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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis including those Previously Treated with Biologic Anti-TNFα Agent(s)

    Summary
    EudraCT number
    2016-001163-37
    Trial protocol
    HU   CZ   ES   DE   PL  
    Global end of trial date
    14 Nov 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Nov 2020
    First version publication date
    30 Nov 2020
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO1959PSA3001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03162796
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, P.O. Box 300, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of guselkumab treatment in subjects with active psoriatic arthritis (PsA) including those previously treated with biologic anti-tumor necrosis factor alpha (anti-TNF alpha) agent(s) by assessing the reduction in signs and symptoms of PsA.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. The safety assessments included adverse events (AEs), clinical laboratory tests, physical examinations, vital signs, suicidal ideation or behavior (using the eC-SSRS questionnaires), concomitant medication review, and early detection of tuberculosis (TB).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Czechia: 12
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Poland: 107
    Country: Number of subjects enrolled
    Russian Federation: 64
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Taiwan: 16
    Country: Number of subjects enrolled
    Ukraine: 70
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    381
    EEA total number of subjects
    170
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    352
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    A total of 383 subjects were enrolled. Among them, 381 subjects received at least one dose of study drug (126 in placebo group, 127 in guselkumab 100 mg q8w group and 128 in guselkumab 100 mg q4w group). One subjects was randomized to guselkumab 100 mg q8w but not treated.

    Pre-assignment
    Screening details
    One subjects was accidentally randomized before completion of screening assessments. Subsequently, this subjects screen failed and was later re-screened and randomized using a new subjects number.Therefore, this subjects was counted twice in the number of subjects enrolled, but only once in the number of subjects randomized.

    Period 1
    Period 1 title
    Placebo Controlled Period: Week 0 - 24
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Sponsor was also blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects 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.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP).

    Arm title
    Guselkumab 100 mg q8w
    Arm description
    Subjects 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.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w).

    Arm title
    Guselkumab 100 mg q4w
    Arm description
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.

    Number of subjects in period 1
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Started
    126
    127
    128
    Completed
    114
    123
    125
    Not completed
    12
    4
    3
         Lack of efficacy
    4
    -
    -
         Adverse event, serious fatal
    1
    -
    -
         Initiated prohibited medication
    1
    -
    -
         Adverse event, non-fatal
    2
    3
    1
         Unspecified
    -
    1
    1
         Consent withdrawn by subject
    3
    -
    1
         Lost to follow-up
    1
    -
    -
    Period 2
    Period 2 title
    Active Treatment Period: Week 24 - 52
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Sponsor was also blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects 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.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP).

    Arm title
    Guselkumab 100 mg q8w
    Arm description
    Subjects 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.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w).

    Arm title
    Guselkumab 100 mg q4w
    Arm description
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.

    Number of subjects in period 2
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Started
    114
    123
    125
    Completed
    107
    116
    124
    Not completed
    7
    7
    1
         Lack of efficacy
    4
    3
    1
         Adverse event, non-fatal
    3
    2
    -
         Consent withdrawn by subject
    -
    2
    -
    Period 3
    Period 3 title
    Safety Follow-up: Week 52 - 60
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Sponsor was also blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects 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. Subjects were followed-up for 8 weeks after Week 52 during safety follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Guselkumab 100 mg q8w
    Arm description
    Subjects 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. Subjects were followed-up for 8 weeks after Week 52 during safety follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Guselkumab 100 mg q4w
    Arm description
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48. Subjects were followed-up for 8 weeks after Week 52 during safety follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Started
    107
    116
    124
    Completed
    106
    114
    123
    Not completed
    1
    2
    1
         Consent withdrawn by subject
    1
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects 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.

    Reporting group title
    Guselkumab 100 mg q8w
    Reporting group description
    Subjects 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.

    Reporting group title
    Guselkumab 100 mg q4w
    Reporting group description
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.

    Reporting group values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w Total
    Number of subjects
    126 127 128 381
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    114 118 120 352
        From 65-84 years
    12 9 8 29
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49 ± 11.1 48.9 ± 11.52 47.4 ± 11.59 -
    Sex: Female, Male
    Units: subjects
        Female
    65 59 62 186
        Male
    61 68 66 195
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    2 2 0 4
        Not Hispanic or Latino
    122 124 128 374
        Unknown or Not Reported
    2 1 0 3
    Region of Enrollment
    Units: Subjects
        AUSTRALIA
    5 8 4 17
        CANADA
    8 3 4 15
        CZECH REPUBLIC
    5 4 3 12
        GERMANY
    3 10 10 23
        HUNGARY
    3 4 9 16
        MALAYSIA
    5 1 2 8
        POLAND
    37 36 34 107
        RUSSIAN FEDERATION
    22 19 23 64
        SOUTH KOREA
    3 1 0 4
        SPAIN
    5 6 1 12
        TAIWAN
    4 7 5 16
        UKRAINE
    19 22 29 70
        UNITED STATES
    7 6 4 17
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    12 10 7 29
        Native Hawaiian or Other Pacific Islander
    0 1 0 1
        Black or African American
    0 0 0 0
        White
    112 116 121 349
        More than one race
    0 0 0 0
        Unknown or Not Reported
    2 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects 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.

    Reporting group title
    Guselkumab 100 mg q8w
    Reporting group description
    Subjects 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.

    Reporting group title
    Guselkumab 100 mg q4w
    Reporting group description
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
    Reporting group title
    Placebo
    Reporting group description
    Subjects 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.

    Reporting group title
    Guselkumab 100 mg q8w
    Reporting group description
    Subjects 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.

    Reporting group title
    Guselkumab 100 mg q4w
    Reporting group description
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
    Reporting group title
    Placebo
    Reporting group description
    Subjects 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. Subjects were followed-up for 8 weeks after Week 52 during safety follow-up period.

    Reporting group title
    Guselkumab 100 mg q8w
    Reporting group description
    Subjects 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. Subjects were followed-up for 8 weeks after Week 52 during safety follow-up period.

    Reporting group title
    Guselkumab 100 mg q4w
    Reporting group description
    Subjects were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48. Subjects were followed-up for 8 weeks after Week 52 during safety follow-up period.

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

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    End point title
    Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
    End point description
    ACR 20: >=20% improvement from baseline in both SJC(66 joints) and TJC(68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient’s assessment of pain using VAS(0-100mm, 0=no pain and 100=worst possible pain), PtGA of disease activity (arthritis, VAS; 0-100mm, 0=excellent and 100=poor), PGA of disease activity (VAS; 0-100mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform task), and CRP. TF criteria - discontinued study drug, initiated/increased dose of non-biologic DMARDs or oral corticosteroids, initiated prohibited psoriatic arthritis treatment. Analysis population is FAS1. Subjects who achieved ACR 20 response at Week 24 and did not meet any TF criteria before Week 24 considered responders. Subjects who met 1/more TF criteria or with missing data considered non-responders.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
        number (not applicable)
    22.2
    52.0
    59.4
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    29.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.6
         upper limit
    41.1
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    37.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    26.1
         upper limit
    48.2

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

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    End point title
    Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
    End point description
    HAQ-DI score assess functional status of subject. 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. Analysis population is full analysis set-1 (FAS1). Data after meeting one or more treatment failure (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).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -0.0743 (-0.1605 to 0.0119)
    -0.3225 (-0.4082 to -0.2369)
    -0.3968 (-0.4825 to -0.3112)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Square (LS) Mean Difference
    Point estimate
    -0.2483
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.364
         upper limit
    -0.1325
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.3226
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4385
         upper limit
    -0.2066

    Secondary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24

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    End point title
    Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
    End point description
    ACR 50 defined as greater than or equal to (>=)50 percent (%) improvement from baseline in both SJC(66 joints) and TJC(68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient’s assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain and 100=worst possible pain), PtGA of disease activity (arthritis, VAS; 0-100mm, 0=excellent and 100=poor), 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 C-Reactive Protein (CRP). Analysis population is FAS1. Subjects who achieved ACR 50 response at Week 24 and did not meet any TF criteria before Week 24 considered as responders. Subjects who met 1 or more TF criteria or with missing data considered as nonresponders.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
        number (not applicable)
    8.7
    29.9
    35.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    21.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.1
         upper limit
    30.7
    Notes
    [1] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    27.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17.6
         upper limit
    36.8
    Notes
    [2] - Nominal

    Secondary: Percentage of Subjects With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 grade reduction from baseline) at Week 24 Among Subjects With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline

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    End point title
    Percentage of Subjects With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 grade reduction from baseline) at Week 24 Among Subjects With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline
    End point 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 subject’s psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). FAS1 among the subjects with >=3% BSA psoriatic involvement and an IGA score of >=2 (mild) at baseline. Subjects who achieved psoriasis IGA response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Subjects who met 1 or more TF criteria or with missing data were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: percentage of subjects
        number (not applicable)
    15.4
    57.3
    75.3
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.9
         upper limit
    55.1
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    60
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48.3
         upper limit
    71.8

    Secondary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16

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    End point title
    Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
    End point 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 HAQ-DI (20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform task in that area), and CRP. Analysis population is FAS1. Subjects who achieved ACR 20 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Subjects who met 1 or more TF criteria or with missing data were considered as nonresponders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
        number (not applicable)
    25.4
    52.0
    60.2
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    26.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.3
         upper limit
    38.1
    Notes
    [3] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    34.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.5
         upper limit
    46
    Notes
    [4] - Nominal

    Secondary: Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24

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    End point title
    Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24
    End point 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. 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 MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -0.70 (-0.89 to -0.51)
    -1.43 (-1.61 to -1.24)
    -1.61 (-1.80 to -1.42)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [5]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.98
         upper limit
    -0.48
    Notes
    [5] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.16
         upper limit
    -0.66
    Notes
    [6] - Nominal

    Secondary: Percentage of Subjects who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24

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    End point title
    Percentage of Subjects who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24
    End point 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 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. Analysis population is FAS1. Subjects who achieved ACR 70 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Subjects who met 1 or more TF criteria or with missing data were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
        number (not applicable)
    5.6
    11.8
    20.3
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.069
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    6.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    13.1
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    14.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.9
         upper limit
    22.7

    Secondary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16

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    End point title
    Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
    End point description
    ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (SJC; 66 joints) and tender joint count (TJC; 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 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. Analysis population is FAS1. Subjects who achieved ACR 50 response at Week 16 and did not meet any TF criteria before Week 16 considered as responders. Subjects who met 1 or more TF criteria or with missing data considered as nonresponders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
        number (not applicable)
    12.7
    22.8
    26.6
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.036 [7]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    10.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1
         upper limit
    19.3
    Notes
    [7] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    13.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.4
         upper limit
    23.4
    Notes
    [8] - Nominal

    Secondary: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

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    End point title
    Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
    End point 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. 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 MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
        least squares mean (confidence interval 95%)
    1.96 (0.69 to 3.24)
    6.10 (4.83 to 7.37)
    6.87 (5.60 to 8.14)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    4.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.42
         upper limit
    5.85
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    4.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.19
         upper limit
    6.63

    Secondary: Percentage of Subjects With Resolution of Enthesitis at Week 24 Among the Subjects With Enthesitis at Baseline

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    End point title
    Percentage of Subjects With Resolution of Enthesitis at Week 24 Among the Subjects With Enthesitis at Baseline
    End point description
    Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in subjects 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 greater than (>) 0. Analysis population is FAS1 among the subjects with enthesitis (LEI) at baseline. Subjects who achieved resolution of enthesitis at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Subjects who met 1 or more TF criteria or with missing data were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    77
    72
    73
    Units: percentage of subjects
        number (not applicable)
    27.3
    40.3
    47.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.094 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.6
         upper limit
    27.5
    Notes
    [9] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.013 [10]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    19.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.9
         upper limit
    34.6
    Notes
    [10] - Nominal

    Secondary: Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Subjects with Enthesitis at Baseline

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    End point title
    Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Subjects with Enthesitis at Baseline
    End point description
    Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in subjects 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 indicates improvement of enthesitis. Analysis population is FAS1 among the subjects with enthesitis (LEI) at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    77
    72
    73
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -1.01 (-1.37 to -0.66)
    -1.35 (-1.72 to -0.98)
    -1.75 (-2.13 to -1.38)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.185 [11]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.83
         upper limit
    0.16
    Notes
    [11] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004 [12]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.24
         upper limit
    -0.24
    Notes
    [12] - Nominal

    Secondary: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24

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    End point title
    Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24
    End point 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. 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 MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
        least squares mean (confidence interval 95%)
    2.37 (0.93 to 3.81)
    3.20 (1.78 to 4.63)
    3.60 (2.17 to 5.02)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.398 [13]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    2.77
    Notes
    [13] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.214 [14]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    1.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.71
         upper limit
    3.16
    Notes
    [14] - Nominal

    Secondary: Percentage of Subjects With Resolution of Dactylitis at Week 24 Among the Subjects with Dactylitis at Baseline

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    End point title
    Percentage of Subjects With Resolution of Dactylitis at Week 24 Among the Subjects with Dactylitis at Baseline
    End point 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. Analysis population is FAS1 among the subjects with dactylitis at baseline. Subjects who achieved resolution of dactylitis at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Subjects who met 1 or more TF criteria or with missing data were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    55
    49
    38
    Units: percentage of subjects
        number (not applicable)
    49.1
    65.3
    63.2
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.088 [15]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    16.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    34.8
    Notes
    [15] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.212 [16]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    13.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.9
         upper limit
    33.7
    Notes
    [16] - Nominal

    Secondary: Change From Baseline in Dactylitis Scores at Week 24 Among the Subjects with Dactylitis at Baseline

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    End point title
    Change From Baseline in Dactylitis Scores at Week 24 Among the Subjects with Dactylitis at Baseline
    End point 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. A higher score indicates more severe dactylitis. Negative change from baseline indicates improvement in dactylitis. Analysis population is FAS1 among the subjects with dactylitis at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    55
    49
    38
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -4.30 (-5.96 to -2.63)
    -6.11 (-7.81 to -4.41)
    -5.82 (-7.82 to -3.83)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab 100 mg q8w
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.121 [17]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -1.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.12
         upper limit
    0.49
    Notes
    [17] - Nominal
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Guselkumab 100 mg q4w
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.225 [18]
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -1.53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    0.95
    Notes
    [18] - Nominal

    Secondary: Percentage of Subjects who Achieved ACR 20 Response by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects who Achieved ACR 20 Response by Visit Over Time Through Week 24
    End point description
    ACR 20 response was defined as >=20% improvement from baseline in both SJC (66 joints) and TJC (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient’s assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), PtGA of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100=poor), 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 HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. Analysis population is FAS1. Subjects 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. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 4
    7.9
    15.7
    20.3
        Week 8
    18.3
    36.2
    39.1
        Week 12
    27.0
    43.3
    53.1
        Week 16
    25.4
    52.0
    60.2
        Week 20
    30.2
    51.2
    62.5
        Week 24
    22.2
    52.0
    59.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved ACR 50 Response by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects who Achieved ACR 50 Response by Visit Over Time Through Week 24
    End point description
    ACR 50 response was defined as >=50% improvement from baseline in both SJC (66 joints) and TJC (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient’s assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), PtGA of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), 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 HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. Analysis population is FAS1. Subjects who achieved ACR 50 response at a specific time point and did not meet any treatment failure (TF) criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as nonresponders.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 4
    2.4
    1.6
    3.1
        Week 8
    7.9
    7.9
    10.9
        Week 12
    10.3
    20.5
    24.2
        Week 16
    12.7
    22.8
    26.6
        Week 20
    13.5
    29.1
    37.5
        Week 24
    8.7
    29.9
    35.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved ACR 70 Response by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects who Achieved ACR 70 Response by Visit Over Time Through Week 24
    End point description
    ACR 70 response was defined as >=70% improvement from baseline in both SJC (66 joints) and TJC (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient’s assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), PtGA of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), 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 HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. Analysis population is FAS1. Subjects 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. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 4
    0
    0.8
    0
        Week 8
    1.6
    3.1
    2.3
        Week 12
    4.8
    7.1
    6.3
        Week 16
    5.6
    7.9
    7.8
        Week 20
    7.1
    11.8
    17.2
        Week 24
    5.6
    11.8
    20.3
    No statistical analyses for this end point

    Secondary: ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24

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    End point title
    ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24
    End point description
    ACR components including swollen joint count (66 joints) and tender joint count (68 joints) were measured. Analysis population is FAS1. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: joints
    arithmetic mean (standard deviation)
        Week 4: Swollen Joint Count (n=124, 124, 128)
    8.0 ± 7.71
    7.7 ± 7.89
    5.7 ± 4.89
        Week 8: Swollen Joint Count (n=122, 125, 128)
    6.6 ± 5.83
    6.2 ± 9.36
    4.4 ± 5.22
        Week 12: Swollen Joint Count (n=123, 126, 127)
    6.1 ± 6.41
    4.5 ± 6.63
    3.5 ± 5.60
        Week 16: Swollen Joint Count (n=122, 123, 127)
    5.9 ± 6.09
    3.8 ± 5.15
    2.7 ± 4.25
        Week 20: Swollen Joint Count (n=118, 122, 126)
    5.2 ± 5.72
    4.0 ± 6.28
    2.7 ± 4.87
        Week 24: Swollen Joint Count (n=118, 123, 127)
    4.9 ± 6.14
    3.8 ± 6.53
    2.8 ± 5.27
        Week 4: Tender Joint Count (n=124, 124, 128)
    17.0 ± 13.81
    16.3 ± 14.11
    14.4 ± 11.85
        Week 8: Tender Joint Count (n=122, 125, 128)
    15.8 ± 13.68
    13.5 ± 13.86
    12.2 ± 11.53
        Week 12: Tender Joint Count (n=123, 126, 127)
    15.1 ± 14.21
    11.5 ± 13.16
    9.7 ± 11.14
        Week 16: Tender Joint Count (n=122, 123, 127)
    15.5 ± 13.61
    10.3 ± 12.06
    9.0 ± 10.29
        Week 20: Tender Joint Count (n=118, 122, 126)
    13.4 ± 13.02
    9.9 ± 12.53
    7.9 ± 9.54
        Week 24: Tender Joint Count (n=118, 123, 127)
    13.2 ± 12.09
    9.9 ± 12.82
    8.4 ± 10.47
    No statistical analyses for this end point

    Secondary: ACR Components- Patient’s Assessment of Pain, Patient’s Global Assessment of Disease Activity, Physician’s Global Assessment of Disease Activity Through Week 24

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    End point title
    ACR Components- Patient’s Assessment of Pain, Patient’s Global Assessment of Disease Activity, Physician’s Global Assessment of Disease Activity Through Week 24
    End point description
    ACR components included 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). Analysis population is FAS1. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: millimeters
    arithmetic mean (standard deviation)
        Week4: Patient's Assessment of Pain(n=124,123,128)
    5.74 ± 2.296
    5.49 ± 2.159
    5.18 ± 2.224
        Week8: Patient's Assessment of Pain(n=123,126,128)
    5.06 ± 2.257
    4.90 ± 2.310
    4.54 ± 2.397
        Week12:Patient's Assessment of Pain(n=123,126,127)
    4.96 ± 2.355
    4.35 ± 2.503
    4.09 ± 2.346
        Week16:Patient's Assessment of Pain(n=122,124,127)
    5.01 ± 2.417
    4.25 ± 2.471
    3.85 ± 2.462
        Week20:Patient's Assessment of Pain(n=118,124,126)
    4.98 ± 2.497
    4.00 ± 2.481
    3.51 ± 2.409
        Week24:Patient's Assessment of Pain(n=118,123,127)
    5.09 ± 2.379
    3.82 ± 2.470
    3.52 ± 2.502
        Week4:PtGA of Disease Activity(n=124,123,128)
    5.86 ± 2.281
    5.80 ± 2.181
    5.36 ± 2.200
        Week8: PtGA of Disease Activity(n=123,126,128)
    5.26 ± 2.271
    4.99 ± 2.381
    4.82 ± 2.384
        Week12: PtGA of Disease Activity(n=123,126,127)
    5.13 ± 2.398
    4.46 ± 2.459
    4.18 ± 2.441
        Week16: PtGA of Disease Activity(n=122,124,127)
    5.12 ± 2.379
    4.59 ± 2.541
    3.96 ± 2.458
        Week20: PtGA of Disease Activity(n=118,124,126)
    5.08 ± 2.596
    4.21 ± 2.604
    3.57 ± 2.443
        Week24: PtGA of Disease Activity(n=118,123,127)
    5.19 ± 2.419
    4.03 ± 2.603
    3.48 ± 2.412
        Week4: PGA of Disease Activity(n=122,123,126)
    5.53 ± 1.986
    4.94 ± 1.977
    4.72 ± 1.955
        Week8: PGA of Disease Activity(n=122,125,128)
    4.79 ± 2.197
    3.88 ± 2.299
    3.63 ± 2.035
        Week12: PGA of Disease Activity(n=122,125,127)
    4.31 ± 2.196
    3.47 ± 1.992
    3.08 ± 2.031
        Week16: PGA of Disease Activity(n=120,123,124)
    4.31 ± 2.296
    3.39 ± 2.260
    2.73 ± 2.022
        Week20: PGA of Disease Activity(n=117,121,125)
    3.96 ± 2.367
    2.90 ± 2.132
    2.44 ± 1.780
        Week24: PGA of Disease Activity(n=117,122,127)
    4.07 ± 2.361
    2.81 ± 2.169
    2.34 ± 1.889
    No statistical analyses for this end point

    Secondary: ACR Component- C-reactive Protein (CRP) Through Week 24

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    End point title
    ACR Component- C-reactive Protein (CRP) Through Week 24
    End point description
    ACR component including CRP was measured. Analysis population is FAS1. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: milligrams per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Week 4 (n=124, 123, 128)
    1.220 ± 1.5753
    1.159 ± 1.7641
    0.785 ± 1.1917
        Week 8 (n=120, 124, 127)
    1.184 ± 1.8722
    1.059 ± 1.4736
    0.720 ± 1.2637
        Week 12 (n=122, 123, 127)
    1.138 ± 1.5889
    0.936 ± 1.3470
    0.629 ± 0.7882
        Week 16 (n=120, 123, 124)
    1.143 ± 1.6005
    0.996 ± 1.5296
    0.592 ± 0.7861
        Week 20 (n=119, 124, 126)
    1.105 ± 1.6401
    0.941 ± 1.5067
    0.592 ± 0.8831
        Week 24 (n=119, 123, 127)
    1.319 ± 3.0033
    0.894 ± 1.5386
    0.633 ± 1.0522
    No statistical analyses for this end point

    Secondary: ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24

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    End point title
    ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24
    End point description
    Patient's assessment of physical function was measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI). HAQ-DI score assess functional status of subject. 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. Analysis population is FAS1. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4 (n=124, 124, 128)
    1.2188 ± 0.67806
    1.1371 ± 0.59755
    0.9824 ± 0.65278
        Week 8 (n=123, 126, 128)
    1.1331 ± 0.66928
    1.0188 ± 0.61463
    0.9150 ± 0.65488
        Week 12 (n=123, 126, 127)
    1.1169 ± 0.63813
    0.9831 ± 0.64058
    0.8012 ± 0.63060
        Week 16 (n=122, 124, 127)
    1.1035 ± 0.65372
    0.9375 ± 0.65845
    0.7776 ± 0.66011
        Week 20 (n=118, 124, 126)
    1.1049 ± 0.67838
    0.8730 ± 0.62347
    0.7619 ± 0.66491
        Week 24 (n=118, 123, 127)
    1.1133 ± 0.69279
    0.8770 ± 0.60691
    0.7264 ± 0.63225
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24

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    End point title
    Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24
    End point 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 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. Analysis population is FAS1. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percent change
    arithmetic mean (standard deviation)
        Week 4: Swollen Joint Count (n=124, 124, 128)
    -22.4 ± 49.78
    -27.5 ± 42.92
    -29.3 ± 50.85
        Week 8: Swollen Joint Count (n=122, 125, 128)
    -29.4 ± 50.57
    -45.3 ± 66.29
    -46.5 ± 53.81
        Week 12: Swollen Joint Count (n=123, 126, 127)
    -38.1 ± 55.69
    -60.0 ± 48.23
    -61.1 ± 42.62
        Week 16: Swollen Joint Count (n=122, 123, 127)
    -36.6 ± 56.25
    -65.8 ± 40.42
    -71.3 ± 34.69
        Week 20: Swollen Joint Count (n=118, 122, 126)
    -44.4 ± 54.01
    -66.2 ± 38.24
    -71.0 ± 40.88
        Week 24: Swollen Joint Count (n=118, 123, 127)
    -49.5 ± 45.66
    -66.6 ± 47.09
    -73.3 ± 37.95
        Week 4: Tender Joint Count (n=124, 124, 124)
    -15.4 ± 36.11
    -22.2 ± 36.99
    -17.2 ± 50.26
        Week 8: Tender Joint Count (n=122, 125, 128)
    -21.4 ± 41.36
    -35.7 ± 47.45
    -31.4 ± 47.13
        Week 12: Tender Joint Count (n=123, 126, 127)
    -24.5 ± 50.74
    -48.0 ± 40.24
    -47.9 ± 38.76
        Week 16: Tender Joint Count (n=122, 123, 127)
    -19.9 ± 50.84
    -52.6 ± 36.33
    -49.2 ± 57.97
        Week 20: Tender Joint Count (n=118, 122, 126)
    -30.8 ± 53.79
    -55.4 ± 40.17
    -59.4 ± 35.91
        Week 24: Tender Joint Count (n=118, 123, 127)
    -29.1 ± 53.54
    -53.7 ± 45.12
    -56.0 ± 41.76
        Week4: Patient's Assessment of Pain(n=123,123,127)
    2.98 ± 38.337
    -2.41 ± 43.139
    -9.12 ± 37.068
        Week8: Patient's Assessment of Pain(n=122,126,127)
    -7.41 ± 42.846
    -12.18 ± 46.920
    -19.41 ± 45.862
        Week12:Patient's Assessment of Pain(n=122,126,126)
    -7.82 ± 49.910
    -22.74 ± 45.048
    -27.28 ± 42.305
        Week16:Patient's Assessment of Pain(n=121,124,126)
    -7.86 ± 47.980
    -25.45 ± 47.860
    -29.74 ± 53.817
        Week20:Patient's Assessment of Pain(n=117,124,125)
    -8.31 ± 54.287
    -29.36 ± 46.581
    -38.45 ± 46.235
        Week24:Patient's Assessment of Pain(n=117,123,126)
    -5.35 ± 53.599
    -32.65 ± 45.343
    -38.97 ± 43.873
        Week 4: PtGA of Disease Activity (n=124,123,128)
    0.06 ± 37.022
    -9.57 ± 30.374
    -2.82 ± 58.438
        Week 8: PtGA of Disease Activity (n=123, 126, 128)
    -9.06 ± 43.197
    -20.08 ± 45.707
    -14.95 ± 46.672
        Week12: PtGA of Disease Activity (n=123, 126, 127)
    -10.00 ± 49.346
    -28.38 ± 40.863
    -26.84 ± 48.800
        Week16: PtGA of Disease Activity (n=122, 124, 127)
    -8.56 ± 55.279
    -26.93 ± 42.999
    -30.16 ± 47.486
        Week20: PtGA of Disease Activity (n=118, 124, 126)
    -11.67 ± 54.531
    -34.61 ± 40.905
    -38.76 ± 43.118
        Week24: PtGA of Disease Activity (n=118, 123, 127)
    -4.91 ± 65.728
    -37.16 ± 39.760
    -40.32 ± 42.037
        Week 4: PGA of Disease Activity (n=122, 123, 126)
    -10.50 ± 30.144
    -17.83 ± 34.370
    -22.42 ± 34.627
        Week 8: PGA of Disease Activity (n=122, 125, 128)
    -20.87 ± 38.908
    -36.57 ± 34.906
    -41.05 ± 31.682
        Week 12: PGA of Disease Activity (n=122, 125, 127)
    -30.47 ± 32.894
    -40.61 ± 37.367
    -48.87 ± 35.082
        Week 16: PGA of Disease Activity (n=120, 123, 124)
    -29.42 ± 36.058
    -45.04 ± 36.363
    -55.36 ± 32.848
        Week 20: PGA of Disease Activity (n=117, 121, 125)
    -36.48 ± 35.490
    -51.88 ± 34.491
    -59.57 ± 30.353
        Week 24: PGA of Disease Activity (n=117, 122, 127)
    -33.95 ± 34.349
    -53.43 ± 37.305
    -61.39 ± 31.234
        Week 4: HAQ-DI Score (n=118, 121, 119)
    4.3521 ± 61.86548
    -0.4964 ± 54.63888
    -5.9245 ± 53.44204
        Week 8: HAQ-DI Score (n=117, 123, 119)
    -3.3329 ± 48.15101
    -9.1556 ± 65.76295
    -11.3467 ± 69.07565
        Week 12: HAQ-DI Score (n=119, 123, 118)
    -2.1600 ± 88.42239
    -13.1115 ± 69.57297
    -21.6242 ± 65.32053
        Week 16: HAQ-DI Score (n=116, 122, 118)
    -3.2447 ± 109.78825
    -19.5421 ± 55.80512
    -27.7444 ± 68.28273
        Week 20: HAQ-DI Score (n=112, 122, 118)
    -10.5259 ± 44.67386
    -23.6139 ± 65.27566
    -26.2478 ± 74.38446
        Week 24: HAQ-DI Score (n=112, 121, 118)
    -7.3745 ± 61.62081
    -8.7950 ± 148.19861
    -31.1750 ± 72.70079
        Week 4: CRP (n=124, 123, 128)
    9.972 ± 66.9599
    -4.060 ± 76.1801
    -1.054 ± 102.5692
        :Week 8: CRP (n=120, 124, 127)
    10.402 ± 83.4766
    5.403 ± 111.6889
    11.791 ± 273.1510
        Week 12: CRP (n=122, 123, 127)
    9.295 ± 94.9020
    -2.507 ± 98.4549
    -7.908 ± 114.4983
        Week 16: CRP (n=120, 123, 124)
    82.057 ± 734.6577
    7.139 ± 134.6682
    2.759 ± 208.7305
        Week 20: CRP (n=119, 124, 126)
    5.768 ± 98.6914
    -11.151 ± 84.9807
    -14.684 ± 98.0041
        Week 24: CRP (n=119, 123, 127)
    31.628 ± 239.7722
    -7.404 ± 101.4807
    -6.112 ± 148.2088
    No statistical analyses for this end point

    Secondary: Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24

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    End point title
    Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24
    End point description
    HAQ-DI score assess functional status of subject. 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    0.0043 (-0.0562 to 0.0647)
    -0.0571 (-0.1173 to 0.0031)
    -0.1095 (-0.1695 to -0.0494)
        Week 8
    -0.0781 (-0.1498 to -0.0064)
    -0.1711 (-0.2423 to -0.0999)
    -0.1907 (-0.2619 to -0.1194)
        Week 12
    -0.1013 (-0.1783 to -0.0243)
    -0.2174 (-0.2938 to -0.1410)
    -0.3209 (-0.3973 to -0.2444)
        Week 16
    -0.1131 (-0.1955 to -0.0307)
    -0.2620 (-0.3438 to -0.1802)
    -0.3393 (-0.4211 to -0.2575)
        Week 20
    -0.1079 (-0.1935 to -0.0223)
    -0.3293 (-0.4143 to -0.2443)
    -0.3708 (-0.4558 to -0.2858)
        Week 24
    -0.0743 (-0.1605 to -0.0119)
    -0.3225 (-0.4082 to -0.2369)
    -0.3968 (-0.4825 to -0.3112)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved a Clinically Meaningful Improvement (>=0.35 improvement from baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Subjects With HAQ-DI score >=0.35 at Baseline

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    End point title
    Percentage of Subjects who Achieved a Clinically Meaningful Improvement (>=0.35 improvement from baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Subjects With HAQ-DI score >=0.35 at Baseline
    End point description
    HAQ-DI 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=no difficulty, to 3=inability to perform task. Total HAQ score is average of 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 and decrease of 0.35 from baseline in HAQDI score indicates a meaningful improvement. FAS1 among the subjects with HAQ-DI Score >=0.35 at baseline. Subjects with HAQ-DI >=0.35 improvement from baseline at specific timepoint and did not meet any TF criteria before, considered responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    110
    112
    110
    Units: percentage of subjects
    number (not applicable)
        Week 4
    20.0
    26.8
    30.9
        Week 8
    25.5
    40.2
    38.2
        Week 12
    27.3
    45.5
    51.8
        Week 16
    30.9
    46.4
    57.3
        Week 20
    28.2
    50.9
    56.4
        Week 24
    29.1
    50.9
    57.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24
    End point description
    DAS28 based on CRP is an index combining TJC(28 joints), SJC(28 joints), CRP and PtGA of disease activity. Set of 28 joint count is based on evaluation of shoulder, elbow, wrist, MCP1 to MCP5, PIP1 to PIP5 joints of both upper right and left extremity as well as knee joints of lower right and left extremities. DAS28(CRP) response criteria 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. DAS28(CRP) responder defined as achieving good or moderate DAS28 response at specific visit. Analysis population is FAS1. Subjects who achieved DAS28(CRP) response at specific timepoint and did not meet TF criteria before considered as responders at that timepoint. Subjects who met 1/more TF criteria before or with missing data at that time point considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 4
    27.0
    33.1
    40.6
        Week 8
    35.7
    59.1
    54.7
        Week 12
    41.3
    67.7
    74.2
        Week 16
    44.4
    65.4
    73.4
        Week 20
    46.0
    66.1
    75.0
        Week 24
    44.4
    70.9
    76.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24
    End point 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. Analysis population is FAS1. Subjects who achieved DAS28 (CRP) remission at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 4
    3.2
    7.9
    7.8
        Week 8
    7.9
    11.0
    11.7
        Week 12
    9.5
    22.0
    21.9
        Week 16
    7.9
    19.7
    25.0
        Week 20
    17.5
    25.2
    36.7
        Week 24
    12.7
    23.6
    35.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24

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    End point title
    Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24
    End point 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 change from baseline indicates improvement of arthritis. 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 MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -0.35 (-0.48 to -0.22)
    -0.53 (-0.67 to -0.40)
    -0.56 (-0.69 to -0.43)
        Week 8
    -0.55 (-0.71 to -0.39)
    -0.83 (-0.99 to -0.67)
    -0.88 (-1.04 to -0.72)
        Week 12
    -0.63 (-0.80 to -0.47)
    -1.16 (-1.33 to -0.99)
    -1.23 (-1.39 to -1.06)
        Week 16
    -0.64 (-0.82 to -0.46)
    -1.19 (-1.37 to -1.01)
    -1.38 (-1.56 to -1.20)
        Week 20
    -0.80 (-1.00 to -0.60)
    -1.38 (-1.58 to -1.19)
    -1.56 (-1.76 to -1.37)
        Week 24
    -0.70 (-0.89 to -0.51)
    -1.43 (-1.61 to -1.24)
    -1.61 (-1.80 to -1.42)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24
    End point 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) using 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. Analysis population is FAS1. Subjects 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. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 4
    20.6
    29.1
    33.6
        Week 8
    32.5
    56.7
    48.4
        Week 12
    41.3
    58.3
    66.4
        Week 16
    36.5
    64.6
    68.0
        Week 20
    41.3
    66.1
    75.8
        Week 24
    31.0
    59.8
    72.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Subjects With Enthesitis at Baseline

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    End point title
    Percentage of Subjects who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Subjects With Enthesitis at Baseline
    End point description
    Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in subjects 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. FAS1 among the subjects with enthesitis at baseline. Subjects who achieved enthesitis resolution at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 16, and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    77
    72
    73
    Units: percentage of subjects
    number (not applicable)
        Week 4
    22.1
    18.1
    27.4
        Week 8
    23.4
    30.6
    30.1
        Week 16
    37.7
    34.7
    45.2
        Week 24
    27.3
    40.3
    47.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Subjects with Enthesitis at Baseline

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    End point title
    Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Subjects with Enthesitis at Baseline
    End point description
    Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in subjects 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. Analysis population is FAS1 among the subjects with enthesitis at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    77
    72
    73
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -0.37 (-0.69 to -0.05)
    -0.45 (-0.78 to -0.11)
    -0.96 (-1.30 to -0.62)
        Week 8
    -0.65 (-1.00 to -0.31)
    -0.83 (-1.19 to -0.47)
    -1.11 (-1.48 to -0.74)
        Week 16
    -0.99 (-1.36 to -0.61)
    -1.00 (-1.39 to -0.61)
    -1.51 (-1.90 to -1.11)
        Week 24
    -1.01 (-1.37 to -0.66)
    -1.35 (-1.72 to -0.98)
    -1.75 (-2.13 to -1.38)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Subjects With Dactylitis at Baseline

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    End point title
    Percentage of Subjects With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Subjects With Dactylitis at Baseline
    End point 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. FAS1 among the subjects with dactylitis at baseline. Subjects who achieved dactylitis resolution at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    55
    49
    38
    Units: percentage of subjects
    number (not applicable)
        Week 4
    41.8
    34.7
    31.6
        Week 8
    41.8
    40.8
    44.7
        Week 16
    43.6
    59.2
    57.9
        Week 24
    49.1
    65.3
    63.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Subjects With Dactylitis at Baseline

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    End point title
    Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Subjects With Dactylitis at Baseline
    End point 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. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis. Analysis population is FAS1 among the subjects with dactylitis at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    55
    49
    38
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -2.77 (-4.24 to -1.30)
    -2.24 (-3.76 to -0.72)
    -2.63 (-4.39 to -0.86)
        Week 8
    -2.92 (-4.58 to -1.26)
    -4.00 (-5.72 to -2.29)
    -3.92 (-5.90 to -1.93)
        Week 16
    -4.03 (-5.76 to -2.30)
    -6.00 (-7.79 to -4.22)
    -6.29 (-8.36 to -4.22)
        Week 24
    -4.30 (-5.96 to -2.63)
    -6.11 (-7.81 to -4.41)
    -5.82 (-7.82 to -3.83)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24

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    End point title
    Change from Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24
    End point description
    PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a compositive score of overall disease activity combining PtGA of Disease Activity (arthritis and psoriasis, using VAS), PGA of Disease Activity using VAS, SJC (0-66 joints), TJC (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. Cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. Analysis population is FAS1. Data after meeting 1/more TF criteria were imputed as no change from baseline. Missing data assumed to be MAR. The LS mean is based on Mixed-effect repeated measures (MMRM) model that included data from all visits for all subjects included in model.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 8
    -0.759 (-0.961 to -0.556)
    -1.315 (-1.518 to -1.113)
    -1.428 (-1.628 to -1.228)
        Week 16
    -0.980 (-1.221 to -0.739)
    -1.779 (-2.019 to -1.539)
    -2.083 (-2.322 to -1.843)
        Week 24
    -0.959 (-1.212 to -0.707)
    -2.124 (-2.376 to -1.871)
    -2.407 (-2.657 to -2.156)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24

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    End point title
    Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24
    End point description
    GRACE index: composite PsA disease activity score converted from Arithmetic Mean of Desirability Function derived from TJC(0-68) and SJC(0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100mm, 0=excellent and 100=poor), patient’s assessment of skin disease activity (0-100mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis(0-100mm, 0=excellent and 100=poor), PASI(0-72), and PsA Quality of Life Index (PsAQOL=25.355+[2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), Total score: 0-10, lower score=better response. Higher score: more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. FAS1 where data after meeting 1/more TF criteria were imputed as no change from baseline. Missing data assumed to be MAR. LS mean based on MMRM model that included data from all visits for all subjects included in model. n= number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 16
    -0.918 (-1.176 to -0.659)
    -2.024 (-2.283 to -1.765)
    -2.368 (-2.625 to -2.111)
        Week 24
    -0.854 (-1.122 to -0.586)
    -2.368 (-2.636 to -2.099)
    -2.735 (-3.001 to -2.468)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24

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    End point title
    Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24
    End point description
    DAPSA assessed the joint domain of psoriatic arthritis (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 (0–10 centimeter [cm] VAS, 0=no pain, 10=worst possible pain), and patient’s global assessment of disease activity on arthritis (0 to 10 cm 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. 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 MAR. The LS mean is based on MMRM model that included data from all visits for all subjects included in the model.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -4.826 (-6.901 to -2.752)
    -7.815 (-9.926 to -5.705)
    -8.574 (-10.636 to -6.511)
        Week 8
    -8.776 (-11.307 to -6.246)
    -13.601 (-16.118 to -11.084)
    -13.231 (-15.731 to -10.732)
        Week 12
    -10.135 (-12.670 to -7.599)
    -18.167 (-20.704 to -15.631)
    -17.433 (-19.949 to -14.918)
        Week 16
    -9.964 (-12.568 to -7.359)
    -19.830 (-22.426 to -17.234)
    -19.389 (-21.977 to -16.802)
        Week 20
    -11.552 (-14.228 to -8.876)
    -20.570 (-23.248 to -17.891)
    -21.244 (-23.903 to -18.586)
        Week 24
    -10.749 (-13.396 to -8.102)
    -21.332 (-23.977 to -18.688)
    -20.621 (-23.251 to -17.992)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24
    End point description
    MDA was considered achieved if at least 5 of the following 7 criteria were met at the analysis visit: tender joint count less than or equal to (<=) 1; swollen joint count <=1; psoriasis activity and severity index <=1; patient’s assessment of pain VAS score of <=15; patient’s global assessment of disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI <=0.5; and tender entheseal points <=1. Analysis population is FAS1. Subjects who achieved MDA at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 16
    7.1
    15.7
    18.0
        Week 24
    11.1
    22.8
    30.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement from Baseline in BASDAI Score Through Week 24 Among the Subjects With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline

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    End point title
    Percentage of Subjects who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement from Baseline in BASDAI Score Through Week 24 Among the Subjects With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
    End point description
    BASDAI is self‑assessment tool with 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative and quantitative morning stiffness. First 5 items scored on 10 centimeter(cm) VAS. Quantitative morning stiffness scored on 10cm VAS ranging from 0=0 hours to 10=2/more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of 5 scores of each symptom, ranging from 0=none to 10=very severe. Higher scores indicate greater disease severity and improvement of 50% from baseline considered clinically meaningful. FAS1 with spondylitis and peripheral arthritis and BASDAI score >0 at baseline. Subjects with specified improvement in BASDAI at specific time point and did not meet TF criteria before, considered responders at that time point. Subjects who met 1/more TF criteria before or with missing data at that time point considered non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    23
    24
    20
    Units: percentage of subjects
    number (not applicable)
        Week 8: Subjects with >=20% Improvement
    26.1
    58.3
    55.0
        Week 16: Subjects with >=20% Improvement
    52.2
    75.0
    65.0
        Week 24: Subjects with >=20% Improvement
    26.1
    70.8
    65.0
        Week 8: Subjects with >=50% Improvement
    4.3
    25.0
    25.0
        Week 16: Subjects with >=50% Improvement
    26.1
    29.2
    35.0
        Week 24: Subjects with >=50% Improvement
    13.0
    41.7
    35.0
        Week 8: Subjects with >=70% Improvement
    4.3
    4.2
    15.0
        Week 16: Subjects with >=70% Improvement
    8.7
    25.0
    15.0
        Week 24: Subjects with >=70% Improvement
    8.7
    29.2
    5.0
        Week 8: Subjects with >=90% Improvement
    0
    0
    0
        Week 16: Subjects with >=90% Improvement
    0
    8.3
    10.0
        Week 24: Subjects with >=90% Improvement
    0
    16.7
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 8, 16, and Week 24 Among Subjects with Spondylitis and Peripheral Arthritis at Baseline

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    End point title
    Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 8, 16, and Week 24 Among Subjects with Spondylitis and Peripheral Arthritis at Baseline
    End point description
    BASDAI is a tool with 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative and quantitative morning stiffness. First 5 items scored on 10 cm VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness scored on 10cm VAS ranging from 0=0 hours to 10=2/more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of 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 considered clinically meaningful. Analysis population is FAS1 among subjects with spondylitis and peripheral arthritis at baseline. Data after meeting 1/more TF criteria were imputed as no change from baseline. Missing data assumed to be MAR. The LS mean based on MMRM model that included data from all visits for all subjects included in model.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    23
    24
    20
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 8
    -0.595 (-1.351 to -0.162)
    -1.577 (-2.296 to -0.859)
    -1.976 (-2.779 to -1.174)
        Week 16
    -1.604 (-2.483 to -0.725)
    -2.419 (-3.261 to -1.577)
    -2.469 (-3.405 to -1.533)
        Week 24
    -0.919 (-1.795 to -0.043)
    -2.665 (-3.503 to -1.826)
    -2.074 (-3.006 to -1.142)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with low or very low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects with low or very low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24
    End point description
    PASDAS (score range of 0-10, where higher score indicated more severe disease) is a compositive score of overall disease activity combining PtGA of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100=poor]), PGA of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), SJC (0-66 joints), TJC (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). Analysis population is FAS1. Subjects with low or very low disease activity at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 8
    4.0
    10.2
    14.8
        Week 16
    8.7
    22.0
    27.3
        Week 24
    11.1
    30.7
    36.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects with low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24
    End point description
    GRACE index is composite PsA disease activity score converted from AMDF, which was derived from TJC(0-68) and SJC(0-66), HAQ-DI(0-3), PtGA of disease activity on arthritis and psoriasis (0-100mm, 0=excellent and 100=poor), patient’s assessment of skin disease activity (0-100mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100mm, 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]), Total score from 0-10, where lower score=better response. Higher score=more active disease activity. Analysis population is FAS1. Subjects with low disease activity at specific timepoint and did not meet any TF criteria before, considered as responders at that time point. Subjects who met 1/more TF criteria before or with missing data at that time point considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 16
    10.3
    22.0
    28.9
        Week 24
    11.9
    30.7
    42.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects with low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24
    End point 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), patient assessment of pain (0–10 cm VAS, 0=no pain, 10=worst possible pain), and patient’s global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. The assessment does not have a score range with an upper or lower bound. Analysis population is FAS1. Subjects with low disease activity or remission at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Baseline
    1.6
    2.4
    0.8
        Week 4
    10.3
    8.7
    13.3
        Week 8
    13.5
    17.3
    25.0
        Week 12
    18.3
    27.6
    37.5
        Week 16
    13.5
    29.9
    36.7
        Week 20
    22.2
    37.8
    46.1
        Week 24
    16.7
    40.9
    49.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Very low Disease Activity (VLDA) by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects with Very low Disease Activity (VLDA) by Visit Over Time Through Week 24
    End point description
    A measurement 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 subject was considered as having achieved VLDA at a visit if the subject fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit. Analysis population is FAS1. Subjects who achieved VLDA response at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 16
    2.4
    3.1
    3.1
        Week 24
    1.6
    3.9
    9.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PASI 75 Response at Weeks 16 and 24 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

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    End point title
    Percentage of Subjects Who Achieved PASI 75 Response at Weeks 16 and 24 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
    End point 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. FAS1 among subjects with >=3% BSA of psoriasis and IGA score >=2 at baseline. Subjects with PASI 75 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Subjects who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: percentage of subjects
    number (not applicable)
        Week 16
    20.5
    63.4
    73.0
        Week 24
    14.1
    75.6
    86.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PASI 90 Response at Weeks 16 and 24 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

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    End point title
    Percentage of Subjects Who Achieved PASI 90 Response at Weeks 16 and 24 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
    End point 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. FAS1 among subjects with >=3% BSA of psoriasis and IGA score >=2 at baseline. Subjects with PASI 90 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: percentage of subjects
    number (not applicable)
        Week 16
    10.3
    45.1
    52.8
        Week 24
    11.5
    50.0
    62.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

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    End point title
    Percentage of Subjects Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
    End point 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. FAS1 among subjects with >=3% BSA of psoriasis and IGA score >=2 at baseline. Subjects with PASI 100 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Subjects who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: percentage of subjects
    number (not applicable)
        Week 16
    7.7
    23.2
    32.6
        Week 24
    6.4
    25.6
    44.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Subjects with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at Baseline

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    End point title
    Percentage of Subjects who Achieved both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Subjects with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at Baseline
    End point description
    In PASI, each area (head, trunk, upper/lower extremities) 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 0-4 that is none to maximum severtiy. PASI produces numeric score from 0-72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. FAS1 subjects with >=3% BSA psoriatic involvement and IGA score >=2 at baseline. Subjects with both PASI75 and ACR20 responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Subjects who met 1/more TF criteria before or with missing data at that time point considered non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: percentage of subjects
    number (not applicable)
        Week 16
    6.4
    35.4
    48.3
        Week 24
    6.4
    40.2
    52.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved both PASI 75 and Modified PsARC Response by visit over time Through Week 24 Among Subjects with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at Baseline

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    End point title
    Percentage of Subjects who Achieved both PASI 75 and Modified PsARC Response by visit over time Through Week 24 Among Subjects with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at Baseline
    End point 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 0-4 that is none to maximum severtiy. PASI produces numeric score range 0-72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. FAS1 with >=3% BSA psoriatic involvement and IGA score >=2 at baseline. Subjects with both PASI 75 and modified PsARC responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Subjects who met 1/more TF criteria before or with missing data at that time point considered non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: percentage of subjects
    number (not applicable)
        Week 16
    9.0
    48.8
    55.1
        Week 24
    5.1
    50.0
    62.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Subjects with >=3% BSA Psoriatic Involvement and an IGA score of >=2 (mild) at Baseline

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    End point title
    Percentage of Subjects with an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Subjects with >=3% BSA Psoriatic Involvement and an IGA score of >=2 (mild) at Baseline
    End point description
    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 subject's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Subjects who achieved IGA Score of 0 (cleared) at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders. Analysis population is FAS1 among subjects with >=3% BSA psoriatic involvement and an IGA score of >=2 at baseline.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: percentage of subjects
    number (not applicable)
        Week 16
    9.0
    32.9
    40.4
        Week 24
    7.7
    37.8
    53.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in PASI Score at Weeks 16 and 24 Among the Subjects with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at Baseline

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    End point title
    Change From Baseline in PASI Score at Weeks 16 and 24 Among the Subjects with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at Baseline
    End point 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. Analysis population is FAS1 among subjects who had >=3% BSA of psoriatic involvement and IGA score >=2 (mild) at baseline. Data after meeting one/more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. LS mean is based on MMRM model that included data from all visits for all subjects included in model.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    78
    82
    89
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 16
    -2.910 (-4.207 to -1.612)
    -9.631 (-10.881 to -8.381)
    -10.096 (-11.318 to -8.874)
        Week 24
    -2.317 (-3.709 to -0.926)
    -9.974 (-11.323 to -8.624)
    -10.915 (-12.224 to -9.605)
    No statistical analyses for this end point

    Secondary: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24

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    End point title
    Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24
    End point 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. 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 MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 8
    2.15 (1.06 to 3.23)
    2.87 (1.80 to 3.95)
    4.46 (3.39 to 5.54)
        Week 16
    2.50 (1.31 to 3.69)
    5.26 (4.08 to 6.43)
    6.72 (5.54 to 7.89)
        Week 24
    1.96 (0.69 to 3.24)
    6.10 (4.83 to 7.37)
    6.87 (5.60 to 8.14)
    No statistical analyses for this end point

    Secondary: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24

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    End point title
    Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24
    End point 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. 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 MAR and imputed using MI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 8
    1.99 (0.73 to 3.24)
    2.72 (1.47 to 3.97)
    2.46 (1.22 to 3.71)
        Week 16
    2.25 (0.87 to 3.63)
    2.61 (1.25 to 3.98)
    3.04 (1.68 to 4.41)
        Week 24
    2.37 (0.93 to 3.81)
    3.20 (1.78 to 4.63)
    3.60 (2.17 to 5.02)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24

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    End point title
    Change from Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24
    End point 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. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. 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 MAR. The LS mean is based on MMRM model that included data from all visits for all subjects included in the model.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 8: Physical Function Score
    1.362 (0.201 to 2.524)
    2.616 (1.456 to 3.777)
    4.082 (2.927 to 5.237)
        Week 16: Physical Function Score
    1.901 (0.603 to 3.199)
    5.143 (3.851 to 6.434)
    6.190 (4.902 to 7.478)
        Week 24: Physical Function Score
    1.636 (0.249 to 3.023)
    5.776 (4.394 to 7.158)
    6.952 (5.571 to 8.333)
        Week 8: Role-physical Score
    2.212 (1.104 to 3.321)
    2.084 (0.978 to 3.190)
    3.834 (2.730 to 4.938)
        Week 16: Role-physical Score
    2.242 (1.037 to 3.447)
    4.224 (3.027 to 5.422)
    5.447 (4.250 to 6.644)
        Week 24: Role-physical Score
    2.319 (1.063 to 3.576)
    4.878 (3.627 to 6.130)
    5.442 (4.189 to 6.694)
        Week 8: Bodily Pain Score
    3.081 (1.876 to 4.286)
    3.886 (2.682 to 5.089)
    5.140 (3.941 to 6.338)
        Week 16: Bodily Pain Score
    3.125 (1.859 to 4.391)
    5.059 (3.800 to 6.318)
    6.778 (5.521 to 8.035)
        Week 24: Bodily Pain Score
    2.854 (1.468 to 4.240)
    6.840 (5.459 to 8.221)
    7.490 (6.110 to 8.871)
        Week 8: General Health Score
    1.989 (0.806 to 3.172)
    3.071 (1.890 to 4.252)
    3.486 (2.309 to 4.663)
        Week 16: General Health Score
    1.683 (0.492 to 2.874)
    3.769 (2.585 to 4.953)
    5.225 (4.042 to 6.408)
        Week 24: General Health Score
    1.690 (0.510 to 2.869)
    4.349 (3.175 to 5.524)
    5.174 (3.998 to 6.349)
        Week 8: Vitality Score
    2.312 (1.081 to 3.542)
    3.917 (2.689 to 5.144)
    4.614 (3.389 to 5.838)
        Week 16: Vitality Score
    3.084 (1.720 to 4.449)
    4.777 (3.422 to 6.133)
    5.589 (4.234 to 6.943)
        Week 24: Vitality Score
    2.311 (0.881 to 3.742)
    5.596 (4.172 to 7.020)
    6.426 (5.000 to 7.852)
        Week 8: Social Function Score
    2.025 (0.643 to 3.407)
    3.287 (1.907 to 4.667)
    3.798 (2.423 to 5.173)
        Week 16: Social Function Score
    2.455 (1.020 to 3.890)
    3.531 (2.105 to 4.957)
    4.817 (3.392 to 6.241)
        Week 24: Social Function Score
    2.582 (1.240 to 3.924)
    5.426 (4.089 to 6.762)
    5.227 (3.889 to 6.564)
        Week 8: Role-emotional Score
    1.980 (0.615 to 3.345)
    2.237 (0.877 to 3.598)
    1.987 (0.631 to 3.343)
        Week 16: Role-emotional Score
    1.784 (0.316 to 3.253)
    2.496 (1.040 to 3.953)
    3.265 (1.810 to 4.720)
        Week 24: Role-emotional Score
    2.201 (0.753 to 3.649)
    2.415 (0.976 to 3.853)
    3.531 (2.090 to 4.972)
        Week 8: Mental Health Score
    2.124 (0.901 to 3.348)
    2.574 (1.358 to 3.790)
    3.126 (1.914 to 4.339)
        Week 16: Mental Health Score
    2.360 (1.058 to 3.662)
    3.489 (2.200 to 4.777)
    3.984 (2.696 to 5.272)
        Week 24: Mental Health Score
    2.062 (0.658 to 3.466)
    3.818 (2.425 to 5.211)
    4.356 (2.961 to 5.751)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved >=5-point Improvement from Baseline in SF-36 MCS Score by Visit Over Time Through Week 24

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    End point title
    Percentage of Subjects who Achieved >=5-point Improvement from Baseline in SF-36 MCS Score by Visit Over Time Through Week 24
    End point description
    SF-36 is 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 PCS with score range 0-100 (higher score-better quality of life) and MCS with score range 0-100 (higher score-better quality of life) in addition to subscale scores. MCS scores normalized to mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful. FAS1 with subjects who achieved >=5-point improvement from baseline in SF-36 MCS score at specific time point and did not meet any TF criteria before, considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 8
    27.0
    33.9
    35.2
        Week 16
    31.0
    32.3
    39.8
        Week 24
    25.4
    37.8
    43.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24

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    End point title
    Percentage of Subjects Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24
    End point description
    SF-36 is multi-domain instrument with 36 items to evaluate 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 PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher scorebetter quality of life) in addition to subscale scores. The PCS scores normalized to mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with increase of 5 points considered to be clinically meaningful. FAS1 with subjects who achieved >=5-point improvement from baseline in SF-36 PCS score at specific time point and did not meet any TF criteria before, considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 8
    31.0
    33.9
    46.1
        Week 16
    29.4
    48.0
    50.0
        Week 24
    28.6
    51.2
    53.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24

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    End point title
    Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24
    End point description
    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. 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 MAR. The LS mean is based on MMRM model that included data from all visits for all subjects included in the model.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 8
    2.356 (1.081 to 3.632)
    3.643 (2.369 to 4.917)
    3.576 (2.306 to 4.845)
        Week 16
    2.164 (0.782 to 3.547)
    4.853 (3.478 to 6.228)
    4.544 (3.171 to 5.918)
        Week 24
    2.206 (0.773 to 3.638)
    5.609 (4.181 to 7.036)
    5.841 (4.416 to 7.267)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved >=4-point Improvement from Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24

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    End point title
    Percentage of Subjects Who Achieved >=4-point Improvement from Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24
    End point description
    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. Subscale consists 13-item instrument to measure fatigue. Each of 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. Analysis population is FAS1. Subjects who achieved >=4-point improvement from baseline in FACIT-fatigue score at specific time point and did not meet any TF criteria before, considered responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point considered non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16, and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 8 (n=126, 127, 125)
    35.7
    44.1
    43.8
        Week 16 (n=107, 119, 121)
    34.1
    50.4
    52.3
        Week 24 (n=104, 114, 124)
    34.9
    53.5
    63.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24

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    End point title
    Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24
    End point description
    PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 numeric rating scale (NRS). The raw score of each domain is converted into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for the general population in the US (T-Score). 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 MAR. The LS mean is based on MMRM model that included data from all visits for all subjects included in the model.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16 and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: T-score
    least squares mean (confidence interval 95%)
        Week 8: Anxiety
    -1.98 (-3.29 to -0.66)
    -2.19 (-3.50 to -0.88)
    -1.83 (-3.14 to -0.53)
        Week 16: Anxiety
    -2.30 (-3.63 to -0.97)
    -3.08 (-4.40 to -1.75)
    -2.23 (-3.54 to -0.91)
        Week 24: Anxiety
    -1.37 (-2.71 to -0.03)
    -3.23 (-4.57 to -1.89)
    -2.92 (-4.25 to -1.59)
        Week 8: Depression
    -0.86 (-2.07 to 0.35)
    -2.42 (-3.63 to -1.21)
    -1.54 (-2.74 to -0.34)
        Week 16: Depression
    -0.85 (-2.02 to 0.31)
    -2.70 (-3.87 to -1.54)
    -2.69 (-3.85 to -1.54)
        Week 24: Depression
    -0.85 (-2.12 to 0.42)
    -3.40 (-4.66 to -2.14)
    -2.67 (-3.92 to -1.41)
        Week 8: Fatigue
    -1.87 (-3.13 to -0.62)
    -3.25 (-4.50 to -1.99)
    -2.90 (-4.14 to -1.65)
        Week 16: Fatigue
    -2.29 (-3.57 to -1.02)
    -4.26 (-5.53 to -2.99)
    -4.14 (-5.40 to -2.88)
        Week 24: Fatigue
    -1.86 (-3.24 to -0.48)
    -4.79 (-6.16 to -3.42)
    -5.08 (-6.45 to -3.71)
        Week 8: Pain Interference
    -2.42 (-3.40 to -1.43)
    -2.99 (-3.97 to -2.00)
    -3.32 (-4.30 to -2.33)
        Week 16: Pain Interference
    -2.62 (-3.69 to -1.55)
    -3.99 (-5.06 to -2.93)
    -5.02 (-6.08 to -3.96)
        Week 24: Pain Interference
    -2.30 (-3.46 to -1.13)
    -5.49 (-6.65 to -4.34)
    -5.69 (-6.85 to -4.53)
        Week 8: Physical Function
    1.34 (0.44 to 2.23)
    1.31 (0.42 to 2.20)
    2.37 (1.48 to 3.26)
        Week 16: Physical Function
    1.53 (0.49 to 2.57)
    3.21 (2.17 to 4.24)
    4.12 (3.09 to 5.15)
        Week 24: Physical Function
    1.34 (0.25 to 2.43)
    3.89 (2.81 to 4.98)
    5.05 (3.96 to 6.13)
        Week 8: Sleep Disturbance
    -1.22 (-2.23 to -0.21)
    -1.91 (-2.92 to -0.91)
    -2.09 (-3.09 to -1.09)
        Week 16: Sleep Disturbance
    -1.54 (-2.53 to -0.54)
    -3.82 (-4.82 to -2.83)
    -3.09 (-4.08 to -2.10)
        Week 24: Sleep Disturbance
    -1.17 (-2.25 to -0.09)
    -3.48 (-4.56 to -2.40)
    -2.46 (-3.53 to -1.38)
        Week 8: Satisfaction-Social Role and Activity
    1.52 (0.39 to 2.64)
    3.13 (2.01 to 4.25)
    3.18 (2.06 to 4.29)
        Week 16: Satisfaction-Social Role and Activity
    1.86 (0.65 to 3.08)
    3.93 (2.72 to 5.14)
    3.97 (2.76 to 5.17)
        Week 24: Satisfaction-Social Role and Activity
    1.45 (0.22 to 2.69)
    4.90 (3.66 to 6.13)
    4.52 (3.29 to 5.75)
        Week 8: Pain Intensity
    -0.74 (-1.06 to -0.41)
    -1.34 (-1.66 to -1.01)
    -1.28 (-1.61 to -0.96)
        Week 16: Pain Intensity
    -0.73 (-1.09 to -0.37)
    -1.63 (-1.98 to -1.27)
    -2.03 (-2.38 to -1.67)
        Week 24: Pain Intensity
    -0.56 (-0.94 to -0.19)
    -1.98 (-2.36 to -1.61)
    -2.32 (-2.69 to -1.94)
    No statistical analyses for this end point

    Secondary: Change from Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 response at Week 24

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    End point title
    Change from Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 response at Week 24
    End point description
    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Here, n (number analyzed) signifies the number of subjects who were ACR 20 responders or non-responders at Week 24.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: units on a scale
    arithmetic mean (standard deviation)
        Among ACR 20 responders (n=28, 66, 76)
    8.571 ± 7.8995
    9.242 ± 10.8473
    6.684 ± 8.0948
        Among ACR 20 non-responders (n=98, 61, 52)
    0.316 ± 6.8181
    1.984 ± 7.8877
    3.635 ± 6.8170
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24

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    End point title
    Percentage of Subjects Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24
    End point description
    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. Subscale consists 13-item instrument to measure fatigue. Each of 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. FAS1. Subjects who achieved >=4-point improvement from baseline at Week 24 and did not meet any TF criteria before Week 24: responders. Subjects who met 1 or more TF criteria or with missing data: non-responders. Here, n (number analyzed) signifies the number of subjects who were ACR 20 responders or non-responders at Week 24.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Among ACR 20 responders (n=28, 66, 76)
    67.9
    68.2
    73.7
        Among ACR 20 non-responders (n=98, 61, 52)
    25.5
    37.7
    48.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved an Improvement of >=3 Points from Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24

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    End point title
    Percentage of Subjects who Achieved an Improvement of >=3 Points from Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24
    End point description
    PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score). Analysis population is FAS1. Subjects who achieved >=3-point improvement from baseline in PROMIS-29 domain scores at a specific timepoint and did not meet any TF criteria before, considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point, considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16, and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 8: Anxiety
    41.3
    41.7
    39.1
        Week 16: Anxiety
    -34.9
    42.5
    41.4
        Week 24: Anxiety
    34.9
    45.7
    42.2
        Week 8: Depression
    24.6
    30.7
    34.4
        Week 16: Depression
    25.4
    35.4
    33.6
        Week 24: Depression
    26.2
    39.4
    38.3
        Week 8: Fatigue
    34.1
    39.4
    42.2
        Week 16: Fatigue
    38.9
    49.6
    49.2
        Week 24: Fatigue
    32.5
    48.8
    55.5
        Week 8: Pain Interference
    34.9
    41.7
    43.8
        Week 16: Pain Interference
    39.7
    47.2
    56.3
        Week 24: Pain Interference
    33.3
    54.3
    57.0
        Week 8: Physical Function
    28.6
    30.7
    40.6
        Week 16: Physical Function
    28.6
    44.1
    45.3
        Week 24: Physical Function
    22.2
    48.0
    53.9
        Week 8: Sleep Disturbance
    35.7
    38.6
    39.1
        Week 16: Sleep Disturbance
    36.5
    48.8
    38.3
        Week 24: Sleep Disturbance
    31.0
    48.8
    40.6
        Week 8: Satisfaction-Social Role and Activity
    35.7
    44.9
    49.2
        Week 16: Satisfaction-Social Role and Activity
    37.3
    46.5
    46.1
        Week 24: Satisfaction-Social Role and Activity
    32.5
    52.0
    50.0
        Week 8: Pain Intensity
    15.1
    22.8
    26.6
        Week 16: Pain Intensity
    18.3
    33.1
    42.2
        Week 24: Pain Intensity
    15.1
    37.0
    45.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved an Improvement of >=5 points from Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24

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    End point title
    Percentage of Subjects who Achieved an Improvement of >=5 points from Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24
    End point description
    PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score). Analysis population is FAS1. Subjects who achieved >=5-point improvement from baseline in PROMIS-29 domain scores at a specific timepoint and did not meet any TF criteria before, considered as responders at that time point. Subjects who met 1 or more TF criteria before or with missing data at that time point, considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16, and 24
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    126
    127
    128
    Units: percentage of subjects
    number (not applicable)
        Week 8: Anxiety
    33.3
    37.0
    29.7
        Week 16: Anxiety
    29.4
    34.6
    33.6
        Week 24: Anxiety
    28.6
    41.7
    38.3
        Week 8: Depression
    17.5
    27.6
    26.6
        Week 16: Depression
    19.0
    32.3
    28.9
        Week 24: Depression
    19.8
    36.2
    30.5
        Week 8: Fatigue
    27.8
    29.1
    33.6
        Week 16: Fatigue
    33.3
    40.9
    43.0
        Week 24: Fatigue
    31.0
    45.7
    47.7
        Week 8: Pain Interference
    22.2
    29.9
    35.9
        Week 16: Pain Interference
    29.4
    38.6
    43.8
        Week 24: Pain Interference
    23.8
    46.5
    51.6
        Week 8: Physical Function
    15.1
    18.9
    22.7
        Week 16: Physical Function
    18.3
    26.8
    32.8
        Week 24: Physical Function
    15.9
    36.2
    39.8
        Week 8: Sleep Disturbance
    24.6
    24.4
    27.3
        Week 16: Sleep Disturbance
    24.6
    40.2
    30.5
        Week 24: Sleep Disturbance
    21.4
    37.0
    32.8
        Week 8: Satisfaction-Social Role and Activity
    25.4
    40.2
    38.3
        Week 16: Satisfaction-Social Role and Activity
    30.2
    42.5
    39.8
        Week 24: Satisfaction-Social Role and Activity
    22.2
    45.7
    43.0
        Week 8: Pain Intensity
    5.6
    6.3
    6.3
        Week 16: Pain Intensity
    6.3
    8.7
    14.8
        Week 24: Pain Intensity
    4.0
    18.1
    18.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52

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    End point title
    Percentage of Subjects who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52
    End point 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 the 5 assessments: patient’s assessment of pain using 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 HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. Analysis population is full analysis set 2 (FAS2) included all randomized subjects who were still on study treatment at Week 24. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=114, 123, 125)
    27.2
    54.5
    60.8
        Week 28 (n=112, 122, 125)
    50.0
    68.9
    74.4
        Week 36 (n=109, 118, 121)
    56.9
    70.3
    71.1
        Week 44 (n=107, 117, 125)
    61.7
    73.5
    72.0
        Week 52 (n=104, 112, 124)
    68.3
    67.9
    75.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52

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    End point title
    Percentage of Subjects who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52
    End point 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 the 5 assessments: patient’s assessment of pain using 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 HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=114, 123, 125)
    9.6
    30.9
    36.8
        Week 28 (n=112, 122, 125)
    21.4
    42.6
    39.2
        Week 36 (n=110, 119, 121)
    32.7
    47.1
    44.6
        Week 44 (n=107, 117, 124)
    30.8
    51.3
    46.0
        Week 52 (n=104, 113, 124)
    36.5
    43.4
    55.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52

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    End point title
    Percentage of Subjects who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52
    End point 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 the 5 assessments: patient’s assessment of pain using 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 HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=114, 123, 125)
    6.1
    12.2
    20.8
        Week 28 (n=112, 122, 125)
    9.8
    20.5
    24.8
        Week 36 (n=111, 119, 121)
    18.0
    25.2
    26.4
        Week 44 (n=107, 116, 125)
    16.8
    28.4
    26.4
        Week 52 (n=104, 114, 124)
    19.2
    28.9
    29.8
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52

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    End point title
    Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
    End point 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 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. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24: Swollen Joint Count (n=114, 123, 125)
    -48.33 ± 45.987
    -66.62 ± 47.086
    -73.23 ± 38.120
        Week 28: Swollen Joint Count (n=112, 123, 125)
    -59.95 ± 47.826
    -75.42 ± 33.774
    -80.93 ± 27.197
        Week 36: Swollen Joint Count (n=111, 119, 122)
    -70.50 ± 37.359
    -79.16 ± 35.141
    -80.19 ± 29.160
        Week 44: Swollen Joint Count (n=108, 117, 125)
    -72.63 ± 38.625
    -80.35 ± 34.653
    -82.46 ± 31.652
        Week 52: Swollen Joint Count (n=103, 112, 124)
    -78.23 ± 37.345
    -79.63 ± 36.471
    -86.73 ± 26.776
        Week 24: Tender Joint Count (n=114, 123, 125)
    -27.58 ± 53.737
    -53.73 ± 45.118
    -56.56 ± 41.774
        Week 28: Tender Joint Count (n=112, 123, 125)
    -42.99 ± 62.128
    -64.03 ± 40.678
    -66.68 ± 31.528
        Week 36: Tender Joint Count (n=111, 119, 122)
    -57.06 ± 43.351
    -68.44 ± 39.771
    -64.67 ± 41.606
        Week 44: Tender Joint Count (n=108, 117, 125)
    -60.08 ± 42.811
    -69.23 ± 51.229
    -71.90 ± 31.422
        Week 52: Tender Joint Count (n=103, 112, 124)
    -65.65 ± 37.682
    -72.39 ± 35.102
    -72.70 ± 37.487
        Week24:Patient’s Assessment of Pain(n=113,123,124)
    -6.05 ± 52.682
    -32.65 ± 45.343
    -38.90 ± 43.955
        Week28:Patient’s Assessment of Pain(n=110,122,124)
    -21.93 ± 52.597
    -38.86 ± 45.149
    -43.59 ± 39.524
        Week36:Patient’s Assessment of Pain(n=109,120,120)
    -27.61 ± 56.373
    -42.85 ± 43.952
    -47.23 ± 41.167
        Week44:Patient’s Assessment of Pain(n=107,117,124)
    -27.98 ± 64.080
    -45.27 ± 47.794
    -48.97 ± 36.509
        Week52:Patient’s Assessment of Pain(n=103,114,123)
    -35.64 ± 66.672
    -42.67 ± 47.250
    -50.03 ± 50.203
        Week 24: PtGA of Disease Activity(n=114, 123, 125)
    -7.63 ± 58.147
    -37.16 ± 39.760
    -40.27 ± 42.250
        Week 28: PtGA of Disease Activity(n=111, 122, 125)
    -21.74 ± 57.662
    -45.35 ± 41.564
    -37.62 ± 60.121
        Week 36: PtGA of Disease Activity(n=110, 120, 121)
    -26.51 ± 60.926
    -46.03 ± 39.547
    -45.17 ± 39.277
        Week 44: PtGA of Disease Activity(n=108, 117, 125)
    -21.76 ± 81.481
    -46.11 ± 40.973
    -45.84 ± 43.368
        Week 52: PtGA of Disease Activity(n=103, 114, 124)
    -35.17 ± 56.398
    -45.84 ± 42.176
    -47.85 ± 55.429
        Week 24: PGA of Disease Activity(n=113, 122, 125)
    -33.22 ± 34.014
    -53.43 ± 37.305
    -61.59 ± 31.445
        Week 28: PGA of Disease Activity(n=111, 122, 123)
    -53.88 ± 31.619
    -57.70 ± 33.724
    -65.96 ± 29.400
        Week 36: PGA of Disease Activity(n=109, 117, 120)
    -62.40 ± 29.215
    -64.51 ± 34.389
    -68.37 ± 27.206
        Week 44: PGA of Disease Activity(n=107, 117, 124)
    -64.93 ± 28.895
    -69.08 ± 30.743
    -72.65 ± 25.842
        Week 52: PGA of Disease Activity(n=103, 111, 124)
    -68.67 ± 32.861
    -68.83 ± 32.776
    -74.71 ± 25.456
        Week 24: HAQ-DI score(n=108, 121, 118)
    -7.65 ± 62.206
    -8.80 ± 148.199
    -31.18 ± 72.701
        Week 28: HAQ-DI score (n=105, 121, 118)
    -15.62 ± 51.720
    -29.10 ± 60.044
    -33.41 ± 72.942
        Week 36: HAQ-DI score (n=104, 118, 114)
    -15.37 ± 53.391
    -29.43 ± 73.712
    -32.74 ± 86.404
        Week 44: HAQ-DI score (n=102, 116, 118)
    -29.61 ± 45.603
    -34.54 ± 73.685
    -35.91 ± 80.885
        Week 52: HAQ-DI score (n=100, 112, 117)
    -28.42 ± 45.473
    -31.09 ± 60.232
    -46.13 ± 56.354
        Week 24: CRP (n=114, 122, 125)
    -13.58 ± 150.494
    -7.83 ± 101.789
    -6.48 ± 149.288
        Week 28: CRP (n=111, 121, 124)
    -8.67 ± 122.851
    -5.58 ± 99.590
    -10.30 ± 97.703
        Week 36: CRP (n=112, 119, 124)
    -17.33 ± 102.168
    -31.55 ± 50.560
    -14.65 ± 113.746
        Week 44: CRP (n=107, 116, 124)
    -29.10 ± 70.460
    -17.81 ± 76.247
    -4.39 ± 190.368
        Week 52: CRP (n=106, 117, 123)
    -1.68 ± 167.086
    -19.28 ± 69.875
    -15.76 ± 129.101
    No statistical analyses for this end point

    Secondary: Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52

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    End point title
    Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52
    End point description
    HAQ-DI score assess functional status of subject. 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. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 (n=114, 123, 125)
    -0.1217 ± 0.52442
    -0.3374 ± 0.56967
    -0.3740 ± 0.45914
        Week 28 (n=111, 123, 125)
    -0.2241 ± 0.50876
    -0.4004 ± 0.52303
    -0.3850 ± 0.46381
        Week 36 (n=110, 120, 121)
    -0.2602 ± 0.51278
    -0.4396 ± 0.54426
    -0.4132 ± 0.47155
        Week 44 (n=108, 118, 125)
    -0.3634 ± 0.53486
    -0.4672 ± 0.57140
    -0.4180 ± 0.51394
        Week 52 (n=104, 114, 124)
    -0.3642 ± 0.51084
    -0.4364 ± 0.56400
    -0.4970 ± 0.47990
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved a Clinically Meaningful Improvement (>=0.35 improvement from baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Subjects With HAQ-DI score >=0.35 at Baseline

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    End point title
    Percentage of Subjects who Achieved a Clinically Meaningful Improvement (>=0.35 improvement from baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Subjects With HAQ-DI score >=0.35 at Baseline
    End point description
    HAQ-DI score assess functional status of subject. 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 and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement. Analysis population is FAS2 among subjects with HAQ-DI score >=0.35 at baseline. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    100
    109
    109
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=100, 109, 109)
    36.0
    53.2
    57.8
        Week 28 (n=97, 109, 109)
    40.2
    61.5
    61.5
        Week 36 (n=96, 106, 105)
    41.7
    60.4
    61.9
        Week 44 (n=94, 104, 109)
    50.0
    58.7
    62.4
        Week 52 (n=92, 101, 108)
    54.3
    57.4
    68.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52

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    End point title
    Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52
    End point 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. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 (n=114, 122, 125)
    -0.84 ± 1.043
    -1.49 ± 1.140
    -1.57 ± 1.045
        Week 28 (n=110, 120, 124)
    -1.33 ± 1.121
    -1.71 ± 1.126
    -1.67 ± 1.020
        Week 36 (n=110, 118, 121)
    -1.60 ± 1.123
    -1.96 ± 1.145
    -1.78 ± 1.054
        Week 44 (n=105, 114, 124)
    -1.69 ± 1.224
    -1.96 ± 1.226
    -1.92 ± 1.116
        Week 52 (n=103, 112, 123)
    -1.84 ± 1.087
    -2.03 ± 1.250
    -1.99 ± 1.062
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52

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    End point title
    Percentage of Subjects Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52
    End point 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. DAS28 (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 was defined as achieving a good or moderate DAS28 response at a specific visit. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=114, 122, 125)
    51.8
    74.6
    78.4
        Week 28 (n=110, 120, 124)
    73.6
    83.3
    83.9
        Week 36 (n=110, 118, 121)
    76.4
    89.0
    86.8
        Week 44 (n=105, 114, 124)
    80.0
    86.8
    89.5
        Week 52 (n=103, 112, 121)
    86.4
    88.4
    87.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52

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    End point title
    Percentage of Subjects Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52
    End point 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. DAS28 (CRP) remission was defined as DAS28 (CRP) value <2.6 at the analysis visit. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=114, 122, 125)
    14.9
    24.6
    36.8
        Week 28 (n=110, 120, 124)
    26.4
    37.5
    38.7
        Week 36 (n=110, 118, 121)
    39.1
    40.7
    40.5
        Week 44 (n=105, 114, 124)
    38.1
    45.6
    51.6
        Week 52 (n=103, 112, 123)
    37.9
    43.8
    56.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Subjects Who Achieved a HAQ-DI response at Week 24

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    End point title
    Percentage of Subjects Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Subjects Who Achieved a HAQ-DI response at Week 24 [19]
    End point description
    HAQ-DI score assess functional status of subject. 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 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. Analysis population is FAS2 among subjects who achieved a HAQ-DI response at Week 24. Outcome measure (OM) was planned to assess the maintenance of guselkumab effect only through Week 52, hence the data in this outcome measure is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 52
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    53
    63
    Units: percentage of subjects
        number (not applicable)
    84.9
    87.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52

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    End point title
    Percentage of Subjects Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52
    End point 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. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=113, 122, 125)
    37.2
    63.1
    74.4
        Week 28 (n=111, 122, 124)
    64.9
    78.7
    82.3
        Week 36 (n=109, 118, 120)
    68.8
    80.5
    80.0
        Week 44 (n=107, 116, 125)
    73.8
    81.9
    80.0
        Week 52 (n=103, 111, 124)
    73.8
    83.8
    83.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52

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    End point title
    Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52
    End point 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), 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. Analysis population is FAS2. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 28, 36, 44 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    114
    123
    125
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 (n=114, 122, 125)
    -12.962 ± 17.9137
    -23.373 ± 20.2784
    -20.530 ± 13.2678
        Week 28 (n=110, 120, 124)
    -18.632 ± 19.4997
    -26.790 ± 19.3655
    -22.766 ± 12.8366
        Week 36 (n=110, 118, 121)
    -22.360 ± 18.8976
    -30.070 ± 21.0899
    -24.067 ± 14.0976
        Week 44 (n=105, 114, 124)
    -23.602 ± 19.9198
    -30.312 ± 22.5854
    -26.010 ± 15.3230
        Week 52 (n=103, 112, 123)
    -26.058 ± 18.6507
    -30.906 ± 23.0188
    -26.562 ± 15.1985
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

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    End point title
    Percentage of Subjects Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
    End point 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 0-4. PASI produces numeric score range from 0-72. Higher scores=more severe disease. PASI75 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 (0-100mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS: 0-100mm, 0=no arthritis and 100=extremely active arthritis, and at least 1 of 2 joint criteria with no deterioration in other criteria. FAS2 among the subjects who had >=3% BSA of psoriatic involvement and an IGA score >=2(mild) at baseline. Here, n (number analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    68
    82
    88
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=68, 81, 88)
    8.8
    50.6
    63.6
        Week 52 (n=65, 75, 88)
    69.2
    70.7
    79.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

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    End point title
    Percentage of Subjects Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
    End point 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 0-4. PASI produces numeric score from 0-72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in SJC (66 joints)+TJC (68 joints) and >=20% improvement in 3 of 5: patient’s assessment of pain using VAS, PtGA of disease activity using VAS, PGA of disease activity using VAS, patient's assessment of physical function (HAQ-DI: 20-question instrument; range: 0=no difficulty to 3=inability to perform task) and CRP. FAS2 among the subjects who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 24 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    68
    82
    88
    Units: percentage of subjects
    number (not applicable)
        Week 24 (n=68, 81, 88)
    10.3
    40.7
    53.4
        Week 52 (n=65, 75, 88)
    64.6
    58.7
    73.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in PASI Score at Weeks 24 and 52 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

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    End point title
    Change From Baseline in PASI Score at Weeks 24 and 52 Among Subjects With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
    End point 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 severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative changes from baseline indicate improvement of psoriasis. Analysis population is FAS2 among the subjects who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24 and 52
    End point values
    Placebo Guselkumab 100 mg q8w Guselkumab 100 mg q4w
    Number of subjects analysed
    68
    82
    88
    Units: units on a scale
    arithmetic mean (standard deviation)