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    Clinical Trial Results:
    MAXIMISE (Managing AXIal Manifestations in Psoriatic Arthritis with SEcukinumab), a randomized, double-blind, placebo-controlled, multicenter, 52 week study to assess the efficacy and safety of secukinumab 150 mg or 300 mg s.c. in patients with active psoriatic arthritis and axial skeleton involvement who have inadequate response to non steroidal anti-inflammatory drugs (NSAIDs)

    Summary
    EudraCT number
    		 2016-000814-31
    Trial protocol
    		 ES   CZ   FR   GB   HU   EE   IE   BE   FI   DK   DE   BG   GR   PL   IT  
    Global end of trial date
    26 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2020
    First version publication date
    26 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F3302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02721966
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 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
    03 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that secukinumab 300 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12.
    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
    03 Oct 2016
    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
    Russian Federation: 44
    Country: Number of subjects enrolled
    Romania: 12
    Country: Number of subjects enrolled
    Poland: 121
    Country: Number of subjects enrolled
    United Kingdom: 32
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Bulgaria: 26
    Country: Number of subjects enrolled
    Czech Republic: 33
    Country: Number of subjects enrolled
    Estonia: 19
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Switzerland: 13
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    Spain: 76
    Worldwide total number of subjects
    498
    EEA total number of subjects
    423
    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)
    472
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 503 participants completed the screening period; as 5 participants were mis-randomized, the randomized set consists of 498 patients

    Pre-assignment
    Screening details
    		 95.9% of the randomized participants completed period 1 and continued to period 2; and 85.3% completed treatment period 2

    Period 1
    Period 1 title
    Treatment Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo sc injections at baseline and weekly until Week 4 and at Week 8, followed by Secukinumab 150 mg or Secukinumab 300 mg injections every 4 weeks between Week 12 and Week 48
    Arm type
    		 Placebo

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo sc injections at baseline and weekly until week 4 and at week 8, followed by Secukinumab 150 mg injections every week between week 12 and week 48.

    Arm title
    		 AIN457 150 mg
    Arm description
    		 Secukinumab 150 mg sc. injections at baseline and weekly until Week 4 followed by Secukinumab 150 mg inejections every 4 weeks between week 8 and week 48
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 150 mg
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg sc. injections at baseline and weekly until Week 4 followed by Secukinumab 150 mg inejections every 4 weeks between week 8 and week 48

    Arm title
    		 AIN457 300 mg
    Arm description
    		 Secukinumab 300 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 300 mg
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48

    Number of subjects in period 1
    		Placebo AIN457 150 mg AIN457 300 mg
    Started
    166
    165
    167
    Completed
    145
    142
    138
    Not completed
    21
    23
    29
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    10
    2
    9
         Physician decision
    -
    1
    1
         Did not continue to period 2
    5
    12
    5
         Adverse event, non-fatal
    3
    4
    4
         Pregnancy
    -
    -
    1
         Lost to follow-up
    3
    -
    -
         Lack of efficacy
    -
    4
    7
         Protocol deviation
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo sc injections at baseline and weekly until Week 4 and at Week 8, followed by Secukinumab 150 mg or Secukinumab 300 mg injections every 4 weeks between Week 12 and Week 48

    Reporting group title
    AIN457 150 mg
    Reporting group description
    		 Secukinumab 150 mg sc. injections at baseline and weekly until Week 4 followed by Secukinumab 150 mg inejections every 4 weeks between week 8 and week 48

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 Secukinumab 300 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48

    Reporting group values
    		 Placebo AIN457 150 mg AIN457 300 mg Total
    Number of subjects
    		 166 165 167 498
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 157 156 159 472
        From 65-84 years
    		 9 9 8 26
        85 years and over
    		 0 0 0 0
    Age continuous
    mean age
    Units: years
        arithmetic mean (standard deviation)
    		 46.6 ± 11.51 46.9 ± 11.50 46.2 ± 12.32 -
    Gender categorical
    Units: Subjects
        Female
    		 78 84 90 252
        Male
    		 88 81 77 246
    Race
    Units: Subjects
        Black
    		 0 0 1 1
        Asian
    		 2 0 0 2
        White
    		 164 159 162 485
        Missing
    		 0 6 4 10
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants randomized and fulfilling the key inclusion criteria for disease activity

    Subject analysis sets values
    		 Full Analysis Set (FAS)
    Number of subjects
    498
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    mean age
    Units: years
        arithmetic mean (standard deviation)
    ±
    Gender categorical
    Units: Subjects
        Female
        Male
    Race
    Units: Subjects
        Black
    1
        Asian
    2
        White
    485
        Missing
    10

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo sc injections at baseline and weekly until Week 4 and at Week 8, followed by Secukinumab 150 mg or Secukinumab 300 mg injections every 4 weeks between Week 12 and Week 48

    Reporting group title
    AIN457 150 mg
    Reporting group description
    		 Secukinumab 150 mg sc. injections at baseline and weekly until Week 4 followed by Secukinumab 150 mg inejections every 4 weeks between week 8 and week 48

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 Secukinumab 300 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants randomized and fulfilling the key inclusion criteria for disease activity

    Primary: PRIMARY OUTCOME MEASURE: Proportion of participants with response to treatment (300 mg AIN457) as assessed by the ASAS20 criteria at week 12

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    End point title
    		 PRIMARY OUTCOME MEASURE: Proportion of participants with response to treatment (300 mg AIN457) as assessed by the ASAS20 criteria at week 12
    End point description
    Purpose of this measure: was to demonstrate that secukinumab 300 mg s.c. is superior to placebo in the achievement of ASAS20 response at Week 12 ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
    End point type
    Primary
    End point timeframe
    at week 12
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: proportion of participants
        number (confidence interval 95%)
    31.2 (24.6 to 38.7)
    66.3 (58.4 to 73.3)
    62.9 (55.2 to 70.0)
    Statistical analysis title
    		 AIN457 300 mg vs palcebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    AIN457 300 mg v Placebo
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.41
         upper limit
    		 6.1
    Notes
    [1] - Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variable

    Secondary: KEY SECONDARY OUTCOME: Proportion of participants with response to treatment (150 mg AIN457) as assessed by the ASAS20 criteria at week 12

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    End point title
    		 KEY SECONDARY OUTCOME: Proportion of participants with response to treatment (150 mg AIN457) as assessed by the ASAS20 criteria at week 12
    End point description
    The purpose of this key secondary measure was to demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg was established. Note that 300mg and 150mg are presented side by side for clarity ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: proportion of participants
        number (confidence interval 95%)
    31.2 (24.6 to 38.7)
    66.3 (58.4 to 73.3)
    62.9 (55.2 to 70.0)
    Statistical analysis title
    		 AIN457 150mg vs Placebo AIN457
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.72
         upper limit
    		 7.01
    Notes
    [2] - Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables

    Secondary: Proportion of participants with response to treatment (150 mg/300 mg AIN457) as assessed by the ASAS40 criteria at week 12

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    End point title
    		 Proportion of participants with response to treatment (150 mg/300 mg AIN457) as assessed by the ASAS40 criteria at week 12
    End point description
    Proportion of patients with response to treatment as assessed by the Assessment of spondyloarthritis international society (ASAS) 40 criteria at week 12 ASAS40 was defined as an improvement of ≥40% and absolute improvement of ≥20 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: proportion of participants
        number (confidence interval 95%)
    12.2 (7.8 to 18.4)
    39.5 (32.1 to 47.4)
    43.6 (36.2 to 51.3)
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.67
         upper limit
    		 8.33
    Notes
    [3] - Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variable
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 9.84
    Notes
    [4] - Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables

    Secondary: Proportion of patients with response to treatment as assessed by BASDAI50 at week 12

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    End point title
    		 Proportion of patients with response to treatment as assessed by BASDAI50 at week 12
    End point description
    Bath ankylosing spondylitis disease activity index (BASDAI) 50 response BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164 [5]
    Units: proportion of participants
        number (confidence interval 95%)
    9.8 (5.9 to 15.6)
    32.7 (25.8 to 40.5)
    37.4 (30.1 to 45.4)
    Notes
    [5] - 164
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variable
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.43
         upper limit
    		 8.33
    Notes
    [6] - Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.04
         upper limit
    		 10.21
    Notes
    [7] - Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables

    Secondary: Change from baseline in Spinal pain visual analog scale (VAS) - Pain at any time

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    End point title
    		 Change from baseline in Spinal pain visual analog scale (VAS) - Pain at any time
    End point description
    Change from baseline in Spinal pain visual analog scale (VAS) at week 12 VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best)
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: scores on a scale
        least squares mean (standard error)
    -13.6 ± 1.83
    -28.5 ± 1.88
    -26.5 ± 1.84
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -14.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20
         upper limit
    		 -9.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.62
    Notes
    [8] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -12.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18
         upper limit
    		 -7.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.59
    Notes
    [9] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate

    Secondary: Change from baseline in Spinal pain visual analog scale (VAS) - Pain at night

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    End point title
    		 Change from baseline in Spinal pain visual analog scale (VAS) - Pain at night
    End point description
    Change from baseline in Spinal pain visual analog scale (VAS) at week 12 VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best)
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: scores on a scale
        least squares mean (standard error)
    -15.2 ± 1.89
    -30.3 ± 1.95
    -30.2 ± 1.90
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    AIN457 150 mg v Placebo
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -15.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.4
         upper limit
    		 -9.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.71
    Notes
    [10] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.3
         upper limit
    		 -9.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.68
    Notes
    [11] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate

    Secondary: Change from baseline Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index score at week 12

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    End point title
    		 Change from baseline Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index score at week 12
    End point description
    The Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index score range is 0-16, where 0 is the best outcome, and 16 the worst. The assessor determines whether the site shows tenderness and therefore would count as site with enthesitis. This is done by applying pressure to the site and getting feedback from patient about whether the site is tender.
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: scores on a scale
        least squares mean (standard error)
    -1.7 ± 0.21
    -2.2 ± 0.22
    -2.4 ± 0.21
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.0971
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [12] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline SPARCC index as continuous covariate
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.0207
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [13] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline SPARCC index as continuous covariate

    Secondary: Change from baseline in Health assessment questionnaire – disability index (HAQ-DI) score at week 12

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    End point title
    		 Change from baseline in Health assessment questionnaire – disability index (HAQ-DI) score at week 12
    End point description
    The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The questionnaire is a patient reported outcome (PRO) which is usually self-administered by the patient. The following categories are assessed by the HAQ-DI: dressing and grooming arising eating walking hygiene reach grip common daily activities Patients report the amount of difficulty they have in performing some of these activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3)
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: scores on a scale
        least squares mean (standard error)
    -0.155 ± 0.0351
    -0.330 ± 0.0360
    -0.389 ± 0.0353
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 = 0.0005
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -0.175
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.273
         upper limit
    		 -0.076
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0502
    Notes
    [14] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    AIN457 300 mg v Placebo
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 < 0.0001 [16]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -0.234
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.331
         upper limit
    		 -0.136
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0497
    Notes
    [15] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate
    [16] - Up to week 12, all participants in the group "placebo AIN457" took placebo only

    Secondary: Change from baseline in Functional assessment of chronic illness therapy fatigue scale (FACIT-Fatigue) at week 12

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    End point title
    		 Change from baseline in Functional assessment of chronic illness therapy fatigue scale (FACIT-Fatigue) at week 12
    End point description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: scores on a scale
        least squares mean (standard error)
    4.2 ± 0.70
    8.0 ± 0.72
    7.6 ± 0.71
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 5.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.01
    Notes
    [17] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline FACIT-Fatigue score as continuous covariate
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of treatment Difference
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 5.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.99
    Notes
    [18] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline FACIT-Fatigue score as continuous covariate

    Secondary: Change from Baseline in ASAS Health Index at week 12

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    End point title
    		 Change from Baseline in ASAS Health Index at week 12
    End point description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    154
    Units: scores on a scale
        least squares mean (standard error)
    -1.2 ± 0.28
    -2.9 ± 0.29
    -2.8 ± 0.28
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -0.9
    Notes
    [19] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [20]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean of Treatment Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [20] - Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment*visit, baseline*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate

    Secondary: Proportion of participants with response to treatment as assessed by the ACR20 criteria at week 12

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    End point title
    		 Proportion of participants with response to treatment as assessed by the ACR20 criteria at week 12
    End point description
    American College of Rheumatology 20% (ACR20) Response at Week 12 is the % of responders with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)
    End point type
    Secondary
    End point timeframe
    at 12 weeks
    End point values
    		 Placebo AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    164
    157
    164
    Units: proportion of participants
        number (confidence interval 95%)
    18.5 (13.1 to 25.5)
    56.5 (47.5 to 65.1)
    51.6 (43.4 to 59.8)
    Statistical analysis title
    		 AIN457 150 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 150 mg
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.31
         upper limit
    		 9.95
    Notes
    [21] - Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables
    Statistical analysis title
    		 AIN457 300 mg vs placebo
    Statistical analysis description
    Up to week 12, all participants in the group "placebo AIN457" took placebo only
    Comparison groups
    Placebo v AIN457 300 mg
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [22]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.83
         upper limit
    		 8.16
    Notes
    [22] - Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire treatment period (including 12 weeks after last study treatment)
    Adverse event reporting additional description
    An adverse event (AE) is any untoward sign or symptom that occurs during the study treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Secukinumab 300 mg s.c. injections weekly until Week 4 followed by Secukinumab 300 mg s.c. injections every 4 weeks between week 8 and week 48 and placebo-switchers to Secukinumab 300 mg s.c. injections at week 12 onwards

    Reporting group title
    Secukinumab 150 mg
    Reporting group description
    		 Secukinumab 150 mg s.c. injections weekly until Week 4 followed by Secukinumab 150 mg s.c. injections every 4 weeks between week 8 and week 48 and placebo-switchers to Secukinumab 150 mg s.c. injections at week 12 onwards

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo s.c. injections at baseline and weekly until Week 4, then at Week 8

    Serious adverse events
    		 Secukinumab 300 mg Secukinumab 150 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 248 (5.65%)
    14 / 245 (5.71%)
    4 / 166 (2.41%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 245 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to spine
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 245 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiogenic shock
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 245 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 245 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Genitourinary tract infection
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonsillitis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 245 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 245 (0.41%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Food intolerance
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Secukinumab 300 mg Secukinumab 150 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 248 (46.77%)
    108 / 245 (44.08%)
    47 / 166 (28.31%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    8 / 248 (3.23%)
    6 / 245 (2.45%)
    0 / 166 (0.00%)
         occurrences all number
    10
    7
    0
    Hepatic enzyme increased
         subjects affected / exposed
    5 / 248 (2.02%)
    0 / 245 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    5
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 248 (1.61%)
    10 / 245 (4.08%)
    2 / 166 (1.20%)
         occurrences all number
    4
    11
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 248 (2.82%)
    7 / 245 (2.86%)
    6 / 166 (3.61%)
         occurrences all number
    7
    8
    7
    Sciatica
         subjects affected / exposed
    1 / 248 (0.40%)
    6 / 245 (2.45%)
    2 / 166 (1.20%)
         occurrences all number
    1
    6
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 248 (2.42%)
    3 / 245 (1.22%)
    4 / 166 (2.41%)
         occurrences all number
    7
    3
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    16 / 248 (6.45%)
    7 / 245 (2.86%)
    4 / 166 (2.41%)
         occurrences all number
    23
    7
    6
    Vomiting
         subjects affected / exposed
    5 / 248 (2.02%)
    3 / 245 (1.22%)
    1 / 166 (0.60%)
         occurrences all number
    5
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 248 (2.82%)
    6 / 245 (2.45%)
    3 / 166 (1.81%)
         occurrences all number
    7
    6
    3
    Oropharyngeal pain
         subjects affected / exposed
    5 / 248 (2.02%)
    9 / 245 (3.67%)
    4 / 166 (2.41%)
         occurrences all number
    9
    9
    4
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 248 (0.00%)
    5 / 245 (2.04%)
    0 / 166 (0.00%)
         occurrences all number
    0
    5
    0
    Pruritus
         subjects affected / exposed
    5 / 248 (2.02%)
    2 / 245 (0.82%)
    1 / 166 (0.60%)
         occurrences all number
    6
    2
    1
    Psoriasis
         subjects affected / exposed
    5 / 248 (2.02%)
    6 / 245 (2.45%)
    2 / 166 (1.20%)
         occurrences all number
    5
    6
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 248 (2.02%)
    7 / 245 (2.86%)
    5 / 166 (3.01%)
         occurrences all number
    5
    8
    6
    Back pain
         subjects affected / exposed
    9 / 248 (3.63%)
    6 / 245 (2.45%)
    6 / 166 (3.61%)
         occurrences all number
    10
    7
    6
    Psoriatic arthropathy
         subjects affected / exposed
    4 / 248 (1.61%)
    7 / 245 (2.86%)
    1 / 166 (0.60%)
         occurrences all number
    4
    7
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    11 / 248 (4.44%)
    9 / 245 (3.67%)
    1 / 166 (0.60%)
         occurrences all number
    12
    9
    1
    Ear infection
         subjects affected / exposed
    5 / 248 (2.02%)
    2 / 245 (0.82%)
    0 / 166 (0.00%)
         occurrences all number
    6
    2
    0
    Gastroenteritis
         subjects affected / exposed
    5 / 248 (2.02%)
    4 / 245 (1.63%)
    2 / 166 (1.20%)
         occurrences all number
    6
    4
    2
    Nasopharyngitis
         subjects affected / exposed
    34 / 248 (13.71%)
    22 / 245 (8.98%)
    11 / 166 (6.63%)
         occurrences all number
    42
    32
    12
    Pharyngitis
         subjects affected / exposed
    7 / 248 (2.82%)
    13 / 245 (5.31%)
    5 / 166 (3.01%)
         occurrences all number
    7
    14
    5
    Rhinitis
         subjects affected / exposed
    9 / 248 (3.63%)
    5 / 245 (2.04%)
    0 / 166 (0.00%)
         occurrences all number
    10
    7
    0
    Sinusitis
         subjects affected / exposed
    4 / 248 (1.61%)
    6 / 245 (2.45%)
    0 / 166 (0.00%)
         occurrences all number
    5
    6
    0
    Tonsillitis
         subjects affected / exposed
    7 / 248 (2.82%)
    3 / 245 (1.22%)
    0 / 166 (0.00%)
         occurrences all number
    7
    4
    0
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 248 (4.84%)
    14 / 245 (5.71%)
    5 / 166 (3.01%)
         occurrences all number
    13
    18
    5
    Urinary tract infection
         subjects affected / exposed
    8 / 248 (3.23%)
    11 / 245 (4.49%)
    2 / 166 (1.20%)
         occurrences all number
    8
    15
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 248 (0.40%)
    6 / 245 (2.45%)
    1 / 166 (0.60%)
         occurrences all number
    1
    9
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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