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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

    Summary
    EudraCT number
    		 2016-002995-29
    Trial protocol
    		 DE   ES   HU   CZ   PL  
    Global end of trial date
    20 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2019
    First version publication date
    22 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959PSO3009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03090100
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry group, Janssen- Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen-Cilag International NV, 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
    20 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of subjects with moderate to severe plaque-type psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. The safety assessments included adverse events (AEs), clinical laboratory tests (hematology, chemistry, lipids, serology, and pregnancy testing), vital signs and Electrocardiogram (ECG) parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 158
    Country: Number of subjects enrolled
    Czech Republic: 55
    Country: Number of subjects enrolled
    Australia: 71
    Country: Number of subjects enrolled
    Germany: 122
    Country: Number of subjects enrolled
    Spain: 68
    Country: Number of subjects enrolled
    France: 58
    Country: Number of subjects enrolled
    Hungary: 45
    Country: Number of subjects enrolled
    Poland: 238
    Country: Number of subjects enrolled
    United States: 233
    Worldwide total number of subjects
    1048
    EEA total number of subjects
    586
    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)
    949
    From 65 to 84 years
    98
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of total 1,048 randomized subjects, 534 were assigned to receive Guselkumab + Placebo and 514 subjects were assigned to receive Secukinumab.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Guselkumab 100 mg + Placebo
    Arm description
    		 Subjects received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Subjects were continued to follow-up period from Week 44 through Week 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 injection of Placebo at Week 0, 4 and 12 and thereafter q8w through Week 44 or 2 injections of Placebo at Week 1, 2, 3, and 8 and thereafter every q8w through Week 40.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Guselkumab 100 mg SC injection at Week 0, 4 and 12 and thereafter q8w through Week 44.

    Arm title
    		 Secukinumab 300 mg
    Arm description
    		 Subjects received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Subjects were continued to follow-up period from Week 44 through Week 56.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of Secukinumab 300 mg SC injection (2*150 mg) at Week 0, 1, 2, 3, and 4 and thereafter every 4 weeks (q4w) through Week 44.

    Number of subjects in period 1
    		Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Started
    534
    514
    Treated
    507
    511
    Completed
    507
    466
    Not completed
    27
    48
         Consent withdrawn by subject
    7
    19
         Adverse event, non-fatal
    5
    5
         Pregnancy
    1
    1
         Non-compliance with study drug
    2
    -
         Adverse event, serious non-fatal
    3
    5
         Unspecified
    2
    2
         Lost to follow-up
    2
    2
         Adverse event - worsening of psoriasis
    1
    1
         Protocol deviation
    2
    6
         Lack of efficacy
    2
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Guselkumab 100 mg + Placebo
    Reporting group description
    		 Subjects received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Subjects were continued to follow-up period from Week 44 through Week 56.

    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Subjects received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Subjects were continued to follow-up period from Week 44 through Week 56.

    Reporting group values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg Total
    Number of subjects
    		 534 514 1048
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 480 469 949
        From 65 to 84 years
    		 53 45 98
        85 years and over
    		 1 0 1
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.3 ± 13.67 45.3 ± 13.57 -
    Title for Gender
    Units: subjects
        Female
    		 169 172 341
        Male
    		 365 342 707

    End points

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    End points reporting groups
    Reporting group title
    Guselkumab 100 mg + Placebo
    Reporting group description
    		 Subjects received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Subjects were continued to follow-up period from Week 44 through Week 56.

    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Subjects received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Subjects were continued to follow-up period from Week 44 through Week 56.

    Primary: Percentage of Subjects who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48

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    End point title
    		 Percentage of Subjects who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions, their response to therapy. PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to a numeric score (0 (no involvement) to 6 [90-100% involvement]), for erythema, induration, scaling, rated on scale of 0 to 4. PASI produces numeric score (0 [no psoriasis]-72). Higher score indicates more severe disease. PASI 90 response: at least 90 percent (%) reduction in PASI relative to baseline. Full analysis set (FAS): subjects randomized at Week 0. Subjects who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 90 non-responders at Week 48.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    84.5
    70.0
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 z-test
    Parameter type
    		 Difference in percentage
    Point estimate
    14.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.2
         upper limit
    		 19.2
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects who Achieved a PASI-75 Response at Both Week 12 and 48

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    End point title
    		 Percentage of Subjects who Achieved a PASI-75 Response at Both Week 12 and 48
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions, their response to therapy. PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to a numeric score (0 (no involvement) to 6 [90-100% involvement]), for erythema, induration, scaling, rated on scale of 0 to 4. PASI produces numeric score (0 [no psoriasis]-72). Higher score indicates more severe disease. PASI 75 response: at least a 75% reduction in PASI relative to baseline. Full analysis set: subjects randomized at Week 0. Subjects who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 12 or Week 48 were considered as non-responders for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 and 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    84.6
    80.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 z-test
    Parameter type
    		 Difference in percentage
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 8.9
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.062
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects who Achieved a PASI-90 Response at Week 12

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    End point title
    		 Percentage of Subjects who Achieved a PASI-90 Response at Week 12
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions, their response to therapy. PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to a numeric score (0 (no involvement) to 6 [90-100% involvement]), for erythema, induration, scaling, rated on scale of 0 to 4. PASI produces numeric score (0 [no psoriasis]-72). Higher score indicates more severe disease. PASI 90 response: at least 90% reduction in PASI relative to baseline. Full analysis set included. Subjects who met treatment failure criteria prior to Week 12, who had a missing PASI score at Week 12 were considered PASI 90 non-responders at Week 12. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.
    End point type
    Secondary
    End point timeframe
    Weak 12
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    69.1
    76.1
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 -1.7

    Secondary: Percentage of Subjects who Achieved a PASI-75 Response at Week 12

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    End point title
    		 Percentage of Subjects who Achieved a PASI-75 Response at Week 12
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions, their response to therapy. PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to a numeric score (0 (no involvement) to 6 [90-100% involvement]), for erythema, induration, scaling, rated on scale of 0 to 4. PASI produces numeric score (0 [no psoriasis]-72). Higher score indicates more severe disease. PASI 75 response: at least 75% reduction in PASI relative to baseline. Full analysis set included. Subjects who met treatment failure criteria prior to Week 12 or who had a missing PASI score at Week 12 were considered PASI 75 non-responders at Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    89.3
    91.6
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 1.2

    Secondary: Percentage of Subjects who Achieved a PASI-100 Response at Week 48

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    End point title
    		 Percentage of Subjects who Achieved a PASI-100 Response at Week 48
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions, their response to therapy. PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to a numeric score (0 (no involvement) to 6 [90-100% involvement]), for erythema, induration, scaling, rated on scale of 0 to 4. PASI produces numeric score (0 [no psoriasis]-72). Higher score indicates more severe disease. PASI 100 response: at least 100% reduction in PASI relative to baseline. Full analysis set included. Subjects who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 100 non-responders at Week 48.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    58.2
    48.4
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 15.5

    Secondary: Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) at Week 48

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    End point title
    		 Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) at Week 48
    End point description
    The IGA documents the investigator's assessment of the subject's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) non-responders at Week 48.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    62.2
    50.4
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    11.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.8
         upper limit
    		 17.4

    Secondary: Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48

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    End point title
    		 Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
    End point description
    The IGA documents the investigator's assessment of the subject's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) or minimal (1) non-responders at Week 48.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    85.0
    74.9
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 14.5

    Secondary: Percentage of Subjects who Achieved a PASI-90 Response at Both Week 16 and 48

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    End point title
    		 Percentage of Subjects who Achieved a PASI-90 Response at Both Week 16 and 48
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions, their response to therapy. PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to a numeric score (0 (no involvement) to 6 [90-100% involvement]), for erythema, induration, scaling, rated on scale of 0 to 4. PASI produces numeric score (0 [no psoriasis]-72). Higher score indicates more severe disease. PASI 90 response: at least 90% reduction in PASI relative to baseline. Full analysis set: subjects randomized at Week 0. Subjects who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 16 or Week 48 were considered as non-responders for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16 and 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    72.3
    64.4
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.3
         upper limit
    		 13.2

    Secondary: Percentage of Subjects who Achieved a PASI-75 Response at Week 16

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    End point title
    		 Percentage of Subjects who Achieved a PASI-75 Response at Week 16
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 75 non-responders at Week 16.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    92.7
    92.8
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 3.1

    Secondary: Percentage of Subjects who Achieved a PASI-90 Response at Week 16

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    End point title
    		 Percentage of Subjects who Achieved a PASI-90 Response at Week 16
    End point description
    he PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline. Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 90 non-responders at Week 16.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    78.5
    79.6
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 3.4

    Secondary: Percentage of Subjects who Achieved a PASI-90 Response at all 7 Visits From Week 24 Through Week 48

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    End point title
    		 Percentage of Subjects who Achieved a PASI-90 Response at all 7 Visits From Week 24 Through Week 48
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each areas is assessed separately for percentage of area involved, which translates to numeric score (0: no involvement to 6: 90%-100% involvement), and for erythema, induration, scaling, which are each rated on scale of 0 to 4. PASI produces a numeric score that could range from 0 (no psoriasis) to 72. Higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. FAS population included. Subjects who met treatment failure criteria prior to Week 48 or who had missing PASI score at any visit from Week 24 through Week 48 were considered as non-responders for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24 up to Week 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    71.0
    61.5
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 15.3

    Secondary: Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16

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    End point title
    		 Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
    End point description
    The IGA documents the investigator's assessment of the subject's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria prior to Week 16 or who had a missing IGA score at Week 16 were considered non-responders for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    86.7
    86.6
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 3.9

    Secondary: Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12

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    End point title
    		 Percentage of Subjects with Investigator’s Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
    End point description
    The IGA documents the investigator's assessment of the subject's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria prior to Week 12 or who had a missing IGA score at Week 12 were considered non-responders for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
        number (not applicable)
    85.6
    86.4
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab 100 mg + Placebo v Secukinumab 300 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 3.3

    Secondary: Percentage of Subjects who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12

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    End point title
    		 Percentage of Subjects who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
    End point description
    PASI is system used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI system, body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. Full analysis set included all the subjects randomized at Week 0 and who achieved PASI 75 response at Week 12. Subjects who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    477
    471
    Units: Percentage of subjects
        number (not applicable)
    94.8
    87.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16

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    End point title
    		 Percentage of Subjects who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
    End point description
    PASI is system used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI system, body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Full analysis set included all the subjects randomized at Week 0 and who achieved PASI 90 response at Week 16. Subjects who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    419
    409
    Units: Percentage of subjects
        number (not applicable)
    92.1
    80.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56

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    End point title
    		 Percentage of Subjects who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
    End point description
    PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Subjects with >=50%, >= 75%, >=90% and >= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria or who had missing PASI score were considered as non-responders for the specific visit.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
    number (not applicable)
        Week 1: 100% improvement
    0
    0
        Week 1: >=90% improvement
    0
    0
        Week 1: >=75% improvement
    2.1
    1.8
        Week 1: >=50% improvement
    10.7
    12.8
        Week 2: 100 improvement
    0.2
    0.6
        Week 2: >=90% improvement
    1.1
    2.7
        Week 2: >=75% improvement
    6.4
    11.5
        Week 2: >=50% improvement
    30.9
    42.0
        Week 3: 100% improvement
    1.7
    1.6
        Week 3: >=90% improvement
    5.6
    8.6
        Week 3: >=75% improvement
    19.5
    28.4
        Week 3: >=50% improvement
    56.4
    66.9
        Week 4: 100% improvement
    4.1
    5.1
        Week 4: >=90% improvement
    13.1
    21.8
        Week 4: >=75% improvement
    39.3
    50.2
        Week 4: >=50% improvement
    73.4
    85.4
        Week 8: 100% improvement
    20.0
    27.2
        Week 8: >=90% improvement
    48.7
    62.1
        Week 8: >=75% improvement
    76.4
    86.2
        Week 8: >=50% improvement
    95.3
    96.9
        Week 12: 100% improvement
    37.8
    42.0
        Week 12: >=50% improvement
    96.8
    96.1
        Week 16: 100% improvement
    47.8
    46.1
        Week 16: >=50% improvement
    97.6
    96.3
        Week 20: 100% improvement
    51.3
    48.6
        Week 20: >=90% improvement
    80.1
    81.1
        Week 20: >=75% improvement
    93.6
    92.4
        Week 20: >=50% improvement
    97.6
    95.1
        Week 24: 100% improvement
    54.7
    50.4
        Week 24: >=90% improvement
    83.1
    78.2
        Week 24: >=75% improvement
    94.2
    90.3
        Week 24: >=50% improvement
    97.8
    93.0
        Week 28: 100% improvement
    57.1
    51.0
        Week 28: >=90% improvement
    85.4
    77.2
        Week 28: >=75% improvement
    94.0
    90.3
        Week 28: >=50% improvement
    97.2
    93.0
        Week 32: 100% improvement
    57.5
    50.2
        Week 32:>=90 % improvement
    84.8
    77.4
        Week 32: >=75% improvement
    94.0
    89.3
        Week 32: >=50% improvement
    97.0
    93.0
        Week 36: 100% improvement
    58.6
    50.0
        Week 36: >=90% improvement
    84.5
    75.7
        Week 36: >=75% improvement
    93.6
    87.0
        Week 36: >=50% improvement
    97.2
    92.2
        Week 40: 100% improvement
    58.2
    48.6
        Week 40: >=90% improvement
    84.6
    73.7
        Week 40: >=75% improvement
    92.9
    85.8
        Week 40: >=50% improvement
    95.9
    90.9
        Week 44: 100% improvement
    58.6
    49.4
        Week 44: >=90% improvement
    84.1
    72.6
        Week 44: >=75% improvement
    92.3
    85.2
        Week 44: >=50% improvement
    94.2
    91.4
        Week 48: >=75% improvement
    92.1
    83.5
        Week 48: >=50% improvement
    94.0
    89.3
        Week 56: 100% improvement
    50.4
    27.0
        Week 56: >=90% improvement
    77.3
    51.4
        Week 56: >=75% improvement
    88.0
    70.4
        Week 56: >=50% improvement
    91.0
    82.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with IGA Responses Through Week 56

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    End point title
    		 Percentage of Subjects with IGA Responses Through Week 56
    End point description
    The IGA documents the investigator's assessment of the subject's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Full analysis set included all the subjects randomized at Week 0. Subjects who met treatment failure criteria or who had missing IGA score were considered as non-responders for the specific visit.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percentage of subjects
    number (not applicable)
        Week 1: cleared (0)
    0
    0
        Week 1: cleared (0) or minimal (1)
    3.4
    2.5
        Week 1: mild or better (=<2)
    27.2
    34.2
        Week 2: cleared (0)
    0.2
    0.8
        Week 2: cleared (0) or minimal (1)
    12.4
    20.2
        Week 2: mild or better (=<2)
    54.1
    63.8
        Week 3: cleared (0)
    2.6
    3.3
        Week 3: cleared (0) or minimal (1)
    27.2
    39.9
        Week 3: mild or better (=<2)
    75.3
    82.5
        Week 4: cleared (0)
    6.7
    9.7
        Week 4: cleared (0) or minimal (1)
    44.2
    59.3
        Week 4: mild or better (=<2)
    85.6
    92.2
        Week 8: cleared (0)
    29.2
    35.8
        Week 8: cleared (0) or minimal (1)
    76.6
    83.5
        Week 8: mild or better (=<2)
    96.3
    96.3
        Week 12: cleared (0)
    46.3
    50.2
        Week 12: mild or better (=<2)
    96.8
    95.3
        Week 16: cleared (0)
    55.4
    53.5
        Week 16: mild or better (=<2)
    96.8
    94.7
        Week 20: cleared (0)
    56.9
    53.9
        Week 20: cleared (0) or minimal (1)
    87.8
    85.6
        Week 20: mild or better (=<2)
    95.3
    93.2
        Week 24: cleared (0)
    61.0
    56.0
        Week 24: cleared (0) or minimal (1)
    88.6
    82.7
        Week 24: mild or better (=<2)
    96.3
    91.6
        Week 28: cleared (0)
    62.2
    56.2
        Week 28: cleared (0) or minimal (1)
    87.8
    82.9
        Week 28: mild or better (<=2)
    95.5
    90.9
        Week 32: cleared (0)
    63.1
    54.5
        Week 32: cleared (0) or minimal (1)
    88.6
    81.5
        Week 32: mild or better (=<2)
    95.5
    90.5
        Week 36: cleared (0)
    60.7
    53.7
        Week 36: cleared (0) or minimal (1)
    86.5
    79.6
        Week 36: mild or better (=<2)
    95.5
    88.9
        Week 40: cleared (0)
    63.1
    52.3
        Week 40: cleared (0) or minimal (1)
    86.3
    78.0
        Week 40: mild or better (=<2)
    93.6
    87.9
        Week 44: cleared (0)
    62.2
    51.9
        Week 44: cleared (0) or minimal (1)
    86.0
    76.5
        Week 44: mild or better (=<2)
    92.3
    87.5
        Week 48: cleared (0)
    62.2
    50.4
        Week 48: cleared (0) or minimal (1)
    85.0
    74.9
        Week 48: mild or better (=<2)
    92.7
    86.8
        Week 56: cleared (0)
    54.3
    29.4
        Week 56: cleared (0) or minimal (1)
    78.8
    58.2
        Week 56: mild or better (=<2)
    87.5
    76.3
    No statistical analyses for this end point

    Secondary: Percent Improvement From Baseline in PASI Through Week 56

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    End point title
    		 Percent Improvement From Baseline in PASI Through Week 56
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Here 'n' signifies the number of subjects analyzed at specified time point. Full analysis set: subjects randomized at Week 0. Zero percent improvement was assigned from the point when subjects met treatment failure criteria and no other data imputation was applied.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56
    End point values
    		 Guselkumab 100 mg + Placebo Secukinumab 300 mg
    Number of subjects analysed
    534
    514
    Units: Percent improvement
    arithmetic mean (standard deviation)
        Week 1 (n=531, 510)
    20.30 ± 20.743
    24.72 ± 20.711
        Week 2 (n=533, 509)
    37.85 ± 23.567
    44.56 ± 23.600
        Week 3 (n=531, 507)
    52.76 ± 24.186
    60.57 ± 21.871
        Week 4 (n=531, 507)
    64.63 ± 22.862
    72.80 ± 19.478
        Week 8 (n=531, 506)
    84.36 ± 17.278
    89.40 ± 13.579
        Week 12 (n=527, 505)
    90.85 ± 14.484
    92.60 ± 13.703
        Week 16 (n=526, 501)
    93.65 ± 12.849
    93.94 ± 12.123
        Week 20 (n=525, 495)
    94.35 ± 11.525
    94.41 ± 12.152
        Week 24 (n=525, 490)
    95.27 ± 9.848
    93.75 ± 14.314
        Week 28 (n=521, 492)
    95.58 ± 9.663
    92.96 ± 16.835
        Week 32 (n=521, 491)
    95.74 ± 9.336
    92.95 ± 16.641
        Week 36 (n=523, 487)
    95.45 ± 11.119
    92.40 ± 17.125
        Week 40 (n=516, 484)
    95.78 ± 10.456
    91.77 ± 17.733
        Week 44 (n=511, 486)
    95.45 ± 12.293
    91.34 ± 18.246
        Week 48 (n=508, 478)
    95.76 ± 11.629
    90.87 ± 19.181
        Week 56 (n=499, 469)
    93.35 ± 16.116
    81.67 ± 27.627
    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 included all randomized and treated subjects who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Subjects received single dose of Secukinumab 300 mg SC injection on Week 0, 1, 2, 3, and 4 and thereafter every 4 weeks (q4w) through Week 44. Subjects go under the follow-up phase from Week 44 through Week 56.

    Reporting group title
    Guselkumab 100 mg
    Reporting group description
    		 Subjects received Guselkumab 100 milligrams (mg) subcutaneous (SC) injection and Placebo on Week 0, 4 and 12 and thereafter every 8 weeks (q8w) through Week 44 and 2 injections of Placebo on Week 1, 2, 3, and 8 and thereafter every q8w through Week 40. Subjects go under the follow-up phase from Week 44 through Week 56.

    Serious adverse events
    		 Secukinumab 300 mg Guselkumab 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 511 (7.24%)
    33 / 534 (6.18%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Finger Amputation
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise Tolerance Decreased
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactoid Reaction
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Bartholin's Cyst
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial Lung Disease
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Cyst
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Polyps
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mixed Anxiety and Depressive Disorder
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram Repolarisation Abnormality
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Clavicle Fracture
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wolff-Parkinson-White Syndrome
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Macular Fibrosis
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukoplakia Oral
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-Induced Liver Injury
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Chronic Cutaneous Lupus Erythematosus
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Eruption
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Morbilliform
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    2 / 511 (0.39%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess Limb
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 511 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroborreliosis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 511 (0.20%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 511 (0.20%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Secukinumab 300 mg Guselkumab 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    254 / 511 (49.71%)
    249 / 534 (46.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    48 / 511 (9.39%)
    48 / 534 (8.99%)
         occurrences all number
    65
    59
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    20 / 511 (3.91%)
    27 / 534 (5.06%)
         occurrences all number
    21
    31
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    25 / 511 (4.89%)
    30 / 534 (5.62%)
         occurrences all number
    37
    37
    Back Pain
         subjects affected / exposed
    18 / 511 (3.52%)
    29 / 534 (5.43%)
         occurrences all number
    19
    35
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    125 / 511 (24.46%)
    118 / 534 (22.10%)
         occurrences all number
    194
    200
    Upper Respiratory Tract Infection
         subjects affected / exposed
    92 / 511 (18.00%)
    83 / 534 (15.54%)
         occurrences all number
    129
    110

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2017
    To add information regarding the benefit-risk assessment for subjects who participated in this study. To be consistent with the European Union (EU) definitions of highly effective contraception by removing examples of contraceptives (including barrier methods which are not considered highly effective) from the relevant inclusion criterion; a unique number was assigned to the modified criterion. To update the inclusion criteria for consistency with the secukinumab EU Summary of Product Characteristics (SmPC) requiring subjects to wait 20 weeks rather than 16 weeks after their last treatment with secukinumab before donating eggs or sperm; and to require men who are sexually active with a woman of childbearing potential, and who have not had a vasectomy, to use a barrier method of birth control during the study for 20 rather than 16 weeks after the last administration of secukinumab (unique numbers were assigned to each modified criterion). To update the exclusion criteria for consistency with the secukinumab EU SmPC to exclude enrollment of subjects who are pregnant, nursing, or planning a pregnancy during the study or within 20 weeks after the last administration of secukinumab or within 12 weeks after receiving the last administration of guselkumab (a unique number was assigned to the modified criterion). To update the time frame for prohibitions and restrictions for contraception and sperm/egg donation to be consistent with the secukinumab EU SmPC (20 weeks rather than 16 weeks) after the last administration of secukinumab. To add the statement that discontinuation of study treatment should be considered if the subject does not show a response to treatment by Week 16.

    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.
    None reported
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