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

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

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CR105964
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02319759
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    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
    17 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this study were to evaluate the efficacy of guselkumab in subjects with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA and to assess the safety and tolerability of guselkumab in subjects with active PsA.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki that are consistent with Good Clinical Practices and applicable regulatory requirements. The study protocol and amendment were reviewed by an Independent Ethics Committee (IEC) and Institutional Review Board (IRB). Subjects or their legally acceptable representatives provided their written consent to participate in the study after having been informed about the nature and purpose of the study, participation/termination conditions, and risks and benefits of treatment. Safety was evaluated throughout the study and included adverse events (AEs), including injection-site and allergic reactions, clinical laboratory tests, vital signs, physical examinations, concomitant medication review and early detection of active tuberculosis (TB). An independent data monitoring committee was commissioned for this study to review unblinded data at regularly scheduled intervals.
    Background therapy
    Stable dose of methotrexate [less than or equal to (<=) 25 milligram per week (mg/week)], oral corticosteroids [<=10 milligram (mg) of prednisone/day or equivalent], or nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics were permitted but not required.
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    Romania: 5
    Country: Number of subjects enrolled
    Russian Federation: 89
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    149
    EEA total number of subjects
    43
    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)
    136
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

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

    Period 1
    Period 1 title
    W0 - W16: placebo-controlled
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

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

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo at Weeks 0, 4, 12, and 20.

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    CNTO1275
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects in the placebo group crossed over and received 100 mg guselkumab at Weeks 24, 28, 36, and 44.

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

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 100 mg guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    CNTO1275
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo at Weeks 24 for maintaining the blind.

    Number of subjects in period 1
    Placebo Guselkumab
    Started
    49
    100
    Subjects Early escaped (EE) at Week 16
    17 [1]
    10 [2]
    Completed
    48
    99
    Not completed
    1
    1
         unspecified
    -
    1
         Lack of efficacy
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 17 subjects who early escaped from placebo to ustekinumab at Week 16 were considered as completers at Week 16.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 10 subjects who early escaped from guselkumab to ustekinumab at Week 16 were considered as completers at Week 16.
    Period 2
    Period 2 title
    W16 - W24: placebo-controlled
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

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

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo at Weeks 0, 4, 12, and 20.

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    CNTO1275
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects in the placebo group crossed over and received 100 mg guselkumab at Weeks 24, 28, 36, and 44.

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

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 100 mg guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo at Weeks 24 for maintaining the blind.

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    CNTO1275
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

    Number of subjects in period 2 [3]
    Placebo Guselkumab
    Started
    31
    89
    Subjects EE to Ustekinumab at W16
    17 [4]
    10 [5]
    Cross-over to/continue Guselkumab at W24
    29
    86
    Completed
    29
    86
    Not completed
    2
    3
         Lack of efficacy
    1
    1
         Consent withdrawn by subject
    -
    2
         Lost to follow-up
    1
    -
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects who early escaped at Week 16 were included in the completers in the preceding period but were not included in the number of subjects starting this period.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 17 subjects who early escaped from placebo to ustekinumab at Week 16 were counted in the previous period, but not in this period.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 10 subjects who early escaped from guselkumab to ustekinumab at Week 16 were counted in the previous period, but not counted in this period.
    Period 3
    Period 3 title
    W24 - W56: Active Treatment & Follow-up
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Crossover (Placebo to Guselkumab)
    Arm description
    Subjects remained in the placebo group at Week 24 crossed over to receive guselkumab at at Weeks 24, 28, 36, and 44.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects remaining in the placebo group at Week 24 crossed over to receive guselkumab 100 mg at Weeks 24, 28, 36 and 44.

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

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 100 mg guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    CNTO1275
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Early escaped subjects received ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo at Weeks 24 for maintaining the blind.

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

    Baseline characteristics

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

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

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

    End points

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

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

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

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

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

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    End point title
    Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
    End point description
    ACR 20 response is defined as >=20% improvement in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS) (scale ranges from 0=no arthritis activity to 100=extremely active arthritis),Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0= no difficulty to 3= inability to do task in that area), Serum CRP. Full analysis set (FAS) for efficacy endpoints through Week 24 include all randomized subjects who received at least 1 dose of study drug and analyzed based on their assigned treatment regardless of their actual treatment received. Subjects set to non-responders if they met treatment failure (TF), early escape (EE) criteria at week 16 or had data missing.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [1]
    100 [2]
    Units: Percentage of subjects
        number (not applicable)
    18.4
    58.0
    Notes
    [1] - FAS population
    [2] - FAS population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Guselkumab v Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    39.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    25.3
         upper limit
    54.1

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

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    End point title
    Percentage of Subjects who Achieved a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24
    End point description
    A PASI 75 response is defined as >= 75% improvement in PASI score from baseline. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from (0 [best] - 72 [worst]). The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. PASI response through Week 24 is based on the imputed PASI values with last observation carry forward (LOCF) for EE and missing data. Subjects with missing baseline were excluded from the analysis. Here, 'N' number of participants analysed are those who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    48 [3]
    98 [4]
    Units: Percentage of subjects
        number (not applicable)
    12.5
    78.6
    Notes
    [3] - FAS population
    [4] - FAS population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    66.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.8
         upper limit
    78.4

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

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    End point title
    Change from Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24
    End point description
    The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Based on the imputed HAQ-DI scores using last observation carry forward for EE and missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [5]
    100 [6]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    1.34 ± 0.542
    1.42 ± 0.621
        Change at Week 24
    -0.06 ± 0.530
    -0.42 ± 0.512
    Notes
    [5] - FAS Population
    [6] - FAS Population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    LS Mean Difference
    Point estimate
    -0.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.471
         upper limit
    -0.148
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.082

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

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    End point title
    Percentage of Subjects who Achieved an ACR 20 Response at Week 16
    End point description
    ACR 20 response is defined as >=20% improvement in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0-no difficulty to 3-inability to perform a task in that area), and Serum C-reactive protein (CRP). Subjects were set to non-responders if they met TF criteria prior to week 16 or had data missing.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [7]
    100 [8]
    Units: Percentage of subjects
        number (not applicable)
    16.3
    60.0
    Notes
    [7] - FAS Population
    [8] - FAS population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    43.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    29.6
         upper limit
    57.6

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

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    End point title
    Percentage of Subjects who Achieved an ACR 50 Response at Week 24
    End point description
    ACR 20 response is defined as >=20% improvement in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0-no difficulty to 3-inability to perform a task in that area), and Serum C-reactive protein (CRP). Subjects were set to non-responders if they met TF, EE criteria prior to week 16 or had data missing.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [9]
    100 [10]
    Units: Percentage of Subjects
        number (not applicable)
    10.2
    34.0
    Notes
    [9] - FAS Population
    [10] - FAS Population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage
    Point estimate
    23.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.3
         upper limit
    36.3

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

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    End point title
    Percent (%) Change from Baseline in Enthesitis Scores at Week 24 Among Subjects with Enthesitis at Baseline
    End point description
    Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analysed' signifies that those subjects who had enthesitis at baseline and were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    31 [11]
    76 [12]
    Units: Percent change
        median (inter-quartile range (Q1-Q3))
    -33.33 (-100.0 to 0.0)
    -100.00 (-100.0 to -10.0)
    Notes
    [11] - Full Analysis Set with Enthesitis at Baseline
    [12] - Full Analysis Set with Enthesitis at Baseline
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009
    Method
    Wilcoxon rank sum test
    Confidence interval

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

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    End point title
    Percent Change from Baseline in Dactylitis Scores at Week 24 Among Subjects with Dactylitis at Baseline
    End point description
    Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analyzed' signifies that those subjects who had Dactylitis at baseline and were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    23 [13]
    58 [14]
    Units: Percent change
        median (inter-quartile range (Q1-Q3))
    -33.33 (-66.7 to 0.0)
    -100.00 (-100.00 to -50.0)
    Notes
    [13] - Full Analysis Set with Dactylitis at Baseline
    [14] - Full Analysis Set with Dactylitis at Baseline
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Wilcoxon rank sum test
    Confidence interval

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

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    End point title
    Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response Through Week 24
    End point description
    ACR 20, 50 and 70 responses were defined as >= 20, 50 and 70 % improvement, respectively, in both TJC (68 joints) and SJC (66 joints) and >= 20, 50 and 70% improvement respectively in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0-no difficulty to 3-inability to perform a task in that area), and Serum C-reactive protein (CRP). Subjects were set to non-responders if they met TF, EE criteria prior to week 16 or had data missing.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49
    100
    Units: Percentage of subjects
    number (not applicable)
        Week 4: ACR 20
    0
    21
        Week 4: ACR 50
    0
    0.1
        Week 4: ACR 70
    0
    0
        Week 8: ACR 20
    22.4
    42.0
        Week 8: ACR 50
    6.1
    12.0
        Week 8: ACR 70
    2.0
    4.0
        Week 12: ACR 20
    12.2
    49.0
        Week 12: ACR 50
    6.1
    15.0
        Week 12: ACR 70
    0
    7.0
        Week 16: ACR 50
    6.1
    30.0
        Week 16: ACR 70
    4.1
    9.0
        Week 20: ACR 20
    22.4
    63.0
        Week 20: ACR 50
    10.2
    37.0
        Week 20: ACR 70
    2.0
    11.0
        Week 24: ACR 70
    2.0
    14.0
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects who Achieved ACR 20, ACR 50, and ACR 70 Response from Week 24 to 56 [15]
    End point description
    ACR 20, 50, 70 responses are defined as >=20, 50, 70% improvement, respectively, in TJC(68 joints) and SJC(66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain),Subject’s global assessment of disease activity (VAS)(scale ranges from 0= Excellent to 100= poor), Physician’s global assessment of disease activity (VAS)(scale ranges from 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale ranges from 0= no difficulty to 3= inability to do task in that area), and Serum CRP. Post Week 24 Efficacy Analysis Set (EAS) included all randomized subjects who did not EE to ustekinumab at Week 16 and did not discontinue study treatment prior to or at Week 24. No data imputation rules applied after Week 24. Here ‘n’ signifies number of subjects analyzed at specific time-points.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 36, 44 and 56
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [16]
    86 [17]
    Units: Percentage of subjects
    number (not applicable)
        Week 24: ACR 20 (n= 86, 29)
    31.0
    66.3
        Week 24: ACR 50 (n= 86, 29)
    17.2
    39.5
        Week 24: ACR 70 (n= 86, 29)
    3.4
    16.3
        Week 28: ACR 20 (n= 85, 28)
    57.1
    75.3
        Week 28: ACR 50 (n= 85, 28)
    28.6
    44.7
        Week 28: ACR 70 (n= 85, 28)
    14.3
    30.6
        Week 32: ACR 20 (n= 84, 28)
    60.7
    75.0
        Week 32: ACR 50 (n= 84, 28)
    42.9
    51.2
        Week 32: ACR 70 (n= 84, 28)
    21.4
    29.8
        Week 36: ACR 20 (n= 84, 28)
    71.4
    73.8
        Week 36: ACR 50 (n= 84, 28)
    46.4
    48.8
        Week 36: ACR 70 (n= 84, 27)
    29.6
    31.0
        Week 44: ACR 20 (n= 84, 28)
    75.0
    77.4
        Week 44: ACR 50 (n= 84, 28)
    46.4
    46.4
        Week 44: ACR 70 (n= 84, 28)
    25.0
    26.2
        Week 56: ACR 20 (n= 83, 27)
    81.5
    73.5
        Week 56: ACR 50 (n= 83, 27)
    66.7
    53.0
        Week 56: ACR 70 (n= 83, 28)
    28.6
    32.5
    Notes
    [16] - Post Week 24 EAS population
    [17] - Post Week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Percent Change from Baseline in Selected ACR Components Through Week 24
    End point description
    The selected ACR components were: TJC, SJC and CRP. LOCF method was used for missing data and to replace the data after EE for subjects who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [18]
    100 [19]
    Units: Percent change
    median (inter-quartile range (Q1-Q3))
        %Change at Week 4 (SJC)
    -18.18 (-41.2 to 0.0)
    -28.42 (-60.0 to 0.0)
        %Change at Week 8 (SJC)
    -33.33 (-50.0 to 0.0)
    -51.47 (-84.7 to -11.1)
        %Change at Week 12 (SJC)
    -29.41 (-50.0 to 0.0)
    -64.50 (-93.8 to -30.0)
        %Change at Week 16 (SJC)
    -16.67 (-66.7 to 7.7)
    -71.43 (-100.0 to -33.3)
        %Change at Week 20 (SJC)
    -16.67 (-66.7 to 4.3)
    -80.00 (-100.0 to -42.2)
        %Change at Week 24 (SJC)
    -11.76 (-59.1 to 11.8)
    -84.11 (-100.0 to -43.2)
        %Change at Week 4 (TJC)
    -10.00 (-30.8 to 7.7)
    -17.71 (-42.5 to 0.0)
        %Change at Week 8 (TJC)
    -18.75 (-46.8 to 15.4)
    -40.59 (-67.9 to -17.3)
        %Change at Week 12 (TJC)
    -13.33 (-46.7 to 15.4)
    -45.80 (-78.0 to -25.0)
        %Change at Week 16 (TJC)
    3.23 (-37.5 to 35.7)
    -60.00 (-83.3 to -21.1)
        %Change at Week 20 (TJC)
    14.29 (-50.0 to 39.5)
    -65.37 (-87.5 to -27.9)
        %Change at Week 24 (TJC)
    -5.56 (-53.1 to 30.8)
    -70.00 (-89.6 to -23.7)
        %Change at Week 4 (CRP)
    -8.35 (-26.3 to 23.3)
    -20.13 (-57.1 to 14.1)
        %Change at Week 8 (CRP)
    5.24 (-32.7 to 57.3)
    -41.08 (-63.7 to 2.0)
        %Change at Week 12 (CRP)
    -3.95 (-41.3 to 51.2)
    -42.95 (-69.8 to 10.7)
        %Change at Week 16 (CRP)
    -1.05 (-40.5 to 52.5)
    -44.21 (-72.4 to -1.4)
        %Change at Week 20 (CRP)
    7.94 (-33.9 to 53.7)
    -52.99 (-74.5 to -12.7)
        %Change at Week 24 (CRP)
    7.94 (-30.3 to 93.5)
    -42.64 (-77.7 to 2.3)
    Notes
    [18] - FAS Population
    [19] - FAS Population
    No statistical analyses for this end point

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

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    End point title
    Percent Change from Baseline in Selected ACR Components from Week 24 to Week 56 [20]
    End point description
    The selected ACR components were TJC, SJC and CRP. Based on observed data in the post Week 24 efficacy analysis population, here ‘n’ is defined as “number of subjects analyzed’’ at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 36, 44 and 56
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [21]
    86 [22]
    Units: Percent change
    median (inter-quartile range (Q1-Q3))
        SJC %Change: Week 24 (n= 29, 86)
    -33.33 (-80.0 to -11.8)
    -85.71 (-100.0 to -63.3)
        SJC % Change: Week 28 (n= 28, 85)
    -69.05 (-83.3 to -32.7)
    -93.75 (-100.0 to -60.9)
        SJC % Change: Week 32 (n= 28, 84)
    -84.91 (-95.8 to -50.0)
    -100.00 (-100.00 to -73.9)
        SJC % Change: Week 36 (n= 28, 84)
    -79.14 (-100.0 to -57.7)
    -93.93 (-100.0 to -66.7)
        SJC % Change: Week 44 (n= 28, 84)
    -86.11 (-100.0 to -64.6)
    -94.56 (-100.0 to -70.6)
        SJC % Change: Week 56 (n= 27, 83)
    -100.00 (-100.00 to -63.6)
    -100.00 (-100.00 to -75.0)
        TJC % Change: Week 24 (n=29, 86)
    -50.00 (-74.5 to -14.9)
    -72.00 (-90.0 to -45.8)
        TJC % Change: Week 28 (n=28, 85)
    -65.99 (-83.3 to -17.0)
    -74.36 (-91.3 to -50.0)
        TJC % Change: Week 32 (n=28, 84)
    -71.76 (-86.1 to -27.7)
    -79.66 (-92.3 to -50.0)
        TJC % Change: Week 36 (n=28, 84)
    -81.67 (-91.2 to -27.1)
    -73.32 (-94.6 to -50.5)
        TJC % Change: Week 44 (n=28, 84)
    -86.06 (-93.5 to -50.0)
    -77.22 (-97.0 to -49.0)
        TJC % Change: Week 56 (n=27, 83)
    -80.00 (-93.8 to -51.2)
    -77.27 (-100.0 to -58.8)
        CRP % Change: Week 24 (n= 29, 86)
    6.19 (-30.3 to 93.5)
    -43.62 (-79.0 to 3.7)
        CRP % Change: Week 28 (n= 28, 84)
    -35.63 (-52.7 to -1.6)
    -52.70 (-79.6 to -1.7)
        CRP % Change: Week 32 (n= 28, 84)
    -42.61 (-60.8 to -21.8)
    -50.63 (-78.7 to -4.1)
        CRP % Change: Week 36 (n= 28, 85)
    -38.90 (-70.0 to -13.3)
    -53.22 (-81.4 to -6.0)
        CRP % Change: Week 44 (n= 28, 84)
    -53.43 (-76.9 to -36.5)
    -53.36 (-75.7 to -10.3)
        CRP % Change: Week 56 (n= 28, 84)
    -51.26 (-81.5 to -37.8)
    -54.91 (-79.3 to -25.7)
    Notes
    [21] - Post Week 24 EAS population
    [22] - Post Week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in HAQ-DI score Through Week 24
    End point description
    The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. LOCF method was used to impute missing values. Last observation at or prior EE was used to replace data after EE for subjects who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [23]
    100 [24]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        HAQ-DI: Baseline
    1.34 ± 0.542
    1.42 ± 0.621
        Change at Week 4
    -0.02 ± 0.329
    -0.17 ± 0.322
        Change at Week 8
    -0.07 ± 0.440
    -0.32 ± 0.442
        Change at Week 12
    -0.05 ± 0.450
    -0.33 ± 0.390
        Change at Week 16
    -0.05 ± 0.428
    -0.38 ± 0.397
        Change at Week 20
    -0.08 ± 0.479
    -0.41 ± 0.453
    Notes
    [23] - FAS population
    [24] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in HAQ-DI Score from Week 24 to Week 56 [25]
    End point description
    The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Based on observed data in the post Week 24 Efficacy Analysis Set. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 36, 44 and 56
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [26]
    86 [27]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n= 29, 86)
    -0.19 ± 0.581
    -0.46 ± 0.530
        Change at Week 28 (n= 28, 85)
    -0.40 ± 0.646
    -0.51 ± 0.571
        Change at Week 32 (n= 28, 84)
    -0.50 ± 0.624
    -0.56 ± 0.595
        Change at Week 36 (n= 28, 84)
    -0.59 ± 0.650
    -0.53 ± 0.618
        Change at Week 44 (n= 28, 84)
    -0.63 ± 0.612
    -0.54 ± 0.598
        Change at Week 56 (n= 28, 83)
    -0.67 ± 0.558
    -0.55 ± 0.621
    Notes
    [26] - Post Week 24 EAS population
    [27] - Post Week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) Through Week 24
    End point description
    The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. HAQ-DI response is defined as at least 0.30 improvement from baseline in HAQ-DI score and based on the imputed HAQ-DI score using LOCF for missing data and early escape.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [28]
    100 [29]
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    12.2
    29.0
        Week 8
    26.5
    43.0
        Week 12
    22.4
    47.0
        Week 16
    20.4
    50.0
        Week 20
    22.4
    48.0
        Week 24
    28.6
    51.0
    Notes
    [28] - FAS Population
    [29] - FAS Population
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Achieving a HAQ-DI response (>= 0.30 Improvement from Baseline in HAQ-DI Score) from Week 24 to Week 56 [30]
    End point description
    The HAQ-DI score is an evaluation of the functional status for a subject. The 20- question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. HAQ-DI response is defined as at least 0.30 improvement from baseline in HAQ-DI score and is based on observed values in the post week 24 efficacy analysis set. Here, N 'number of subjects analyzed' signifies that these subjects were evaluable for this endpoint and ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 36, 44 and 56
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [31]
    86 [32]
    Units: Percentage of subjects
    number (not applicable)
        Week 24 (n=29, 86)
    44.8
    55.8
        Week 28 (n=28, 85)
    53.6
    60.0
        Week 32 (n=28, 84)
    57.1
    56.0
        Week 36 (n=28, 84)
    64.3
    59.5
        Week 44 (n=28, 84)
    71.4
    61.9
        Week 56 (n=28, 83)
    75.0
    59.0
    Notes
    [31] - Post Week 24 EAS population
    [32] - Post Week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline Through Week 24
    End point description
    Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [33]
    100 [34]
    Units: Percent change
    median (inter-quartile range (Q1-Q3))
        % change at Week 4
    -33.33 (-50.0 to 0.0)
    -32.46 (-100.0 to 0.0)
        % change at Week 8
    -50.00 (-100.0 to 0.0)
    -75.00 (-100.0 to -10.0)
        % change at Week 16
    -50.00 (-80.0 to 0.0)
    -100.00 (-100.0 to -33.3)
    Notes
    [33] - FAS Population
    [34] - FAS Population
    No statistical analyses for this end point

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

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    End point title
    Percent Change from Baseline in the Dactylitis Score Among Subjects With Dactylitis at Baseline from Week 24 to Week 56 [35]
    End point description
    Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. Based on observed values in post Week 24 efficacy analysis set among subjects with dactylitis at baseline. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 44 and 56
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    16 [36]
    50 [37]
    Units: Percent change
    median (inter-quartile range (Q1-Q3))
        % change at Week 24 (n= 16, 50)
    -45.00 (-70.8 to 0.0)
    -100.00 (-100.00 to -80.0)
        % change at Week 28 (n= 16, 49)
    -70.83 (-100.0 to -22.5)
    -100.00 (-100.0 to -66.7)
        % change at Week 32 (n= 16, 49)
    -100.00 (-100.00 to 79.2)
    -100.00 (-100.00 to -70.0)
        % change at Week 44 (n= 16, 49)
    -100.00 (-100.00 to -100.00)
    -100.00 (-100.00 to -100.00)
        % change at Week 56 (n= 16, 48)
    -100.00 (-100.00 to -100.00)
    -100.00 (-100.00 to -95.0)
    Notes
    [36] - Post Week 24 EAS with Dactylitis at Baseline
    [37] - Post Week 24 EAS with Dactylitis at Baseline
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects with One or More Digits with Dactylitis Through Week 24 in Subjects with Dactylitis at Baseline
    End point description
    Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    23 [38]
    58 [39]
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    91.3
    72.4
        Week 8
    69.6
    56.9
        Week 16
    78.3
    48.3
        Week 24
    82.6
    44.8
    Notes
    [38] - FAS population with Dactylitis at Baseline
    [39] - FAS population with Dactylitis at Baseline
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects with One or More Digits with Dactylitis from Week 24 to Week 56 in Subjects with Dactylitis at Baseline [40]
    End point description
    Presence and severity of dactylitis were assessed in both hands and feet using a scoring system from 0 to 3 (0 – no dactylitis, 1 – mild dactylitis, 2 – moderate dactylitis, and 3 – severe dactylitis). The results for each digit were summed to produce a final score. The Dactylitis index ranges from 0 to 60. Higher score indicates more severe dactylitis. Based on observed values in post Week 24 efficacy analysis set, among subjects with dactylitis at baseline. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 44 and 56
    Notes
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    16 [41]
    50 [42]
    Units: Percentage of subjects
    number (not applicable)
        Week 24 (n= 16, 50)
    81.3
    40.0
        Week 28 (n= 16, 49)
    62.5
    38.8
        Week 32 (n= 16, 49)
    31.3
    36.7
        Week 44 (n= 16, 49)
    12.5
    20.4
        Week 56 (n= 16, 48)
    6.3
    25.0
    Notes
    [41] - Post Week 24 FAS with Dactylitis at Baseline
    [42] - Post Week 24 FAS with Dactylitis at Baseline
    No statistical analyses for this end point

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

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    End point title
    Percent Change from Baseline in the Enthesitis Score Through Week 24 in Subjects with Enthesitis at Baseline
    End point description
    Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analyzed' signifies that these subjects were evaluated with Enthesitis at Baseline for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    31 [43]
    76 [44]
    Units: Percent Change
    median (inter-quartile range (Q1-Q3))
        % change at Week 4
    0.00 (-50.0 to 0.0)
    -18.33 (-79.2 to 0.0)
        % change at Week 8
    0.00 (-60.0 to 0.0)
    -58.33 (-100.0 to 0.0)
        % change at Week 16
    0.00 (-50.0 to 0.0)
    -70.83 (-100.0 to 0.0)
        % change at Week 24
    -33.33 (-100.0 to 0.0)
    -100.00 (-100.0 to -10.0)
    Notes
    [43] - FAS population
    [44] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Percent Change from Baseline in the Enthesitis Score from Week 24 to Week 56 in Subjects with Enthesitis at Baseline [45]
    End point description
    Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Based on observed values in the post Week 24 efficacy analysis set with enthesitis at baseline. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 44 and 56
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    18 [46]
    67 [47]
    Units: Percent change
    median (inter-quartile range (Q1-Q3))
        % change at Week 24 (n= 18, 67)
    -50.00 (-100.0 to 0.0)
    -100.00 (-100.0 to -50.0)
        % change at Week 28 (n= 17, 67)
    -60.00 (-100.0 to -40.0)
    -100.00 (-100.0 to -50.0)
        % change at Week 32 (n= 17, 66)
    -100.00 (-100.0 to -60.0)
    -100.00 (-100.00 to -66.7)
        % change at Week 44 (n= 17, 66)
    -100.00 (-100.00 to -60.0)
    -100.00 (-100.00 to -50.0)
        % change at Week 56 (n= 16, 65)
    -100.00 (-100.00 to -35.0)
    -100.00 (-100.00 to -50.0)
    Notes
    [46] - Post Week 24 EAS with Enthesitis at Baseline
    [47] - Post Week 24 EAS with Enthesitis at Baseline
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline Through Week 24
    End point description
    Enthesitis were be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Here, N 'number of subjects analyzed' signifies that these subjects were evaluated with Enthesitis at Baseline for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    31 [48]
    76 [49]
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    87.1
    76.3
        Week 8
    87.1
    59.2
        Week 16
    83.9
    53.9
        Week 24
    71.0
    43.4
    Notes
    [48] - Subjects in FAS with Enthesitis at Baseline
    [49] - Subjects in FAS with Enthesitis at Baseline
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects with Enthesitis in Subjects with Enthesitis at Baseline from Week 24 to Week 56 [50]
    End point description
    Enthesitis were assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Based on the observed values in the post Week 24 efficacy analysis set with enthesitis at baseline. Here, N 'number of subjects analyzed' signifies that these subjects were evaluated with Enthesitis at Baseline for this endpoint in the post Week 24 efficacy analysis set and ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 44 and 56
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    18 [51]
    67 [52]
    Units: Percentage of Subjects
    number (not applicable)
        Week 24 (n=18, 67)
    66.7
    38.8
        Week 28 (n=17, 67)
    64.7
    44.8
        Week 32 (n=17, 66)
    35.3
    31.8
        Week 44 (n=17, 66)
    47.1
    37.9
        Week 56 (n=16, 65)
    37.5
    29.2
    Notes
    [51] - Post week 24 EAS with Enthesitis at Baseline
    [52] - Post week 24 in EAS with Enthesitis at Baseline
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Score Through Week 24
    End point description
    PASDAS is calculated using variables: patient global VAS (arthritis, psoriasis rescaled to 0 [excellent]–100[Poor]),physician global VAS (rescaled to 0 [no arthritis]–100 [extremely active arthritis]),66 SJC 68 TJC, CRP level (mg/L), enthesitis (measured by LEI and rescaled to 0 [nontenderness]–6 [tenderness] range), tender dactylitis count (scoring each digit from 0 [no dactylitis]–3[severe dactylitis] and recoding to 0–1, with score >0 equaled 1), and PCS scale of 36-item short form health survey (SF-36). The score ranges from 0 to10. Smaller values mean better condition; a negative change from baseline shows improvement. LOCF method was used to impute missing data and Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [53]
    100 [54]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    6.33 ± 1.032
    6.62 ± 1.094
        Change at Week 16
    -0.45 ± 1.099
    -2.24 ± 1.458
        Change at Week 24
    -0.49 ± 1.333
    -2.50 ± 1.587
    Notes
    [53] - FAS population
    [54] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in PASDAS Score from Week 24 to 44 [55]
    End point description
    PASDAS is calculated using variables: patient global VAS (arthritis, psoriasis rescaled to 0 [excellent]–100[Poor]),physician global VAS (rescaled to 0 [no arthritis]–100 [extremely active arthritis]),66 SJC 68 TJC, CRP level (mg/L), enthesitis (measured by LEI and rescaled to 0 [nontenderness]–6 [tenderness] range), tender dactylitis count (scoring each digit from 0 [no dactylitis]–3[severe dactylitis] and recoding to 0–1, with score >0 equaled 1), and PCS scale of 36-item short form health survey (SF-36). The score ranges from 0 to10. Smaller values mean better condition; a negative change from baseline shows improvement. Based on observed data in the post Week 24 efficacy analyisis set. Here‘n’ signifies number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24 and 44
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [56]
    86 [57]
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n=28, 86)
    -1.05 ± 1.440
    -2.80 ± 1.454
        Change at Week 44 (n=28, 83)
    -3.17 ± 1.524
    -3.15 ± 1.570
    Notes
    [56] - Post Week 24 EAS population
    [57] - Post Week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in Grappa Composite Score (GRACE) Index Through Week 24
    End point description
    GRACE index is GRAPPA composite score, which is [1- Arithmetic Mean of the Desirability Function(AMDF)]*10. AMDF is calculated using the following parameters: TJC (0-68), SJC (0-66), HAQ(0-3), Patient’s global assessment of disease activity by VAS(arthritis and psoriasis, 0-100 mm), Patient’s assessment of skin disease activity by VAS (0-100 mm), Patient’s global assessment of disease activity(arthritis) by VAS(0-100 mm), PASI(0-72), Psoriatic arthritis Quality of Life Index (PsAQOL), derived as 25.355+ (2.367*HAQ)–(0.234*PCS)–(0.244*MCS). LOCF method was used to impute missing values. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria. Subjects with missing baseline were excluded from the analysis. Here, ‘n’ signifies number of subjects analyzed at specific time-points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [58]
    100 [59]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 48, 98)
    5.94 ± 1.119
    6.15 ± 1.250
        Change at Week 16 (n= 48, 98)
    -0.29 ± 1.174
    -2.49 ± 1.614
        Change at Week 24 (n= 48, 98)
    -0.35 ± 1.394
    -2.73 ± 1.756
    Notes
    [58] - FAS population
    [59] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in GRACE Index from Week 24 to 44 [60]
    End point description
    GRACE index is GRAPPA composite score, which is [1- Arithmetic Mean of the Desirability Function(AMDF)]*10. AMDF is calculated using the following parameters: TJC (0-68), SJC (0-66), HAQ(0-3), Patient’s global assessment of disease activity by VAS(arthritis and psoriasis, 0-100 mm), Patient’s assessment of skin disease activity by VAS (0-100 mm), Patient’s global assessment of disease activity(arthritis) by VAS(0-100 mm), PASI(0-72), Psoriatic arthritis Quality of Life Index (PsAQOL), derived as 25.355+ (2.367*HAQ)–(0.234*PCS)–(0.244*MCS). Based on observed values in the post Week 24 efficacy analysis set. Here, ‘n’ signifies number of subjects analyzed at specific time-points.
    End point type
    Secondary
    End point timeframe
    Week 24 and 44
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [61]
    86 [62]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n= 27, 85)
    -0.91 ± 1.498
    -2.96 ± 1.717
        Change at Week 44 (n= 27, 82)
    -3.21 ± 1.698
    -3.26 ± 1.856
    Notes
    [61] - Post week 24 EAS population
    [62] - Post week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24
    End point description
    The mCPDAI assesses 4 domains (joints, skin, entheses, and dactylitis) and calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0 [not involved in specific condition] to 3 (severe condition]) is assigned. Higher score range indicates severe condition. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria. Subjects with missing baseline were excluded from the analysis. Here, ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [63]
    100 [64]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 48, 98)
    6.9 ± 2.16
    7.8 ± 2.27
        Change at Week 16 (n= 48, 98)
    -0.5 ± 2.00
    -3.3 ± 2.52
        Change at Week 24 (n= 48, 98)
    -0.8 ± 2.26
    -3.9 ± 2.79
    Notes
    [63] - FAS population
    [64] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in mCPDAI Score at Week 24 and Week 44 [65]
    End point description
    The mCPDAI assesses 4 domains (joints, skin, entheses, and dactylitis) and calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0 [not involved in specific condition] to 3 (severe condition]) is assigned. Higher score range indicates severe condition. Based on observed values in the Post Week 24 Efficacy Analysis Set. Here ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24 and 44
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [66]
    86 [67]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n= 27, 85)
    -1.6 ± 2.27
    -4.3 ± 2.70
        Change at Week 44 (n= 27, 82)
    -4.4 ± 2.79
    -5.0 ± 2.48
    Notes
    [66] - Post week 24 EAS population
    [67] - Post week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Index Through Week 24
    End point description
    DAPSA is calculated as the sum of the following components: tender joint count (0 [non-tenderness]– 68 [tenderness]), swollen joint count (0[not swollen]–66 [swollen]), CRP level (milligram per deciliter [mg/dL]), patient VAS for pain (0 [no pain]–10 [the worst possible pain]), and patient VAS for global disease activity (arthritis, 0[Excellent] –10[Poor]). Higher score indicates more severe condition. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16, 20 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [68]
    100 [69]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    45.16 ± 19.990
    47.38 ± 20.645
        Change at Week 4
    -5.62 ± 13.030
    -10.03 ± 11.207
        Change at Week 8
    -8.25 ± 15.158
    -16.65 ± 15.948
        Change at Week 12
    -6.84 ± 16.334
    -18.84 ± 16.266
        Change at Week 16
    -4.98 ± 16.045
    -21.26 ± 17.811
        Change at Week 20
    -4.70 ± 17.408
    -22.56 ± 19.918
        Change at Week 24
    -4.97 ± 20.114
    -23.08 ± 20.206
    Notes
    [68] - FAS population
    [69] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in DAPSA Index from Week 24 to Week 56 [70]
    End point description
    DAPSA is calculated as the sum of the following components: tender joint count (0 [non-tenderness]– 68 [tenderness]), swollen joint count (0[not swollen]–66 [swollen]), CRP level (milligram per deciliter [mg/dL]), patient VAS for pain (0 [no pain]–10 [the worst possible pain]), and patient VAS for global disease activity (arthritis, 0[Excellent] –10[Poor]). Higher score indicates more severe condition. Based on observed data in the Post Week 24 Efficacy Analysis Set. Here ‘n’ signifies the number of subjects analyzed at specific time-points.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 36, 44 and 56
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [71]
    86 [72]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n=29, 86)
    -12.99 ± 22.328
    -26.93 ± 18.238
        Change at Week 28 (n=28, 85)
    -20.85 ± 21.434
    -29.71 ± 18.911
        Change at Week 32 (n=28, 84)
    -26.12 ± 21.309
    -30.59 ± 19.720
        Change at Week 36 (n=28, 85)
    -27.37 ± 22.480
    -30.43 ± 18.114
        Change at Week 44 (n=28, 84)
    -29.54 ± 20.785
    -30.55 ± 18.188
        Change at Week 56 (n=28, 84)
    -31.98 ± 20.359
    -32.02 ± 18.328
    Notes
    [71] - Post week 24 EAS population
    [72] - Post week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects who Achieved a Minimal Disease Activity (MDA) at Week 16 and 24
    End point description
    MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient’s perspective of pain and disease activity, physical function and enthesitis). Subjects were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <= 1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity on arthritis and psoriasis VAS score of <=20; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1. Subjects were set to non-responders if they met TF, EE criteria prior to week 16 or had data missing.
    End point type
    Secondary
    End point timeframe
    Week 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [73]
    100 [74]
    Units: Percentage of subjects
    number (not applicable)
        Week 16
    0
    18.0
        Week 24
    2.0
    23.0
    Notes
    [73] - FAS population
    [74] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects who Achieved a MDA at Week 24 and 44 [75]
    End point description
    MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient’s perspective of pain and disease activity, physical function and enthesitis). Subjects were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <= 1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity on arthritis and psoriasis VAS score of<=20; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1. Based on observed data in the Post Week 24 Efficacy Analysis Set. Here, ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24 and 44
    Notes
    [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [76]
    86 [77]
    Units: Percentage of subjects
    number (not applicable)
        Week 24 (n= 29, 86)
    3.4
    26.7
        Week 44 (n= 28, 84)
    28.6
    34.5
    Notes
    [76] - Post week 24 EAS population
    [77] - Post week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in Physical Component Summary Scores (PCS) and Mental Component Summary Scores (MCS) of the 36-item Short Form Healthy Survey (SF-36) at Week 16 and 24
    End point description
    SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 with higher scores= better health. Based on scale scores, summary scores, PCS and MCS were derived using algorithm. Summary MCS and PCS score is also scaled from 0 to 100 and normalized based on general population with higher scores= better health. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [78]
    100 [79]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        PCS: Baseline
    34.39 ± 8.014
    33.46 ± 7.093
        PCS: Change at Week 16
    -0.44 ± 5.025
    5.86 ± 7.315
        PCS: Change at Week 24
    0.46 ± 6.513
    6.59 ± 7.465
        MCS: Baseline
    45.99 ± 12.523
    43.27 ± 11.481
        MCS: Change at Week 16
    1.14 ± 7.075
    4.80 ± 8.952
        MCS: Change at Week 24
    0.42 ± 6.737
    4.95 ± 9.064
    Notes
    [78] - FAS population
    [79] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in PCS and MCS of the 36-item Short Form Healthy Survey (SF-36) at Week 24 to 44 [80]
    End point description
    SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 with higher scores= better health. Based on scale scores, summary scores, PCS and MCS were derived using algorithm. Summary MCS and PCS score is also scaled from 0 to 100 and normalized based on general population with higher scores= better health. Based on observed data in the Post Week 24 Efficacy Analysis set. Here, 'n’ signifies number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24 and 44
    Notes
    [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [81]
    86 [82]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        PCS: Change at Week 24 (n= 28, 86)
    2.13 ± 7.365
    7.40 ± 7.448
        PCS: Change at Week 44 (n= 28, 84)
    8.02 ± 8.647
    8.34 ± 8.783
        MCS: Change at Week 24 (n= 28, 86)
    0.51 ± 6.770
    5.45 ± 9.081
        MCS: Change at Week 44 (n= 28, 84)
    5.53 ± 9.013
    4.56 ± 9.548
    Notes
    [81] - Post week 24 EAS population
    [82] - Post week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in Norm-based scores of SF-36 Scales at Week 16 and 24
    End point description
    SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 and normalized based on general population, with higher scores= better health. LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [83]
    100 [84]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Physical functioning: Baseline
    34.61 ± 9.396
    32.95 ± 8.854
        Physical functioning: Change at Week 16
    -0.31 ± 6.657
    6.30 ± 7.255
        Physical functioning: Change at Week 24
    -0.04 ± 8.227
    6.93 ± 8.009
        Role-physical: Baseline
    36.90 ± 7.879
    34.99 ± 7.776
        Role-physical: Change at Week 16
    -0.23 ± 5.674
    4.22 ± 7.146
        Role-physical: Change at Week 24
    -0.09 ± 6.813
    4.69 ± 7.961
        Bodily pain: Baseline
    35.82 ± 6.255
    34.72 ± 6.294
        Bodily pain: Change at Week 16
    0.21 ± 5.675
    6.56 ± 7.832
        Bodily pain: Change at Week 24
    0.81 ± 6.445
    7.56 ± 8.288
        General health: Baseline
    38.57 ± 8.758
    37.27 ± 7.597
        General health: Change at Week 16
    0.74 ± 5.857
    6.19 ± 7.964
        General health: Change at Week 24
    1.49 ± 7.274
    6.48 ± 7.676
        Vitality: Baseline
    42.29 ± 10.576
    41.22 ± 10.012
        Vitality: Change at Week 16
    0.73 ± 7.779
    5.85 ± 8.138
        Vitality: Change at Week 24
    1.46 ± 7.254
    6.39 ± 8.861
        Social functioning: Baseline
    41.99 ± 9.837
    39.39 ± 10.157
        Social functioning: Change at Week 16
    -0.82 ± 8.272
    5.87 ± 9.346
        Social functioning: Change at Week 24
    -0.82 ± 7.613
    6.22 ± 10.426
        Role-emotional: Baseline
    43.02 ± 10.133
    40.05 ± 11.476
        Role-emotional: Change at Week 16
    1.14 ± 8.774
    4.77 ± 9.643
        Role-emotional: Change at Week 24
    0.64 ± 8.754
    4.67 ± 9.393
        Mental health: Baseline
    42.33 ± 11.818
    39.80 ± 10.621
        Mental health: Change at Week 16
    1.28 ± 7.007
    5.10 ± 8.683
        Mental health: Change at Week 24
    0.21 ± 7.020
    5.68 ± 8.877
    Notes
    [83] - FAS population
    [84] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in Norm-based scores of SF-36 Scales at Week 24 and 44 [85]
    End point description
    SF-36 questionnaire is health related quality of life (QOL) instrument and consists of 36 questions with 8 multi-item scales: Limitations in physical functioning (health problems); Limitations in usual role activities (physical health problems); Bodily pain; Limitations in General mental health (psychological distress and well-being); Limitations in usual role activities (personal or emotional problems); Limitations in social functioning (physical or mental health problems); Limitations in Vitality (energy and fatigue); General health perception. Each scale was scored from 0 to 100 and normalized based on general population, with higher scores= better health. Based on observed values in the Post Week 24 Efficacy Analysis set. Here, N 'number of subjects analyzed' signifies that these subjects were evaluable for this endpoint and ‘n’ signifies number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24 and 44
    Notes
    [85] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [86]
    86 [87]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Physical function: Change at Week 24(n=28,86)
    1.09 ± 8.953
    7.54 ± 8.228
        Physical function: Change at Week 44(n=28,84)
    8.41 ± 9.969
    8.50 ± 8.633
        Role-physical: Change at Week 24(n=28,86)
    1.92 ± 7.119
    5.74 ± 7.480
        Role-physical: Change at Week 44(n=28,84)
    6.82 ± 9.198
    6.66 ± 7.664
        Bodily pain: Change at Week 24(n=28,86)
    2.88 ± 6.856
    8.39 ± 8.332
        Bodily pain: Change at Week 44(n=28,84)
    9.42 ± 8.914
    8.95 ± 9.952
        General health: Change at Week 24(n=28,86)
    1.94 ± 8.185
    7.05 ± 7.657
        General health: Change at Week 44(n=28,84)
    6.25 ± 8.998
    6.74 ± 8.496
        Vitality: Change at Week 24 (n=28,86)
    1.49 ± 7.387
    7.39 ± 8.727
        Vitality: Change at Week 44 (n=28,84)
    7.53 ± 10.802
    7.11 ± 9.891
        Social function: Change at Week 24(n=28,86)
    -0.18 ± 7.776
    6.41 ± 10.919
        Social function: Change at Week 44(n=28,84)
    6.09 ± 10.151
    5.73 ± 10.357
        Role-emotion: Change at Week 24(n=28,86)
    2.11 ± 7.891
    5.30 ± 9.013
        Role-emotion: Change at Week 44(n=28,84)
    5.47 ± 9.160
    5.68 ± 9.635
        Mental health: Change at Week 24(n=28,86)
    0.19 ± 7.465
    6.30 ± 8.994
        Mental health: Change at Week 44(n=28,84)
    7.29 ± 9.952
    5.42 ± 8.978
    Notes
    [86] - Post week 24 EAS Population
    [87] - Post week 24 EAS Population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 16 and 24
    End point description
    RAPID3 scores were designed for usual clinical care, although they also may be useful for clinical research. The 3 Core Data Set measures on multi-dimensional health assessment questionnaire (MDHAQ), for function (FN), pain, and patient global estimate, were each scored 0-10 and recorded on the MDHAQ. The scores for each domain were then added together to give a final score range of 0–30 (with a positive change indicating worsening of disease activity). LOCF method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [88]
    100 [89]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    16.51 ± 4.991
    17.06 ± 5.300
        Change at Week 16
    -0.19 ± 4.405
    -5.41 ± 5.307
        Change at Week 24
    -0.57 ± 5.123
    -5.81 ± 5.968
    Notes
    [88] - FAS population
    [89] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in RAPID3 Score at Week 24 and 44 [90]
    End point description
    RAPID3 scores were designed for usual clinical care, although they also may be useful for clinical research. The 3 Core Data Set measures on multi-dimensional health assessment questionnaire (MDHAQ), for function (FN), pain, and patient global estimate, were each scored 0-10 and recorded on the MDHAQ. The scores for each domain were then added together to give a final score range of 0–30 (with a positive change indicating worsening of disease activity). Based on observed data in the Post Week 24 Efficacy Analysis Set. Here ‘n’ signifies number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24 and 44
    Notes
    [90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [91]
    86 [92]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n=28, 86)
    -2.28 ± 5.244
    -6.36 ± 6.205
        Change at Week 44 (n=28, 84)
    -7.60 ± 6.588
    -7.48 ± 6.310
    Notes
    [91] - Post week 24 EAS population
    [92] - Post week 24 EAS population
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Achieving Greater Than or Equal to 50%, 75%, 90%, and Equal to 100% Improvement in PASI Response from Baseline Through Week 24
    End point description
    The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 50, 75, 90 and 100 responses is defined as >= 50, 75, 90 and 100 percent (%) improvement respectively in PASI score from baseline. LOCF method was used for missing PASI values and the last observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Subjects with missing baseline PASI were excluded in the analysis. here ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    49 [93]
    100 [94]
    Units: Percentage of subjects
    number (not applicable)
        W4:>=100% improvement (n=48,98)
    0
    3.1
        W4:>=90% improvement (n=48,98)
    0
    9.2
        W4:>=75% improvement (n=48,98)
    4.2
    16.3
        W4:>=50% improvement (n=48,98)
    12.5
    43.9
        W8:>=100% improvement (n=48,98)
    2.1
    12.2
        W8:>=90% improvement (n=48,98)
    2.1
    27.6
        W8:>=75% improvement (n=48,98)
    4.2
    42.9
        W8:>=50% improvement (n=48,98)
    10.4
    67.3
        W16:>=100% improvement (n=48,98)
    6.3
    31.6
        W16:>=90% improvement (n=48,98)
    6.3
    53.1
        W16:>=75% improvement (n=48,98)
    8.3
    71.4
        W16:>=50% improvement (n=48,98)
    27.1
    81.6
        W24:>=100% improvement (n=48,98)
    6.3
    39.8
        W24:>=90% improvement (n=48,98)
    6.3
    66.3
        W24:>=75% improvement (n=48,98)
    12.5
    78.6
        W24:>=50% improvement (n=48,98)
    29.2
    86.7
    Notes
    [93] - FAS population
    [94] - FAS population
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Achieving a Greater Than or Equal to 50%, 75%, 90%, and Equal to 100% Improvement in PASI Response from Baseline from Week 24 to 56 [95]
    End point description
    The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 50, 75, 90 and 100 responses is defined as >= 50, 75, 90 and 100 percent (%) improvement respectively in PASI score from baseline. Based on observed values in the Post Week 24 Efficacy Analysis set. Subjects with missing baseline were excluded in the analysis. Here ‘n’ signifies number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 44 and 56
    Notes
    [95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [96]
    86 [97]
    Units: Percentage of Subjects
    number (not applicable)
        W 24: PASI 50 responders (n= 29, 86)
    37.9
    89.5
        W 24: PASI 75 responders (n= 29, 86)
    20.7
    82.6
        W 24: PASI 90 responders (n= 29, 86)
    10.3
    70.9
        W 24: Subjects with PASI=0 (n= 29, 86)
    10.3
    44.2
        W 28: PASI 50 responders (n= 28, 84)
    60.7
    95.2
        W 28: PASI 75 responders (n= 28, 84)
    35.7
    84.5
        W 28: PASI 90 responders (n= 28, 84)
    25.0
    72.6
        W 28: Subjects with PASI=0 (n= 28, 84)
    17.9
    53.6
        W 32: PASI 50 responders (n= 28, 83)
    78.6
    92.8
        W 32: PASI 75 responders (n= 28, 83)
    67.9
    86.7
        W 32: PASI 90 responders (n= 28, 83)
    50.0
    80.7
        W 32: Subjects with PASI=0 (n= 28, 83)
    35.7
    62.7
        W 44: PASI 50 responders (n= 28, 83)
    89.3
    94.0
        W 44: PASI 75 responders (n= 28, 83)
    82.1
    90.4
        W 44: PASI 90 responders (n= 28, 83)
    75.0
    81.9
        W 44: Subjects with PASI=0 (n= 28, 83)
    67.9
    63.9
        W 56: PASI 50 responders (n= 27, 82)
    96.3
    92.7
        W 56: PASI 75 responders (n= 27, 82)
    81.5
    85.4
        W 56: PASI 90 responders (n= 27, 82)
    74.1
    78.0
        W 56: Subjects with PASI=0 (n= 27, 82)
    55.6
    57.3
    Notes
    [96] - Post week 24 EAS population
    [97] - Post week 24 EAS population
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in PASI Through Week 24

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    End point title
    Percent Change from Baseline in PASI Through Week 24
    End point description
    The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). LOCF method was used to impute missing data and the Last Observation at or prior EE was used to replace the data after EE for subjects who met EE criteria. Subjects with missing baseline were excluded in the analysis. Here, N 'number of participants analyzed' signifies that these participants were evaluable for this endpoint and ‘n’ signifies the number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 16 and 24
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    48 [98]
    98 [99]
    Units: Percent change
    median (inter-quartile range (Q1-Q3))
        % change at Week 4 (n= 48, 98)
    0.00 (-16.0 to 17.0)
    -41.49 (-64.7 to -12.2)
        % change at Week 8 (n= 48, 98)
    1.58 (-20.2 to 24.9)
    -66.67 (-93.6 to -41.9)
        % change at Week 16 (n= 48, 98)
    -1.10 (-50.0 to 35.9)
    -90.55 (-100.0 to -65.6)
        % change at Week 24 (n= 48, 98)
    -7.89 (-54.2 to 34.0)
    -96.21 (-100.0 to -82.6)
    Notes
    [98] - FAS Population
    [99] - FAS Population
    No statistical analyses for this end point

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

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    End point title
    Percent Change from Baseline in PASI from Week 24 to 56 [100]
    End point description
    The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). Based on observed data in the Post Week 24 Efficacy Analysis Set. Subjects with missing baseline were excluded in the analysis. Here ‘n’ signifies number of subjects analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Week 24, 28, 32, 44 and 56
    Notes
    [100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo arm at baseline is not applicable for the endpoints post Week 24, as all remaining placebo subjects crossed over to receive guselkumab at Week 24. Therefore the reporting group is renamed as "Crossover (placebo to Guselkumab)".
    End point values
    Crossover (Placebo to Guselkumab) Guselkumab
    Number of subjects analysed
    29 [101]
    86 [102]
    Units: Percent change
    median (inter-quartile range (Q1-Q3))
        % change at Week 24 (n= 28, 85)
    -34.26 (-72.9 to 26.9)
    -97.85 (-100.0 to -87.2)
        % change at Week 28 (n= 27, 83)
    -57.69 (-94.3 to -39.4)
    -100.00 (-100.0 to -88.2)
        % change at Week 32 (n= 27, 82)
    -90.61 (-100.0 to -62.5)
    -100.00 (-100.0 to -94.0)
        % change at Week 44 (n= 27, 82)
    -100.00 (-100.0 to -91.0)
    -100.00 (-100.0 to -95.4)
        % change at Week 56 (n= 26, 81)
    -100.00 (-100.00 to -91.0)
    -100.00 (-100.00 to -91.4)
    Notes
    [101] - Post Week 24 EAS population
    [102] - Post Week 24 EAS population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 56
    Adverse event reporting additional description
    Safety analysis set includes all subjects randomized at Week 0 who received at least (partial or complete) dose of study agent administration and were analyzed according to the actual treatment received (at the time of onset of AE event) after randomization, regardless of treatments they were randomized to.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1/19.1
    Reporting groups
    Reporting group title
    Week (W) 0 to 24: Placebo
    Reporting group description
    Include subjects who were randomized in the placebo group and received at least one injection of placebo. AEs that occurred between Week 0 and Week 24 while subjects were on placebo were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

    Reporting group title
    W0 to 24: Guselkumab
    Reporting group description
    Include subjects who were randomized in the guselkumab group and received at least one injection of guselkumab. AEs that occurred between Week 0 and Week 24 while subjects were on guselkumab were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

    Reporting group title
    W24 to 44: Crossover (Placebo to Guselkumab)
    Reporting group description
    Include subjects who remained in the placebo group and crossed over to guselkumab 100 mg at Week 24. AEs that occurred between Week 24 and Week 44 while subjects were on guselkumab were included in this group.

    Reporting group title
    W24 to 44: Guselkumab
    Reporting group description
    Include subjects who were randomized in the guselkumab group and received at least one injection of guselkumab. AEs that occurred between Week 24 and Week 44 while subjects were on guselkumab were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

    Reporting group title
    W44 to 56: Crossover (Placebo to Guselkumab)
    Reporting group description
    Include subjects who remained in the placebo group and crossed over to guselkumab 100 mg at Week 24. AEs that occurred during the follow-up period (12 weeks from the last study agent administration) were included in this group‌.

    Reporting group title
    W44 to 56: Guselkumab
    Reporting group description
    Include subjects who were randomized in the guselkumab group and received at least one injection of guselkumab. AEs that occurred during the follow-up period (12 weeks from the last study agent administration) were included in this group. For subjects who early escaped to ustekinumab at Week 16, AEs that occurred after early escape were excluded.

    Serious adverse events
    Week (W) 0 to 24: Placebo W0 to 24: Guselkumab W24 to 44: Crossover (Placebo to Guselkumab) W24 to 44: Guselkumab W44 to 56: Crossover (Placebo to Guselkumab) W44 to 56: Guselkumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    5 / 100 (5.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Joint Injury
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Pupils Unequal
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulcerative Keratitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Week (W) 0 to 24: Placebo W0 to 24: Guselkumab W24 to 44: Crossover (Placebo to Guselkumab) W24 to 44: Guselkumab W44 to 56: Crossover (Placebo to Guselkumab) W44 to 56: Guselkumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 49 (32.65%)
    35 / 100 (35.00%)
    4 / 29 (13.79%)
    22 / 100 (22.00%)
    1 / 29 (3.45%)
    8 / 100 (8.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Uterine Leiomyoma
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Social circumstances
    Pregnancy of Partner
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injection Site Erythema
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Local Swelling
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Reproductive system and breast disorders
    Postmenopausal Haemorrhage
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Burns Second Degree
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Chest Injury
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Foot Fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Humerus Fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Procedural Pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 100 (2.00%)
    2 / 29 (6.90%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    2
    2
    2
    0
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 100 (2.00%)
    2 / 29 (6.90%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    2
    1
    0
    0
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood Bilirubin Increased
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    1 / 29 (3.45%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Liver Function Test Abnormal
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Liver Function Test Increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Lymphocyte Morphology Abnormal
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    1 / 29 (3.45%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Neutrophil Count Decreased
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Transaminases Increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Weight Increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rhinitis Allergic
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Sinus Congestion
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Upper Respiratory Tract Inflammation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 49 (0.00%)
    4 / 100 (4.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    1 / 29 (3.45%)
    0 / 100 (0.00%)
         occurrences all number
    0
    4
    0
    1
    1
    0
    Neutropenia
         subjects affected / exposed
    0 / 49 (0.00%)
    4 / 100 (4.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Nervous system disorders
    Morton's Neuralgia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eye disorders
    Pupils Unequal
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Pancreatic Disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Calculus Urinary
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Renal Colic
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gallbladder Disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Hepatic Steatosis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    Hepatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hepatomegaly
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Liver Disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Scab
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    1 / 29 (3.45%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Joint Effusion
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pain in Extremity
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Psoriatic Arthropathy
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Spinal Pain
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    Diverticulitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Herpes Simplex
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Herpes Zoster
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 49 (10.20%)
    7 / 100 (7.00%)
    0 / 29 (0.00%)
    3 / 100 (3.00%)
    0 / 29 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    8
    8
    0
    3
    0
    2
    Oral Herpes
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rhinotracheitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Tooth Infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 100 (1.00%)
    1 / 29 (3.45%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    1
    1
    2
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 100 (2.00%)
    0 / 29 (0.00%)
    1 / 100 (1.00%)
    0 / 29 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2015
    The overall reasons for the amendment is to provide additional treatment options for subjects with ongoing disease activity after Week 24, to collect Ribonucleic acid (RNA) and stool samples to evaluate the mechanism of action of guselkumab, and to add additional results from the CNTO1275ARA2001 study to support the CNTO1959PSA2001 study design.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study results were limited by small sample size, relatively short duration of follow-up to detect rare AEs. Lack of an active comparator limited comparison with other PsA therapies.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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