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A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT03158285
Recruitment Status : Completed
First Posted : May 18, 2017
Results First Posted : November 5, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Arthritis, Psoriatic
Interventions Drug: Guselkumab
Drug: Placebo
Enrollment 741
Recruitment Details  
Pre-assignment Details A total of 741 participants were randomized and 739 participants received at least one dose of study drug: 246 in placebo group, 248 in guselkumab 100 mg q8w group, and 245 in guselkumab 100 mg q4w group. Two participants were randomized in error and were never treated. Participant flow is reported for treatment discontinuation up to Week 48.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period. Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48. Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Period Title: Placebo-controlled Period: Week 0 - 24
Started 246 248 245
Pooled Population: Enthesitis Assessment 255 [1] 230 [2] 243 [3]
Pooled Population: Dactylitis Assessment 154 [4] 160 [5] 159 [6]
Completed 240 240 236
Not Completed 6 8 9
Reason Not Completed
Adverse Event             4             2             6
Lack of Efficacy             0             3             3
Lost to Follow-up             0             1             0
Withdrawal by Subject             1             1             0
Other             1             1             0
[1]
Pooled population (255) = 77 (CNTO1959PSA3001[NCT03162796]) + 178 (CNTO1959PSA3002)
[2]
Pooled population (230)= 72 (CNTO1959PSA3001) + 158 (CNTO1959PSA3002)
[3]
Pooled population (243)= 73 (CNTO1959PSA3001) + 170 (CNTO1959PSA3002)
[4]
Pooled population (154) = 55 (CNTO1959PSA3001) + 99 (CNTO1959PSA3002)
[5]
Pooled population (160) = 49 (CNTO1959PSA3001) + 111 (CNTO1959PSA3002)
[6]
Pooled population (159) = 38 (CNTO1959PSA3001) + 121 (CNTO1959PSA3002)
Period Title: Active Treatment Period: Week 24 - 52
Started 238 [1] 240 234 [1]
Completed 228 234 227
Not Completed 10 6 7
Reason Not Completed
Adverse Event             3             0             1
Lack of Efficacy             5             3             4
Pregnancy             0             0             1
Withdrawal by Subject             1             2             1
Other             1             1             0
[1]
2 participants who discontinued without receiving study agent at and post Week 24 were not included.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w Total
Hide Arm/Group Description Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period. Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48. Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48. Total of all reporting groups
Overall Number of Baseline Participants 246 248 245 739
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) 1 included all participants who received at least 1 dose (complete/partial) of study agent according to randomized treatment group regardless of treatment actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants 248 participants 245 participants 739 participants
46.3  (11.68) 44.9  (11.89) 45.9  (11.47) 45.7  (11.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 248 participants 245 participants 739 participants
Female
129
  52.4%
119
  48.0%
103
  42.0%
351
  47.5%
Male
117
  47.6%
129
  52.0%
142
  58.0%
388
  52.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 248 participants 245 participants 739 participants
Hispanic or Latino
1
   0.4%
1
   0.4%
0
   0.0%
2
   0.3%
Not Hispanic or Latino
245
  99.6%
247
  99.6%
245
 100.0%
737
  99.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 248 participants 245 participants 739 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   1.6%
8
   3.2%
3
   1.2%
15
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
242
  98.4%
240
  96.8%
242
  98.8%
724
  98.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 248 participants 245 participants 739 participants
BULGARIA
14
   5.7%
9
   3.6%
6
   2.4%
29
   3.9%
CZECH REPUBLIC
13
   5.3%
5
   2.0%
15
   6.1%
33
   4.5%
ESTONIA
5
   2.0%
8
   3.2%
5
   2.0%
18
   2.4%
LATVIA
3
   1.2%
3
   1.2%
0
   0.0%
6
   0.8%
LITHUANIA
8
   3.3%
8
   3.2%
4
   1.6%
20
   2.7%
MALAYSIA
3
   1.2%
6
   2.4%
3
   1.2%
12
   1.6%
POLAND
35
  14.2%
27
  10.9%
23
   9.4%
85
  11.5%
RUSSIAN FEDERATION
92
  37.4%
77
  31.0%
104
  42.4%
273
  36.9%
SPAIN
3
   1.2%
12
   4.8%
4
   1.6%
19
   2.6%
TAIWAN
0
   0.0%
1
   0.4%
0
   0.0%
1
   0.1%
TURKEY
2
   0.8%
8
   3.2%
6
   2.4%
16
   2.2%
UKRAINE
65
  26.4%
83
  33.5%
73
  29.8%
221
  29.9%
UNITED STATES
3
   1.2%
1
   0.4%
2
   0.8%
6
   0.8%
1.Primary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Hide Description ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is full analysis set 1 (FAS1). Participants who achieved ACR 20 response at Week 24 and did not meet any treatment failure (TF) criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
32.9 64.1 63.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.2
Confidence Interval (2-Sided) 95%
22.9 to 39.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 30.8
Confidence Interval (2-Sided) 95%
22.4 to 39.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Hide Description HAQ-DI score assess functional status of participant. It is 20 question instrument that assess 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. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.1300
(-0.1912 to -0.0687)
-0.3672
(-0.4282 to -0.3062)
-0.4004
(-0.4617 to -0.3390)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean difference
Estimated Value -0.2372
Confidence Interval (2-Sided) 95%
-0.3210 to -0.1534
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.2704
Confidence Interval (2-Sided) 95%
-0.3544 to -0.1864
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieved an ACR 50 Response at Week 24
Hide Description ACR 50 response was defined as greater than or equal to (>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved ACR 50 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
14.2 31.5 33.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.2
Confidence Interval 95%
10.0 to 24.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 18.8
Confidence Interval (2-Sided) 95%
11.5 to 26.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline
Hide Description A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with >=3% BSA psoriatic involvement and an IGA score >=2 (mild) at baseline. Participants who achieved psoriasis IGA response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Measure Type: Number
Unit of Measure: percentage of participants
19.1 70.5 68.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 50.9
Confidence Interval (2-Sided) 95%
42.2 to 59.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 49.8
Confidence Interval (2-Sided) 95%
41.2 to 58.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Hide Description ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved ACR 20 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria before Week 16 or with missing data were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
33.7 55.2 55.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 21.5
Confidence Interval (2-Sided) 95%
13.1 to 30.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 22.2
Confidence Interval (2-Sided) 95%
13.7 to 30.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
Hide Description Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 for structural damage (FAS1-SD) included all participants who received at least 1 dose (complete/partial) of study agent according to randomized treatment group regardless of treatment actually received. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be MAR and imputed using MI.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.95
(0.61 to 1.29)
0.52
(0.18 to 0.86)
0.29
(-0.05 to 0.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.90 to 0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.13 to -0.19
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Hide Description Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with enthesitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with enthesitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 255 230 243
Measure Type: Number
Unit of Measure: percentage of participants
29.4 49.6 44.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 20.1
Confidence Interval (2-Sided) 95%
11.8 to 28.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 14.6
Confidence Interval (2-Sided) 95%
6.4 to 22.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline
Hide Description The presence and severity of dactylitis was 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) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with dactylitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with dactylitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 154 160 159
Measure Type: Number
Unit of Measure: percentage of participants
42.2 59.4 63.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 18.0
Confidence Interval (2-Sided) 95%
7.4 to 28.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 21.3
Confidence Interval (2-Sided) 95%
10.5 to 32.0
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline
Hide Description Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1 among participants with enthesitis at baseline pooled from both CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 255 230 243
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.02
(-1.22 to -0.82)
-1.52
(-1.73 to -1.31)
-1.59
(-1.79 to -1.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.77 to -0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-0.83 to -0.31
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline
Hide Description The presence and severity of dactylitis was 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) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1 among participants with dactylitis at baseline pooled from both from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 154 160 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.21
(-5.05 to -3.36)
-6.10
(-6.92 to -5.27)
-5.97
(-6.84 to -5.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.89
Confidence Interval (2-Sided) 95%
-2.99 to -0.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Nominal
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.77
Confidence Interval (2-Sided) 95%
-2.87 to -0.66
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Hide Description SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.42
(2.53 to 4.32)
7.39
(6.50 to 8.29)
7.04
(6.14 to 7.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 3.97
Confidence Interval (2-Sided) 95%
2.75 to 5.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 3.62
Confidence Interval (2-Sided) 95%
2.39 to 4.85
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24
Hide Description The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.97
(-1.11 to -0.84)
-1.59
(-1.72 to -1.45)
-1.62
(-1.76 to -1.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.80 to -0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-0.83 to -0.47
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24
Hide Description SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.14
(1.07 to 3.22)
4.17
(3.10 to 5.23)
4.22
(3.14 to 5.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 2.02
Confidence Interval (2-Sided) 95%
0.56 to 3.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 2.07
Confidence Interval (2-Sided) 95%
0.60 to 3.54
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
Hide Description ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved ACR 50 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
9.3 28.6 20.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
12.6 to 25.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.5
Confidence Interval (2-Sided) 95%
5.2 to 17.7
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24
Hide Description ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved ACR 70 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
4.1 18.5 13.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q8w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 14.5
Confidence Interval (2-Sided) 95%
9.1 to 19.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Nominal
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.0
Confidence Interval (2-Sided) 95%
4.1 to 13.8
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants Who Achieved ACR 20 Response Through Week 24
Hide Description ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved ACR 20 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 8.1 10.1 10.6
Week 4 11.8 19.8 21.6
Week 8 17.5 39.1 40.0
Week 12 26.4 49.6 51.0
Week 16 33.7 55.2 55.9
Week 20 29.7 62.9 58.8
Week 24 32.9 64.1 63.7
17.Secondary Outcome
Title Percentage of Participants Who Achieved ACR 50 Response Through Week 24
Hide Description ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved ACR 50 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 0.4 1.6 0.4
Week 4 1.2 4.0 3.3
Week 8 4.1 10.1 11.0
Week 12 6.1 19.0 16.7
Week 16 9.3 28.6 20.8
Week 20 16.3 31.5 29.8
Week 24 14.2 31.5 33.1
18.Secondary Outcome
Title Percentage of Participants Who Achieved ACR 70 Response Through Week 24
Hide Description ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved ACR 70 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 0 0 0
Week 4 0.8 0.4 0.8
Week 8 0.8 3.6 2.0
Week 12 0.4 8.1 4.9
Week 16 0.8 13.7 8.2
Week 20 3.3 15.3 13.9
Week 24 4.1 18.5 13.1
19.Secondary Outcome
Title Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Description ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment (PGA) of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Here 'n' (number analyzed) signifies number of participants with observed data regardless meeting TF criteria at specified categories.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Mean (Standard Deviation)
Unit of Measure: percent change
Week 2: Swollen Joint Count Number Analyzed 242 participants 245 participants 239 participants
-18.9  (32.16) -18.8  (39.68) -18.5  (38.38)
Week 4: Swollen Joint Count Number Analyzed 245 participants 246 participants 240 participants
-27.1  (37.29) -30.5  (36.92) -33.6  (37.57)
Week 8: Swollen Joint Count Number Analyzed 246 participants 246 participants 243 participants
-37.4  (39.03) -46.8  (40.68) -46.7  (37.69)
Week 12: Swollen Joint Count Number Analyzed 246 participants 246 participants 242 participants
-46.1  (41.20) -57.6  (39.22) -58.3  (35.42)
Week 16: Swollen Joint Count Number Analyzed 245 participants 244 participants 240 participants
-48.6  (43.01) -64.1  (35.46) -63.7  (34.42)
Week 20: Swollen Joint Count Number Analyzed 243 participants 243 participants 236 participants
-54.2  (41.70) -69.3  (33.63) -71.4  (30.42)
Week 24: Swollen Joint Count Number Analyzed 243 participants 243 participants 240 participants
-53.9  (45.54) -71.3  (34.06) -73.1  (30.67)
Week 2: Tender Joint Count Number Analyzed 242 participants 245 participants 239 participants
-9.4  (25.99) -10.4  (40.31) -14.8  (28.31)
Week 4: Tender Joint Count Number Analyzed 245 participants 246 participants 240 participants
-14.1  (36.04) -15.0  (41.57) -22.6  (32.91)
Week 8: Tender Joint Count Number Analyzed 246 participants 246 participants 243 participants
-21.9  (37.83) -31.0  (42.36) -33.8  (37.58)
Week 12: Tender Joint Count Number Analyzed 246 participants 246 participants 242 participants
-30.4  (37.57) -40.9  (42.73) -43.0  (35.90)
Week 16: Tender Joint Count Number Analyzed 245 participants 244 participants 240 participants
-30.6  (41.87) -47.0  (40.96) -48.1  (37.01)
Week 20: Tender Joint Count Number Analyzed 243 participants 243 participants 236 participants
-33.9  (44.22) -53.9  (37.83) -54.2  (35.43)
Week 24: Tender Joint Count Number Analyzed 243 participants 243 participants 240 participants
-33.3  (44.87) -54.2  (37.15) -57.3  (34.98)
Week 2: Patient's Assessment of Pain Number Analyzed 244 participants 246 participants 240 participants
0.05  (35.794) -8.92  (32.374) -4.66  (32.229)
Week 4: Patient's Assessment of Pain Number Analyzed 246 participants 247 participants 240 participants
-0.64  (35.849) -12.58  (33.065) -7.96  (37.958)
Week 8: Patient's Assessment of Pain Number Analyzed 246 participants 245 participants 243 participants
-6.76  (34.213) -21.61  (36.705) -17.05  (44.783)
Week 12: Patient's Assessment of Pain Number Analyzed 246 participants 246 participants 242 participants
-9.01  (36.061) -26.26  (40.223) -25.91  (37.862)
Week 16: Patient's Assessment of Pain Number Analyzed 245 participants 244 participants 240 participants
-9.70  (41.673) -31.94  (42.882) -27.85  (38.913)
Week 20: Patient's Assessment of Pain Number Analyzed 244 participants 243 participants 237 participants
-10.85  (46.497) -35.16  (39.471) -35.35  (39.016)
Week 24: Patient's Assessment of Pain Number Analyzed 243 participants 243 participants 240 participants
-11.84  (48.324) -38.06  (40.565) -36.52  (38.423)
Week 2: PtGA of Disease Activity Number Analyzed 244 participants 246 participants 240 participants
-1.12  (35.882) -10.15  (31.060) -5.25  (32.658)
Week 4: PtGA of Disease Activity Number Analyzed 246 participants 247 participants 240 participants
-2.27  (34.291) -12.71  (34.440) -11.02  (33.605)
Week 8: PtGA of Disease Activity Number Analyzed 246 participants 245 participants 243 participants
-6.51  (35.908) -21.58  (33.697) -19.13  (40.545)
Week 12: PtGA of Disease Activity Number Analyzed 246 participants 246 participants 242 participants
-9.30  (37.185) -27.86  (38.900) -28.33  (34.058)
Week 16: PtGA of Disease Activity Number Analyzed 245 participants 244 participants 240 participants
-12.34  (39.207) -32.25  (40.056) -28.60  (39.759)
Week 20: PtGA of Disease Activity Number Analyzed 244 participants 243 participants 237 participants
-12.52  (42.498) -35.31  (36.205) -35.11  (37.791)
Week 24: PtGA of Disease Activity Number Analyzed 243 participants 243 participants 240 participants
-13.87  (45.650) -37.05  (38.372) -34.13  (51.445)
Week 2: PGA of Disease Activity Number Analyzed 240 participants 241 participants 231 participants
-9.79  (25.687) -15.06  (27.150) -13.85  (23.307)
Week 4: PGA of Disease Activity Number Analyzed 243 participants 245 participants 239 participants
-16.63  (27.573) -23.72  (27.658) -22.32  (28.183)
Week 8: PGA of Disease Activity Number Analyzed 244 participants 244 participants 240 participants
-23.29  (28.416) -36.54  (31.224) -37.99  (29.970)
Week 12: PGA of Disease Activity Number Analyzed 245 participants 243 participants 242 participants
-27.63  (32.379) -46.54  (30.489) -42.84  (31.305)
Week 16: PGA of Disease Activity Number Analyzed 245 participants 244 participants 240 participants
-31.11  (32.023) -52.02  (31.915) -49.18  (31.383)
Week 20: PGA of Disease Activity Number Analyzed 240 participants 243 participants 234 participants
-34.13  (36.576) -54.32  (30.941) -54.59  (29.336)
Week 24: PGA of Disease Activity Number Analyzed 243 participants 242 participants 238 participants
-36.59  (33.740) -57.22  (32.480) -58.70  (28.255)
Week 2: HAQ-DI Score Number Analyzed 240 participants 236 participants 237 participants
-0.3191  (36.62364) -6.3577  (50.81980) -0.2385  (57.44896)
Week 4: HAQ-DI Score Number Analyzed 242 participants 237 participants 237 participants
-2.8744  (46.90795) -9.1272  (53.41051) -5.1209  (85.16625)
Week 8: HAQ-DI Score Number Analyzed 242 participants 235 participants 240 participants
-5.0965  (39.89566) -12.7684  (67.23239) -9.8081  (86.78973)
Week 12: HAQ-DI Score Number Analyzed 242 participants 236 participants 239 participants
-8.0811  (46.90093) -18.0336  (66.96524) -17.7758  (67.44643)
Week 16: HAQ-DI Score Number Analyzed 241 participants 235 participants 237 participants
-7.1776  (48.33253) -19.3627  (70.83578) -26.6732  (53.14973)
Week 20: HAQ-DI Score Number Analyzed 240 participants 234 participants 234 participants
-10.4296  (50.87958) -24.9496  (64.86820) -28.9317  (60.67279)
Week 24: HAQ-DI Score Number Analyzed 239 participants 233 participants 237 participants
-6.7995  (54.78602) -25.2578  (63.15450) -33.8837  (51.59441)
Week 2: CRP Number Analyzed 246 participants 247 participants 242 participants
86.677  (645.0281) 0.935  (91.3783) 10.664  (132.5947)
Week 4: CRP Number Analyzed 242 participants 244 participants 236 participants
28.042  (208.6385) -16.885  (79.3501) 1.128  (168.9301)
Week 8: CRP Number Analyzed 240 participants 240 participants 241 participants
45.451  (322.4433) -11.214  (150.1689) -17.474  (112.3803)
Week 12: CRP Number Analyzed 241 participants 242 participants 236 participants
47.034  (313.9875) -25.620  (97.1384) -22.277  (122.3489)
Week 16: CRP Number Analyzed 241 participants 239 participants 238 participants
28.595  (237.6660) -19.874  (134.5210) -26.592  (86.8465)
Week 20: CRP Number Analyzed 241 participants 239 participants 236 participants
42.282  (284.1330) -13.551  (193.3814) -28.701  (83.0912)
Week 24: CRP Number Analyzed 240 participants 243 participants 239 participants
19.263  (149.5120) -27.470  (109.5239) -28.125  (87.7229)
20.Secondary Outcome
Title Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Description HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess 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. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative changes from baseline indicate improvement of physical function.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 2
-0.0594
(-0.1023 to -0.0165)
-0.1423
(-0.1850 to -0.0997)
-0.0795
(-0.1226 to -0.0364)
Week 4
-0.0722
(-0.1196 to -0.0247)
-0.1472
(-0.1944 to -0.1000)
-0.1605
(-0.2081 to -0.1128)
Week 8
-0.0942
(-0.1464 to -0.0420)
-0.2294
(-0.2815 to -0.1773)
-0.2336
(-0.2859 to -0.1813)
Week 12
-0.1332
(-0.1875 to -0.0790)
-0.2870
(-0.3411 to -0.2330)
-0.3010
(-0.3554 to -0.2466)
Week 16
-0.1167
(-0.1753 to -0.0582)
-0.3177
(-0.3760 to -0.2595)
-0.3442
(-0.4029 to -0.2855)
Week 20
-0.1565
(-0.2163 to -0.0968)
-0.3536
(-0.4131 to -0.2941)
-0.4019
(-0.4618 to -0.3420)
Week 24
-0.1300
(-0.1912 to -0.0687)
-0.3672
(-0.4282 to -0.3062)
-0.4004
(-0.4617 to -0.3390)
21.Secondary Outcome
Title Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline
Hide Description HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess 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. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time Frame Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with HAQ-DI >=0.35 at baseline. Participants with HAQ-DI >=0.35 improvement from baseline at specific timepoint and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 236 228 228
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 19.9 30.7 23.2
Week 4 23.7 32.0 35.1
Week 8 28.0 43.4 42.5
Week 12 31.8 47.4 46.9
Week 16 30.9 50.0 51.8
Week 20 38.6 48.7 53.1
Week 24 31.4 50.0 56.1
22.Secondary Outcome
Title Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24
Hide Description DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS 28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder is defined as achieving a good or moderate DAS28 response at a specific visit.
Time Frame Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved a DAS28 (CRP) response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 21.5 23.8 24.5
Week 4 32.9 38.7 40.8
Week 8 38.6 56.9 54.7
Week 12 51.2 67.3 65.7
Week 16 51.2 69.8 72.7
Week 20 50.4 75.0 76.3
Week 24 52.4 75.4 80.0
23.Secondary Outcome
Title Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24
Hide Description DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS 28 (CRP) remission was defined as DAS 28 (CRP) value <2.6 at the analysis visit.
Time Frame Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved a DAS28 (CRP) remission at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 0.8 2.4 2.4
Week 4 2.0 5.2 4.9
Week 8 0.8 10.5 9.0
Week 12 6.1 14.1 11.8
Week 16 6.5 18.5 16.3
Week 20 9.8 23.0 21.2
Week 24 8.5 24.6 23.3
24.Secondary Outcome
Title Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Description DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 2
-0.29
(-0.37 to -0.21)
-0.42
(-0.50 to -0.33)
-0.43
(-0.51 to -0.35)
Week 4
-0.44
(-0.53 to -0.35)
-0.62
(-0.71 to -0.53)
-0.65
(-0.74 to -0.55)
Week 8
-0.59
(-0.71 to -0.48)
-0.99
(-1.11 to -0.88)
-0.98
(-1.09 to -0.86)
Week 12
-0.85
(-0.97 to -0.73)
-1.27
(-1.39 to -1.15)
-1.22
(-1.35 to -1.10)
Week 16
-0.88
(-1.01 to -0.75)
-1.39
(-1.52 to -1.26)
-1.37
(-1.50 to -1.24)
Week 20
-1.00
(-1.13 to -0.87)
-1.52
(-1.65 to -1.38)
-1.56
(-1.70 to -1.43)
Week 24
-0.97
(-1.11 to -0.84)
-1.59
(-1.72 to -1.45)
-1.62
(-1.76 to -1.49)
25.Secondary Outcome
Title Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24
Hide Description The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time Frame Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved a modified PsARC response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 13.0 22.2 18.0
Week 4 27.2 32.7 29.8
Week 8 35.8 48.8 50.2
Week 12 40.7 60.9 60.8
Week 16 44.7 66.5 66.5
Week 20 46.7 72.2 69.0
Week 24 44.7 72.6 68.6
26.Secondary Outcome
Title Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline
Hide Description Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.
Time Frame Weeks 2, 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with enthesitis at baseline. Participants with enthesitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 178 158 170
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 16.3 17.7 17.1
Week 4 18.0 21.5 25.3
Week 8 24.7 31.0 27.6
Week 16 30.9 47.5 40.6
Week 24 30.3 53.8 43.5
27.Secondary Outcome
Title Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline
Hide Description The presence and severity of dactylitis was 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) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.
Time Frame Weeks 2, 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with dactylitis at baseline. Participants who achieved dactylitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 99 111 121
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 12.1 13.5 13.2
Week 4 18.2 19.8 20.7
Week 8 29.3 30.6 31.4
Week 16 36.4 45.0 52.1
Week 24 38.4 56.8 63.6
28.Secondary Outcome
Title Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline
Hide Description Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.
Time Frame Baseline, Weeks 2, 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1 among participants with enthesitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 178 158 170
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 2
-0.33
(-0.53 to -0.12)
-0.37
(-0.59 to -0.16)
-0.49
(-0.70 to -0.29)
Week 4
-0.46
(-0.68 to -0.24)
-0.56
(-0.79 to -0.33)
-0.69
(-0.92 to -0.47)
Week 8
-0.67
(-0.90 to -0.45)
-0.92
(-1.16 to -0.67)
-0.88
(-1.11 to -0.64)
Week 16
-0.94
(-1.18 to -0.71)
-1.37
(-1.62 to -1.12)
-1.42
(-1.66 to -1.18)
Week 24
-1.03
(-1.25 to -0.81)
-1.60
(-1.84 to -1.37)
-1.52
(-1.75 to -1.29)
29.Secondary Outcome
Title Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline
Hide Description The presence and severity of dactylitis was 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) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.
Time Frame Baseline, Weeks 2, 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1 among participants with dactylitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 99 111 121
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 2
-0.21
(-1.11 to 0.69)
-1.11
(-1.95 to -0.26)
-0.78
(-1.61 to 0.05)
Week 4
-1.10
(-2.07 to -0.13)
-2.11
(-3.02 to -1.20)
-1.56
(-2.47 to -0.66)
Week 8
-2.17
(-3.19 to -1.16)
-3.17
(-4.12 to -2.22)
-3.11
(-4.05 to -2.17)
Week 16
-3.40
(-4.42 to -2.38)
-4.88
(-5.84 to -3.92)
-4.80
(-5.75 to -3.85)
Week 24
-4.03
(-4.96 to -3.10)
-5.95
(-6.83 to -5.08)
-5.88
(-6.74 to -5.01)
30.Secondary Outcome
Title Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24
Hide Description PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a compositive score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0-6), tender dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score > 0 equaled 1), and the PCS score of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time Frame Baseline, Weeks 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on Mixed-effect repeated measures (MMRM) model that included data from all visits for all participants included in the model.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8
-0.863
(-1.007 to -0.719)
-1.452
(-1.595 to -1.309)
-1.413
(-1.557 to -1.270)
Week 16
-1.158
(-1.327 to -0.988)
-2.110
(-2.278 to -1.942)
-1.994
(-2.164 to -1.825)
Week 24
-1.336
(-1.516 to -1.156)
-2.403
(-2.582 to -2.225)
-2.399
(-2.579 to -2.219)
31.Secondary Outcome
Title Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24
Hide Description GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.
Time Frame Baseline, Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 16
-1.029
(-1.212 to -0.847)
-2.326
(-2.507 to -2.145)
-2.214
(-2.397 to -2.032)
Week 24
-1.198
(-1.395 to -1.001)
-2.593
(-2.789 to -2.397)
-2.589
(-2.786 to -2.392)
32.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24
Hide Description Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPA-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame Baseline, Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 155 145 145
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of work time missed
Week 16
-4.553
(-7.199 to -1.906)
-3.451
(-6.199 to -0.703)
-4.717
(-7.449 to -1.985)
Week 24
-3.491
(-6.403 to -0.578)
-3.103
(-6.062 to -0.144)
-3.827
(-6.826 to -0.828)
33.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24
Hide Description Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPA-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame Baseline, Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 131 129 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of impairment
Week 16
-10.281
(-13.887 to -6.675)
-16.054
(-19.699 to -12.409)
-15.083
(-18.655 to -11.511)
Week 24
-10.157
(-13.663 to -6.650)
-19.366
(-22.857 to -15.875)
-19.492
(-22.982 to -16.003)
34.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24
Hide Description Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPA-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame Baseline, Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 131 129 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of overall work impairment
Week 16
-11.232
(-14.962 to -7.501)
-15.926
(-19.694 to 12.159)
-15.808
(-19.501 to -12.115)
Week 24
-10.869
(-14.591 to -7.147)
-19.711
(-23.416 to -16.006)
-20.023
(-23.726 to -16.320)
35.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24
Hide Description Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPA-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame Baseline, Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 244 247 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of activity impairment
Week 16
-10.569
(-13.262 to -7.877)
-17.107
(-19.787 to -14.428)
-17.029
(-19.727 to -14.331)
Week 24
-10.320
(-13.071 to -7.570)
-21.467
(-24.204 to -18.729)
-20.480
(-23.226 to -17.734)
36.Secondary Outcome
Title Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24
Hide Description The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.
Time Frame Baseline, Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 16
-1.18
(-1.43 to -0.93)
-2.39
(-2.64 to -2.14)
-2.57
(-2.82 to -2.31)
Week 24
-1.30
(-1.57 to -1.04)
-2.94
(-3.20 to -2.68)
-3.09
(-3.35 to -2.83)
37.Secondary Outcome
Title Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Description DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 2
-4.6447
(-5.9287 to -3.3607)
-6.7838
(-8.0642 to -5.5034)
-6.3783
(-7.6664 to -5.0902)
Week 4
-7.6695
(-9.2194 to -6.1197)
-9.9687
(-11.5128 to -8.4246)
-10.2484
(-11.8049 to -8.6919)
Week 8
-10.4480
(-12.1877 to -8.7084)
-15.3303
(-17.0682 to -13.5924)
-15.8657
(-17.6038 to -14.1277)
Week 12
-14.2915
(-16.1107 to -12.4724)
-18.9772
(-20.7912 to -17.1632)
-19.9687
(-21.7915 to -18.1459)
Week 16
-14.8556
(-16.8664 to -12.8448)
-21.6939
(-23.6979 to -19.6899)
-21.4722
(-23.4873 to -19.4571)
Week 20
-16.1375
(-18.1165 to -14.1586)
-23.3163
(-25.2890 to -21.3436)
-24.6844
(-26.6691 to -22.6997)
Week 24
-15.8489
(-17.9229 to -13.7750)
-24.0359
(-26.1019 to -21.9699)
-25.1583
(-27.2341 to -23.0824)
38.Secondary Outcome
Title Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24
Hide Description MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).
Time Frame Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1. Participants who achieved MDA at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 3.3 16.9 13.1
Week 24 6.1 25.0 18.8
39.Secondary Outcome
Title Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
Hide Description Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis with peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time Frame Weeks 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 with spondylitis and peripheral arthritis and BASDAI score >0 at baseline. Participants with the specified improvement in BASDAI at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 92 67 83
Measure Type: Number
Unit of Measure: percentage of participants
Week 8: Participants with >=20% Improvement 38.0 46.3 53.0
Week 16: Participants with >=20% Improvement 39.1 58.2 69.9
Week 24: Participants with >=20% Improvement 42.4 59.7 68.7
Week 8: Participants with >=50% Improvement 6.5 17.9 18.1
Week 16: Participants with >=50% Improvement 17.4 37.3 26.5
Week 24: Participants with >=50% Improvement 21.7 38.8 37.3
Week 8: Participants with >=70% Improvement 3.3 11.9 4.8
Week 16: Participants with >=70% Improvement 5.4 23.9 9.6
Week 24: Participants with >=70% Improvement 8.7 20.9 15.7
Week 8: Participants with >=90% Improvement 0 1.5 0
Week 16: Participants with >=90% Improvement 1.1 0 2.4
Week 24: Participants with >=90% Improvement 2.2 1.5 3.6
40.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 75 response: >=75% improvement in PASI score from baseline.
Time Frame Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with PASI 75 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 18.6 73.3 73.9
Week 24 23.0 79.0 78.3
41.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.
Time Frame Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with PASI 90 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 8.2 55.1 53.8
Week 24 9.8 68.8 60.9
42.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
Hide Description PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline.
Time Frame Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with PASI 100 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 3.8 27.3 33.2
Week 24 2.7 45.5 44.6
43.Secondary Outcome
Title Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with IGA score of 0(cleared) at specific time point and did not meet TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 6.0 38.6 40.8
Week 24 7.5 50.0 51.5
44.Secondary Outcome
Title Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.
Time Frame Baseline, Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants who had >=3% BSA of psoriatic involvement and IGA score >=2 (mild) at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 16
-3.482
(-4.346 to -2.618)
-11.151
(-12.028 to -10.274)
-11.278
(-12.153 to -10.404)
Week 24
-3.904
(-4.748 to -3.059)
-11.407
(-12.265 to -10.549)
-11.471
(-12.325 to -10.617)
45.Secondary Outcome
Title Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.
Time Frame Weeks 8, 16, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 among participants with DLQI >1, >=3% BSA of psoriasis and IGA score >=2 (mild) at baseline. Participants with DLQI score of 0/1 at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 170 158 173
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 7.6 33.5 26.6
Week 16 10.0 51.3 45.1
Week 24 11.8 63.9 59.0
46.Secondary Outcome
Title Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.
Time Frame Weeks 8, 16, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 with DLQI>=5, >=3% BSA of psoriasis and IGA score >=2 (mild) at baseline. Participants with >=5-point improvement from baseline in DLQI score at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 143 132 152
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 30.1 71.2 69.7
Week 16 36.4 79.5 79.6
Week 24 37.8 83.3 86.8
47.Secondary Outcome
Title Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.
Time Frame Baseline, Weeks 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1 among participants with >=3% BSA of psoriasis and an IGA score >=2 (mild) at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. LS mean is based on MMRM model that included data from all visits for all participants included in model.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8
-1.653
(-2.373 to -0.933)
-6.818
(-7.549 to -6.086)
-6.396
(-7.121 to -5.671)
Week 16
-2.410
(-3.109 to -1.710)
-8.545
(-9.255 to -7.835)
-8.147
(-8.853 to -7.441)
Week 24
-2.129
(-2.854 to -1.404)
-8.954
(-9.691 to -8.218)
-8.853
(-9.581 to -8.124)
48.Secondary Outcome
Title Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.
Time Frame Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 participants with >=3% BSA psoriatic involvement and IGA score >=2 at baseline. Participants with both PASI75 and ACR20 responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 10.4 48.9 48.4
Week 24 11.5 56.8 57.1
49.Secondary Outcome
Title Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Hide Description In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.
Time Frame Weeks 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 with >=3% BSA psoriatic involvement and IGA score >=2 at baseline. Participants with both PASI 75 and modified PsARC responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 183 176 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 13.1 56.8 54.3
Week 24 15.3 65.3 60.9
50.Secondary Outcome
Title Change From Baseline in Modified vdH-S Erosion Score at Week 24
Hide Description Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.58
(0.33 to 0.83)
0.36
(0.11 to 0.61)
0.13
(-0.12 to 0.38)
51.Secondary Outcome
Title Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24
Hide Description The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the total JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 to 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. A positive change from baseline in the modified vdH-S JSN score indicates progression of joint space narrowing.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.37
(0.23 to 0.51)
0.16
(0.02 to 0.30)
0.16
(0.02 to 0.30)
52.Secondary Outcome
Title Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24
Hide Description Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were summarized regardless if 1 or more TF criteria were met. Here, 'n' (number analyzed) signifies the number of participants analyzed for a specified score.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Mean (Standard Deviation)
Unit of Measure: units on a scale
Hand Erosion Score Number Analyzed 245 participants 247 participants 240 participants
0.40  (1.555) 0.18  (1.280) -0.03  (1.514)
Hand JSN Score Number Analyzed 245 participants 247 participants 240 participants
0.26  (1.106) 0.10  (0.637) 0.08  (0.607)
Hand Score Number Analyzed 245 participants 247 participants 240 participants
0.66  (2.441) 0.28  (1.649) 0.05  (1.881)
Foot Erosion Score Number Analyzed 245 participants 247 participants 240 participants
0.14  (0.801) 0.15  (0.982) 0.14  (0.894)
Foot JSN Score Number Analyzed 245 participants 247 participants 240 participants
0.10  (0.516) 0.02  (0.516) 0.07  (0.632)
Foot Score Number Analyzed 245 participants 247 participants 240 participants
0.24  (1.116) 0.17  (1.180) 0.21  (1.210)
53.Secondary Outcome
Title Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24
Hide Description Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Change of <=0 from Baseline 64.7 63.5 67.3
Change of <=0.5 from Baseline 72.1 74.4 78.0
54.Secondary Outcome
Title Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24
Hide Description Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Change of <=0 from Baseline 66.8 66.3 71.4
Change of <=0.5 from Baseline 72.9 76.8 80.2
55.Secondary Outcome
Title Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24
Hide Description The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. Change from baseline in the modified vdH-S JSN score <=0 (assessed by both readers) or <=0.5 (assessed by at least one reader) was considered as no progression of JSN.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
Change of <=0 from Baseline 78.6 78.8 80.1
Change of <=0.5 from Baseline 85.5 88.1 88.3
56.Secondary Outcome
Title Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24
Hide Description Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 2.18.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
86.4 87.8 89.3
57.Secondary Outcome
Title Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24
Hide Description Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC defined as the cut-off above which changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score <=SDC of 1.83.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
84.0 89.0 89.9
58.Secondary Outcome
Title Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24
Hide Description The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. The smallest detectable change (SDC) was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score <=SDC of 1.11.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
Arm/Group Title Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
Hide Arm/Group Description:
Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Overall Number of Participants Analyzed 246 248 245
Measure Type: Number
Unit of Measure: percentage of participants
91.3 93.5 91.7
59.Secondary Outcome
Title Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24