number of subjects enrolled

Finland: 3

Country: Number of subjects enrolled

France: 74

Country: Number of subjects enrolled

Germany: 229

Country: Number of subjects enrolled

Greece: 5

Country: Number of subjects enrolled

Hong Kong: 7

Country: Number of subjects enrolled

Hungary: 91

Country: Number of subjects enrolled

Japan: 49

Country: Number of subjects enrolled

Korea, Republic of: 29

Country: Number of subjects enrolled

Mexico: 30

Country: Number of subjects enrolled

Netherlands: 10

Country: Number of subjects enrolled

Poland: 293

Country: Number of subjects enrolled

Puerto Rico: 17

Country: Number of subjects enrolled

Russian Federation: 125

Country: Number of subjects enrolled

Serbia: 16

Country: Number of subjects enrolled

Singapore: 13

Country: Number of subjects enrolled

Slovakia: 20

Country: Number of subjects enrolled

Spain: 21

Country: Number of subjects enrolled

Sweden: 17

Country: Number of subjects enrolled

Switzerland: 6

Country: Number of subjects enrolled

Taiwan: 67

Country: Number of subjects enrolled

Ukraine: 234

Country: Number of subjects enrolled

United Kingdom: 14

Country: Number of subjects enrolled

United States: 679

Worldwide total number of subjects

2867

EEA total number of subjects

919

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)

2672

From 65 to 84 years

195

85 years and over

Subject disposition

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Recruitment details

A total of 2881 subjects were enrolled in this study, however 2867 subjects received treatment.

Screening details

The study was conducted at 282 sites in 36 countries. The start date of the study was 17-Sep-2010 and the study completed on 22-Jun-2016.

Period 1 title

Overall (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Blinding implementation details

Open-Label

Are arms mutually exclusive

Yes

Tofacitinib 10 mg

Arm description

Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

Arm type

Experimental

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received Tofacitinib 10 mg twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

Tofacitinib 5 mg or 10 mg

Arm description

Subjects received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, subjects received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received Tofacitinib 10 mg twice daily for a period of 3 months. After 3 months of treatment, subjects received twice daily dosing of tofacitinib 5 mg or 10 mg until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.

Number of subjects in period 1	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Started	2281	586
Completed	0	0
Not completed	2281	586
Withdrawn Due to Pregnancy	12	2
Adverse Event	300	78
Lost to Follow-up	125	23
Death	17	5
Ongoing	13	4
Insufficient Clinical Response	423	29
Withdrawal by Subject	199	50
Study Terminated by Sponsor	978	349
Medication Error	1	-
Protocol deviation	43	12
Other Unspecified	170	34

Baseline characteristics

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Reporting group title

Tofacitinib 10 mg

Reporting group description

Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

Reporting group title

Tofacitinib 5 mg or 10 mg

Reporting group description

Reporting group values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg	Total
Number of subjects	2281	586	2867
Age Categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	2137	535	2672
From 65-84 years	144	51	195
85 years and over	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	45.3 ( 12.5 )	47 ( 13 )	-
Gender Categorical
Units: Subjects
Female	640	203	843
Male	1641	383	2024

End points

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Reporting group title

Tofacitinib 10 mg

Reporting group description

Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

Reporting group title

Tofacitinib 5 mg or 10 mg

Reporting group description

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

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End point title

Number 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. An 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 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. Safety analysis set included all subjects who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2281	586
Units: subjects
AEs	1876	490
SAEs	304	88

No statistical analyses for this end point

Primary: Number of Adverse Events by Severity

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End point title

Number of Adverse Events 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 according to the severity in 3 categories: a) mild: AEs did not interfere with participant’s usual function; b) moderate: AEs interfered to some extent with participant’s usual function; c) severe: AEs interfered significantly with participant’s usual function. Safety analysis set included all subjects who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2281	586
Units: adverse events
Mild	5354	1749
Moderate	3268	766
Severe	410	136

No statistical analyses for this end point

Primary: Number of Subjects With Laboratory Abnormalities

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End point title

Number of Subjects With Laboratory Abnormalities ^[3]

End point description

Abnormality criteria:hematology (hemoglobin,hematocrit,red blood cell <0.8*lower limit of normal [LLN];reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75*upper limit of normal[ULN];WBC<0.6*LLN,>1.5*ULN;lymphocytes,neutrophils, basophils, eosinophils,monocytes<0.8*LLN; >1.2*ULN;coagulation(prothrombin [PT], PT ratio>1.1*ULN) liver function(bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein,albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN);renal function (blood urea nitrogen, creatinine>1.3*ULN);electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN),chemistry (glucose<0.6*LLN; >1.5* ULN),urinalysis (pH <4.5;>8, glucose, ketones, protein, blood,urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).Safety analysis set.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2271	578
Units: subjects	2203	565

No statistical analyses for this end point

Primary: Change From Baseline in Hemoglobin Level at Month 1

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End point title

Change From Baseline in Hemoglobin Level at Month 1 ^[4]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.

End point type

Primary

End point timeframe

Baseline, Month 1

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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2277	586
Units: gram per deciliter (g/dL)
arithmetic mean (standard deviation)
Baseline (n =2277, 586)	14.64 ( 1.27 )	14.64 ( 1.24 )
Change at Month 1 (n =2201, 563)	-0.24 ( 0.83 )	-0.32 ( 0.86 )

No statistical analyses for this end point

Primary: Change From Baseline in Hemoglobin Level at Month 3

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End point title

Change From Baseline in Hemoglobin Level at Month 3 ^[5]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 3

Notes
[5] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2198	572
Units: g/dL
arithmetic mean (standard deviation)	-0.27 ( 0.85 )	-0.39 ( 0.83 )

No statistical analyses for this end point

Primary: Change From Baseline in Hemoglobin Level at Month 6

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End point title

Change From Baseline in Hemoglobin Level at Month 6 ^[6]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 6

Notes
[6] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2051	563
Units: g/dL
arithmetic mean (standard deviation)	-0.27 ( 0.88 )	-0.3 ( 0.87 )

No statistical analyses for this end point

Primary: Change From Baseline in Hemoglobin Level at Month 12

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End point title

Change From Baseline in Hemoglobin Level at Month 12 ^[7]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 12

Notes
[7] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1759	531
Units: g/dL
arithmetic mean (standard deviation)	-0.34 ( 0.93 )	-0.3 ( 0.9 )

No statistical analyses for this end point

Primary: Change From Baseline in Hemoglobin Level at Month 24

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End point title

Change From Baseline in Hemoglobin Level at Month 24 ^[8]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 24

Notes
[8] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1385	449
Units: g/dL
arithmetic mean (standard deviation)	-0.3 ( 0.96 )	-0.29 ( 0.89 )

No statistical analyses for this end point

Primary: Change From Baseline in Hemoglobin Level at Month 36

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End point title

Change From Baseline in Hemoglobin Level at Month 36 ^[9]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 36

Notes
[9] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1114	380
Units: g/dL
arithmetic mean (standard deviation)	-0.32 ( 0.93 )	-0.37 ( 0.88 )

No statistical analyses for this end point

Primary: Change From Baseline in Hemoglobin Level at Month 48

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End point title

Change From Baseline in Hemoglobin Level at Month 48 ^[10]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 48

Notes
[10] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	415	127
Units: g/dL
arithmetic mean (standard deviation)	-0.35 ( 0.97 )	-0.43 ( 0.94 )

No statistical analyses for this end point

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 1

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End point title

Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 ^[11]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.

End point type

Primary

End point timeframe

Baseline, Month 1

Notes
[11] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2275	586
Units: 1000 cells/mm^3
arithmetic mean (standard deviation)
Baseline: Lymphocyte Count (n =2275, 586)	1.76 ( 0.57 )	1.8 ( 0.56 )
Baseline: Neutrophil Count (n =2275, 586)	4.74 ( 1.68 )	4.55 ( 1.7 )
Change at Month 1: Lymphocyte Count (n =2182, 559)	0.07 ( 0.52 )	0.11 ( 0.56 )
Change at Month 1: Neutrophil Count (n =2182, 559)	-0.37 ( 1.65 )	-0.48 ( 1.58 )

No statistical analyses for this end point

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 3

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End point title

Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 ^[12]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 3

Notes
[12] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2183	570
Units: 1000 cells/mm^3
arithmetic mean (standard deviation)
Lymphocyte count	0 ( 0.52 )	0.02 ( 0.52 )
Neutrophil Count	-0.28 ( 1.63 )	-0.28 ( 1.6 )

No statistical analyses for this end point

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 6

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End point title

Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 ^[13]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 6

Notes
[13] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2034	559
Units: 1000 cells/mm^3
arithmetic mean (standard deviation)
Lymphocyte Count	-0.11 ( 0.51 )	-0.05 ( 0.51 )
Neutrophil Count	-0.25 ( 1.61 )	-0.22 ( 1.64 )

No statistical analyses for this end point

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 12

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End point title

Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 ^[14]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 12

Notes
[14] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1751	530
Units: 1000 cells/mm^3
arithmetic mean (standard deviation)
Lymphocyte Count	-0.21 ( 0.52 )	-0.16 ( 0.48 )
Neutrophil Count	-0.23 ( 1.61 )	-0.18 ( 1.58 )

No statistical analyses for this end point

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 24

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End point title

Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 ^[15]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 24

Notes
[15] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1377	445
Units: 1000 cells/mm^3
arithmetic mean (standard deviation)
Lymphocyte Count	-0.28 ( 0.52 )	-0.18 ( 0.54 )
Neutrophil Count	-0.19 ( 1.69 )	-0.02 ( 1.59 )

No statistical analyses for this end point

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 36

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End point title

Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 ^[16]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 36

Notes
[16] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1111	377
Units: 1000 cells/mm^3
arithmetic mean (standard deviation)
Lymphocyte Count	-0.35 ( 0.55 )	-0.24 ( 0.51 )
Neutrophil Count	-0.26 ( 1.61 )	-0.11 ( 1.68 )

No statistical analyses for this end point

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 48

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End point title

Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 ^[17]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 48

Notes
[17] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	413	127
Units: 1000 cells/mm^3
arithmetic mean (standard deviation)
Lymphocyte Count	-0.42 ( 0.52 )	-0.27 ( 0.46 )
Neutrophil Count	-0.28 ( 1.7 )	-0.07 ( 1.49 )

No statistical analyses for this end point

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1

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End point title

Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 ^[18]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.

End point type

Primary

End point timeframe

Baseline, Month 1

Notes
[18] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2278	586
Units: milligram per deciliter (mg/dL)
arithmetic mean (standard deviation)
Baseline: Creatinine (n =2278, 586)	0.9 ( 0.17 )	0.88 ( 0.16 )
Baseline: LDL-C (n =2253, 585)	114.14 ( 32.53 )	115 ( 35.03 )
Baseline: HDL-C (n =2277, 586)	49.05 ( 13.93 )	51.87 ( 17.33 )
Baseline: TC (n =2277, 586)	192.11 ( 38.1 )	194.96 ( 39.79 )
Change at Month 1: Creatinine (n =2204, 563)	0.03 ( 0.1 )	0.02 ( 0.1 )
Change at Month 1: LDL-C (n =2125, 546)	11.49 ( 28.77 )	11.55 ( 29.55 )
Change at Month 1: HDL-C (n =2203, 562)	8.19 ( 9.89 )	8.63 ( 10.5 )
Change at Month 1: TC (n =2203, 562)	21.12 ( 34.08 )	22.65 ( 34.36 )

No statistical analyses for this end point

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3

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End point title

Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 ^[19]

End point description

End point type

Primary

End point timeframe

Baseline, Month 3

Notes
[19] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2211	573
Units: mg/dL
arithmetic mean (standard deviation)
Creatinine (n =2211, 573)	0.04 ( 0.21 )	0.03 ( 0.1 )
LDL-C (n =2130, 559)	11.97 ( 29.77 )	10.44 ( 32.72 )
HDL-C (n =2204, 573)	7.69 ( 10.23 )	7.96 ( 10.33 )
TC (n =2203, 573)	21.52 ( 35.63 )	21.06 ( 38.34 )

No statistical analyses for this end point

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6

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End point title

Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 ^[20]

End point description

End point type

Primary

End point timeframe

Baseline, Month 6

Notes
[20] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2057	564
Units: mg/dL
arithmetic mean (standard deviation)
Creatinine (n =2057, 564)	0.03 ( 0.11 )	0.03 ( 0.1 )
LDL-C (n =1983, 553)	11.44 ( 30.1 )	8.74 ( 33.22 )
HDL-C (n =2056, 564)	7.68 ( 10.33 )	8.19 ( 11.6 )
TC (n =2057, 564)	20.91 ( 35.94 )	19.17 ( 39.06 )

No statistical analyses for this end point

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12

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End point title

Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 ^[21]

End point description

End point type

Primary

End point timeframe

Baseline, Month 12

Notes
[21] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1777	533
Units: mg/dL
arithmetic mean (standard deviation)
Creatinine (n =1777, 533)	0.04 ( 0.12 )	0.04 ( 0.12 )
LDL-C (n =1728, 521)	11.31 ( 31.45 )	9.65 ( 32.87 )
HDL-C (n =1776, 531)	8.13 ( 10.48 )	6.88 ( 11.15 )
TC (n =1776, 531)	21.2 ( 39.15 )	16.97 ( 37.84 )

No statistical analyses for this end point

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24

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End point title

Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 ^[22]

End point description

End point type

Primary

End point timeframe

Baseline, Month 24

Notes
[22] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1398	450
Units: mg/dL
arithmetic mean (standard deviation)
Creatinine (n =1398, 450)	0.05 ( 0.11 )	0.04 ( 0.11 )
LDL-C (n =1353, 435)	11.35 ( 35.33 )	10.13 ( 35.67 )
HDL-C (n =1397, 450)	9.02 ( 11.62 )	7.55 ( 11.94 )
TC (n =1398, 450)	21.74 ( 41.05 )	19.22 ( 39.69 )

No statistical analyses for this end point

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36

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End point title

Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 ^[23]

End point description

End point type

Primary

End point timeframe

Baseline, Month 36

Notes
[23] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1122	384
Units: mg/dL
arithmetic mean (standard deviation)
Creatinine (n =1122, 384)	0.05 ( 0.12 )	0.04 ( 0.15 )
LDL-C (n =1085, 375)	10.11 ( 35.83 )	7.25 ( 37.41 )
HDL-C (n =1119, 384)	8.8 ( 11.59 )	6.39 ( 11.91 )
TC (n =1119, 384)	20.2 ( 41.28 )	15.55 ( 43.59 )

No statistical analyses for this end point

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48

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End point title

Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 ^[24]

End point description

End point type

Primary

End point timeframe

Baseline, Month 48

Notes
[24] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	417	127
Units: mg/dL
arithmetic mean (standard deviation)
Creatinine (n =417, 127)	0.04 ( 0.12 )	0.04 ( 0.11 )
LDL-C (n =402, 123)	12.98 ( 36.89 )	6.61 ( 34.66 )
HDL-C (n =417, 127)	8.62 ( 11.36 )	8.19 ( 12.72 )
TC (n =417, 127)	24.99 ( 43.35 )	16.36 ( 40.99 )

No statistical analyses for this end point

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1

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End point title

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 ^[25]

End point description

End point type

Primary

End point timeframe

Baseline, Month 1

Notes
[25] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2278	586
Units: international unit per liter (IU/L)
arithmetic mean (standard deviation)
Baseline: AST (n =2278, 586)	24.02 ( 12.22 )	24.66 ( 10.36 )
Baseline: ALT (n =2278, 586)	28.47 ( 17.29 )	28.17 ( 16.56 )
Change at Month 1: AST (n =2198, 564)	3.48 ( 15.39 )	4.07 ( 12.01 )
Change at Month 1: ALT (n =2199, 564)	4.07 ( 19.04 )	4.84 ( 17.5 )

No statistical analyses for this end point

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3

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End point title

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 ^[26]

End point description

End point type

Primary

End point timeframe

Baseline, Month 3

Notes
[26] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2201	573
Units: IU/L
arithmetic mean (standard deviation)
AST (n =2200, 573)	4.09 ( 17.75 )	5.65 ( 16.37 )
ALT (n =2201, 573)	4.86 ( 18.52 )	6.86 ( 20.8 )

No statistical analyses for this end point

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6

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End point title

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 ^[27]

End point description

End point type

Primary

End point timeframe

Baseline, Month 6

Notes
[27] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2054	564
Units: IU/L
arithmetic mean (standard deviation)
AST (n =2052, 564)	4.5 ( 15.6 )	5.07 ( 14.9 )
ALT (n =2054, 564)	5.98 ( 19 )	6.15 ( 18.4 )

No statistical analyses for this end point

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12

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End point title

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 ^[28]

End point description

End point type

Primary

End point timeframe

Baseline, Month 12

Notes
[28] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1774	532
Units: IU/L
arithmetic mean (standard deviation)
AST (n =1772, 531)	4.88 ( 16.63 )	7.29 ( 22.7 )
ALT (n =1774, 532)	6.68 ( 23.12 )	8.91 ( 25.21 )

No statistical analyses for this end point

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24

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End point title

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 ^[29]

End point description

End point type

Primary

End point timeframe

Baseline, Month 24

Notes
[29] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1398	450
Units: IU/L
arithmetic mean (standard deviation)
AST (n =1397, 450)	4.1 ( 14.64 )	6.77 ( 15.74 )
ALT (n =1398, 450)	5.31 ( 19.37 )	7.56 ( 18.93 )

No statistical analyses for this end point

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36

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End point title

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 ^[30]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 36

Notes
[30] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1122	384
Units: IU/L
arithmetic mean (standard deviation)
AST	5.38 ( 20.68 )	5.32 ( 15.65 )
ALT	5.46 ( 20.61 )	6.56 ( 22.43 )

No statistical analyses for this end point

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48

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End point title

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 ^[31]

End point description

End point type

Primary

End point timeframe

Baseline, Month 48

Notes
[31] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	417	127
Units: IU/L
arithmetic mean (standard deviation)
AST (n =416, 127)	4.49 ( 14.05 )	8.4 ( 26.41 )
ALT (n =417, 127)	4.92 ( 27.11 )	6.92 ( 20.98 )

No statistical analyses for this end point

Primary: Number of Subjects With Clinically Significant Change From Baseline in Physical Examination

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End point title

Number of Subjects With Clinically Significant Change From Baseline in Physical Examination ^[32]

End point description

Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion. Safety analysis set. Here, 'N' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Notes
[32] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2268	577
Units: subjects	683	191

No statistical analyses for this end point

Primary: Number of Subjects With Vital Sign Abnormalities

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End point title

Number of Subjects With Vital Sign Abnormalities ^[33]

End point description

Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg); diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg; heart rate: <40 and >120 beats per minute (BPM); SBP values: maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; DBP value: maximum IFB of >=20 mmHg. Safety analysis set. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Notes
[33] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2271	577
Units: subjects
Systolic BP (n =2271, 577)	12	6
Diastolic BP (n =2271, 577)	12	1
Heart Rate (n =2271, 577)	3	1
Maximum IFB in Systolic BP (n =2267, 577)	187	65
Maximum IFB in Diastolic BP (n =2267, 577)	221	74

No statistical analyses for this end point

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1

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End point title

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 ^[34]

End point description

End point type

Primary

End point timeframe

Baseline, Month 1

Notes
[34] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2277	586
Units: millimeter of mercury (mmHg)
arithmetic mean (standard deviation)
Baseline: Systolic BP (n =2277, 586)	126.07 ( 14.03 )	126.24 ( 14.12 )
Baseline: Diastolic BP (n =2277, 586)	79.64 ( 9.42 )	78.88 ( 9.27 )
Change at Month 1: Systolic BP (n =2210, 564)	-0.43 ( 11.83 )	-1.31 ( 11.55 )
Change at Month 1: Diastolic BP (n =2210, 564)	-0.03 ( 8.42 )	0.22 ( 8.45 )

No statistical analyses for this end point

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3

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End point title

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 ^[35]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 3

Notes
[35] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2214	575
Units: mmHg
arithmetic mean (standard deviation)
Systolic BP	-0.16 ( 11.97 )	-0.95 ( 11.85 )
Diastolic BP	-0.26 ( 8.56 )	0.05 ( 8.52 )

No statistical analyses for this end point

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6

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End point title

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 ^[36]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 6

Notes
[36] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2061	566
Units: mmHg
arithmetic mean (standard deviation)
Systolic BP	0.22 ( 12.18 )	-0.15 ( 12.48 )
Diastolic BP	-0.05 ( 8.87 )	0.55 ( 8.74 )

No statistical analyses for this end point

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12

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End point title

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 ^[37]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 12

Notes
[37] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1784	534
Units: mmHg
arithmetic mean (standard deviation)
Systolic BP	0.42 ( 11.97 )	-0.2 ( 12.51 )
Diastolic BP	0.23 ( 8.89 )	0.1 ( 9.1 )

No statistical analyses for this end point

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24

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End point title

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 ^[38]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 24

Notes
[38] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1398	451
Units: mmHg
arithmetic mean (standard deviation)
Systolic BP	0.84 ( 13 )	-0.07 ( 13.02 )
Diastolic BP	0.36 ( 9.45 )	0.35 ( 8.85 )

No statistical analyses for this end point

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36

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End point title

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 ^[39]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 36

Notes
[39] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1123	386
Units: mmHg
arithmetic mean (standard deviation)
Systolic BP	0.52 ( 13.15 )	0.1 ( 13.92 )
Diastolic BP	0.33 ( 9.33 )	-0.06 ( 9.24 )

No statistical analyses for this end point

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48

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End point title

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 ^[40]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 48

Notes
[40] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	422	127
Units: mmHg
arithmetic mean (standard deviation)
Systolic BP	2.35 ( 13.45 )	1.13 ( 15.18 )
Diastolic BP	0.97 ( 9.52 )	0.87 ( 9.8 )

No statistical analyses for this end point

Primary: Change From Baseline in Heart Rate at Month 1

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End point title

Change From Baseline in Heart Rate at Month 1 ^[41]

End point description

End point type

Primary

End point timeframe

Baseline, Month 1

Notes
[41] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2277	586
Units: beats per minute
arithmetic mean (standard deviation)
Baseline (n =2277, 586)	71.81 ( 9.67 )	71.46 ( 9.93 )
Change at Month 1 (n =2210, 563)	-0.82 ( 9.16 )	-1.23 ( 9.03 )

No statistical analyses for this end point

Primary: Change From Baseline in Heart Rate at Month 3

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End point title

Change From Baseline in Heart Rate at Month 3 ^[42]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 3

Notes
[42] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2214	573
Units: beats per minute
arithmetic mean (standard deviation)	-0.57 ( 9.35 )	-0.32 ( 9.19 )

No statistical analyses for this end point

Primary: Change From Baseline in Heart Rate at Month 6

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End point title

Change From Baseline in Heart Rate at Month 6 ^[43]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 6

Notes
[43] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2061	565
Units: beats per minute
arithmetic mean (standard deviation)	-0.73 ( 9.65 )	-1.05 ( 9.18 )

No statistical analyses for this end point

Primary: Change From Baseline in Heart Rate at Month 12

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End point title

Change From Baseline in Heart Rate at Month 12 ^[44]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 12

Notes
[44] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1784	534
Units: beats per minute
arithmetic mean (standard deviation)	-1.13 ( 9.66 )	-1.14 ( 9.07 )

No statistical analyses for this end point

Primary: Change From Baseline in Heart Rate at Month 24

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End point title

Change From Baseline in Heart Rate at Month 24 ^[45]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 24

Notes
[45] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1398	451
Units: beats per minute
arithmetic mean (standard deviation)	-1.07 ( 9.91 )	-0.94 ( 8.89 )

No statistical analyses for this end point

Primary: Change From Baseline in Heart Rate at Month 36

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End point title

Change From Baseline in Heart Rate at Month 36 ^[46]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 36

Notes
[46] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1123	386
Units: beats per minute
arithmetic mean (standard deviation)	-1.38 ( 9.81 )	-1 ( 9.26 )

No statistical analyses for this end point

Primary: Change From Baseline in Heart Rate at Month 48

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End point title

Change From Baseline in Heart Rate at Month 48 ^[47]

End point description

Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Month 48

Notes
[47] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	422	127
Units: beats per minute
arithmetic mean (standard deviation)	-0.91 ( 10.64 )	-0.64 ( 10.64 )

No statistical analyses for this end point

Primary: Number of Subjects With Electrocardiogram (ECG) Abnormalities

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End point title

Number of Subjects With Electrocardiogram (ECG) Abnormalities ^[48]

End point description

Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett’s Correction) and QTcF (Fridericia’s Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec. Safety analysis set included all subjects who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Notes
[48] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2281	586
Units: subjects	7	2

No statistical analyses for this end point

Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6

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End point title

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 ^[49]

End point description

End point type

Primary

End point timeframe

Baseline, Month 6

Notes
[49] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2264	583
Units: milliseconds (msec)
arithmetic mean (standard deviation)
Baseline: QRS Complex (n =2264, 583)	92.88 ( 9.12 )	92.31 ( 9.75 )
Baseline: PR Interval (n =2258, 583)	162.32 ( 21.32 )	158.91 ( 20.62 )
Baseline: QT Interval (n =2264, 583)	392.39 ( 29.12 )	395.75 ( 29.7 )
Baseline: QTcB Interval (n =2264, 583)	415.7 ( 23.83 )	416.91 ( 23.04 )
Baseline: QTcF Interval (n =2264, 583)	407.48 ( 20.74 )	409.42 ( 20.11 )
Baseline: RR Interval (n =2264, 583)	901.27 ( 145.58 )	911.59 ( 150.35 )
Change at Month 6: QRS Complex (n =1995, 550)	1.51 ( 8.28 )	2.01 ( 7.5 )
Change at Month 6: PR Interval (n =1986, 549)	2.46 ( 13.79 )	2.76 ( 14.81 )
Change at Month 6: QT Interval (n =1995, 550)	2.25 ( 24.49 )	2.52 ( 24.39 )
Change at Month 6: QTcB Interval (n =1995, 550)	-0.84 ( 20.49 )	-1.38 ( 20.31 )
Change at Month 6: QTcF Interval (n =1995, 550)	0.23 ( 17.14 )	-0.03 ( 17.68 )
Change at Month 6: RR Interval (n =1995, 550)	14.35 ( 130.91 )	18.77 ( 123.49 )

No statistical analyses for this end point

Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12

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End point title

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 ^[50]

End point description

End point type

Primary

End point timeframe

Baseline, Month 12

Notes
[50] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1727	516
Units: msec
arithmetic mean (standard deviation)
QRS Complex (n =1726, 516)	1.89 ( 7.93 )	2.11 ( 7.53 )
PR Interval (n =1717, 515)	2.8 ( 14.32 )	3.21 ( 14.31 )
QT Interval (n =1726, 516)	2.49 ( 23.26 )	2.69 ( 23 )
QTcB Interval (n =1726, 516)	-1.04 ( 20.63 )	-1.09 ( 20.83 )
QTcF Interval (n =1726, 516)	0.16 ( 16.71 )	0.23 ( 17.2 )
RR Interval (n =1727, 516)	15.94 ( 130.6 )	17.55 ( 128.16 )

No statistical analyses for this end point

Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24

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End point title

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 ^[51]

End point description

End point type

Primary

End point timeframe

Baseline, Month 24

Notes
[51] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	1352	432
Units: msec
arithmetic mean (standard deviation)
QRS Complex (n =1352, 432)	2 ( 8.55 )	2.42 ( 9.13 )
PR Interval (n =1346, 432)	3.49 ( 14.55 )	3.81 ( 14.67 )
QT Interval (n =1352, 432)	3.93 ( 24.93 )	2.28 ( 24.8 )
QTcB Interval (n =1352, 431)	0.15 ( 20.77 )	0.78 ( 21.06 )
QTcF Interval (n =1352, 431)	1.47 ( 16.86 )	1.25 ( 17.72 )
RR Interval (n =1352, 432)	17.7 ( 139.47 )	8.66 ( 135.06 )

No statistical analyses for this end point

Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36

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End point title

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 ^[52]

End point description

End point type

Primary

End point timeframe

Baseline, Month 36

Notes
[52] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	845	283
Units: msec
arithmetic mean (standard deviation)
QRS Complex (n =845, 283)	1.75 ( 8.47 )	1.85 ( 10.37 )
PR Interval (n =840, 282)	4.18 ( 14.5 )	3.25 ( 15.5 )
QT Interval (n =844, 283)	4.31 ( 24.93 )	2.52 ( 22.63 )
QTcB Interval (n =844, 283)	0.44 ( 21.29 )	-0.01 ( 22.21 )
QTcF Interval (n =844, 283)	1.79 ( 17.57 )	0.84 ( 17.63 )
RR Interval (n =845, 283)	18.24 ( 136.44 )	15.14 ( 131.42 )

No statistical analyses for this end point

Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48

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End point title

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 ^[53]

End point description

End point type

Primary

End point timeframe

Baseline, Month 48

Notes
[53] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	126	55
Units: msec
arithmetic mean (standard deviation)
QRS Complex (n =126, 55)	2.37 ( 10.17 )	1.31 ( 5.37 )
PR Interval (n =126, 55)	6.26 ( 12.58 )	1.98 ( 13.2 )
QT Interval (n =126, 55)	6.43 ( 24.05 )	1.69 ( 23.43 )
QTcB Interval (n =125, 55)	3.42 ( 20.11 )	-2 ( 22.64 )
QTcF Interval (n =125, 55)	4.55 ( 15.84 )	-0.87 ( 19.38 )
RR Interval (n =126, 55)	15.69 ( 143.06 )	20.78 ( 119.61 )

No statistical analyses for this end point

Primary: Number of Subjects With Adjudicated Cardiovascular Events

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End point title

Number of Subjects With Adjudicated Cardiovascular Events ^[54]

End point description

Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable. Safety analysis set included all subjects who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Notes
[54] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2281	586
Units: subjects	32	13

No statistical analyses for this end point

Primary: Number of Subjects With Malignancy Events

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End point title

Number of Subjects With Malignancy Events ^[55]

End point description

Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read. Safety analysis set included all subjects who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Notes
[55] - 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 reported for this endpoint

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2281	586
Units: subjects	87	26

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'

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End point title

Percentage of Subjects Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'

End point description

PGA of psoriasis was scored on a 5-point scale,reflecting a global consideration of the erythema (E),induration (I) and scaling (S) across all psoriatic lesions in subjects.The severity rating scores(Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders;Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. Total average was rounded to the nearest whole number score to determine the PGA.The 5-point scale for PGA was: 0= clear;1= almost clear;2= mild;3= moderate;4= severe,where higher score indicating more severity.Percentage of subjects with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported. Full analysis set (FAS).Here,‘number of subjects analyzed’ =subjects evaluable for this endpoint and ‘n’=subjects evaluable at specified time points for each arm, respectively.

End point type

Secondary

End point timeframe

Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2200	571
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =2196, 563)	50.36 (48.27 to 52.46)	77.8 (74.36 to 81.23)
Month 3 (n =2200, 571)	54.86 (52.78 to 56.94)	85.29 (82.38 to 88.19)
Month 6 (n =2052, 564)	54.97 (52.82 to 57.12)	82.09 (78.93 to 85.26)
Month 12 (n =1776, 532)	54.79 (52.47 to 57.1)	75.19 (71.52 to 78.86)
Month 24 (n =1397, 448)	54.62 (52.01 to 57.23)	79.46 (75.72 to 83.2)
Month 36 (n =1123, 385)	57.35 (54.45 to 60.24)	76.36 (72.12 to 80.61)
Month 48 (n =422, 126)	48.58 (43.81 to 53.35)	77.78 (70.52 to 85.04)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

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End point title

Percentage of Subjects Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

End point description

PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease),with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=75% reduction from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2200	566
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =2194, 555)	51.96 (49.87 to 54.05)	71.89 (68.15 to 75.63)
Month 3 (n =2200, 566)	58.45 (56.4 to 60.51)	84.45 (81.47 to 87.44)
Month 6 (n =2048, 557)	61.67 (59.56 to 63.78)	86 (83.11 to 88.88)
Month 12 (n =1775, 525)	65.24 (63.02 to 67.45)	80.76 (77.39 to 84.13)
Month 24 (n =1393, 445)	67.26 (64.8 to 69.73)	84.94 (81.62 to 88.27)
Month 36 (n =1118, 380)	70.75 (68.08 to 73.42)	83.95 (80.26 to 87.64)
Month 48 (n =422, 124)	64.93 (60.38 to 69.48)	83.06 (76.46 to 89.67)

No statistical analyses for this end point

Secondary: Psoriasis Area and Severity Index (PASI) Scores

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End point title

Psoriasis Area and Severity Index (PASI) Scores

End point description

PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2266	585
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n =2266, 585)	21.85 ( 9.48 )	19.05 ( 8.89 )
Month 1 (n =2198, 561)	6.6 ( 7.14 )	3.09 ( 4.81 )
Month 3 (n =2205, 572)	5.64 ( 6.33 )	1.95 ( 3.25 )
Month 6 (n =2051, 563)	5.31 ( 6.31 )	1.9 ( 3.25 )
Month 12 (n =1779, 531)	4.72 ( 5.29 )	2.38 ( 3.57 )
Month 24 (n =1397, 449)	4.41 ( 5.08 )	1.9 ( 2.65 )
Month 36 (n =1121, 384)	3.91 ( 4.66 )	2.19 ( 3.23 )
Month 48 (n =422, 126)	4.75 ( 5.37 )	1.85 ( 2.31 )

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

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End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

End point description

PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2201	572
Units: units on a scale
arithmetic mean (standard deviation)
Month 1 (n =2195, 561)	-15.26 ( 9.96 )	-16 ( 9.57 )
Month 3 (n =2201, 572)	-16.18 ( 9.73 )	-16.99 ( 9.27 )
Month 6 (n =2049, 563)	-16.56 ( 9.54 )	-17.03 ( 9.16 )
Month 12 (n =1776, 531)	-17.01 ( 9.33 )	-16.45 ( 9.04 )
Month 24 (n =1394, 449)	-17.25 ( 9.35 )	-16.67 ( 8.7 )
Month 36 (n =1119, 384)	-17.44 ( 9.23 )	-16.49 ( 8.81 )
Month 48 (n =422, 126)	-16.16 ( 8.61 )	-15.47 ( 9.04 )

No statistical analyses for this end point

Secondary: Psoriasis Area and Severity Index (PASI) Component Scores: Erythema

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End point title

Psoriasis Area and Severity Index (PASI) Component Scores: Erythema

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2266	585
Units: units on a scale
arithmetic mean (standard deviation)
Baseline: Head/Neck (n =2266, 585)	2.26 ( 0.99 )	2.13 ( 1.08 )
Month 1: Head/Neck (n =2198, 561)	0.82 ( 0.96 )	0.47 ( 0.81 )
Month 3: Head/Neck (n =2205, 572)	0.76 ( 0.95 )	0.34 ( 0.65 )
Month 6: Head/Neck (n =2051, 563)	0.75 ( 0.95 )	0.42 ( 0.75 )
Month 12: Head/Neck (n =1779, 531)	0.7 ( 0.92 )	0.49 ( 0.82 )
Month 24: Head/Neck (n =1397, 449)	0.66 ( 0.93 )	0.47 ( 0.75 )
Month 36: Head/Neck (n =1121, 384)	0.57 ( 0.88 )	0.48 ( 0.79 )
Month 48: Head/Neck (n =422, 126)	0.7 ( 0.93 )	0.34 ( 0.69 )
Baseline: Upper Limbs (n =2266, 585)	2.82 ( 0.74 )	2.68 ( 0.86 )
Month 1: Upper Limbs (n =2198, 561)	1.29 ( 0.98 )	0.71 ( 0.86 )
Month 3: Upper Limbs (n =2205, 572)	1.23 ( 1 )	0.57 ( 0.79 )
Month 6: Upper Limbs (n =2051, 563)	1.2 ( 1.01 )	0.58 ( 0.83 )
Month 12: Upper Limbs (n =1779, 531)	1.16 ( 1.01 )	0.74 ( 0.95 )
Month 24: Upper Limbs (n =1397, 449)	1.13 ( 1.03 )	0.61 ( 0.85 )
Month 36: Upper Limbs (n =1121, 384)	1.06 ( 1.01 )	0.68 ( 0.86 )
Month 48: Upper Limbs (n =422, 126)	1.18 ( 1.03 )	0.58 ( 0.84 )
Baseline: Trunk (n =2266, 585)	2.83 ( 0.83 )	2.73 ( 0.94 )
Month 1: Trunk (n =2198, 561)	1.18 ( 1.11 )	0.62 ( 0.92 )
Month 3: Trunk (n =2205, 572)	1.06 ( 1.09 )	0.41 ( 0.73 )
Month 6: Trunk (n =2051, 563)	1.03 ( 1.09 )	0.41 ( 0.79 )
Month 12: Trunk (n =1779, 531)	0.99 ( 1.08 )	0.51 ( 0.89 )
Month 24: Trunk (n =1397, 449)	0.96 ( 1.08 )	0.49 ( 0.84 )
Month 36: Trunk (n =1121, 384)	0.86 ( 1.06 )	0.53 ( 0.9 )
Month 48: Trunk (n =422, 126)	1 ( 1.1 )	0.5 ( 0.86 )
Baseline: Lower Limbs (n =2266, 585)	3.1 ( 0.7 )	2.94 ( 0.89 )
Month 1: Lower Limbs (n =2198, 561)	1.37 ( 1.09 )	0.79 ( 0.95 )
Month 3: Lower Limbs (n =2205, 572)	1.24 ( 1.08 )	0.58 ( 0.84 )
Month 6: Lower Limbs (n =2051, 563)	1.2 ( 1.11 )	0.52 ( 0.81 )
Month 12: Lower Limbs (n =1779, 531)	1.17 ( 1.1 )	0.69 ( 0.98 )
Month 24: Lower Limbs (n =1397, 449)	1.15 ( 1.11 )	0.59 ( 0.9 )
Month 36: Lower Limbs (n =1121, 384)	1.07 ( 1.11 )	0.67 ( 0.96 )
Month 48: Lower Limbs (n =422, 126)	1.2 ( 1.11 )	0.61 ( 0.91 )

No statistical analyses for this end point

Secondary: Psoriasis Area and Severity Index (PASI) Component Scores: Induration

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End point title

Psoriasis Area and Severity Index (PASI) Component Scores: Induration

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2266	585
Units: units on a scale
arithmetic mean (standard deviation)
Baseline: Head/Neck (n =2266, 585)	1.97 ( 1.01 )	1.88 ( 1.1 )
Month 1: Head/Neck (n =2198, 561)	0.65 ( 0.85 )	0.35 ( 0.73 )
Month 3: Head/Neck (n =2205, 572)	0.6 ( 0.84 )	0.26 ( 0.56 )
Month 6: Head/Neck (n =2051, 563)	0.59 ( 0.86 )	0.31 ( 0.67 )
Month 12: Head/Neck (n =1779, 531)	0.55 ( 0.81 )	0.38 ( 0.71 )
Month 24: Head/Neck (n =1397, 449)	0.53 ( 0.82 )	0.37 ( 0.68 )
Month 36: Head/Neck (n =1121, 384)	0.46 ( 0.77 )	0.37 ( 0.68 )
Month 48: Head/Neck (n =422, 126)	0.6 ( 0.85 )	0.26 ( 0.6 )
Baseline: Upper Limbs (n =2266, 585)	2.64 ( 0.77 )	2.5 ( 0.93 )
Month 1: Upper Limbs (n =2198, 561)	1.21 ( 0.99 )	0.66 ( 0.88 )
Month 3: Upper Limbs (n =2205, 572)	1.17 ( 1.01 )	0.53 ( 0.81 )
Month 6: Upper Limbs (n =2051, 563)	1.15 ( 1.02 )	0.55 ( 0.85 )
Month 12: Upper Limbs (n =1779, 531)	1.11 ( 1.01 )	0.69 ( 0.95 )
Month 24: Upper Limbs (n =1397, 449)	1.08 ( 1.02 )	0.53 ( 0.84 )
Month 36: Upper Limbs (n =1121, 384)	1 ( 1.01 )	0.6 ( 0.82 )
Month 48: Upper Limbs (n =422, 126)	1.09 ( 1 )	0.5 ( 0.75 )
Baseline: Trunk (n =2266, 585)	2.57 ( 0.86 )	2.51 ( 1.01 )
Month 1: Trunk (n =2198, 561)	1.02 ( 1.04 )	0.52 ( 0.86 )
Month 3: Trunk (n =2205, 572)	0.91 ( 1.02 )	0.34 ( 0.68 )
Month 6: Trunk (n =2051, 563)	0.88 ( 1 )	0.34 ( 0.71 )
Month 12: Trunk (n =1779, 531)	0.87 ( 1 )	0.42 ( 0.77 )
Month 24: Trunk (n =1397, 449)	0.82 ( 0.98 )	0.39 ( 0.73 )
Month 36: Trunk (n =1121, 384)	0.75 ( 0.97 )	0.43 ( 0.79 )
Month 48: Trunk (n =422, 126)	0.91 ( 1.05 )	0.44 ( 0.8 )
Baseline: Lower Limbs (n =2266, 585)	2.85 ( 0.76 )	2.77 ( 0.96 )
Month 1: Lower Limbs (n =2198, 561)	1.22 ( 1.04 )	0.68 ( 0.95 )
Month 3: Lower Limbs (n =2205, 572)	1.1 ( 1.04 )	0.51 ( 0.84 )
Month 6: Lower Limbs (n =2051, 563)	1.08 ( 1.06 )	0.47 ( 0.82 )
Month 12: Lower Limbs (n =1779, 531)	1.05 ( 1.03 )	0.61 ( 0.94 )
Month 24: Lower Limbs (n =1397, 449)	1.02 ( 1.03 )	0.49 ( 0.83 )
Month 36: Lower Limbs (n =1121, 384)	0.95 ( 1.03 )	0.57 ( 0.87 )
Month 48: Lower Limbs (n =422, 126)	1.07 ( 1.04 )	0.48 ( 0.79 )

No statistical analyses for this end point

Secondary: Psoriasis Area and Severity Index (PASI) Component Scores: Scaling

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End point title

Psoriasis Area and Severity Index (PASI) Component Scores: Scaling

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2266	585
Units: units on a scale
arithmetic mean (standard deviation)
Baseline: Head/Neck (n =2266, 585)	2.22 ( 1.08 )	2.1 ( 1.11 )
Month 1: Head/Neck (n =2198, 561)	0.75 ( 0.95 )	0.42 ( 0.79 )
Month 3: Head/Neck (n =2205, 572)	0.71 ( 0.95 )	0.32 ( 0.66 )
Month 6: Head/Neck (n =2051, 563)	0.71 ( 0.97 )	0.4 ( 0.77 )
Month 12: Head/Neck (n =1779, 531)	0.67 ( 0.92 )	0.48 ( 0.84 )
Month 24: Head/Neck (n =1397, 449)	0.6 ( 0.88 )	0.45 ( 0.77 )
Month 36: Head/Neck (n =1121, 384)	0.55 ( 0.88 )	0.47 ( 0.79 )
Month 48: Head/Neck (n =422, 126)	0.65 ( 0.93 )	0.34 ( 0.72 )
Baseline: Upper Limbs (n =2266, 585)	2.65 ( 0.82 )	2.52 ( 0.96 )
Month 1: Upper Limbs (n =2198, 561)	1.22 ( 1.01 )	0.69 ( 0.89 )
Month 3: Upper Limbs (n =2205, 572)	1.18 ( 1.04 )	0.55 ( 0.8 )
Month 6: Upper Limbs (n =2051, 563)	1.16 ( 1.05 )	0.58 ( 0.87 )
Month 12: Upper Limbs (n =1779, 531)	1.12 ( 1.03 )	0.72 ( 0.97 )
Month 24: Upper Limbs (n =1397, 449)	1.08 ( 1.03 )	0.58 ( 0.84 )
Month 36: Upper Limbs (n =1121, 384)	1.01 ( 1.02 )	0.62 ( 0.83 )
Month 48: Upper Limbs (n =422, 126)	1.13 ( 1.09 )	0.53 ( 0.79 )
Baseline: Trunk (n =2266, 585)	2.55 ( 0.89 )	2.47 ( 1 )
Month 1: Trunk (n =2198, 561)	0.97 ( 1.02 )	0.5 ( 0.83 )
Month 3: Trunk (n =2205, 572)	0.87 ( 1 )	0.33 ( 0.64 )
Month 6: Trunk (n =2051, 563)	0.85 ( 0.99 )	0.33 ( 0.7 )
Month 12: Trunk (n =1779, 531)	0.83 ( 0.97 )	0.4 ( 0.76 )
Month 24: Trunk (n =1397, 449)	0.78 ( 0.95 )	0.39 ( 0.72 )
Month 36: Trunk (n =1121, 384)	0.71 ( 0.93 )	0.42 ( 0.77 )
Month 48: Trunk (n =422, 126)	0.86 ( 0.99 )	0.4 ( 0.78 )
Baseline: Lower Limbs (n =2266, 585)	2.89 ( 0.81 )	2.79 ( 1 )
Month 1: Lower Limbs (n =2198, 561)	1.23 ( 1.08 )	0.7 ( 0.93 )
Month 3: Lower Limbs (n =2205, 572)	1.12 ( 1.08 )	0.48 ( 0.78 )
Month 6: Lower Limbs (n =2051, 563)	1.11 ( 1.1 )	0.48 ( 0.83 )
Month 12: Lower Limbs (n =1779, 531)	1.07 ( 1.07 )	0.64 ( 0.98 )
Month 24: Lower Limbs (n =1397, 449)	1.04 ( 1.06 )	0.53 ( 0.84 )
Month 36: Lower Limbs (n =1121, 384)	0.94 ( 1.03 )	0.6 ( 0.9 )
Month 48: Lower Limbs (n =422, 126)	1.09 ( 1.09 )	0.48 ( 0.76 )

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48

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End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2201	572
Units: units on a scale
arithmetic mean (standard deviation)
Month 1: Head/Neck (n =2195, 561)	-1.43 ( 1.15 )	-1.66 ( 1.2 )
Month 3: Head/Neck (n =2201, 572)	-1.5 ( 1.18 )	-1.8 ( 1.18 )
Month 6: Head/Neck (n =2049, 563)	-1.52 ( 1.2 )	-1.72 ( 1.21 )
Month 12: Head/Neck (n =1776, 531)	-1.56 ( 1.19 )	-1.64 ( 1.22 )
Month 24: Head/Neck (n =1394, 449)	-1.62 ( 1.19 )	-1.67 ( 1.23 )
Month 36: Head/Neck (n =1119, 384)	-1.72 ( 1.18 )	-1.67 ( 1.2 )
Month 48: Head/Neck (n =422, 126)	-1.55 ( 1.19 )	-1.7 ( 1.13 )
Month 1: Upper Limbs (n =2195, 561)	-1.53 ( 1.12 )	-1.98 ( 1.18 )
Month 3: Upper Limbs (n =2201, 572)	-1.59 ( 1.15 )	-2.12 ( 1.14 )
Month 6: Upper Limbs (n =2049, 563)	-1.62 ( 1.15 )	-2.09 ( 1.13 )
Month 12: Upper Limbs (n =1776, 531)	-1.67 ( 1.15 )	-1.94 ( 1.21 )
Month 24: Upper Limbs (n =1394, 449)	-1.7 ( 1.18 )	-2.05 ( 1.19 )
Month 36: Upper Limbs (n =1119, 384)	-1.78 ( 1.17 )	-2 ( 1.18 )
Month 48: Upper Limbs (n =422, 126)	-1.62 ( 1.16 )	-1.9 ( 1.22 )
Month 1: Trunk (n =2195, 561)	-1.65 ( 1.22 )	-2.12 ( 1.26 )
Month 3: Trunk (n =2201, 572)	-1.77 ( 1.24 )	-2.33 ( 1.17 )
Month 6: Trunk (n =2049, 563)	-1.81 ( 1.24 )	-2.32 ( 1.19 )
Month 12: Trunk (n =1776, 531)	-1.86 ( 1.24 )	-2.21 ( 1.25 )
Month 24: Trunk (n =1394, 449)	-1.88 ( 1.25 )	-2.22 ( 1.26 )
Month 36: Trunk (n =1119, 384)	-1.99 ( 1.26 )	-2.18 ( 1.3 )
Month 48: Trunk (n =422, 126)	-1.82 ( 1.22 )	-2.08 ( 1.17 )
Month 1: Lower Limbs (n =2195, 561)	-1.72 ( 1.19 )	-2.16 ( 1.26 )
Month 3: Lower Limbs (n =2201, 572)	-1.87 ( 1.21 )	-2.36 ( 1.21 )
Month 6: Lower Limbs (n =2049, 563)	-1.9 ( 1.22 )	-2.42 ( 1.18 )
Month 12: Lower Limbs (n =1776, 531)	-1.94 ( 1.23 )	-2.24 ( 1.33 )
Month 24: Lower Limbs (n =1394, 449)	-1.95 ( 1.25 )	-2.32 ( 1.24 )
Month 36: Lower Limbs (n =1119, 384)	-2.04 ( 1.23 )	-2.28 ( 1.3 )
Month 48: Lower Limbs (n =422, 126)	-1.87 ( 1.2 )	-2.17 ( 1.21 )

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48

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End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2201	572
Units: units on a scale
arithmetic mean (standard deviation)
Month 1: Head/Neck (n =2195, 561)	-1.32 ( 1.13 )	-1.53 ( 1.15 )
Month 3: Head/Neck (n =2201, 572)	-1.37 ( 1.17 )	-1.63 ( 1.14 )
Month 6: Head/Neck (n =2049, 563)	-1.4 ( 1.16 )	-1.57 ( 1.18 )
Month 12: Head/Neck (n =1776, 531)	-1.44 ( 1.18 )	-1.49 ( 1.18 )
Month 24: Head/Neck (n =1394, 449)	-1.48 ( 1.17 )	-1.51 ( 1.21 )
Month 36: Head/Neck (n =1119, 384)	-1.55 ( 1.17 )	-1.51 ( 1.15 )
Month 48: Head/Neck (n =422, 126)	-1.35 ( 1.17 )	-1.41 ( 1.1 )
Month 1: Upper Limbs (n =2195, 561)	-1.43 ( 1.14 )	-1.85 ( 1.22 )
Month 3: Upper Limbs (n =2201, 572)	-1.47 ( 1.17 )	-1.97 ( 1.16 )
Month 6: Upper Limbs (n =2049, 563)	-1.49 ( 1.15 )	-1.94 ( 1.19 )
Month 12: Upper Limbs (n =1776, 531)	-1.54 ( 1.14 )	-1.82 ( 1.27 )
Month 24: Upper Limbs (n =1394, 449)	-1.57 ( 1.18 )	-1.97 ( 1.19 )
Month 36: Upper Limbs (n =1119, 384)	-1.65 ( 1.17 )	-1.92 ( 1.18 )
Month 48: Upper Limbs (n =422, 126)	-1.53 ( 1.14 )	-1.83 ( 1.14 )
Month 1: Trunk (n =2195, 561)	-1.55 ( 1.19 )	-2.01 ( 1.26 )
Month 3: Trunk (n =2201, 572)	-1.65 ( 1.22 )	-2.17 ( 1.18 )
Month 6: Trunk (n =2049, 563)	-1.7 ( 1.19 )	-2.18 ( 1.2 )
Month 12: Trunk (n =1776, 531)	-1.71 ( 1.2 )	-2.1 ( 1.24 )
Month 24: Trunk (n =1394, 449)	-1.76 ( 1.19 )	-2.13 ( 1.2 )
Month 36: Trunk (n =1119, 384)	-1.85 ( 1.2 )	-2.09 ( 1.23 )
Month 48: Trunk (n =422, 126)	-1.68 ( 1.17 )	-1.87 ( 1.2 )
Month 1: Lower Limbs (n =2195, 561)	-1.63 ( 1.22 )	-2.09 ( 1.31 )
Month 3: Lower Limbs (n =2201, 572)	-1.75 ( 1.22 )	-2.26 ( 1.24 )
Month 6: Lower Limbs (n =2049, 563)	-1.78 ( 1.23 )	-2.3 ( 1.23 )
Month 12: Lower Limbs (n =1776, 531)	-1.82 ( 1.2 )	-2.17 ( 1.33 )
Month 24: Lower Limbs (n =1394, 449)	-1.85 ( 1.22 )	-2.28 ( 1.24 )
Month 36: Lower Limbs (n =1119, 384)	-1.93 ( 1.21 )	-2.22 ( 1.29 )
Month 48: Lower Limbs (n =422, 126)	-1.77 ( 1.18 )	-2.07 ( 1.24 )

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48

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End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2201	572
Units: units on a scale
arithmetic mean (standard deviation)
Month 1: Head/Neck (n =2195, 561)	-1.46 ( 1.19 )	-1.69 ( 1.2 )
Month 3: Head/Neck (n =2201, 572)	-1.51 ( 1.24 )	-1.78 ( 1.19 )
Month 6: Head/Neck (n =2049, 563)	-1.52 ( 1.24 )	-1.7 ( 1.22 )
Month 12: Head/Neck (n =1776, 531)	-1.56 ( 1.25 )	-1.61 ( 1.24 )
Month 24: Head/Neck (n =1394, 449)	-1.63 ( 1.24 )	-1.63 ( 1.27 )
Month 36: Head/Neck (n =1119, 384)	-1.68 ( 1.22 )	-1.64 ( 1.22 )
Month 48: Head/Neck (n =422, 126)	-1.53 ( 1.24 )	-1.58 ( 1.17 )
Month 1: Upper Limbs (n =2195, 561)	-1.44 ( 1.18 )	-1.84 ( 1.24 )
Month 3: Upper Limbs (n =2201, 572)	-1.47 ( 1.2 )	-1.97 ( 1.18 )
Month 6: Upper Limbs (n =2049, 563)	-1.49 ( 1.21 )	-1.94 ( 1.26 )
Month 12: Upper Limbs (n =1776, 531)	-1.52 ( 1.21 )	-1.82 ( 1.3 )
Month 24: Upper Limbs (n =1394, 449)	-1.56 ( 1.22 )	-1.96 ( 1.22 )
Month 36: Upper Limbs (n =1119, 384)	-1.65 ( 1.19 )	-1.93 ( 1.15 )
Month 48: Upper Limbs (n =422, 126)	-1.45 ( 1.19 )	-1.78 ( 1.22 )
Month 1: Trunk (n =2195, 561)	-1.58 ( 1.2 )	-1.98 ( 1.24 )
Month 3: Trunk (n =2201, 572)	-1.67 ( 1.22 )	-2.14 ( 1.14 )
Month 6: Trunk (n =2049, 563)	-1.7 ( 1.19 )	-2.14 ( 1.22 )
Month 12: Trunk (n =1776, 531)	-1.72 ( 1.21 )	-2.08 ( 1.23 )
Month 24: Trunk (n =1394, 449)	-1.77 ( 1.2 )	-2.11 ( 1.19 )
Month 36: Trunk (n =1119, 384)	-1.84 ( 1.2 )	-2.06 ( 1.23 )
Month 48: Trunk (n =422, 126)	-1.62 ( 1.19 )	-1.8 ( 1.18 )
Month 1: Lower Limbs (n =2195, 561)	-1.67 ( 1.24 )	-2.09 ( 1.3 )
Month 3: Lower Limbs (n =2201, 572)	-1.77 ( 1.26 )	-2.3 ( 1.23 )
Month 6: Lower Limbs (n =2049, 563)	-1.79 ( 1.27 )	-2.3 ( 1.25 )
Month 12: Lower Limbs (n =1776, 531)	-1.83 ( 1.26 )	-2.15 ( 1.36 )
Month 24: Lower Limbs (n =1394, 449)	-1.86 ( 1.27 )	-2.25 ( 1.24 )
Month 36: Lower Limbs (n =1119, 384)	-1.97 ( 1.23 )	-2.21 ( 1.26 )
Month 48: Lower Limbs (n =422, 126)	-1.77 ( 1.29 )	-2.11 ( 1.23 )

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

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End point title

Percentage of Subjects Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

End point description

PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=50% reduction from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2200	566
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =2194, 555)	76.53 (74.75 to 78.3)	86.67 (83.84 to 89.49)
Month 3 (n =2200, 566)	81.59 (79.97 to 83.21)	95.05 (93.27 to 96.84)
Month 6 (n =2048, 557)	85.64 (84.13 to 87.16)	93.9 (91.91 to 95.88)
Month 12 (n =1775, 525)	87.66 (86.13 to 89.19)	93.14 (90.98 to 95.3)
Month 24 (n =1393, 445)	88.87 (87.22 to 90.52)	94.61 (92.51 to 96.71)
Month 36 (n =1118, 380)	90.97 (89.29 to 92.65)	92.63 (90 to 95.26)
Month 48 (n =422, 124)	88.86 (85.86 to 91.86)	97.58 (94.88 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

Top of page

End point title

Percentage of Subjects Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

End point description

PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=90% reduction from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2200	566
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =2194, 555)	29.99 (28.07 to 31.91)	56.04 (51.91 to 60.17)
Month 3 (n =2200, 566)	33.73 (31.75 to 35.7)	65.37 (61.45 to 69.29)
Month 6 (n =2048, 557)	35.21 (33.14 to 37.27)	65.89 (61.95 to 69.83)
Month 12 (n =1775, 525)	35.94 (33.71 to 38.18)	61.71 (57.56 to 65.87)
Month 24 (n =1393, 445)	38.33 (35.78 to 40.89)	62.02 (57.51 to 66.53)
Month 36 (n =1118, 380)	43.02 (40.12 to 45.93)	60.53 (55.61 to 65.44)
Month 48 (n =422, 124)	34.36 (29.83 to 38.89)	58.06 (49.38 to 66.75)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores

Top of page

End point title

Percentage of Subjects Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores

End point description

PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=125% increase from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2200	566
Units: percentage of subjects
number (confidence interval 95%)
Month 1 (n =2194, 555)	0.96 (0.55 to 1.36)	1.08 (0.22 to 1.94)
Month 3 (n =2200, 566)	1.18 (0.73 to 1.63)	0.71 (0.02 to 1.4)
Month 6 (n =2048, 557)	1.27 (0.78 to 1.75)	0.9 (0.11 to 1.68)
Month 12 (n =1775, 525)	0.9 (0.46 to 1.34)	1.33 (0.35 to 2.31)
Month 24 (n =1393, 445)	0.93 (0.43 to 1.44)	0.9 (0.02 to 1.78)
Month 36 (n =1118, 380)	0.54 (0.11 to 0.96)	1.32 (0.17 to 2.46)
Month 48 (n =422, 124)	0.71 (0 to 1.51)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Itch Severity Item (ISI) Scores

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End point title

Itch Severity Item (ISI) Scores

End point description

ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Subjects were asked to rate their “severity of itching’’ due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms “0=no itching” and “10=worst possible itching” at the ends. Higher scores indicated greater severity of itching. FAS included all subjects who received at least 1 dose of study drug, excluding the subjects who had compliance issues. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2197	572
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n =2172, 566)	5.76 ( 2.91 )	5.17 ( 3 )
Month 1 (n =2196, 561)	1.88 ( 2.26 )	0.92 ( 1.53 )
Month 3 (n =2197, 572)	1.83 ( 2.32 )	0.72 ( 1.39 )
Month 6 (n =2047, 560)	1.87 ( 2.33 )	0.82 ( 1.51 )
Month 12 (n =1774, 530)	1.79 ( 2.21 )	1.08 ( 1.67 )
Month 24 (n =1394, 449)	1.83 ( 2.23 )	1.01 ( 1.54 )
Month 36 (n =1117, 383)	1.69 ( 2.12 )	1.21 ( 1.72 )
Month 48 (n =417, 127)	1.92 ( 2.3 )	1.24 ( 1.74 )

No statistical analyses for this end point

Secondary: Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

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End point title

Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2107	554
Units: units on a scale
arithmetic mean (standard deviation)
Month 1 (n =2107, 544)	-3.88 ( 3.06 )	-4.26 ( 3.07 )
Month 3 (n =2103, 554)	-3.94 ( 3.18 )	-4.44 ( 3.06 )
Month 6 (n =1958, 543)	-3.91 ( 3.2 )	-4.36 ( 3.14 )
Month 12 (n =1693, 514)	-3.9 ( 3.17 )	-4.01 ( 3.3 )
Month 24 (n =1340, 435)	-3.8 ( 3.14 )	-4.11 ( 3.17 )
Month 36 (n =1078, 372)	-3.95 ( 3.18 )	-3.84 ( 3.06 )
Month 48 (n =411, 126)	-4.03 ( 3.19 )	-3.78 ( 3.25 )

No statistical analyses for this end point

Secondary: Dermatology Life Quality Index (DLQI) Scores

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End point title

Dermatology Life Quality Index (DLQI) Scores

End point description

The DLQI is a validated, self-administered, 10-item quality-of-life questionnaire that consists of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2243	582
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n =2243, 582)	12.73 ( 7.12 )	10.95 ( 6.61 )
Month 1 (n =2189, 559)	4.11 ( 5.23 )	2.14 ( 3.43 )
Month 6 (n =2028, 557)	3.68 ( 5 )	1.67 ( 3.33 )
Month 12 (n =1751, 528)	3.44 ( 4.65 )	1.71 ( 2.92 )
Month 24 (n =1361, 441)	3.49 ( 4.71 )	1.94 ( 3.29 )
Month 36 (n =1093, 372)	2.97 ( 4.05 )	1.98 ( 3.35 )
Month 48 (n =407, 124)	3.2 ( 4.39 )	1.81 ( 2.98 )

No statistical analyses for this end point

Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48

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End point title

Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48

End point description

End point type

Secondary

End point timeframe

Baseline, Month 1, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2163	556
Units: units on a scale
arithmetic mean (standard deviation)
Month 1 (n =2163, 556)	-8.61 ( 7 )	-8.75 ( 6.56 )
Month 6 (n =2005, 554)	-9.14 ( 7.06 )	-9.22 ( 6.92 )
Month 12 (n =1730, 525)	-9.23 ( 6.91 )	-9.02 ( 6.68 )
Month 24 (n =1345, 438)	-9.08 ( 6.82 )	-8.47 ( 6.43 )
Month 36 (n =1083, 369)	-9.47 ( 6.8 )	-8.46 ( 6.14 )
Month 48 (n =404, 122)	-8.99 ( 6.74 )	-7.78 ( 6.1 )

No statistical analyses for this end point

Secondary: 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores

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End point title

36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores

End point description

The SF-36 questionnaire, version 2 is a 36-item generic health status measure. SF-36 evaluates 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranges from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranges from 0 (worst) to 100 (best), with higher scores indicating good health condition. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2233	580
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n =2233, 580)	47.31 ( 9.38 )	48.94 ( 9.12 )
Month 6 (n =2025, 557)	51.78 ( 8.24 )	53.51 ( 7.3 )
Month 12 (n =1750, 524)	51.96 ( 8.13 )	53.58 ( 7.19 )
Month 24 (n =1362, 442)	51.91 ( 7.8 )	53.15 ( 7.32 )
Month 36 (n =857, 286)	52.01 ( 8.08 )	53.05 ( 7.28 )
Month 48 (n =124, 56)	52.93 ( 6.79 )	52.36 ( 8.39 )

No statistical analyses for this end point

Secondary: 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores

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End point title

36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores

End point description

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2233	580
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n =2233, 580)	43.51 ( 11.98 )	43.96 ( 11.23 )
Month 6 (n =2025, 557)	48.86 ( 10.02 )	50.03 ( 9.14 )
Month 12 (n =1750, 524)	49.1 ( 9.89 )	49.78 ( 9.28 )
Month 24 (n =1362, 442)	49.22 ( 9.82 )	49.66 ( 9.54 )
Month 36 (n =857, 286)	49.21 ( 9.95 )	50.17 ( 8.2 )
Month 48 (n =124, 56)	50.14 ( 8.96 )	49.6 ( 8.24 )

No statistical analyses for this end point

Secondary: Number of Subjects With Patient Global Assessment (PtGA) Response of “Clear” or “Almost Clear”

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End point title

Number of Subjects With Patient Global Assessment (PtGA) Response of “Clear” or “Almost Clear”

End point description

The PtGA evaluated the overall skin disease of subjects at that point in time on a single-item. Subjects provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Subjects who provided their response as “clear (score of 0)” or “almost clear (score of 1)” in PtGA at each specified visit were reported in this endpoint. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2244	583
Units: subjects
Baseline: Clear (n =2244, 583)	1	3
Baseline: Almost Clear (n =2244, 583)	25	16
Month 1: Clear (n =2192, 561)	211	127
Month 1: Almost Clear (n =2192, 561)	703	246
Month 3: Clear (n =2177, 568)	248	174
Month 3: Almost Clear (n =2177, 568)	762	254
Month 6: Clear (n =2030, 562)	247	176
Month 6: Almost Clear (n =2030, 562)	748	265
Month 12: Clear (n =1758, 530)	209	151
Month 12: Almost Clear (n =1758, 530)	662	236
Month 24: Clear (n =1380, 449)	171	111
Month 24: Almost Clear (n =1380, 449)	502	202
Month 36: Clear (n =1112, 377)	162	75
Month 36: Almost Clear (n =1112, 377)	418	183
Month 48: Clear (n =410, 125)	40	25
Month 48: Almost Clear (n =410, 125)	151	60

No statistical analyses for this end point

Secondary: Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores

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End point title

Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores

End point description

EQ-5D: subject rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigns a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2242	581
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n =2242, 581)	0.77 ( 0.19 )	0.8 ( 0.17 )
Month 6 (n =2021, 559)	0.87 ( 0.15 )	0.91 ( 0.13 )
Month 12 (n =1750, 523)	0.88 ( 0.15 )	0.91 ( 0.13 )
Month 24 (n =1364, 443)	0.88 ( 0.14 )	0.9 ( 0.14 )
Month 36 (n =857, 284)	0.88 ( 0.14 )	0.91 ( 0.12 )
Month 48 (n =124, 56)	0.9 ( 0.13 )	0.89 ( 0.12 )

No statistical analyses for this end point

Secondary: Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)

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End point title

Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)

End point description

EQ-5D VAS was a subject rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2224	570
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n =2224, 570)	66.39 ( 23.2 )	68.21 ( 22.91 )
Month 6 (n =2026, 559)	78.28 ( 17.11 )	83.95 ( 16.18 )
Month 12 (n =1749, 525)	78.91 ( 16.95 )	83.8 ( 14.85 )
Month 24 (n =1365, 443)	79.8 ( 16.98 )	83.47 ( 15.55 )
Month 36 (n =856, 286)	79.43 ( 17.01 )	84.62 ( 14.28 )
Month 48 (n =124, 56)	82.14 ( 14.07 )	84.5 ( 16.87 )

No statistical analyses for this end point

Secondary: Number of Subjects Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)

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End point title

Number of Subjects Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)

End point description

Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included subject’s interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, subjects were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this endpoint, number of subjects who answered Ps-HCRU at any specified visits were reported.Safety analysis set included all subjects who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 12, 24, 36, 48

End point values	Tofacitinib 10 mg	Tofacitinib 5 mg or 10 mg
Number of subjects analysed	2281	586
Units: subjects
Baseline	156	44
Month 1	153	30
Month 3	204	55
Month 6	288	71
Month 12	234	71
Month 24	171	50
Month 36	114	30
Month 48	22	11

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Adverse event reporting additional description

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non serious in another subject, or one subject may have experienced both a serious and non serious event during the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Tofacitinib 5 mg or 10 mg

Reporting group description

Reporting group title

Tofacitinib 10 mg

Reporting group description

Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

Serious adverse events	Tofacitinib 5 mg or 10 mg	Tofacitinib 10 mg
Total subjects affected by serious adverse events
subjects affected / exposed	88 / 586 (15.02%)	304 / 2281 (13.33%)
number of deaths (all causes)	7	22
number of deaths resulting from adverse events	4	9
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	2 / 586 (0.34%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	1 / 2	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bowen’s disease
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	0 / 586 (0.00%)	5 / 2281 (0.22%)
occurrences causally related to treatment / all	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	2 / 586 (0.34%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer metastatic
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 0
Fibroadenoma of breast
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder cancer metastatic
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hairy cell leukaemia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Keratoacanthoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liposarcoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma metastatic
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Lung adenocarcinoma stage IV
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung cancer metastatic
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	1 / 2
Lung neoplasm
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 0	1 / 1
Malignant melanoma
subjects affected / exposed	1 / 586 (0.17%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma in situ
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm papilla of Vater
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Metastases to liver
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Metastases to pleura
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic neoplasm
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal cavity cancer
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oligodendroglioma
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	2 / 2
Pancreatic carcinoma metastatic
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	4 / 586 (0.68%)	10 / 2281 (0.44%)
occurrences causally related to treatment / all	2 / 4	7 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcomatosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer metastatic
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine adenocarcinoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	2 / 586 (0.34%)	4 / 2281 (0.18%)
occurrences causally related to treatment / all	0 / 3	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular malignant teratoma
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Throat cancer
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Aortic aneurysm rupture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial stenosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Deep vein thrombosis
subjects affected / exposed	1 / 586 (0.17%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 0
Hypertensive crisis
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subgaleal haematoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vein disorder
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden death
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Bartholin’s cyst
Additional description: This is gender specific event. The number of subjects evaluable for this event are 640 and 203.
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast pain
Additional description: This is gender specific event. The number of subjects evaluable for this event are 640 and 203.
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metrorrhagia
Additional description: This is gender specific event. The number of subjects evaluable for this event are 640 and 203.
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
Additional description: This is gender specific event. The number of subjects evaluable for this event are 640 and 203.
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic haematoma
Additional description: This is gender specific event. The number of subjects evaluable for this event are 640 and 203.
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatism
Additional description: This is gender specific event. The number of subjects evaluable for this event are 1641 and 383.
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
Additional description: This is gender specific event. The number of subjects evaluable for this event are 640 and 203.
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	2 / 2
Acute respiratory failure
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Bronchitis chronic
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	2 / 586 (0.34%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Organising pneumonia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	2 / 586 (0.34%)	7 / 2281 (0.31%)
occurrences causally related to treatment / all	1 / 2	2 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary infarction
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary thrombosis
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Sleep apnoea syndrome
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord polyp
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Completed suicide
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Depression
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device occlusion
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholangitis
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	1 / 586 (0.17%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Jaundice cholestatic
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
SEVERE REBOUND PSORIASIS - THE PATIENT’S LAST DOSE OF MEDICATION WAS 06 APR 2015 AND THE PATIENT BEG
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	3 / 586 (0.51%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 586 (0.17%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	3 / 586 (0.51%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	1 / 586 (0.17%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	1 / 586 (0.17%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 586 (0.00%)	7 / 2281 (0.31%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 2
Skin abrasion
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 0
Tendon rupture
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound haematoma
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Hydrocele
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 586 (0.17%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	2 / 586 (0.34%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Atrial fibrillation
subjects affected / exposed	1 / 586 (0.17%)	4 / 2281 (0.18%)
occurrences causally related to treatment / all	0 / 1	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	1 / 3
Cardiac valve disease
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	1 / 586 (0.17%)	5 / 2281 (0.22%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Coronary artery occlusion
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive cardiomyopathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Myocardial infarction
subjects affected / exposed	2 / 586 (0.34%)	6 / 2281 (0.26%)
occurrences causally related to treatment / all	0 / 2	2 / 6
deaths causally related to treatment / all	0 / 1	0 / 2
Myocardial ischaemia
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertonia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic stroke
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	2 / 586 (0.34%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 586 (0.17%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	1 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Hypoacusis
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden hearing loss
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tympanic membrane perforation
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	2 / 586 (0.34%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	2 / 586 (0.34%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital fat herniation
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn’s disease
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric vein thrombosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Noninfective sialoadenitis
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 586 (0.17%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertensive gastropathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland disorder
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erythrodermic psoriasis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	1 / 586 (0.17%)	6 / 2281 (0.26%)
occurrences causally related to treatment / all	1 / 1	2 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pustular psoriasis
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	2 / 586 (0.34%)	4 / 2281 (0.18%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive uropathy
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular acidosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric obstruction
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Thyroid cyst
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic nodular goitre
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 586 (0.34%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	2 / 586 (0.34%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone pain
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	2 / 586 (0.34%)	5 / 2281 (0.22%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament disorder
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 586 (0.00%)	7 / 2281 (0.31%)
occurrences causally related to treatment / all	0 / 0	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sacroiliitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal disorder
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal instability
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abscess limb
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	2 / 586 (0.34%)	5 / 2281 (0.22%)
occurrences causally related to treatment / all	1 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteriuria
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bartonellosis
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 586 (0.00%)	3 / 2281 (0.13%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 586 (0.00%)	6 / 2281 (0.26%)
occurrences causally related to treatment / all	0 / 0	4 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic tonsillitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 586 (0.17%)	6 / 2281 (0.26%)
occurrences causally related to treatment / all	1 / 1	7 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Ear infection
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Empyema
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder empyema
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer helicobacter
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes simplex meningitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 586 (0.00%)	7 / 2281 (0.31%)
occurrences causally related to treatment / all	0 / 0	7 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Listeria encephalitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis bacterial
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pertussis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pilonidal cyst
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	5 / 586 (0.85%)	16 / 2281 (0.70%)
occurrences causally related to treatment / all	2 / 5	11 / 16
deaths causally related to treatment / all	0 / 0	3 / 3
Pneumonia influenzal
subjects affected / exposed	2 / 586 (0.34%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Post procedural infection
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 586 (0.17%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Purulence
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal abscess
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal abscess
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syphilis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection bacterial
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 586 (0.17%)	4 / 2281 (0.18%)
occurrences causally related to treatment / all	0 / 1	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Viral rash
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound abscess
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	2 / 586 (0.34%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	1 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	0 / 586 (0.00%)	4 / 2281 (0.18%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 586 (0.17%)	0 / 2281 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 586 (0.00%)	1 / 2281 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	0 / 586 (0.00%)	2 / 2281 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Tofacitinib 5 mg or 10 mg	Tofacitinib 10 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	394 / 586 (67.24%)	1415 / 2281 (62.03%)
Investigations
Blood cholesterol increased
subjects affected / exposed	33 / 586 (5.63%)	86 / 2281 (3.77%)
occurrences all number	38	104
Blood creatine phosphokinase increased
subjects affected / exposed	92 / 586 (15.70%)	294 / 2281 (12.89%)
occurrences all number	118	392
Gamma-glutamyltransferase increased
subjects affected / exposed	38 / 586 (6.48%)	81 / 2281 (3.55%)
occurrences all number	48	96
Vascular disorders
Hypertension
subjects affected / exposed	44 / 586 (7.51%)	169 / 2281 (7.41%)
occurrences all number	48	180
Nervous system disorders
Headache
subjects affected / exposed	38 / 586 (6.48%)	119 / 2281 (5.22%)
occurrences all number	49	177
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	32 / 586 (5.46%)	73 / 2281 (3.20%)
occurrences all number	35	80
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	39 / 586 (6.66%)	148 / 2281 (6.49%)
occurrences all number	45	172
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	40 / 586 (6.83%)	164 / 2281 (7.19%)
occurrences all number	44	191
Infections and infestations
Bronchitis
subjects affected / exposed	48 / 586 (8.19%)	134 / 2281 (5.87%)
occurrences all number	61	166
Herpes zoster
subjects affected / exposed	33 / 586 (5.63%)	136 / 2281 (5.96%)
occurrences all number	34	141
Influenza
subjects affected / exposed	23 / 586 (3.92%)	126 / 2281 (5.52%)
occurrences all number	30	163
Nasopharyngitis
subjects affected / exposed	122 / 586 (20.82%)	476 / 2281 (20.87%)
occurrences all number	208	878
Upper respiratory tract infection
subjects affected / exposed	51 / 586 (8.70%)	264 / 2281 (11.57%)
occurrences all number	84	428
Urinary tract infection
subjects affected / exposed	42 / 586 (7.17%)	145 / 2281 (6.36%)
occurrences all number	69	209
Metabolism and nutrition disorders
Dyslipidaemia
subjects affected / exposed	52 / 586 (8.87%)	73 / 2281 (3.20%)
occurrences all number	66	88
Hypercholesterolaemia
subjects affected / exposed	30 / 586 (5.12%)	134 / 2281 (5.87%)
occurrences all number	35	159

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

01 Mar 2011

1. Proposed INN changed from tasocitinib to tofacitinib since WHO did not accept the name tasocitinib; 2. Protocol Summary, Study Design updated to clarify that beyond Month 12, study visit frequency occurs every three months up to at least two years post First Market Approval in a global, major market; 3. Section 7.1: Modified requirements for the psoriasis evaluator 1) to be a dermatologist (board certified or equivalent); an experienced and qualified non-dermatologist physician or medical professional may be permitted to perform these evaluations with approval of the Pfizer Clinician or designee, and 2) the same evaluator for a given subject to begin at the Baseline/Day 1 visit instead of the Screening visit(s) because the Screening psoriasis assessments are not used in data analysis.

25 Oct 2012

1.Protocol language updated globally to match CT02 language revisions: All references to “legally acceptable representative” changed to “legal representative” throughout document; Section 4.4.7.1 - changed “adequate” to “highly effective” method of contraception, clarified “one ovulatory cycle” by replacing with “at least 28 days”, added “correctly placed” and “or Intrauterine system (IUS)” to Intrauterine device method of contraception; 2. Exclusion criteria 4.2.2 added: Absolute lymphocyte count of <0.5 x 10^9 /L (<500/mm^3) at screening visit; 3.Section 9.5 Data Monitoring Committee name was changed to Data Safety Monitoring Board; 4. Study A3921147 has been added to the list of qualifying studies throughout the document; 5.Appendix 1: Additional medication armodafinil (Nuvigil) added to Prohibited Concomitant Medications list of moderate CYP3A inducers.Study Investigators were notified of this change by letter on 25 JAN 2012, and were notified that this change would be added to the protocol when an amendment was needed.

08 Apr 2013

1. Additional Hepatitis B test information added; 2. Single positive HBc Ab and a negative HBs Ab was added as a reason for subject discontinuation; 3.Name Tofacitinib citrate added.

01 May 2015

1.Sponsor designation of “CP-690,550” replaced by generic name “tofacitinib” throughout document except on title page and at initial appearance of “CP-690,550” in Section 1.1; 2. Section 4.4.5: removed ECG; 3. Sections 5.3.3 and 5.3.4: deleted dosing diary and compliance text based on dosing diary. Updated text for medication errors; 4. Section 6:deleted reference to ECG throughout section; 5. Section 6.2: deleted dosing diary reference, Short form 36 questionnaire (SF-36), EuroQoL 5 Dimensions (EQ 5D), Psoriasis Health Care Resource Utilization (Ps-HCRU); updated language regarding adjudication review; 6. Section 6.4.1: deleted PROs, vital signs, weight, waist and hip circumference, targeted physical exam, lipid panel, urinalysis, PASI, PGA, BSA, dosing diary; 7. Section 7.2: deleted SF-36, EQ 5D, Ps-HCRU; 8. Section 7.2.2 SF-36: deleted section; 9. Section 7.2.4 Ps-HCRU: deleted section; 10.Section 7.2.3 EC-5D: deleted section; 11. In Appendix 10: A3921061 Immunogenicity Substudy, pneumococcal data updated to titers/concentrations; Ig G “concentrations” rather than “titers” were evaluated.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
08 Mar 2016	The study was terminated by the sponsor on 08 March 2016 as it had met its objectives of characterizing long-term safety and tolerability.The study termination was not due to any safety concerns	-

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 PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

Primary: Number of Adverse Events by Severity

Primary: Number of Adverse Events by Severity

Primary: Number of Subjects With Laboratory Abnormalities

Primary: Number of Subjects With Laboratory Abnormalities

Primary: Change From Baseline in Hemoglobin Level at Month 1

Primary: Change From Baseline in Hemoglobin Level at Month 1

Primary: Change From Baseline in Hemoglobin Level at Month 3

Primary: Change From Baseline in Hemoglobin Level at Month 3

Primary: Change From Baseline in Hemoglobin Level at Month 6

Primary: Change From Baseline in Hemoglobin Level at Month 6

Primary: Change From Baseline in Hemoglobin Level at Month 12

Primary: Change From Baseline in Hemoglobin Level at Month 12

Primary: Change From Baseline in Hemoglobin Level at Month 24

Primary: Change From Baseline in Hemoglobin Level at Month 24

Primary: Change From Baseline in Hemoglobin Level at Month 36

Primary: Change From Baseline in Hemoglobin Level at Month 36

Primary: Change From Baseline in Hemoglobin Level at Month 48

Primary: Change From Baseline in Hemoglobin Level at Month 48

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 1

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 1

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 3

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 3

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 6

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 6

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 12

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 12

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 24

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 24

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 36

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 36

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 48

Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 48

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48

Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48

Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48

Primary: Number of Subjects With Clinically Significant Change From Baseline in Physical Examination

Primary: Number of Subjects With Clinically Significant Change From Baseline in Physical Examination

Primary: Number of Subjects With Vital Sign Abnormalities

Primary: Number of Subjects With Vital Sign Abnormalities

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3

Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3

Clinical Trial Results:
A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS