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Clinical Trial Results:
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis

Summary
EudraCT number	2014-003697-17
Trial protocol	DE ES RO
Global end of trial date	17 Jan 2017

Results information
Results version number	v1(current)
This version publication date	21 Feb 2018
First version publication date	21 Feb 2018
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

CR105964

ISRCTN number

US NCT number

NCT02319759

WHO universal trial number (UTN)

Sponsor organisation name

Janssen-Cilag International N.V.

Sponsor organisation address

Turnhoutseweg 30, Beerse, Belgium, 2340

Public contact

Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.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

17 Jan 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Jan 2017

Was the trial ended prematurely?

Main objective of the trial

The main objectives of this study were to evaluate the efficacy of guselkumab in subjects with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA and to assess the safety and tolerability of guselkumab in subjects with active PsA.

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki that are consistent with Good Clinical Practices and applicable regulatory requirements. The study protocol and amendment were reviewed by an Independent Ethics Committee (IEC) and Institutional Review Board (IRB). Subjects or their legally acceptable representatives provided their written consent to participate in the study after having been informed about the nature and purpose of the study, participation/termination conditions, and risks and benefits of treatment. Safety was evaluated throughout the study and included adverse events (AEs), including injection-site and allergic reactions, clinical laboratory tests, vital signs, physical examinations, concomitant medication review and early detection of active tuberculosis (TB). An independent data monitoring committee was commissioned for this study to review unblinded data at regularly scheduled intervals.

Background therapy

Stable dose of methotrexate [less than or equal to (<=) 25 milligram per week (mg/week)], oral corticosteroids [<=10 milligram (mg) of prednisone/day or equivalent], or nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics were permitted but not required.

Evidence for comparator

Actual start date of recruitment

27 Mar 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 6

Country: Number of subjects enrolled

Germany: 4

Country: Number of subjects enrolled

Spain: 9

Country: Number of subjects enrolled

Poland: 25

Country: Number of subjects enrolled

Romania: 5

Country: Number of subjects enrolled

Russian Federation: 89

Country: Number of subjects enrolled

United States: 11

Worldwide total number of subjects

149

EEA total number of subjects

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)

136

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

251 were screened; 149 were randomized into placebo (n=49) and guselkumab (n=100) treatment groups. Eligible Subjects had PsA for at least 6 months who met ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, >= 3 swollen and 3 tender joints,with C-reactive protein (CRP) level of >= 0.3 mg/dL, and >=3% body surface area of psoriasis.

Period 1 title

W0 - W16: placebo-controlled

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Subjects were randomized to receive subcutaneous (SC) injection of placebo for guselkumab at Weeks (W) 0, 4, 12, and 20, and guselkumab 100 mg at Weeks 24, 28, 36, and 44. Subjects who met the early escape (EE) criterion at week 16 switched to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the psoriatic arthritis (PsA) indication.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received matching placebo at Weeks 0, 4, 12, and 20.

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

CNTO1275

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

CNTO1959

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects in the placebo group crossed over and received 100 mg guselkumab at Weeks 24, 28, 36, and 44.

Guselkumab

Arm description

Subjects were randomized to receive SC injection of guselkumab 100 milligram (mg) at Weeks 0, 4, 12, 20, 28, 36, and 44, and placebo at Week 24. Subjects who met the EE criterion at week 16 switched to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Arm type

Experimental

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

CNTO1959

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 100 mg guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

CNTO1275

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received matching placebo at Weeks 24 for maintaining the blind.

Number of subjects in period 1	Placebo	Guselkumab
Started	49	100
Subjects Early escaped (EE) at Week 16	17 ^[1]	10 ^[2]
Completed	48	99
Not completed	1	1
unspecified	-	1
Lack of efficacy	1	-

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 17 subjects who early escaped from placebo to ustekinumab at Week 16 were considered as completers at Week 16.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 10 subjects who early escaped from guselkumab to ustekinumab at Week 16 were considered as completers at Week 16.

Period 2 title

W16 - W24: placebo-controlled

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Subjects were randomized to receive SC injection of placebo at Weeks 0, 4, 12, and 20, and guselkumab 100 mg at Weeks 24, 28, 36, and 44. Subjects who met the EE criterion at week 16 switched to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received matching placebo at Weeks 0, 4, 12, and 20.

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

CNTO1275

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

CNTO1959

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects in the placebo group crossed over and received 100 mg guselkumab at Weeks 24, 28, 36, and 44.

Guselkumab

Arm description

Subjects were randomized to receive SC injection of guselkumab 100 mg at Weeks 0, 4, 12, 20, 28, 36, and 44, and placebo at Week 24. Subjects who met the EE criterion at week 16 switched to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Arm type

Experimental

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

CNTO1959

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 100 mg guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received matching placebo at Weeks 24 for maintaining the blind.

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

CNTO1275

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Number of subjects in period 2 ^[3]	Placebo	Guselkumab
Started	31	89
Subjects EE to Ustekinumab at W16	17 ^[4]	10 ^[5]
Cross-over to/continue Guselkumab at W24	29	86
Completed	29	86
Not completed	2	3
Consent withdrawn by subject	-	2
Lost to follow-up	1	-
Lack of efficacy	1	1

Notes
[3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Subjects who early escaped at Week 16 were included in the completers in the preceding period but were not included in the number of subjects starting this period.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 17 subjects who early escaped from placebo to ustekinumab at Week 16 were counted in the previous period, but not in this period.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 10 subjects who early escaped from guselkumab to ustekinumab at Week 16 were counted in the previous period, but not counted in this period.

Period 3 title

W24 - W56: Active Treatment & Follow-up

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Crossover (Placebo to Guselkumab)

Arm description

Subjects remained in the placebo group at Week 24 crossed over to receive guselkumab at at Weeks 24, 28, 36, and 44.

Arm type

Experimental

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

CNTO1959

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects remaining in the placebo group at Week 24 crossed over to receive guselkumab 100 mg at Weeks 24, 28, 36 and 44.

Guselkumab

Arm description

Arm type

Experimental

Investigational medicinal product name

Guselkumab

Investigational medicinal product code

CNTO1959

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 100 mg guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

CNTO1275

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received matching placebo at Weeks 24 for maintaining the blind.

Number of subjects in period 3	Crossover (Placebo to Guselkumab)	Guselkumab
Started	29	86
Completed	28	84
Not completed	1	2
Consent withdrawn by subject	1	-
Adverse event, non-fatal	-	2

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Reporting group title

Guselkumab

Reporting group description

Reporting group values	Placebo	Guselkumab	Total
Number of subjects	49	100	149
Title for AgeCategorical
Units: subjects
Adults (18-64 years)	47	89	136
From 65 to 84 years	2	11	13
Title for AgeContinuous
Units: years
arithmetic mean (standard deviation)	44.2 ± 12.43	47.4 ± 12.83	-
Title for Gender
Units: subjects
Female	25	48	73
Male	24	52	76
Tender Joints Count TJC (0-68)
Units: Units on a scale
arithmetic mean (standard deviation)	20.1 ± 12.45	20.7 ± 12.16	-
Swollen Joints Count SJC (0-66)
Units: Units on a scale
arithmetic mean (standard deviation)	10.6 ± 7.51	11.9 ± 7.60	-
C-Reactive Protein (CRP)
Units: Milligram per deciliter (mg/dL)
median (inter-quartile range (Q1-Q3))	0.91 (0.4 to 2.0)	0.94 (0.5 to 1.8)	-
Psoriatic Area and Severity Index (PASI) score (0-72)
Units: Units on a scale
arithmetic mean (standard deviation)	9.88 ± 7.977	12.03 ± 10.520	-
Body Surface Area (BSA)
Units: Percentage
arithmetic mean (standard deviation)	13.6 ± 12.53	17.2 ± 15.57	-

End points

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Reporting group title

Placebo

Reporting group description

Reporting group title

Guselkumab

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

Guselkumab

Reporting group description

Reporting group title

Crossover (Placebo to Guselkumab)

Reporting group description

Subjects remained in the placebo group at Week 24 crossed over to receive guselkumab at at Weeks 24, 28, 36, and 44.

Reporting group title

Guselkumab

Reporting group description

Primary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

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End point title

Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

End point description

ACR 20 response is defined as >=20% improvement in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS) (scale ranges from 0=no arthritis activity to 100=extremely active arthritis),Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0= no difficulty to 3= inability to do task in that area), Serum CRP. Full analysis set (FAS) for efficacy endpoints through Week 24 include all randomized subjects who received at least 1 dose of study drug and analyzed based on their assigned treatment regardless of their actual treatment received. Subjects set to non-responders if they met treatment failure (TF), early escape (EE) criteria at week 16 or had data missing.

End point type

Primary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[1]	100 ^[2]
Units: Percentage of subjects
number (not applicable)	18.4	58.0

Notes
[1] - FAS population
[2] - FAS population

Statistical Analysis 1

Comparison groups

Guselkumab v Placebo

Number of subjects included in analysis

149

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

39.7

Confidence interval

level

95%

sides

2-sided

lower limit

25.3

upper limit

54.1

Secondary: Percentage of Subjects who Achieved a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24

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End point title

Percentage of Subjects who Achieved a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24

End point description

A PASI 75 response is defined as >= 75% improvement in PASI score from baseline. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from (0 [best] - 72 [worst]). The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. PASI response through Week 24 is based on the imputed PASI values with last observation carry forward (LOCF) for EE and missing data. Subjects with missing baseline were excluded from the analysis. Here, 'N' number of participants analysed are those who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	48 ^[3]	98 ^[4]
Units: Percentage of subjects
number (not applicable)	12.5	78.6

Notes
[3] - FAS population
[4] - FAS population

Statistical Analysis 1

Comparison groups

Placebo v Guselkumab

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

66.1

Confidence interval

level

95%

sides

2-sided

lower limit

53.8

upper limit

78.4

Secondary: Change from Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24

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End point title

Change from Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24

End point description

The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Based on the imputed HAQ-DI scores using last observation carry forward for EE and missing data.

End point type

Secondary

End point timeframe

Baseline and Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[5]	100 ^[6]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	1.34 ± 0.542	1.42 ± 0.621
Change at Week 24	-0.06 ± 0.530	-0.42 ± 0.512

Notes
[5] - FAS Population
[6] - FAS Population

Statistical Analysis 1

Comparison groups

Placebo v Guselkumab

Number of subjects included in analysis

149

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

LS Mean Difference

Point estimate

-0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-0.471

upper limit

-0.148

Variability estimate

Standard error of the mean

Dispersion value

0.082

Secondary: Percentage of Subjects who Achieved an ACR 20 Response at Week 16

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End point title

Percentage of Subjects who Achieved an ACR 20 Response at Week 16

End point description

ACR 20 response is defined as >=20% improvement in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0-no difficulty to 3-inability to perform a task in that area), and Serum C-reactive protein (CRP). Subjects were set to non-responders if they met TF criteria prior to week 16 or had data missing.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[7]	100 ^[8]
Units: Percentage of subjects
number (not applicable)	16.3	60.0

Notes
[7] - FAS Population
[8] - FAS population

Statistical Analysis 1

Comparison groups

Placebo v Guselkumab

Number of subjects included in analysis

149

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Percentage

Point estimate

43.6

Confidence interval

level

95%

sides

2-sided

lower limit

29.6

upper limit

57.6

Secondary: Percentage of Subjects who Achieved an ACR 50 Response at Week 24

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End point title

Percentage of Subjects who Achieved an ACR 50 Response at Week 24

End point description

ACR 20 response is defined as >=20% improvement in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0-no difficulty to 3-inability to perform a task in that area), and Serum C-reactive protein (CRP). Subjects were set to non-responders if they met TF, EE criteria prior to week 16 or had data missing.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[9]	100 ^[10]
Units: Percentage of Subjects
number (not applicable)	10.2	34.0

Notes
[9] - FAS Population
[10] - FAS Population

Statistical Analysis 1

Comparison groups

Placebo v Guselkumab

Number of subjects included in analysis

149

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

23.8

Confidence interval

level

95%

sides

2-sided

lower limit

11.3

upper limit

36.3

Secondary: Percent (%) Change from Baseline in Enthesitis Scores at Week 24 Among Subjects with Enthesitis at Baseline

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End point title

Percent (%) Change from Baseline in Enthesitis Scores at Week 24 Among Subjects with Enthesitis at Baseline

End point description

Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analysed' signifies that those subjects who had enthesitis at baseline and were evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	31 ^[11]	76 ^[12]
Units: Percent change
median (inter-quartile range (Q1-Q3))	-33.33 (-100.0 to 0.0)	-100.00 (-100.0 to -10.0)

Notes
[11] - Full Analysis Set with Enthesitis at Baseline
[12] - Full Analysis Set with Enthesitis at Baseline

Statistical Analysis 1

Comparison groups

Placebo v Guselkumab

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009

Method

Wilcoxon rank sum test

Confidence interval

Secondary: Percent Change from Baseline in Dactylitis Scores at Week 24 Among Subjects with Dactylitis at Baseline

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End point title

Percent Change from Baseline in Dactylitis Scores at Week 24 Among Subjects with Dactylitis at Baseline

End point description

Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analyzed' signifies that those subjects who had Dactylitis at baseline and were evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Guselkumab
Number of subjects analysed	23 ^[13]	58 ^[14]
Units: Percent change
median (inter-quartile range (Q1-Q3))	-33.33 (-66.7 to 0.0)	-100.00 (-100.00 to -50.0)

Notes
[13] - Full Analysis Set with Dactylitis at Baseline
[14] - Full Analysis Set with Dactylitis at Baseline

Statistical Analysis 1

Comparison groups

Placebo v Guselkumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Wilcoxon rank sum test

Confidence interval

Secondary: Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response Through Week 24

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End point title

Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response Through Week 24

End point description

ACR 20, 50 and 70 responses were defined as >= 20, 50 and 70 % improvement, respectively, in both TJC (68 joints) and SJC (66 joints) and >= 20, 50 and 70% improvement respectively in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0-no difficulty to 3-inability to perform a task in that area), and Serum C-reactive protein (CRP). Subjects were set to non-responders if they met TF, EE criteria prior to week 16 or had data missing.

End point type

Secondary

End point timeframe

Week 4, 8, 12, 16, 20 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49	100
Units: Percentage of subjects
number (not applicable)
Week 4: ACR 20	0	21
Week 4: ACR 50	0	0.1
Week 4: ACR 70	0	0
Week 8: ACR 20	22.4	42.0
Week 8: ACR 50	6.1	12.0
Week 8: ACR 70	2.0	4.0
Week 12: ACR 20	12.2	49.0
Week 12: ACR 50	6.1	15.0
Week 12: ACR 70	0	7.0
Week 16: ACR 50	6.1	30.0
Week 16: ACR 70	4.1	9.0
Week 20: ACR 20	22.4	63.0
Week 20: ACR 50	10.2	37.0
Week 20: ACR 70	2.0	11.0
Week 24: ACR 70	2.0	14.0

No statistical analyses for this end point

Secondary: Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response from Week 24 to 56

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End point title

Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response from Week 24 to 56 ^[15]

End point description

ACR 20, 50, 70 responses are defined as >=20, 50, 70% improvement, respectively, in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0= no difficulty to 3= inability to do task in that area), and Serum CRP. Post Week 24 Efficacy Analysis Set (EAS) included all randomized subjects who did not EE to ustekinumab at Week 16 and did not discontinue study treatment prior to or at Week 24. No data imputation rules applied after Week 24. Here ‘n’ signifies number of subjects analyzed at specific time-points.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 36, 44 and 56

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[16]	86 ^[17]
Units: Percentage of subjects
number (not applicable)
Week 24: ACR 20 (n= 86, 29)	31.0	66.3
Week 24: ACR 50 (n= 86, 29)	17.2	39.5
Week 24: ACR 70 (n= 86, 29)	3.4	16.3
Week 28: ACR 20 (n= 85, 28)	57.1	75.3
Week 28: ACR 50 (n= 85, 28)	28.6	44.7
Week 28: ACR 70 (n= 85, 28)	14.3	30.6
Week 32: ACR 20 (n= 84, 28)	60.7	75.0
Week 32: ACR 50 (n= 84, 28)	42.9	51.2
Week 32: ACR 70 (n= 84, 28)	21.4	29.8
Week 36: ACR 20 (n= 84, 28)	71.4	73.8
Week 36: ACR 50 (n= 84, 28)	46.4	48.8
Week 36: ACR 70 (n= 84, 27)	29.6	31.0
Week 44: ACR 20 (n= 84, 28)	75.0	77.4
Week 44: ACR 50 (n= 84, 28)	46.4	46.4
Week 44: ACR 70 (n= 84, 28)	25.0	26.2
Week 56: ACR 20 (n= 83, 27)	81.5	73.5
Week 56: ACR 50 (n= 83, 27)	66.7	53.0
Week 56: ACR 70 (n= 83, 28)	28.6	32.5

Notes
[16] - Post Week 24 EAS population
[17] - Post Week 24 EAS population

No statistical analyses for this end point

Secondary: Percent Change from Baseline in Selected ACR Components Through Week 24

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End point title

Percent Change from Baseline in Selected ACR Components Through Week 24

End point description

The selected ACR components were: TJC, SJC and CRP. LOCF method was used for missing data and to replace the data after EE for subjects who met EE criteria.

End point type

Secondary

End point timeframe

Baseline, Week 4, 8, 12, 16, 20 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[18]	100 ^[19]
Units: Percent change
median (inter-quartile range (Q1-Q3))
%Change at Week 4 (SJC)	-18.18 (-41.2 to 0.0)	-28.42 (-60.0 to 0.0)
%Change at Week 8 (SJC)	-33.33 (-50.0 to 0.0)	-51.47 (-84.7 to -11.1)
%Change at Week 12 (SJC)	-29.41 (-50.0 to 0.0)	-64.50 (-93.8 to -30.0)
%Change at Week 16 (SJC)	-16.67 (-66.7 to 7.7)	-71.43 (-100.0 to -33.3)
%Change at Week 20 (SJC)	-16.67 (-66.7 to 4.3)	-80.00 (-100.0 to -42.2)
%Change at Week 24 (SJC)	-11.76 (-59.1 to 11.8)	-84.11 (-100.0 to -43.2)
%Change at Week 4 (TJC)	-10.00 (-30.8 to 7.7)	-17.71 (-42.5 to 0.0)
%Change at Week 8 (TJC)	-18.75 (-46.8 to 15.4)	-40.59 (-67.9 to -17.3)
%Change at Week 12 (TJC)	-13.33 (-46.7 to 15.4)	-45.80 (-78.0 to -25.0)
%Change at Week 16 (TJC)	3.23 (-37.5 to 35.7)	-60.00 (-83.3 to -21.1)
%Change at Week 20 (TJC)	14.29 (-50.0 to 39.5)	-65.37 (-87.5 to -27.9)
%Change at Week 24 (TJC)	-5.56 (-53.1 to 30.8)	-70.00 (-89.6 to -23.7)
%Change at Week 4 (CRP)	-8.35 (-26.3 to 23.3)	-20.13 (-57.1 to 14.1)
%Change at Week 8 (CRP)	5.24 (-32.7 to 57.3)	-41.08 (-63.7 to 2.0)
%Change at Week 12 (CRP)	-3.95 (-41.3 to 51.2)	-42.95 (-69.8 to 10.7)
%Change at Week 16 (CRP)	-1.05 (-40.5 to 52.5)	-44.21 (-72.4 to -1.4)
%Change at Week 20 (CRP)	7.94 (-33.9 to 53.7)	-52.99 (-74.5 to -12.7)
%Change at Week 24 (CRP)	7.94 (-30.3 to 93.5)	-42.64 (-77.7 to 2.3)

Notes
[18] - FAS Population
[19] - FAS Population

No statistical analyses for this end point

Secondary: Percent Change from Baseline in Selected ACR Components from Week 24 to Week 56

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End point title

Percent Change from Baseline in Selected ACR Components from Week 24 to Week 56 ^[20]

End point description

The selected ACR components were TJC, SJC and CRP. Based on observed data in the post Week 24 efficacy analysis population, here ‘n’ is defined as “number of subjects analyzed’’ at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 36, 44 and 56

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[21]	86 ^[22]
Units: Percent change
median (inter-quartile range (Q1-Q3))
SJC %Change: Week 24 (n= 29, 86)	-33.33 (-80.0 to -11.8)	-85.71 (-100.0 to -63.3)
SJC % Change: Week 28 (n= 28, 85)	-69.05 (-83.3 to -32.7)	-93.75 (-100.0 to -60.9)
SJC % Change: Week 32 (n= 28, 84)	-84.91 (-95.8 to -50.0)	-100.00 (-100.00 to -73.9)
SJC % Change: Week 36 (n= 28, 84)	-79.14 (-100.0 to -57.7)	-93.93 (-100.0 to -66.7)
SJC % Change: Week 44 (n= 28, 84)	-86.11 (-100.0 to -64.6)	-94.56 (-100.0 to -70.6)
SJC % Change: Week 56 (n= 27, 83)	-100.00 (-100.00 to -63.6)	-100.00 (-100.00 to -75.0)
TJC % Change: Week 24 (n=29, 86)	-50.00 (-74.5 to -14.9)	-72.00 (-90.0 to -45.8)
TJC % Change: Week 28 (n=28, 85)	-65.99 (-83.3 to -17.0)	-74.36 (-91.3 to -50.0)
TJC % Change: Week 32 (n=28, 84)	-71.76 (-86.1 to -27.7)	-79.66 (-92.3 to -50.0)
TJC % Change: Week 36 (n=28, 84)	-81.67 (-91.2 to -27.1)	-73.32 (-94.6 to -50.5)
TJC % Change: Week 44 (n=28, 84)	-86.06 (-93.5 to -50.0)	-77.22 (-97.0 to -49.0)
TJC % Change: Week 56 (n=27, 83)	-80.00 (-93.8 to -51.2)	-77.27 (-100.0 to -58.8)
CRP % Change: Week 24 (n= 29, 86)	6.19 (-30.3 to 93.5)	-43.62 (-79.0 to 3.7)
CRP % Change: Week 28 (n= 28, 84)	-35.63 (-52.7 to -1.6)	-52.70 (-79.6 to -1.7)
CRP % Change: Week 32 (n= 28, 84)	-42.61 (-60.8 to -21.8)	-50.63 (-78.7 to -4.1)
CRP % Change: Week 36 (n= 28, 85)	-38.90 (-70.0 to -13.3)	-53.22 (-81.4 to -6.0)
CRP % Change: Week 44 (n= 28, 84)	-53.43 (-76.9 to -36.5)	-53.36 (-75.7 to -10.3)
CRP % Change: Week 56 (n= 28, 84)	-51.26 (-81.5 to -37.8)	-54.91 (-79.3 to -25.7)

Notes
[21] - Post Week 24 EAS population
[22] - Post Week 24 EAS population

No statistical analyses for this end point

Secondary: Change from Baseline in HAQ-DI score Through Week 24

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End point title

Change from Baseline in HAQ-DI score Through Week 24

End point description

The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. LOCF method was used to impute missing values. Last observation at or prior EE was used to replace data after EE for subjects who met EE criteria.

End point type

Secondary

End point timeframe

Baseline, Week 4, 8, 12, 16, 20 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[23]	100 ^[24]
Units: Units on a scale
arithmetic mean (standard deviation)
HAQ-DI: Baseline	1.34 ± 0.542	1.42 ± 0.621
Change at Week 4	-0.02 ± 0.329	-0.17 ± 0.322
Change at Week 8	-0.07 ± 0.440	-0.32 ± 0.442
Change at Week 12	-0.05 ± 0.450	-0.33 ± 0.390
Change at Week 16	-0.05 ± 0.428	-0.38 ± 0.397
Change at Week 20	-0.08 ± 0.479	-0.41 ± 0.453

Notes
[23] - FAS population
[24] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in HAQ-DI Score from Week 24 to Week 56

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End point title

Change from Baseline in HAQ-DI Score from Week 24 to Week 56 ^[25]

End point description

The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Based on observed data in the post Week 24 Efficacy Analysis Set. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 36, 44 and 56

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[26]	86 ^[27]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 24 (n= 29, 86)	-0.19 ± 0.581	-0.46 ± 0.530
Change at Week 28 (n= 28, 85)	-0.40 ± 0.646	-0.51 ± 0.571
Change at Week 32 (n= 28, 84)	-0.50 ± 0.624	-0.56 ± 0.595
Change at Week 36 (n= 28, 84)	-0.59 ± 0.650	-0.53 ± 0.618
Change at Week 44 (n= 28, 84)	-0.63 ± 0.612	-0.54 ± 0.598
Change at Week 56 (n= 28, 83)	-0.67 ± 0.558	-0.55 ± 0.621

Notes
[26] - Post Week 24 EAS population
[27] - Post Week 24 EAS population

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) Through Week 24

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End point title

Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) Through Week 24

End point description

The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. HAQ-DI response is defined as at least 0.30 improvement from baseline in HAQ-DI score and based on the imputed HAQ-DI score using LOCF for missing data and early escape.

End point type

Secondary

End point timeframe

Week 4, 8, 12, 16, 20 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[28]	100 ^[29]
Units: Percentage of subjects
number (not applicable)
Week 4	12.2	29.0
Week 8	26.5	43.0
Week 12	22.4	47.0
Week 16	20.4	50.0
Week 20	22.4	48.0
Week 24	28.6	51.0

Notes
[28] - FAS Population
[29] - FAS Population

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) from Week 24 to Week 56

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End point title

Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) from Week 24 to Week 56 ^[30]

End point description

The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. HAQ-DI response is defined as at least 0.30 improvement from baseline in HAQ-DI score and is based on observed values in the post week 24 efficacy analysis set. Here, N 'number of subjects analyzed' signifies that these subjects were evaluable for this endpoint and ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 36, 44 and 56

Notes
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[31]	86 ^[32]
Units: Percentage of subjects
number (not applicable)
Week 24 (n=29, 86)	44.8	55.8
Week 28 (n=28, 85)	53.6	60.0
Week 32 (n=28, 84)	57.1	56.0
Week 36 (n=28, 84)	64.3	59.5
Week 44 (n=28, 84)	71.4	61.9
Week 56 (n=28, 83)	75.0	59.0

Notes
[31] - Post Week 24 EAS population
[32] - Post Week 24 EAS population

No statistical analyses for this end point

Secondary: Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline Through Week 24

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End point title

Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline Through Week 24

End point description

End point type

Secondary

End point timeframe

Week 4, 8, 16

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[33]	100 ^[34]
Units: Percent change
median (inter-quartile range (Q1-Q3))
% change at Week 4	-33.33 (-50.0 to 0.0)	-32.46 (-100.0 to 0.0)
% change at Week 8	-50.00 (-100.0 to 0.0)	-75.00 (-100.0 to -10.0)
% change at Week 16	-50.00 (-80.0 to 0.0)	-100.00 (-100.0 to -33.3)

Notes
[33] - FAS Population
[34] - FAS Population

No statistical analyses for this end point

Secondary: Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline from Week 24 to Week 56

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End point title

Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline from Week 24 to Week 56 ^[35]

End point description

Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. Based on observed values in post Week 24 efficacy analysis set among subjects with dactylitis at baseline. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 44 and 56

Notes
[35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	16 ^[36]	50 ^[37]
Units: Percent change
median (inter-quartile range (Q1-Q3))
% change at Week 24 (n= 16, 50)	-45.00 (-70.8 to 0.0)	-100.00 (-100.00 to -80.0)
% change at Week 28 (n= 16, 49)	-70.83 (-100.0 to -22.5)	-100.00 (-100.0 to -66.7)
% change at Week 32 (n= 16, 49)	-100.00 (-100.00 to 79.2)	-100.00 (-100.00 to -70.0)
% change at Week 44 (n= 16, 49)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)
% change at Week 56 (n= 16, 48)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -95.0)

Notes
[36] - Post Week 24 EAS with Dactylitis at Baseline
[37] - Post Week 24 EAS with Dactylitis at Baseline

No statistical analyses for this end point

Secondary: Percentage of Subjects with One or More Digits with Dactylitis Through Week 24 in Subjects with Dactylitis at Baseline

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End point title

Percentage of Subjects with One or More Digits with Dactylitis Through Week 24 in Subjects with Dactylitis at Baseline

End point description

End point type

Secondary

End point timeframe

Week 4, 8, 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	23 ^[38]	58 ^[39]
Units: Percentage of subjects
number (not applicable)
Week 4	91.3	72.4
Week 8	69.6	56.9
Week 16	78.3	48.3
Week 24	82.6	44.8

Notes
[38] - FAS population with Dactylitis at Baseline
[39] - FAS population with Dactylitis at Baseline

No statistical analyses for this end point

Secondary: Percentage of Subjects with One or More Digits with Dactylitis from Week 24 to Week 56 in Subjects with Dactylitis at Baseline

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End point title

Percentage of Subjects with One or More Digits with Dactylitis from Week 24 to Week 56 in Subjects with Dactylitis at Baseline ^[40]

End point description

Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. Based on observed values in post Week 24 efficacy analysis set, among subjects with dactylitis at baseline. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 44 and 56

Notes
[40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	16 ^[41]	50 ^[42]
Units: Percentage of subjects
number (not applicable)
Week 24 (n= 16, 50)	81.3	40.0
Week 28 (n= 16, 49)	62.5	38.8
Week 32 (n= 16, 49)	31.3	36.7
Week 44 (n= 16, 49)	12.5	20.4
Week 56 (n= 16, 48)	6.3	25.0

Notes
[41] - Post Week 24 FAS with Dactylitis at Baseline
[42] - Post Week 24 FAS with Dactylitis at Baseline

No statistical analyses for this end point

Secondary: Percent Change from Baseline in the Enthesitis Score Through Week 24 in Subjects with Enthesitis at Baseline

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End point title

Percent Change from Baseline in the Enthesitis Score Through Week 24 in Subjects with Enthesitis at Baseline

End point description

Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analyzed' signifies that these subjects were evaluated with Enthesitis at Baseline for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 4, 8, 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	31 ^[43]	76 ^[44]
Units: Percent Change
median (inter-quartile range (Q1-Q3))
% change at Week 4	0.00 (-50.0 to 0.0)	-18.33 (-79.2 to 0.0)
% change at Week 8	0.00 (-60.0 to 0.0)	-58.33 (-100.0 to 0.0)
% change at Week 16	0.00 (-50.0 to 0.0)	-70.83 (-100.0 to 0.0)
% change at Week 24	-33.33 (-100.0 to 0.0)	-100.00 (-100.0 to -10.0)

Notes
[43] - FAS population
[44] - FAS population

No statistical analyses for this end point

Secondary: Percent Change from Baseline in the Enthesitis Score from Week 24 to Week 56 in Subjects with Enthesitis at Baseline

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End point title

Percent Change from Baseline in the Enthesitis Score from Week 24 to Week 56 in Subjects with Enthesitis at Baseline ^[45]

End point description

Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Based on observed values in the post Week 24 efficacy analysis set with enthesitis at baseline. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 44 and 56

Notes
[45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	18 ^[46]	67 ^[47]
Units: Percent change
median (inter-quartile range (Q1-Q3))
% change at Week 24 (n= 18, 67)	-50.00 (-100.0 to 0.0)	-100.00 (-100.0 to -50.0)
% change at Week 28 (n= 17, 67)	-60.00 (-100.0 to -40.0)	-100.00 (-100.0 to -50.0)
% change at Week 32 (n= 17, 66)	-100.00 (-100.0 to -60.0)	-100.00 (-100.00 to -66.7)
% change at Week 44 (n= 17, 66)	-100.00 (-100.00 to -60.0)	-100.00 (-100.00 to -50.0)
% change at Week 56 (n= 16, 65)	-100.00 (-100.00 to -35.0)	-100.00 (-100.00 to -50.0)

Notes
[46] - Post Week 24 EAS with Enthesitis at Baseline
[47] - Post Week 24 EAS with Enthesitis at Baseline

No statistical analyses for this end point

Secondary: Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline Through Week 24

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End point title

Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline Through Week 24

End point description

Enthesitis were be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analyzed' signifies that these subjects were evaluated with Enthesitis at Baseline for this endpoint.

End point type

Secondary

End point timeframe

Week 4, 8, 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	31 ^[48]	76 ^[49]
Units: Percentage of subjects
number (not applicable)
Week 4	87.1	76.3
Week 8	87.1	59.2
Week 16	83.9	53.9
Week 24	71.0	43.4

Notes
[48] - Subjects in FAS with Enthesitis at Baseline
[49] - Subjects in FAS with Enthesitis at Baseline

No statistical analyses for this end point

Secondary: Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline from Week 24 to Week 56

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End point title

Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline from Week 24 to Week 56 ^[50]

End point description

Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Based on the observed values in the post Week 24 efficacy analysis set with enthesitis at baseline. Here, N 'number of subjects analyzed' signifies that these subjects were evaluated with Enthesitis at Baseline for this endpoint in the post Week 24 efficacy analysis set and ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 44 and 56

Notes
[50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	18 ^[51]	67 ^[52]
Units: Percentage of Subjects
number (not applicable)
Week 24 (n=18, 67)	66.7	38.8
Week 28 (n=17, 67)	64.7	44.8
Week 32 (n=17, 66)	35.3	31.8
Week 44 (n=17, 66)	47.1	37.9
Week 56 (n=16, 65)	37.5	29.2

Notes
[51] - Post week 24 EAS with Enthesitis at Baseline
[52] - Post week 24 in EAS with Enthesitis at Baseline

No statistical analyses for this end point

Secondary: Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Score Through Week 24

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End point title

Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Score Through Week 24

End point description

PASDAS is calculated using variables: patient global VAS (arthritis, psoriasis rescaled to 0 [excellent]–100[Poor]),physician global VAS (rescaled to 0 [no arthritis]–100 [extremely active arthritis]),66 SJC 68 TJC, CRP level (mg/L), enthesitis (measured by LEI and rescaled to 0 [nontenderness]–6 [tenderness] range), tender dactylitis count (scoring each digit from 0 [no dactylitis]–3[severe dactylitis] and recoding to 0–1, with score >0 equaled 1), and PCS scale of 36-item short form health survey (SF-36). The score ranges from 0 to10. Smaller values mean better condition; a negative change from baseline shows improvement. LOCF method was used to impute missing data and Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.

End point type

Secondary

End point timeframe

Baseline, Week 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[53]	100 ^[54]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	6.33 ± 1.032	6.62 ± 1.094
Change at Week 16	-0.45 ± 1.099	-2.24 ± 1.458
Change at Week 24	-0.49 ± 1.333	-2.50 ± 1.587

Notes
[53] - FAS population
[54] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in PASDAS Score from Week 24 to 44

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End point title

Change from Baseline in PASDAS Score from Week 24 to 44 ^[55]

End point description

PASDAS is calculated using variables: patient global VAS (arthritis, psoriasis rescaled to 0 [excellent]–100[Poor]),physician global VAS (rescaled to 0 [no arthritis]–100 [extremely active arthritis]),66 SJC 68 TJC, CRP level (mg/L), enthesitis (measured by LEI and rescaled to 0 [nontenderness]–6 [tenderness] range), tender dactylitis count (scoring each digit from 0 [no dactylitis]–3[severe dactylitis] and recoding to 0–1, with score >0 equaled 1), and PCS scale of 36-item short form health survey (SF-36). The score ranges from 0 to10. Smaller values mean better condition; a negative change from baseline shows improvement. Based on observed data in the post Week 24 efficacy analyisis set. Here‘n’ signifies number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24 and 44

Notes
[55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[56]	86 ^[57]
Units: Units on a Scale
arithmetic mean (standard deviation)
Change at Week 24 (n=28, 86)	-1.05 ± 1.440	-2.80 ± 1.454
Change at Week 44 (n=28, 83)	-3.17 ± 1.524	-3.15 ± 1.570

Notes
[56] - Post Week 24 EAS population
[57] - Post Week 24 EAS population

No statistical analyses for this end point

Secondary: Change from Baseline in Grappa Composite Score (GRACE) Index Through Week 24

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End point title

Change from Baseline in Grappa Composite Score (GRACE) Index Through Week 24

End point description

GRACE index is GRAPPA composite score, which is [1- Arithmetic Mean of the Desirability Function(AMDF)]*10. AMDF is calculated using the following parameters: TJC (0-68), SJC (0-66), HAQ(0-3), Patient’s global assessment of disease activity by VAS(arthritis and psoriasis, 0-100 mm), Patient’s assessment of skin disease activity by VAS (0-100 mm), Patient’s global assessment of disease activity(arthritis) by VAS(0-100 mm), PASI(0-72), Psoriatic arthritis Quality of Life Index (PsAQOL), derived as 25.355+ (2.367*HAQ)–(0.234*PCS)–(0.244*MCS). LOCF method was used to impute missing values. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria. Subjects with missing baseline were excluded from the analysis. Here, ‘n’ signifies number of subjects analyzed at specific time-points.

End point type

Secondary

End point timeframe

Baseline, Week 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[58]	100 ^[59]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n= 48, 98)	5.94 ± 1.119	6.15 ± 1.250
Change at Week 16 (n= 48, 98)	-0.29 ± 1.174	-2.49 ± 1.614
Change at Week 24 (n= 48, 98)	-0.35 ± 1.394	-2.73 ± 1.756

Notes
[58] - FAS population
[59] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in GRACE Index from Week 24 to 44

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End point title

Change from Baseline in GRACE Index from Week 24 to 44 ^[60]

End point description

GRACE index is GRAPPA composite score, which is [1- Arithmetic Mean of the Desirability Function(AMDF)]*10. AMDF is calculated using the following parameters: TJC (0-68), SJC (0-66), HAQ(0-3), Patient’s global assessment of disease activity by VAS(arthritis and psoriasis, 0-100 mm), Patient’s assessment of skin disease activity by VAS (0-100 mm), Patient’s global assessment of disease activity(arthritis) by VAS(0-100 mm), PASI(0-72), Psoriatic arthritis Quality of Life Index (PsAQOL), derived as 25.355+ (2.367*HAQ)–(0.234*PCS)–(0.244*MCS). Based on observed values in the post Week 24 efficacy analysis set. Here, ‘n’ signifies number of subjects analyzed at specific time-points.

End point type

Secondary

End point timeframe

Week 24 and 44

Notes
[60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[61]	86 ^[62]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 24 (n= 27, 85)	-0.91 ± 1.498	-2.96 ± 1.717
Change at Week 44 (n= 27, 82)	-3.21 ± 1.698	-3.26 ± 1.856

Notes
[61] - Post week 24 EAS population
[62] - Post week 24 EAS population

No statistical analyses for this end point

Secondary: Change from Baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24

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End point title

Change from Baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24

End point description

The mCPDAI assesses 4 domains (joints, skin, entheses, and dactylitis) and calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0 [not involved in specific condition] to 3 (severe condition]) is assigned. Higher score range indicates severe condition. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria. Subjects with missing baseline were excluded from the analysis. Here, ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Baseline, Week 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[63]	100 ^[64]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline (n= 48, 98)	6.9 ± 2.16	7.8 ± 2.27
Change at Week 16 (n= 48, 98)	-0.5 ± 2.00	-3.3 ± 2.52
Change at Week 24 (n= 48, 98)	-0.8 ± 2.26	-3.9 ± 2.79

Notes
[63] - FAS population
[64] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in mCPDAI Score at Week 24 and Week 44

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End point title

Change from Baseline in mCPDAI Score at Week 24 and Week 44 ^[65]

End point description

The mCPDAI assesses 4 domains (joints, skin, entheses, and dactylitis) and calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0 [not involved in specific condition] to 3 (severe condition]) is assigned. Higher score range indicates severe condition. Based on observed values in the Post Week 24 Efficacy Analysis Set. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24 and 44

Notes
[65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[66]	86 ^[67]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 24 (n= 27, 85)	-1.6 ± 2.27	-4.3 ± 2.70
Change at Week 44 (n= 27, 82)	-4.4 ± 2.79	-5.0 ± 2.48

Notes
[66] - Post week 24 EAS population
[67] - Post week 24 EAS population

No statistical analyses for this end point

Secondary: Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Index Through Week 24

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End point title

Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Index Through Week 24

End point description

DAPSA is calculated as the sum of the following components: tender joint count (0 [non-tenderness]– 68 [tenderness]), swollen joint count (0[not swollen]–66 [swollen]), CRP level (milligram per deciliter [mg/dL]), patient VAS for pain (0 [no pain]–10 [the worst possible pain]), and patient VAS for global disease activity (arthritis, 0[Excellent] –10[Poor]). Higher score indicates more severe condition. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.

End point type

Secondary

End point timeframe

Baseline, Week 4, 8, 12, 16, 20 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[68]	100 ^[69]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	45.16 ± 19.990	47.38 ± 20.645
Change at Week 4	-5.62 ± 13.030	-10.03 ± 11.207
Change at Week 8	-8.25 ± 15.158	-16.65 ± 15.948
Change at Week 12	-6.84 ± 16.334	-18.84 ± 16.266
Change at Week 16	-4.98 ± 16.045	-21.26 ± 17.811
Change at Week 20	-4.70 ± 17.408	-22.56 ± 19.918
Change at Week 24	-4.97 ± 20.114	-23.08 ± 20.206

Notes
[68] - FAS population
[69] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in DAPSA Index from Week 24 to Week 56

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End point title

Change from Baseline in DAPSA Index from Week 24 to Week 56 ^[70]

End point description

DAPSA is calculated as the sum of the following components: tender joint count (0 [non-tenderness]– 68 [tenderness]), swollen joint count (0[not swollen]–66 [swollen]), CRP level (milligram per deciliter [mg/dL]), patient VAS for pain (0 [no pain]–10 [the worst possible pain]), and patient VAS for global disease activity (arthritis, 0[Excellent] –10[Poor]). Higher score indicates more severe condition. Based on observed data in the Post Week 24 Efficacy Analysis Set. Here ‘n’ signifies the number of subjects analyzed at specific time-points.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 36, 44 and 56

Notes
[70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[71]	86 ^[72]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 24 (n=29, 86)	-12.99 ± 22.328	-26.93 ± 18.238
Change at Week 28 (n=28, 85)	-20.85 ± 21.434	-29.71 ± 18.911
Change at Week 32 (n=28, 84)	-26.12 ± 21.309	-30.59 ± 19.720
Change at Week 36 (n=28, 85)	-27.37 ± 22.480	-30.43 ± 18.114
Change at Week 44 (n=28, 84)	-29.54 ± 20.785	-30.55 ± 18.188
Change at Week 56 (n=28, 84)	-31.98 ± 20.359	-32.02 ± 18.328

Notes
[71] - Post week 24 EAS population
[72] - Post week 24 EAS population

No statistical analyses for this end point

Secondary: Percentage of Subjects who Achieved a Minimal Disease Activity (MDA) at Week 16 and 24

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End point title

Percentage of Subjects who Achieved a Minimal Disease Activity (MDA) at Week 16 and 24

End point description

MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient’s perspective of pain and disease activity, physical function and enthesitis). Subjects were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <= 1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity on arthritis and psoriasis VAS score of <=20; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1. Subjects were set to non-responders if they met TF, EE criteria prior to week 16 or had data missing.

End point type

Secondary

End point timeframe

Week 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[73]	100 ^[74]
Units: Percentage of subjects
number (not applicable)
Week 16	0	18.0
Week 24	2.0	23.0

Notes
[73] - FAS population
[74] - FAS population

No statistical analyses for this end point

Secondary: Percentage of Subjects who Achieved a MDA at Week 24 and 44

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End point title

Percentage of Subjects who Achieved a MDA at Week 24 and 44 ^[75]

End point description

MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient’s perspective of pain and disease activity, physical function and enthesitis). Subjects were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <= 1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity on arthritis and psoriasis VAS score of<=20; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1. Based on observed data in the Post Week 24 Efficacy Analysis Set. Here, ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24 and 44

Notes
[75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[76]	86 ^[77]
Units: Percentage of subjects
number (not applicable)
Week 24 (n= 29, 86)	3.4	26.7
Week 44 (n= 28, 84)	28.6	34.5

Notes
[76] - Post week 24 EAS population
[77] - Post week 24 EAS population

No statistical analyses for this end point

Secondary: Change from Baseline in Physical Component Summary Scores (PCS) and Mental Component Summary Scores (MCS) of the 36-item Short Form Healthy Survey (SF-36) at Week 16 and 24

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End point title

Change from Baseline in Physical Component Summary Scores (PCS) and Mental Component Summary Scores (MCS) of the 36-item Short Form Healthy Survey (SF-36) at Week 16 and 24

End point description

SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 with higher scores= better health. Based on scale scores, summary scores, PCS and MCS were derived using algorithm. Summary MCS and PCS score is also scaled from 0 to 100 and normalized based on general population with higher scores= better health. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria.

End point type

Secondary

End point timeframe

Baseline, Week 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[78]	100 ^[79]
Units: Units on a scale
arithmetic mean (standard deviation)
PCS: Baseline	34.39 ± 8.014	33.46 ± 7.093
PCS: Change at Week 16	-0.44 ± 5.025	5.86 ± 7.315
PCS: Change at Week 24	0.46 ± 6.513	6.59 ± 7.465
MCS: Baseline	45.99 ± 12.523	43.27 ± 11.481
MCS: Change at Week 16	1.14 ± 7.075	4.80 ± 8.952
MCS: Change at Week 24	0.42 ± 6.737	4.95 ± 9.064

Notes
[78] - FAS population
[79] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in PCS and MCS of the 36-item Short Form Healthy Survey (SF-36) at Week 24 to 44

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End point title

Change from Baseline in PCS and MCS of the 36-item Short Form Healthy Survey (SF-36) at Week 24 to 44 ^[80]

End point description

SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 with higher scores= better health. Based on scale scores, summary scores, PCS and MCS were derived using algorithm. Summary MCS and PCS score is also scaled from 0 to 100 and normalized based on general population with higher scores= better health. Based on observed data in the Post Week 24 Efficacy Analysis set. Here, 'n’ signifies number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24 and 44

Notes
[80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[81]	86 ^[82]
Units: Units on a scale
arithmetic mean (standard deviation)
PCS: Change at Week 24 (n= 28, 86)	2.13 ± 7.365	7.40 ± 7.448
PCS: Change at Week 44 (n= 28, 84)	8.02 ± 8.647	8.34 ± 8.783
MCS: Change at Week 24 (n= 28, 86)	0.51 ± 6.770	5.45 ± 9.081
MCS: Change at Week 44 (n= 28, 84)	5.53 ± 9.013	4.56 ± 9.548

Notes
[81] - Post week 24 EAS population
[82] - Post week 24 EAS population

No statistical analyses for this end point

Secondary: Change from Baseline in Norm-based scores of SF-36 Scales at Week 16 and 24

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End point title

Change from Baseline in Norm-based scores of SF-36 Scales at Week 16 and 24

End point description

SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 and normalized based on general population, with higher scores= better health. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria.

End point type

Secondary

End point timeframe

Baseline, Week 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[83]	100 ^[84]
Units: Units on a scale
arithmetic mean (standard deviation)
Physical functioning: Baseline	34.61 ± 9.396	32.95 ± 8.854
Physical functioning: Change at Week 16	-0.31 ± 6.657	6.30 ± 7.255
Physical functioning: Change at Week 24	-0.04 ± 8.227	6.93 ± 8.009
Role-physical: Baseline	36.90 ± 7.879	34.99 ± 7.776
Role-physical: Change at Week 16	-0.23 ± 5.674	4.22 ± 7.146
Role-physical: Change at Week 24	-0.09 ± 6.813	4.69 ± 7.961
Bodily pain: Baseline	35.82 ± 6.255	34.72 ± 6.294
Bodily pain: Change at Week 16	0.21 ± 5.675	6.56 ± 7.832
Bodily pain: Change at Week 24	0.81 ± 6.445	7.56 ± 8.288
General health: Baseline	38.57 ± 8.758	37.27 ± 7.597
General health: Change at Week 16	0.74 ± 5.857	6.19 ± 7.964
General health: Change at Week 24	1.49 ± 7.274	6.48 ± 7.676
Vitality: Baseline	42.29 ± 10.576	41.22 ± 10.012
Vitality: Change at Week 16	0.73 ± 7.779	5.85 ± 8.138
Vitality: Change at Week 24	1.46 ± 7.254	6.39 ± 8.861
Social functioning: Baseline	41.99 ± 9.837	39.39 ± 10.157
Social functioning: Change at Week 16	-0.82 ± 8.272	5.87 ± 9.346
Social functioning: Change at Week 24	-0.82 ± 7.613	6.22 ± 10.426
Role-emotional: Baseline	43.02 ± 10.133	40.05 ± 11.476
Role-emotional: Change at Week 16	1.14 ± 8.774	4.77 ± 9.643
Role-emotional: Change at Week 24	0.64 ± 8.754	4.67 ± 9.393
Mental health: Baseline	42.33 ± 11.818	39.80 ± 10.621
Mental health: Change at Week 16	1.28 ± 7.007	5.10 ± 8.683
Mental health: Change at Week 24	0.21 ± 7.020	5.68 ± 8.877

Notes
[83] - FAS population
[84] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in Norm-based scores of SF-36 Scales at Week 24 and 44

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End point title

Change from Baseline in Norm-based scores of SF-36 Scales at Week 24 and 44 ^[85]

End point description

SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 and normalized based on general population, with higher scores= better health. Based on observed values in the Post Week 24 Efficacy Analysis set. Here, N 'number of subjects analyzed' signifies that these subjects were evaluable for this endpoint and ‘n’ signifies number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24 and 44

Notes
[85] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[86]	86 ^[87]
Units: Units on a scale
arithmetic mean (standard deviation)
Physical function: Change at Week 24(n=28,86)	1.09 ± 8.953	7.54 ± 8.228
Physical function: Change at Week 44(n=28,84)	8.41 ± 9.969	8.50 ± 8.633
Role-physical: Change at Week 24(n=28,86)	1.92 ± 7.119	5.74 ± 7.480
Role-physical: Change at Week 44(n=28,84)	6.82 ± 9.198	6.66 ± 7.664
Bodily pain: Change at Week 24(n=28,86)	2.88 ± 6.856	8.39 ± 8.332
Bodily pain: Change at Week 44(n=28,84)	9.42 ± 8.914	8.95 ± 9.952
General health: Change at Week 24(n=28,86)	1.94 ± 8.185	7.05 ± 7.657
General health: Change at Week 44(n=28,84)	6.25 ± 8.998	6.74 ± 8.496
Vitality: Change at Week 24 (n=28,86)	1.49 ± 7.387	7.39 ± 8.727
Vitality: Change at Week 44 (n=28,84)	7.53 ± 10.802	7.11 ± 9.891
Social function: Change at Week 24(n=28,86)	-0.18 ± 7.776	6.41 ± 10.919
Social function: Change at Week 44(n=28,84)	6.09 ± 10.151	5.73 ± 10.357
Role-emotion: Change at Week 24(n=28,86)	2.11 ± 7.891	5.30 ± 9.013
Role-emotion: Change at Week 44(n=28,84)	5.47 ± 9.160	5.68 ± 9.635
Mental health: Change at Week 24(n=28,86)	0.19 ± 7.465	6.30 ± 8.994
Mental health: Change at Week 44(n=28,84)	7.29 ± 9.952	5.42 ± 8.978

Notes
[86] - Post week 24 EAS Population
[87] - Post week 24 EAS Population

No statistical analyses for this end point

Secondary: Change from Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 16 and 24

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End point title

Change from Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 16 and 24

End point description

RAPID3 scores were designed for usual clinical care, although they also may be useful for clinical research. The 3 Core Data Set measures on multi-dimensional health assessment questionnaire (MDHAQ), for function (FN), pain, and patient global estimate, were each scored 0-10 and recorded on the MDHAQ. The scores for each domain were then added together to give a final score range of 0–30 (with a positive change indicating worsening of disease activity). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.

End point type

Secondary

End point timeframe

Baseline, Week 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[88]	100 ^[89]
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline	16.51 ± 4.991	17.06 ± 5.300
Change at Week 16	-0.19 ± 4.405	-5.41 ± 5.307
Change at Week 24	-0.57 ± 5.123	-5.81 ± 5.968

Notes
[88] - FAS population
[89] - FAS population

No statistical analyses for this end point

Secondary: Change from Baseline in RAPID3 Score at Week 24 and 44

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End point title

Change from Baseline in RAPID3 Score at Week 24 and 44 ^[90]

End point description

RAPID3 scores were designed for usual clinical care, although they also may be useful for clinical research. The 3 Core Data Set measures on multi-dimensional health assessment questionnaire (MDHAQ), for function (FN), pain, and patient global estimate, were each scored 0-10 and recorded on the MDHAQ. The scores for each domain were then added together to give a final score range of 0–30 (with a positive change indicating worsening of disease activity). Based on observed data in the Post Week 24 Efficacy Analysis Set. Here ‘n’ signifies number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24 and 44

Notes
[90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[91]	86 ^[92]
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 24 (n=28, 86)	-2.28 ± 5.244	-6.36 ± 6.205
Change at Week 44 (n=28, 84)	-7.60 ± 6.588	-7.48 ± 6.310

Notes
[91] - Post week 24 EAS population
[92] - Post week 24 EAS population

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Greater Than or Equal to 50%, 75%, 90%, and Equal to 100% Improvement in PASI Response from Baseline Through Week 24

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End point title

Percentage of Subjects Achieving Greater Than or Equal to 50%, 75%, 90%, and Equal to 100% Improvement in PASI Response from Baseline Through Week 24

End point description

The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 50, 75, 90 and 100 responses is defined as >= 50, 75, 90 and 100 percent (%) improvement respectively in PASI score from baseline. LOCF method was used for missing PASI values and the last observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Subjects with missing baseline PASI were excluded in the analysis. here ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 4, 8, 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	49 ^[93]	100 ^[94]
Units: Percentage of subjects
number (not applicable)
W4:>=100% improvement (n=48,98)	0	3.1
W4:>=90% improvement (n=48,98)	0	9.2
W4:>=75% improvement (n=48,98)	4.2	16.3
W4:>=50% improvement (n=48,98)	12.5	43.9
W8:>=100% improvement (n=48,98)	2.1	12.2
W8:>=90% improvement (n=48,98)	2.1	27.6
W8:>=75% improvement (n=48,98)	4.2	42.9
W8:>=50% improvement (n=48,98)	10.4	67.3
W16:>=100% improvement (n=48,98)	6.3	31.6
W16:>=90% improvement (n=48,98)	6.3	53.1
W16:>=75% improvement (n=48,98)	8.3	71.4
W16:>=50% improvement (n=48,98)	27.1	81.6
W24:>=100% improvement (n=48,98)	6.3	39.8
W24:>=90% improvement (n=48,98)	6.3	66.3
W24:>=75% improvement (n=48,98)	12.5	78.6
W24:>=50% improvement (n=48,98)	29.2	86.7

Notes
[93] - FAS population
[94] - FAS population

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving a Greater Than or Equal to 50%, 75%, 90%, and Equal to 100% Improvement in PASI Response from Baseline from Week 24 to 56

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End point title

Percentage of Subjects Achieving a Greater Than or Equal to 50%, 75%, 90%, and Equal to 100% Improvement in PASI Response from Baseline from Week 24 to 56 ^[95]

End point description

The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 50, 75, 90 and 100 responses is defined as >= 50, 75, 90 and 100 percent (%) improvement respectively in PASI score from baseline. Based on observed values in the Post Week 24 Efficacy Analysis set. Subjects with missing baseline were excluded in the analysis. Here ‘n’ signifies number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 44 and 56

Notes
[95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[96]	86 ^[97]
Units: Percentage of Subjects
number (not applicable)
W 24: PASI 50 responders (n= 29, 86)	37.9	89.5
W 24: PASI 75 responders (n= 29, 86)	20.7	82.6
W 24: PASI 90 responders (n= 29, 86)	10.3	70.9
W 24: Subjects with PASI=0 (n= 29, 86)	10.3	44.2
W 28: PASI 50 responders (n= 28, 84)	60.7	95.2
W 28: PASI 75 responders (n= 28, 84)	35.7	84.5
W 28: PASI 90 responders (n= 28, 84)	25.0	72.6
W 28: Subjects with PASI=0 (n= 28, 84)	17.9	53.6
W 32: PASI 50 responders (n= 28, 83)	78.6	92.8
W 32: PASI 75 responders (n= 28, 83)	67.9	86.7
W 32: PASI 90 responders (n= 28, 83)	50.0	80.7
W 32: Subjects with PASI=0 (n= 28, 83)	35.7	62.7
W 44: PASI 50 responders (n= 28, 83)	89.3	94.0
W 44: PASI 75 responders (n= 28, 83)	82.1	90.4
W 44: PASI 90 responders (n= 28, 83)	75.0	81.9
W 44: Subjects with PASI=0 (n= 28, 83)	67.9	63.9
W 56: PASI 50 responders (n= 27, 82)	96.3	92.7
W 56: PASI 75 responders (n= 27, 82)	81.5	85.4
W 56: PASI 90 responders (n= 27, 82)	74.1	78.0
W 56: Subjects with PASI=0 (n= 27, 82)	55.6	57.3

Notes
[96] - Post week 24 EAS population
[97] - Post week 24 EAS population

No statistical analyses for this end point

Secondary: Percent Change from Baseline in PASI Through Week 24

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End point title

Percent Change from Baseline in PASI Through Week 24

End point description

The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). LOCF method was used to impute missing data and the Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Subjects with missing baseline were excluded in the analysis. Here, N 'number of participants analyzed' signifies that these participants were evaluable for this endpoint and ‘n’ signifies the number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 4, 8, 16 and 24

End point values	Placebo	Guselkumab
Number of subjects analysed	48 ^[98]	98 ^[99]
Units: Percent change
median (inter-quartile range (Q1-Q3))
% change at Week 4 (n= 48, 98)	0.00 (-16.0 to 17.0)	-41.49 (-64.7 to -12.2)
% change at Week 8 (n= 48, 98)	1.58 (-20.2 to 24.9)	-66.67 (-93.6 to -41.9)
% change at Week 16 (n= 48, 98)	-1.10 (-50.0 to 35.9)	-90.55 (-100.0 to -65.6)
% change at Week 24 (n= 48, 98)	-7.89 (-54.2 to 34.0)	-96.21 (-100.0 to -82.6)

Notes
[98] - FAS Population
[99] - FAS Population

No statistical analyses for this end point

Secondary: Percent Change from Baseline in PASI from Week 24 to 56

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End point title

Percent Change from Baseline in PASI from Week 24 to 56 ^[100]

End point description

The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). Based on observed data in the Post Week 24 Efficacy Analysis Set. Subjects with missing baseline were excluded in the analysis. Here ‘n’ signifies number of subjects analyzed at specific timepoints.

End point type

Secondary

End point timeframe

Week 24, 28, 32, 44 and 56

Notes
[100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".

End point values	Crossover (Placebo to Guselkumab)	Guselkumab
Number of subjects analysed	29 ^[101]	86 ^[102]
Units: Percent change
median (inter-quartile range (Q1-Q3))
% change at Week 24 (n= 28, 85)	-34.26 (-72.9 to 26.9)	-97.85 (-100.0 to -87.2)
% change at Week 28 (n= 27, 83)	-57.69 (-94.3 to -39.4)	-100.00 (-100.0 to -88.2)
% change at Week 32 (n= 27, 82)	-90.61 (-100.0 to -62.5)	-100.00 (-100.0 to -94.0)
% change at Week 44 (n= 27, 82)	-100.00 (-100.0 to -91.0)	-100.00 (-100.0 to -95.4)
% change at Week 56 (n= 26, 81)	-100.00 (-100.00 to -91.0)	-100.00 (-100.00 to -91.4)

Notes
[101] - Post Week 24 EAS population
[102] - Post Week 24 EAS population

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to Week 56

Adverse event reporting additional description

Safety analysis set includes all subjects randomized at Week 0 who received at least (partial or complete) dose of study agent administration and were analyzed according to the actual treatment received (at the time of onset of AE event) after randomization, regardless of treatments they were randomized to.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

18.1/19.1

Reporting group title

Week (W) 0 to 24: Placebo

Reporting group description

Include subjects who were randomized in the placebo group and received at least one injection of placebo. AEs that occurred between Week 0 and Week 24 while subjects were on placebo were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

Reporting group title

W0 to 24: Guselkumab

Reporting group description

Include subjects who were randomized in the guselkumab group and received at least one injection of guselkumab. AEs that occurred between Week 0 and Week 24 while subjects were on guselkumab were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

Reporting group title

W24 to 44: Crossover (Placebo to Guselkumab)

Reporting group description

Include subjects who remained in the placebo group and crossed over to guselkumab 100 mg at Week 24. AEs that occurred between Week 24 and Week 44 while subjects were on guselkumab were included in this group.

Reporting group title

W24 to 44: Guselkumab

Reporting group description

Include subjects who were randomized in the guselkumab group and received at least one injection of guselkumab. AEs that occurred between Week 24 and Week 44 while subjects were on guselkumab were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

Reporting group title

W44 to 56: Crossover (Placebo to Guselkumab)

Reporting group description

Include subjects who remained in the placebo group and crossed over to guselkumab 100 mg at Week 24. AEs that occurred during the follow-up period (12 weeks from the last study agent administration) were included in this group‌.

Reporting group title

W44 to 56: Guselkumab

Reporting group description

Include subjects who were randomized in the guselkumab group and received at least one injection of guselkumab. AEs that occurred during the follow-up period (12 weeks from the last study agent administration) were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

Serious adverse events	Week (W) 0 to 24: Placebo	W0 to 24: Guselkumab	W24 to 44: Crossover (Placebo to Guselkumab)	W24 to 44: Guselkumab	W44 to 56: Crossover (Placebo to Guselkumab)	W44 to 56: Guselkumab
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 49 (2.04%)	1 / 100 (1.00%)	0 / 29 (0.00%)	5 / 100 (5.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Joint Injury
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Radius Fracture
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Myocardial Infarction
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Pupils Unequal
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ulcerative Keratitis
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Week (W) 0 to 24: Placebo	W0 to 24: Guselkumab	W24 to 44: Crossover (Placebo to Guselkumab)	W24 to 44: Guselkumab	W44 to 56: Crossover (Placebo to Guselkumab)	W44 to 56: Guselkumab
Total subjects affected by non serious adverse events
subjects affected / exposed	16 / 49 (32.65%)	35 / 100 (35.00%)	4 / 29 (13.79%)	22 / 100 (22.00%)	1 / 29 (3.45%)	8 / 100 (8.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	0	0	1
Uterine Leiomyoma
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 49 (0.00%)	2 / 100 (2.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	3	0	0	0	1
General disorders and administration site conditions
Influenza Like Illness
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Injection Site Erythema
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Local Swelling
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Oedema Peripheral
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Pyrexia
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Social circumstances
Pregnancy of Partner
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Reproductive system and breast disorders
Postmenopausal Haemorrhage
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Catarrh
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Cough
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	0	0	1
Rhinitis Allergic
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Sinus Congestion
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Upper Respiratory Tract Inflammation
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	0	0	0	0
Investigations
Alanine Aminotransferase Increased
subjects affected / exposed	1 / 49 (2.04%)	2 / 100 (2.00%)	2 / 29 (6.90%)	2 / 100 (2.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	2	2	2	0	0
Aspartate Aminotransferase Increased
subjects affected / exposed	0 / 49 (0.00%)	2 / 100 (2.00%)	2 / 29 (6.90%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	2	1	0	0
Blood Alkaline Phosphatase Increased
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Blood Bilirubin Increased
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	1 / 29 (3.45%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	1	0	0	0
C-Reactive Protein Increased
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Liver Function Test Abnormal
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Liver Function Test Increased
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Lymphocyte Morphology Abnormal
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	1 / 29 (3.45%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	1	0	0	0
Neutrophil Count Decreased
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Transaminases Increased
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Weight Increased
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
White Blood Cell Count Decreased
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Injury, poisoning and procedural complications
Burns Second Degree
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Chest Injury
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Foot Fracture
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Humerus Fracture
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Procedural Pain
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Nervous system disorders
Morton's Neuralgia
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Neuropathy Peripheral
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	0 / 49 (0.00%)	4 / 100 (4.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	1 / 29 (3.45%)	0 / 100 (0.00%)
occurrences all number	0	4	0	1	1	0
Neutropenia
subjects affected / exposed	0 / 49 (0.00%)	4 / 100 (4.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	4	0	0	0	0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Eye disorders
Pupils Unequal
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Gastritis
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Gastrooesophageal Reflux Disease
subjects affected / exposed	0 / 49 (0.00%)	2 / 100 (2.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	0	0	0	0
Pancreatic Disorder
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	0	0	1
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	0	0	1
Gallbladder Disorder
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	0	0	1
Hepatic Steatosis
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	1	0	1	0	1
Hepatitis
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Hepatomegaly
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	0	0	1
Liver Disorder
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	0	0	1
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Pruritus
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Psoriasis
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	1	0	0
Rash
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Scab
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Renal and urinary disorders
Calculus Urinary
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Renal Colic
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Musculoskeletal and connective tissue disorders
Back Pain
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	1 / 29 (3.45%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	1	1	0	0
Joint Effusion
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Pain in Extremity
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Psoriatic Arthropathy
subjects affected / exposed	1 / 49 (2.04%)	2 / 100 (2.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	2	0	0	0	0
Spinal Pain
subjects affected / exposed	0 / 49 (0.00%)	2 / 100 (2.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	0	0	0	0
Tendonitis
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Infections and infestations
Acute Sinusitis
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Bronchitis
subjects affected / exposed	1 / 49 (2.04%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	1	1	0	0	0	1
Diverticulitis
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Gastroenteritis Viral
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Gastrointestinal Infection
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	0	0	1	0	0
Gingivitis
subjects affected / exposed	0 / 49 (0.00%)	2 / 100 (2.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	0	0	0	0
Herpes Simplex
subjects affected / exposed	1 / 49 (2.04%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	1	0	0	0	0
Herpes Zoster
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Influenza
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	5 / 49 (10.20%)	7 / 100 (7.00%)	0 / 29 (0.00%)	3 / 100 (3.00%)	0 / 29 (0.00%)	2 / 100 (2.00%)
occurrences all number	8	8	0	3	0	2
Oral Herpes
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	0	1	0	0
Pharyngitis
subjects affected / exposed	0 / 49 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)
occurrences all number	0	0	0	1	0	1
Respiratory Tract Infection
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Rhinotracheitis
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Sinusitis
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Subcutaneous Abscess
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	1	0	0
Tooth Infection
subjects affected / exposed	1 / 49 (2.04%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	0	0	0	0	0
Upper Respiratory Tract Infection
subjects affected / exposed	1 / 49 (2.04%)	1 / 100 (1.00%)	1 / 29 (3.45%)	2 / 100 (2.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	1	1	1	2	0	0
Urinary Tract Infection
subjects affected / exposed	0 / 49 (0.00%)	2 / 100 (2.00%)	0 / 29 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	2	0	1	0	0
Metabolism and nutrition disorders
Diabetes Mellitus
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0
Type 2 Diabetes Mellitus
subjects affected / exposed	0 / 49 (0.00%)	1 / 100 (1.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)	0 / 29 (0.00%)	0 / 100 (0.00%)
occurrences all number	0	1	0	0	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

15 Feb 2015

The overall reasons for the amendment is to provide additional treatment options for subjects with ongoing disease activity after Week 24, to collect Ribonucleic acid (RNA) and stool samples to evaluate the mechanism of action of guselkumab, and to add additional results from the CNTO1275ARA2001 study to support the CNTO1959PSA2001 study design.

Were there any global interruptions to the trial? No

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

Study results were limited by small sample size, relatively short duration of follow-up to detect rare AEs. Lack of an active comparator limited comparison with other PsA therapies.

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Clinical trials

Clinical Trial Results: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

Primary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

Secondary: Percentage of Subjects who Achieved a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24

Secondary: Percentage of Subjects who Achieved a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24

Secondary: Change from Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24

Secondary: Change from Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24

Secondary: Percentage of Subjects who Achieved an ACR 20 Response at Week 16

Secondary: Percentage of Subjects who Achieved an ACR 20 Response at Week 16

Secondary: Percentage of Subjects who Achieved an ACR 50 Response at Week 24

Secondary: Percentage of Subjects who Achieved an ACR 50 Response at Week 24

Secondary: Percent (%) Change from Baseline in Enthesitis Scores at Week 24 Among Subjects with Enthesitis at Baseline

Secondary: Percent (%) Change from Baseline in Enthesitis Scores at Week 24 Among Subjects with Enthesitis at Baseline

Secondary: Percent Change from Baseline in Dactylitis Scores at Week 24 Among Subjects with Dactylitis at Baseline

Secondary: Percent Change from Baseline in Dactylitis Scores at Week 24 Among Subjects with Dactylitis at Baseline

Secondary: Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response Through Week 24

Secondary: Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response Through Week 24

Secondary: Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response from Week 24 to 56

Secondary: Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response from Week 24 to 56

Secondary: Percent Change from Baseline in Selected ACR Components Through Week 24

Secondary: Percent Change from Baseline in Selected ACR Components Through Week 24

Secondary: Percent Change from Baseline in Selected ACR Components from Week 24 to Week 56

Secondary: Percent Change from Baseline in Selected ACR Components from Week 24 to Week 56

Secondary: Change from Baseline in HAQ-DI score Through Week 24

Secondary: Change from Baseline in HAQ-DI score Through Week 24

Secondary: Change from Baseline in HAQ-DI Score from Week 24 to Week 56

Secondary: Change from Baseline in HAQ-DI Score from Week 24 to Week 56

Secondary: Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) Through Week 24

Secondary: Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) Through Week 24

Secondary: Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) from Week 24 to Week 56

Secondary: Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) from Week 24 to Week 56

Secondary: Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline Through Week 24

Secondary: Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline Through Week 24

Secondary: Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline from Week 24 to Week 56

Secondary: Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline from Week 24 to Week 56

Secondary: Percentage of Subjects with One or More Digits with Dactylitis Through Week 24 in Subjects with Dactylitis at Baseline

Secondary: Percentage of Subjects with One or More Digits with Dactylitis Through Week 24 in Subjects with Dactylitis at Baseline

Secondary: Percentage of Subjects with One or More Digits with Dactylitis from Week 24 to Week 56 in Subjects with Dactylitis at Baseline

Secondary: Percentage of Subjects with One or More Digits with Dactylitis from Week 24 to Week 56 in Subjects with Dactylitis at Baseline

Secondary: Percent Change from Baseline in the Enthesitis Score Through Week 24 in Subjects with Enthesitis at Baseline

Secondary: Percent Change from Baseline in the Enthesitis Score Through Week 24 in Subjects with Enthesitis at Baseline

Secondary: Percent Change from Baseline in the Enthesitis Score from Week 24 to Week 56 in Subjects with Enthesitis at Baseline

Secondary: Percent Change from Baseline in the Enthesitis Score from Week 24 to Week 56 in Subjects with Enthesitis at Baseline

Secondary: Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline Through Week 24

Secondary: Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline Through Week 24

Secondary: Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline from Week 24 to Week 56

Secondary: Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline from Week 24 to Week 56

Secondary: Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Score Through Week 24

Secondary: Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Score Through Week 24

Secondary: Change from Baseline in PASDAS Score from Week 24 to 44

Secondary: Change from Baseline in PASDAS Score from Week 24 to 44

Secondary: Change from Baseline in Grappa Composite Score (GRACE) Index Through Week 24

Secondary: Change from Baseline in Grappa Composite Score (GRACE) Index Through Week 24

Secondary: Change from Baseline in GRACE Index from Week 24 to 44

Secondary: Change from Baseline in GRACE Index from Week 24 to 44

Secondary: Change from Baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24

Secondary: Change from Baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24

Secondary: Change from Baseline in mCPDAI Score at Week 24 and Week 44

Secondary: Change from Baseline in mCPDAI Score at Week 24 and Week 44

Secondary: Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Index Through Week 24

Secondary: Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Index Through Week 24

Secondary: Change from Baseline in DAPSA Index from Week 24 to Week 56

Secondary: Change from Baseline in DAPSA Index from Week 24 to Week 56

Secondary: Percentage of Subjects who Achieved a Minimal Disease Activity (MDA) at Week 16 and 24

Secondary: Percentage of Subjects who Achieved a Minimal Disease Activity (MDA) at Week 16 and 24

Secondary: Percentage of Subjects who Achieved a MDA at Week 24 and 44

Secondary: Percentage of Subjects who Achieved a MDA at Week 24 and 44

Secondary: Change from Baseline in Physical Component Summary Scores (PCS) and Mental Component Summary Scores (MCS) of the 36-item Short Form Healthy Survey (SF-36) at Week 16 and 24

Secondary: Change from Baseline in Physical Component Summary Scores (PCS) and Mental Component Summary Scores (MCS) of the 36-item Short Form Healthy Survey (SF-36) at Week 16 and 24

Secondary: Change from Baseline in PCS and MCS of the 36-item Short Form Healthy Survey (SF-36) at Week 24 to 44

Secondary: Change from Baseline in PCS and MCS of the 36-item Short Form Healthy Survey (SF-36) at Week 24 to 44

Clinical Trial Results:
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis