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    Clinical Trial Results:
    A phase III, randomized, double-blind, placebo-controlled multi-center study of subcutaneous secukinumab (150 mg and 300 mg) in prefilled syringe to demonstrate efficacy (including inhibition of structural damage), safety, and tolerability up to 2 years in subjects with active psoriatic arthritis (FUTURE 5)

    Summary
    EudraCT number
    		 2015-000050-38
    Trial protocol
    		 LT   IE   HU   NL   ES   DE   IT   AT   LV   DK   CZ   FI   EE   GR  
    Global end of trial date
    24 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2020
    First version publication date
    09 Feb 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457F2342
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02404350
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis PharmaAG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis PharmaAG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis PharmaAG, 41 613241111, Novartis.email@novartis.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
    07 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate that the efficacy of secukinumab 150 mg sc (with or without loading regimen), or 300 mg sc with loading regimen, at Week 16 is superior to placebo based on proportion of patients with active psoriatic arthritis (PsA) achieving American College of Rheumatology 20 (ACR20) response.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Aug 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
    Austria: 30
    Country: Number of subjects enrolled
    Latvia: 8
    Country: Number of subjects enrolled
    Lithuania: 52
    Country: Number of subjects enrolled
    Hungary: 36
    Country: Number of subjects enrolled
    Spain: 65
    Country: Number of subjects enrolled
    United States: 103
    Country: Number of subjects enrolled
    Russian Federation: 123
    Country: Number of subjects enrolled
    Estonia: 15
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Czech Republic: 80
    Country: Number of subjects enrolled
    United Kingdom: 98
    Country: Number of subjects enrolled
    Germany: 59
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Finland: 15
    Country: Number of subjects enrolled
    Greece: 22
    Country: Number of subjects enrolled
    Israel: 41
    Country: Number of subjects enrolled
    Thailand: 13
    Country: Number of subjects enrolled
    Vietnam: 27
    Country: Number of subjects enrolled
    Philippines: 23
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    Mexico: 34
    Country: Number of subjects enrolled
    Ireland: 4
    Country: Number of subjects enrolled
    India: 38
    Country: Number of subjects enrolled
    Chile: 23
    Country: Number of subjects enrolled
    Guatemala: 12
    Country: Number of subjects enrolled
    Argentina: 11
    Worldwide total number of subjects
    996
    EEA total number of subjects
    513
    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)
    900
    From 65 to 84 years
    96
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 173 centers in 28 countries.

    Pre-assignment
    Screening details
    		 999 were randomized and 996 were randomized and dosed, of which 932 participants completed 24 weeks of treatment. Out of the 64 participants who discontinued the most common reasons were participant/guardian decision (32) and adverse events (16).

    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, Monitor, Carer
    Blinding implementation details
    double-blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 150 mg Without Load
    Arm description
    		 Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab as 1 milliliter (mL) Pre-Filled Syringe (PFS) and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    AIN457F
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg Without Load sc

    Arm title
    		 Secukinumab 150 mg With Load
    Arm description
    		 Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    Other name
    AIN457F
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg With Load

    Arm title
    		 Secukinumab 300 mg With Load
    Arm description
    		 Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    Other name
    AIN457F
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg With Load sc

    Arm title
    		 Placebo
    Arm description
    		 Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
    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
    sc

    Number of subjects in period 1
    		Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Started
    222
    220
    222
    332
    Completed
    207
    214
    216
    295
    Not completed
    15
    6
    6
    37
         Due to Technical problems
    -
    -
    -
    1
         Physician decision
    1
    -
    -
    2
         Consent withdrawn by subject
    7
    3
    3
    19
         Due to Non-compliance with treatment
    -
    -
    -
    1
         Adverse event, non-fatal
    2
    2
    3
    9
         Pregnancy
    -
    -
    -
    1
         Lost to follow-up
    2
    -
    -
    1
         Lack of efficacy
    3
    1
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 150 mg Without Load
    Reporting group description
    		 Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab as 1 milliliter (mL) Pre-Filled Syringe (PFS) and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.

    Reporting group title
    Secukinumab 150 mg With Load
    Reporting group description
    		 Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.

    Reporting group title
    Secukinumab 300 mg With Load
    Reporting group description
    		 Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.

    Reporting group values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo Total
    Number of subjects
    		 222 220 222 332 996
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 204 193 202 301 900
        From 65-84 years
    		 18 27 20 31 96
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.8 ( 11.82 ) 48.4 ( 12.87 ) 48.9 ( 12.80 ) 49.0 ( 12.12 ) -
    Sex: Female, Male
    Units:
        Female
    		 102 109 114 171 496
        Male
    		 120 111 108 161 500
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 25 30 31 51 137
        Not Hispanic or Latino
    		 180 160 174 251 765
        Unknown or Not Reported
    		 17 30 17 30 94
    Participants with psoriasis of hands and feet
    Units: Subjects
        Yes
    		 133 135 127 174 569
        No
    		 89 85 95 158 427
    Subjects with psoriasis of nail
    Units: Subjects
        Yes
    		 153 135 144 231 663
        No
    		 69 85 78 101 333
    Subjects with psoriasis ≥ 3% of BSA
    Units: Subjects
        Yes
    		 117 125 110 162 514
        No
    		 105 95 112 170 482

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 150 mg Without Load
    Reporting group description
    		 Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab as 1 milliliter (mL) Pre-Filled Syringe (PFS) and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.

    Reporting group title
    Secukinumab 150 mg With Load
    Reporting group description
    		 Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.

    Reporting group title
    Secukinumab 300 mg With Load
    Reporting group description
    		 Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.

    Primary: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16

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    End point title
    		 Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16
    End point description
    ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    222
    220
    222
    332
    Units: percentage of participants
        number (not applicable)
    59.5
    55.5
    62.6
    27.4
    Statistical analysis title
    		 Secukinumab 150 mg Without Load, Placebo
    Statistical analysis description
    Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    554
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.78
         upper limit
    		 5.79
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Statistical analysis description
    Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    552
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.35
         upper limit
    		 4.87
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Statistical analysis description
    Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    554
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.16
         upper limit
    		 6.63

    Secondary: Change from baseline to Week 24 with secukinumab compared with placebo for joint/bone structural damage (using van der Heijde modified total Sharp score (mTSS))

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    End point title
    		 Change from baseline to Week 24 with secukinumab compared with placebo for joint/bone structural damage (using van der Heijde modified total Sharp score (mTSS))
    End point description
    PsA modified vdH-mTSS scoring method was used to assess bone erosion & joint space narrowing (JSN) in hands & feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50–99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands & feet combined) ranges from 0 to 528, where higher scores indicate more articular damage
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    222
    220
    222
    332 [1]
    Units: Sharp score
        arithmetic mean (standard error)
    -0.10 ( 0.22 )
    0.13 ( 0.13 )
    0.02 ( 0.13 )
    0.50 ( 0 )
    Notes
    [1] - Placebo cannot be compared to itself
    No statistical analyses for this end point

    Secondary: Count and Percentage of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response

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    End point title
    		 Count and Percentage of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response
    End point description
    The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    117
    125
    110
    162
    Units: participants
    68
    75
    77
    20
    Statistical analysis title
    		 Secukinumab 150 mg Without Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.52
         upper limit
    		 18.63
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.37
         upper limit
    		 21.37
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    18.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.56
         upper limit
    		 34.12

    Secondary: Count and Percentage of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response

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    End point title
    		 Count and Percentage of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response
    End point description
    The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    117
    125
    110
    162
    Units: participants
    37
    46
    59
    15
    Statistical analysis title
    		 Secukinumab 150 mg Without Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate. Missing responses are imputed as non-responders.
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.31
         upper limit
    		 8.83
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate. Missing responses are imputed as non-responders.
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.18
         upper limit
    		 11.87
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate. Missing responses are imputed as non-responders.
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    12.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.43
         upper limit
    		 24.48

    Secondary: Count and Percentage of patients achieving an ACR50 response

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    End point title
    		 Count and Percentage of patients achieving an ACR50 response
    End point description
    ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient’s global assessment of disease status; the patient’s assessment of pain; the patient’s assessment of function measured using the Stanford Health Assessment Questionnaire the physician’s global assessment of disease status; serum C-reactive protein levels.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    222
    220
    222
    332
    Units: participants
    71
    79
    88
    27
    Statistical analysis title
    		 Secukinumab 150 mg Without Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    554
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Log odds ratio
    Point estimate
    5.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 8.73
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    552
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.93
         upper limit
    		 10.32
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Statistical analysis description
    Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    554
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.61
         upper limit
    		 12

    Secondary: Change from baseline in HAQ-DI© score

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    End point title
    		 Change from baseline in HAQ-DI© score
    End point description
    The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    211
    210
    211
    300
    Units: scores on a scale
        least squares mean (standard error)
    -0.45 ( 0.035 )
    -0.44 ( 0.035 )
    -0.55 ( 0.035 )
    -0.21 ( 0.029 )
    Statistical analysis title
    		 Secukinumab 150 mg Without Load
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    511
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment contrast in LS mean (Change)
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 -0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.045
    Notes
    [2] - Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    510
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment Contrast in LS mean (Change)
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 -0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.045
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    511
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment Contrast inj LS mean (Change)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 -0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.045

    Secondary: Change from baseline in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP))

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    End point title
    		 Change from baseline in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP))
    End point description
    The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline. Scores range from 0 (no difficulty) to 3 (unable to do)
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    210
    208
    209
    297
    Units: scores on a scale
        least squares mean (standard error)
    -1.29 ( 0.074 )
    -1.29 ( 0.075 )
    -1.49 ( 0.074 )
    -0.63 ( 0.062 )
    Statistical analysis title
    		 Secukinumab 150 mg Without Load
    Statistical analysis description
    Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    507
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment contrast in LS mean (Change)
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 -0.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.096
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Statistical analysis description
    Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    505
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment Contrast in LS Mean (Change)
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 -0.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.096
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Statistical analysis description
    Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    506
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment contrast in LS mean (Change)
    Point estimate
    -0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 -0.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.096

    Secondary: Count and Percentage of patients with enthesitis in the subset of patients who had enthesitis at baseline

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    End point title
    		 Count and Percentage of patients with enthesitis in the subset of patients who had enthesitis at baseline
    End point description
    The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    129
    141
    140
    192
    Units: participants
    75
    64
    62
    124
    Statistical analysis title
    		 Secukinumab 150 mg Without Load
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.225
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.19
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 0.7
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Regression, Logistic
    Parameter type
    		 Log odds ratio
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 0.69

    Secondary: Count and Percentage of Participants with dactylitis in the subset of patients who have dactylitis at baseline

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    End point title
    		 Count and Percentage of Participants with dactylitis in the subset of patients who have dactylitis at baseline
    End point description
    The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
    Number of subjects analysed
    103
    80
    82
    124
    Units: Participants
    45
    34
    28
    84
    Statistical analysis title
    		 Secukinumab 150 mg Without Load
    Comparison groups
    Secukinumab 150 mg Without Load v Placebo
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 0.65
    Statistical analysis title
    		 Secukinumab 150 mg With Load
    Comparison groups
    Secukinumab 150 mg With Load v Placebo
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 0.6
    Statistical analysis title
    		 Secukinumab 300 mg With Load
    Comparison groups
    Secukinumab 300 mg With Load v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.44

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs & SAEs were collected for maximum duration of treatment & follow up for a participant per protocol for approximately 24 weeks. All cause mortality was collected for as long as participants could be contacted from FPFV until LPLV up to a max of 24 wks
    Adverse event reporting additional description
    An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Secukinumab 150 mg Without Load
    Reporting group description
    		 Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.

    Reporting group title
    Secukinumab 150 mg With Load
    Reporting group description
    		 Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.

    Reporting group title
    Secukinumab 300 mg With Load
    Reporting group description
    		 Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.

    Reporting group title
    Secukinumab Total
    Reporting group description
    		 Participants were s.c. administered with secukinumab and secukinumab matching placebo at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.

    Serious adverse events
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Secukinumab Total Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 222 (2.70%)
    9 / 220 (4.09%)
    7 / 222 (3.15%)
    25 / 822 (3.04%)
    12 / 332 (3.61%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 222 (0.45%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 222 (0.45%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 222 (0.45%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 222 (0.45%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 222 (0.45%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 222 (0.45%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 222 (0.45%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    2 / 332 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    1 / 822 (0.12%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 222 (0.00%)
    0 / 822 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Secukinumab Total Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    95 / 222 (42.79%)
    82 / 220 (37.27%)
    83 / 222 (37.39%)
    275 / 822 (33.45%)
    127 / 332 (38.25%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    3 / 222 (1.35%)
    5 / 220 (2.27%)
    2 / 222 (0.90%)
    10 / 822 (1.22%)
    1 / 332 (0.30%)
         occurrences all number
    3
    5
    2
    10
    1
    Fall
         subjects affected / exposed
    5 / 222 (2.25%)
    1 / 220 (0.45%)
    0 / 222 (0.00%)
    6 / 822 (0.73%)
    2 / 332 (0.60%)
         occurrences all number
    5
    1
    0
    6
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 222 (4.05%)
    5 / 220 (2.27%)
    8 / 222 (3.60%)
    22 / 822 (2.68%)
    10 / 332 (3.01%)
         occurrences all number
    9
    5
    8
    22
    10
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 222 (3.60%)
    9 / 220 (4.09%)
    5 / 222 (2.25%)
    23 / 822 (2.80%)
    13 / 332 (3.92%)
         occurrences all number
    8
    9
    5
    23
    13
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 220 (0.45%)
    6 / 222 (2.70%)
    11 / 822 (1.34%)
    1 / 332 (0.30%)
         occurrences all number
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 222 (1.80%)
    4 / 220 (1.82%)
    4 / 222 (1.80%)
    12 / 822 (1.46%)
    8 / 332 (2.41%)
         occurrences all number
    4
    4
    4
    12
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 222 (3.15%)
    4 / 220 (1.82%)
    9 / 222 (4.05%)
    21 / 822 (2.55%)
    22 / 332 (6.63%)
         occurrences all number
    7
    4
    9
    21
    22
    Nausea
         subjects affected / exposed
    7 / 222 (3.15%)
    4 / 220 (1.82%)
    3 / 222 (1.35%)
    14 / 822 (1.70%)
    12 / 332 (3.61%)
         occurrences all number
    7
    4
    3
    14
    12
    Vomiting
         subjects affected / exposed
    3 / 222 (1.35%)
    6 / 220 (2.73%)
    2 / 222 (0.90%)
    12 / 822 (1.46%)
    2 / 332 (0.60%)
         occurrences all number
    3
    6
    2
    12
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 222 (3.15%)
    2 / 220 (0.91%)
    4 / 222 (1.80%)
    14 / 822 (1.70%)
    6 / 332 (1.81%)
         occurrences all number
    7
    2
    4
    14
    6
    Oropharyngeal pain
         subjects affected / exposed
    5 / 222 (2.25%)
    5 / 220 (2.27%)
    5 / 222 (2.25%)
    16 / 822 (1.95%)
    6 / 332 (1.81%)
         occurrences all number
    5
    5
    5
    16
    6
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 222 (0.90%)
    11 / 220 (5.00%)
    3 / 222 (1.35%)
    16 / 822 (1.95%)
    4 / 332 (1.20%)
         occurrences all number
    2
    11
    3
    16
    4
    Psoriasis
         subjects affected / exposed
    3 / 222 (1.35%)
    3 / 220 (1.36%)
    3 / 222 (1.35%)
    11 / 822 (1.34%)
    12 / 332 (3.61%)
         occurrences all number
    3
    3
    3
    11
    12
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 222 (0.45%)
    5 / 220 (2.27%)
    0 / 222 (0.00%)
    6 / 822 (0.73%)
    1 / 332 (0.30%)
         occurrences all number
    1
    5
    0
    6
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 222 (1.35%)
    4 / 220 (1.82%)
    4 / 222 (1.80%)
    12 / 822 (1.46%)
    10 / 332 (3.01%)
         occurrences all number
    3
    4
    4
    12
    10
    Back pain
         subjects affected / exposed
    8 / 222 (3.60%)
    4 / 220 (1.82%)
    4 / 222 (1.80%)
    16 / 822 (1.95%)
    12 / 332 (3.61%)
         occurrences all number
    8
    4
    4
    16
    12
    Psoriatic arthropathy
         subjects affected / exposed
    3 / 222 (1.35%)
    3 / 220 (1.36%)
    0 / 222 (0.00%)
    7 / 822 (0.85%)
    7 / 332 (2.11%)
         occurrences all number
    3
    3
    0
    7
    7
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 222 (1.35%)
    1 / 220 (0.45%)
    8 / 222 (3.60%)
    12 / 822 (1.46%)
    2 / 332 (0.60%)
         occurrences all number
    3
    1
    8
    12
    2
    Influenza
         subjects affected / exposed
    2 / 222 (0.90%)
    4 / 220 (1.82%)
    5 / 222 (2.25%)
    12 / 822 (1.46%)
    3 / 332 (0.90%)
         occurrences all number
    2
    4
    5
    12
    3
    Oral herpes
         subjects affected / exposed
    3 / 222 (1.35%)
    0 / 220 (0.00%)
    5 / 222 (2.25%)
    8 / 822 (0.97%)
    4 / 332 (1.20%)
         occurrences all number
    3
    0
    5
    8
    4
    Rhinitis
         subjects affected / exposed
    2 / 222 (0.90%)
    2 / 220 (0.91%)
    7 / 222 (3.15%)
    11 / 822 (1.34%)
    3 / 332 (0.90%)
         occurrences all number
    2
    2
    7
    11
    3
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 222 (6.31%)
    17 / 220 (7.73%)
    7 / 222 (3.15%)
    38 / 822 (4.62%)
    11 / 332 (3.31%)
         occurrences all number
    14
    17
    7
    38
    11
    Urinary tract infection
         subjects affected / exposed
    6 / 222 (2.70%)
    8 / 220 (3.64%)
    6 / 222 (2.70%)
    20 / 822 (2.43%)
    8 / 332 (2.41%)
         occurrences all number
    6
    8
    6
    20
    8
    Viral upper respiratory tract infection
         subjects affected / exposed
    13 / 222 (5.86%)
    15 / 220 (6.82%)
    14 / 222 (6.31%)
    44 / 822 (5.35%)
    29 / 332 (8.73%)
         occurrences all number
    13
    15
    14
    44
    29
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    8 / 222 (3.60%)
    4 / 220 (1.82%)
    8 / 222 (3.60%)
    23 / 822 (2.80%)
    11 / 332 (3.31%)
         occurrences all number
    8
    4
    8
    23
    11
    Hypercholesterolaemia
         subjects affected / exposed
    8 / 222 (3.60%)
    9 / 220 (4.09%)
    3 / 222 (1.35%)
    20 / 822 (2.43%)
    2 / 332 (0.60%)
         occurrences all number
    8
    9
    3
    20
    2
    Hyperlipidaemia
         subjects affected / exposed
    1 / 222 (0.45%)
    5 / 220 (2.27%)
    3 / 222 (1.35%)
    9 / 822 (1.09%)
    2 / 332 (0.60%)
         occurrences all number
    1
    5
    3
    9
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Feb 2018
    After a full review of the data, it was confirmed that nineteen patients were impacted by the mapping error, of which, only 10 (1.1%) of the evaluable 936 patients met the criteria of inclusion in the analysis by having both a baseline and post-baseline X-ray. The remaining 9 patients had only baseline X-rays and thus were not included in the radiographic treatment comparison analyses. All possible preventive actions to ensure that this situation will not occur in the future have been taken up with the external radiographic vendor. The purpose of this addendum is to evaluate the effect of using radiographic data from reread X-ray assessments compared to the data from the first read X-rays in patients with inter-reader difference of vdH-mTSS > 8 points between the 2 blinded independent readers. This new analysis was performed after an export mapping error of the 2 sets of X-ray assessments by the external radiographic vendor was identified after Week 24 interim analysis.

    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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