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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 16 weeks to subjects with moderately to severely active psoriatic arthritis

    Summary
    EudraCT number
    		 2016-003637-14
    Trial protocol
    		 EE   ES   CZ   BE   BG  
    Global end of trial date
    12 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2019
    First version publication date
    23 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG0634-CL-224
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03101670
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@glpg.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: - Evaluate the effect of filgotinib compared to placebo on the signs and symptoms of peripheral arthritis, as assessed by the ACR20 at Week 16. Secondary Objectives: - Evaluate the effect of filgotinib compared to placebo on: - The signs and symptoms of psoriatic arthritis (PsA) - The signs and symptoms of peripheral arthritis - Psoriasis - Enthesitis - Dactylitis - Physical function - Fatigue and general quality of life - Evaluate the safety and tolerability of filgotinib
    Protection of trial subjects
    Study GLPG0634-CL-224 was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Council for Harmonisation (ICH) guideline for Good Clinical Practice (GCP) (Sections 7.6 and 8.2) and the original principles embodied in the Declaration of Helsinki. These standards are consistent with the requirements of the European Community Directive 2001/20/EC. For Ukraine, standards are in accordance with Ukraine Guidance “Medicinal Products. Good clinical practice ССТ-Н МОЗУ 42-7.0:2008” approved by MoH Order of 16.02.2009 № 95 and with consideration of requirements of Directive 2001/20/EC. The investigator (or designee) was responsible for obtaining written informed consent from each individual who participated in this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and before undertaking any study-related procedures. Subjects were informed that they were completely free to refuse to enter the study or to withdraw from it at any time for any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Mar 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 35
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 12
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Estonia: 15
    Country: Number of subjects enrolled
    Ukraine: 51
    Worldwide total number of subjects
    131
    EEA total number of subjects
    80
    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)
    118
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 09-March-2017 to 12-March-2018 in 25 investigational sites in 7 countries: Bulgaria, Czech Republic, Estonia, Poland, Ukraine, Belgium and Spain.

    Pre-assignment
    Screening details
    		 In total, 191 subjects were screened, of whom 131 were randomized and received at least one dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Filgotinib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filogotinib
    Investigational medicinal product code
    GLPG0634
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 filgotinib 200 mg tablet once daily for 16 weeks.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo tablet once daily for 16 weeks.

    Number of subjects in period 1
    		Filgotinib Placebo
    Started
    65
    66
    Completed
    60
    64
    Not completed
    5
    2
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    -
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Filgotinib Placebo Total
    Number of subjects
    		 65 66 131
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 58 60 118
        From 65-84 years
    		 7 6 13
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 49 (22 to 69) 51 (23 to 72) -
    Gender categorical
    Units: Subjects
        Female
    		 36 30 66
        Male
    		 29 36 65
    Race
    Units: Subjects
        White
    		 65 66 131
    BMI
    Units: kg/m²
        median (full range (min-max))
    		 27.85 (17.17 to 51.05) 29.45 (19.38 to 52.12) -

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: American College of Rheumatology 20% improvement (ACR20) Response

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    End point title
    		 American College of Rheumatology 20% improvement (ACR20) Response
    End point description
    The signs and symptoms of peripheral arthritis were measured using ACR20. The primary end point was the percentage of subjects achieving ACR20 at Week 16. A subject achieved ACR20 response when this subject had: - ≥ 20% improvement from baseline in the 68 tender joint count (TJC68), and - ≥ 20% improvement from baseline in the 66 swollen joint count (SJC66), and - ≥ 20% improvement from baseline in at least 3 of the following 5 criteria:  - Patient’s Global Assessment of Disease Activity (PGADA) (0–100 mm visual analog scale (VAS))  - Physician's Global Assessment of Disease Activity (PhGADA) (0–100 mm VAS)  - Patient’s Global Assessment of psoriatic arthritis (PsA) pain intensity (0–100 mm VAS)  - Patient’s assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) score  - C-Reactive Protein (CRP)
    End point type
    Primary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: percent
    number (confidence interval 95%)
        Week 16
    80.0 (68.73 to 87.92)
    33.3 (23.16 to 45.34)
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    ACR20 Response Rate difference at Week 16 (NRI)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    46.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.2
         upper limit
    		 59.56

    Secondary: Minimal Disease Activity (MDA) Response

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    End point title
    		 Minimal Disease Activity (MDA) Response
    End point description
    The disease activity in PsA was measured using the MDA, which is a measure to indicate disease remission. The endpoint was the percentage of subjects achieving MDA at Week 16. A subject was classified as having achieved MDA when at least 5 out of 7 of the following criteria were met: - TJC68 ≤ 1 - SJC66 ≤ 1 - Psoriasis Area and Severity Index (PASI) ≤ 1 for subjects with a baseline affected Body Surface Area (BSA) of ≥ 3% (or for subjects with a baseline affected BSA < 3%, this criterion was considered met) - Patient’s Global Assessment of PsA pain intensity score ≤ 15 (0 to 100 mm VAS) - PGADA ≤ 20 (0 to 100 mm VAS) - HAQ-DI ≤ 0.5 - Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index ≤ 1 for subjects with enthesitis (SPARCC Enthesitis Index > 0) at baseline (or for subjects without enthesitis [SPARCC = 0] at baseline, this criterion was considered met).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: percent
    number (confidence interval 95%)
        Week 16
    23.1 (14.51 to 34.64)
    9.1 (4.23 to 18.45)
    Statistical analysis title
    		 Treatment difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    MDA Response Rate difference at Week 16 (NRI)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0212
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 26.53

    Secondary: ACR50/70 Response

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    End point title
    		 ACR50/70 Response
    End point description
    ACR50 and ACR70 were derived using the same algorithm as ACR20, but with 50% and 70% cut-offs, respectively. The endpoint was the percentage of subjects achieving ACR50/70 at Week 16.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: percent
    number (confidence interval 95%)
        ACR50 Week 16
    47.7 (36.02 to 59.62)
    15.2 (8.44 to 25.69)
        ACR70 Week 16
    23.1 (14.51 to 34.64)
    6.1 (2.38 to 14.57)
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    ACR50 Response Rate difference at Week 16 (NRI)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    32.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.81
         upper limit
    		 46.23
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    ACR70 Response Rate difference at Week 16 (NRI)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.94
         upper limit
    		 29.15

    Secondary: Disease Activity Score for 28 joint count using C-reactive protein - DAS28(CRP)

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    End point title
    		 Disease Activity Score for 28 joint count using C-reactive protein - DAS28(CRP)
    End point description
    The DAS28(CRP) is a composite score combining several parameters. DAS28(CRP) was calculated as follows: DAS28(CRP) = 0.56 × √TJC28 + 0.28 × √SJC28 + 0.36 × Ln(CRP + 1) + 0.014 × PGADA + 0.96 Where: - Ln(CRP + 1) is the natural logarithm of (CRP value [mg/L] + 1) - PGADA is on a 0 to 100 mm VAS scale. The DAS28(CRP) could range from 2 to 10, with a higher value indicating a more severe disease activity status.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.9 ( 1.00 )
    5.1 ( 1.04 )
        Week 16
    2.9 ( 1.09 )
    4.1 ( 1.22 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    Comparison of DAS28(CRP) change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 -0.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17

    Secondary: Simplified Disease Activity Index (SDAI)

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    End point title
    		 Simplified Disease Activity Index (SDAI)
    End point description
    The SDAI is a composite score of 5 outcome parameters. SDAI = TJC28 + SJC28 + PGADA (0 to 10 cm VAS) + PhGADA (0 to 10 cm VAS) + CRP (mg/dL) This index has no bounds and higher scores indicate more severe disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    31.0 ( 10.96 )
    33.7 ( 12.40 )
        Week 16
    11.4 ( 8.13 )
    21.8 ( 12.59 )
    Statistical analysis title
    		 Treatment difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    SDAI difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -9.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.44
         upper limit
    		 -6.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.61

    Secondary: Clinical Disease Activity Index (CDAI)

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    End point title
    		 Clinical Disease Activity Index (CDAI)
    End point description
    The CDAI is a further simplification of SDAI (excluding CRP): CDAI = TJC28 + SJC28 + PGADA (0 to 10 cm VAS) + PhGADA (0 to 10 cm VAS) The CDAI could range from 0 to 76, with a higher score indicating a more severe disease activity status.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    29.7 ( 10.36 )
    32.6 ( 11.83 )
        Week 16
    11.1 ( 7.96 )
    20.6 ( 11.87 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    Comparison of CDAI change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -8.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.33
         upper limit
    		 -5.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.56

    Secondary: European League Against Rheumatism (EULAR) response and remission

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    End point title
    		 European League Against Rheumatism (EULAR) response and remission
    End point description
    The end point was the percentage of subjects achieving EULAR response (good, moderate or none) or EULAR remission at Week 16. DAS28 (CRP) was categorized into EULAR response categories (none, moderate, good) as follows: Good = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 1.2; Moderate = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2, Actual DAS28 (CRP) > 3.2 to ≤ 5.1 or > 5.1 AND Improvement in DAS28 (CRP) from baseline > 1.2, or Actual DAS28 (CRP) > 3.2 to ≤ 5.1 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2. None = Actual DAS28 (CRP) > 5.1 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2; Improvement in DAS28 (CRP) from baseline ≤ 6.0 irrespective of the Actual DAS28 (CRP); EULAR remission was defined when scores on TJC28, SJC28, CRP, and PGADA were all ≤ 1.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: percent
    number (not applicable)
        EULAR Response Week 16 - Good
    56.9
    15.2
        EULAR Response Week 16 - Moderate
    35.4
    39.4
        EULAR Response Week 16 - None
    7.7
    45.5
        EULAR Remission Week 16
    6.2
    3.0
    Statistical analysis title
    		 EULAR remission at Week 16
    Statistical analysis description
    Comparison of EULAR remission at Week 16 between the 2 arms (Filgotinib – Placebo) (NRI)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3655
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.13
         upper limit
    		 12.03

    Secondary: Psoriatic Arthritis Response Criteria (PsARC)

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    End point title
    		 Psoriatic Arthritis Response Criteria (PsARC)
    End point description
    The end point was the percentage of subjects achieving PsARC response at Week 16. A PsARC responder was defined as having an improvement in ≥ 2 of the 4 factors (with at least one factor being a joint count) and no worsening in the remaining factors: - TJC68 (improvement defined as a decrease from baseline of ≥ 30%) - SJC66 (improvement defined as a decrease from baseline of ≥ 30%) - PGADA (0 to 100 mm VAS, improvement defined as a decrease from baseline of ≥ 20 mm) - PhGADA (0 to 100 mm VAS, improvement defined as a decrease from baseline of ≥ 20 mm)
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: percent
    number (confidence interval 95%)
        Week 16
    80.0 (68.73 to 87.92)
    47.0 (35.43 to 58.84)
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    PsARC difference at Week 16 (NRI).
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.66
         upper limit
    		 47.03

    Secondary: Physician’s Global Assessment of Disease Activity (PhGADA)

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    End point title
    		 Physician’s Global Assessment of Disease Activity (PhGADA)
    End point description
    Global assessment of the subject’s arthritis disease activity was performed by the physician having access to the joint assessments. A perpendicular line was drawn on the VAS, and the distance between the “no disease activity” anchor and the mark on the 10-cm line in mm (with the end indicating “extreme disease activity”) was the score from 0-100.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: mm
    arithmetic mean (standard deviation)
        Baseline
    66.1 ( 15.01 )
    66.0 ( 15.31 )
        Week 16
    21.4 ( 15.35 )
    40.7 ( 20.70 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    PhGADA difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -19.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.85
         upper limit
    		 -13.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.08

    Secondary: Patient’s Global Assessment of Disease Activity (PGADA)

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    End point title
    		 Patient’s Global Assessment of Disease Activity (PGADA)
    End point description
    The subject’s global assessment of their arthritis disease activity was recorded on a 0 to 100 mm VAS. A perpendicular line was drawn on the VAS, and the distance between the beginning of the line and the mark on the 10-cm line in mm was the score from 0-100. A score of 0 indicated “very well” and 100 indicated “very poor” to the question “Considering all the ways psoriatic arthritis affects you, how well are you doing today?”
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: mm
    arithmetic mean (standard deviation)
        Baseline
    61.8 ( 17.25 )
    63.3 ( 18.97 )
        Week 16
    34.5 ( 19.83 )
    49.8 ( 22.78 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    PGADA difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -15.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.27
         upper limit
    		 -8.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.58

    Secondary: Patient's Global Assessment of PsA pain intensity

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    End point title
    		 Patient's Global Assessment of PsA pain intensity
    End point description
    The patient’s assessment of pain was performed using a 0-100 mm VAS ranging from “no pain” to “unbearable pain” after the question “Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had from your psoriatic arthritis today”. The length of the line from 0 to the patient’s mark was recorded. This assessment was completed before the joint examination. This pain score was also used to derive the ACR20/50/70.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: mm
    arithmetic mean (standard deviation)
        Baseline
    65.2 ( 16.65 )
    61.5 ( 21.57 )
        Week 16
    33.6 ( 21.66 )
    50.5 ( 25.61 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    Patient PsA Pain Difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -18.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.65
         upper limit
    		 -11.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.93

    Secondary: 66/68-Joint Count

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    End point title
    		 66/68-Joint Count
    End point description
    Each of 66 joints were evaluated for swelling (SJC66) and each of 68 joints for tenderness (TJC68). The assessment for each joint was from the following selections: tender only, swollen only, tender and swollen, asymptomatic, temporarily not assessable, or permanently not assessable. Both “temporarily not assessable” and “permanently not assessable” selections were treated as missing assessments.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: Joint Count
    arithmetic mean (standard deviation)
        TJC68 - Baseline
    18.3 ( 9.23 )
    21.6 ( 13.19 )
        TJC68 - Week 16
    6.2 ( 6.80 )
    12.6 ( 9.43 )
        SJC66 - Baseline
    11.6 ( 5.12 )
    12.7 ( 6.69 )
        SJC66 - Week 16
    2.7 ( 4.13 )
    5.9 ( 7.00 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    TJC68 difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -5.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.89
         upper limit
    		 -2.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    SJC66 difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0039
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.39
         upper limit
    		 -0.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.89

    Secondary: C-reactive protein (CRP) measurements

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    End point title
    		 C-reactive protein (CRP) measurements
    End point description
    Descriptive statistics for High Sensitivity Serum C-reactive Protein (hsCRP) over time
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline
    13.9 ( 19.79 )
    10.9 ( 17.18 )
        Week 16
    3.0 ( 4.10 )
    12.6 ( 17.42 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    hsCRP difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -10.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.3
         upper limit
    		 -7.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.81

    Secondary: Psoriasis Area and Severity Index (PASI) Score Including Body Surface Area

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    End point title
    		 Psoriasis Area and Severity Index (PASI) Score Including Body Surface Area
    End point description
    PASI score was used to measure the severity & extent of psoriasis. Psoriasis representative sites were selected for each body region (head [h], upper limbs [u], trunk [t], & lower limbs [l]), & were separately scored by using 3 parameters (erythema [E], infiltration [I] & desquamation [D]), each of which was graded on a severity scale of 0 to 4 (0 = none; 4 = very severe). The area-wise % involvement of the involved sites (head [Ah], upper limbs [Au], trunk [At], & lower limbs [Al]) was calculated as: 0 = no involvement, 1 = < 10%, 2 = 10% to < 30%, 3 = 30% to < 50%, 4 = 50% to < 70%, 5 = 70% to < 90%, & 6 = 90% to 100%. The formula for PASI score was: PASI = 0.1 × (Eh + Ih + Dh) × Ah + 0.2 × (Eu + Iu + Du) × Au + 0.3 × (Et + It + Dt) × At + 0.4 × (El + Il + Dl) × Al The total PASI score ranged from 0 (no disease) to 72 (maximal disease but was considered unreliable when BSA <3). End point values reported are for the subgroup of subjects who had at least 3% BSA at baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    42
    40
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    10.9 ( 11.73 )
    11.7 ( 11.85 )
        Week 16
    4.6 ( 7.11 )
    8.5 ( 11.00 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    PASI difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -3.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.09
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.28

    Secondary: Physician’s Global Assessment of Psoriasis (PhGAP)

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    End point title
    		 Physician’s Global Assessment of Psoriasis (PhGAP)
    End point description
    The physician scored the subject’s psoriasis disease activity according to the following grades: - Induration (I) (0 to 5 scale, averaged over all lesions) - Erythema (E) (0 to 5 scale, averaged over all lesions) - Scaling (S) (0 to 5 scale, averaged over all lesions) The sum of the 3 grades was divided by 3, ie, (I+E+S)/3, and rounded to the nearest integer (ie, 0, 1, 2, 3, 4, 5) to obtain the total average score. Physician’s Static Global Assessment (0-5 scale) was based on the total average score: 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. End point values reported are for the subgroup of subjects who had at least 3% BSA at baseline.
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    42
    40
    Units: score on a scale
    arithmetic mean (standard deviation)
        Total Score (I+E+S)/3 (0-5) - Baseline
    2.5 ( 1.15 )
    2.7 ( 0.97 )
        Total Score (I+E+S)/3 (0-5) - Week 16
    1.3 ( 0.86 )
    2.0 ( 0.96 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    PhGAP Total Score ((I+E+S)/3 (0-5)) difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0209
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Patient’s Global Assessment of Psoriasis (PGAP)

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    End point title
    		 Patient’s Global Assessment of Psoriasis (PGAP)
    End point description
    PGAP is a 5-point Likert scale (clear, almost clear, mild, moderate, and severe) ranging from 0 indicating “clear” to 4 indicating “severe”. The percentage of subjects within these PGAP categories are presented. End point values reported are for the subgroup of subjects who had at least 3% BSA at baseline.
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    42
    40
    Units: percent
    number (not applicable)
        Baseline - Clear
    0
    2.5
        Baseline - Almost Clear
    0
    2.5
        Baseline - Mild
    19.0
    7.5
        Baseline - Moderate
    59.5
    60.0
        Baseline - Severe
    21.4
    27.5
        Week 16 - Clear
    9.5
    0
        Week 16 - Almost Clear
    16.7
    12.5
        Week 16 - Mild
    35.7
    25.0
        Week 16 - Moderate
    35.7
    45.0
        Week 16 - Severe
    2.4
    17.5
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    Difference in PGAP change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0166
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Modified Nail Psoriasis Area and Severity Index (mNAPSI)

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    End point title
    		 Modified Nail Psoriasis Area and Severity Index (mNAPSI)
    End point description
    The mNAPSI was used to assess each nail abnormality for each of the subject’s nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail were graded on a scale from 0 to 3. Four features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula) were graded as either present (1) or absent (0) for each fingernail. Each fingernail had a score between 0 and 13. The total mNAPSI score was the sum of all individual scores of all abnormalities across all fingernails, and ranged from 0 to 130. End point values are reported for the subgroup of subjects who had psoriatic nails at baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    44
    46
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    19.2 ( 24.01 )
    18.2 ( 17.45 )
        Week 16
    13.1 ( 21.09 )
    14.1 ( 12.72 )
    No statistical analyses for this end point

    Secondary: Pruritus numeric rating scale (NRS)

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    End point title
    		 Pruritus numeric rating scale (NRS)
    End point description
    At each study visit, the subject was asked to complete an evaluation of pruritus using a visual rating scale with numbered intervals (integers). The subject rated the intensity of pruritus based on a recall period of 24 hours of the most severe episode of pruritus experienced during that time interval. The subjects were asked to rate their pruritus on a 0 (no itching) to 10 (worst possible itching) scale. End point values reported are for the subgroup of subjects who had at least 3% BSA at baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    42
    40
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.4 ( 2.29 )
    6.0 ( 2.21 )
        Week 16
    2.9 ( 2.03 )
    5.4 ( 2.27 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    Pruritus NRS difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -2.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.06
         upper limit
    		 -1.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.41

    Secondary: Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

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    End point title
    		 Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
    End point description
    The enthesitis examination was based on 16 anatomical sites: the medial epicondyle, the lateral epicondyle, the supraspinatus insertion, the bilateral greater trochanter, the quadriceps tendon insertion into superior border of patella, the patellar ligament insertion into inferior pole of patella or tibial tuberosity, the Achilles tendon insertion, and the plantar fascia insertion, all left and right. Tenderness at each site was quantified on a dichotomous basis: 0 means nontender and 1 means tender. The SPARCC Enthesitis Index was derived as the sum of the tenderness over the 16 sites mentioned above and ranges from 0 to 16. End point values are reporting for the subgroup of patients who had enthesitis at baseline according to the SPARCC.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    37
    48
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.9 ( 2.95 )
    5.5 ( 3.75 )
        Week 16
    2.1 ( 2.68 )
    3.7 ( 3.62 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    SPARCC Enthesitis Index difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.59
         upper limit
    		 -0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.62

    Secondary: Leeds Enthesitis Index (LEI)

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    End point title
    		 Leeds Enthesitis Index (LEI)
    End point description
    The medial femoral condyle (left and right), the lateral epicondyle (left and right), and the Achilles tendon insertion (left and right) were used to calculate the LEI, which in turn was required to calculate the PASDAS. LEI was derived as the sum of the tenderness over the 6 sites mentioned above and ranges from 0 to 6. End point values are reported for the subgroup of patients who had enthesitis at baseline according to the LEI.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    33
    43
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    2.8 ( 1.41 )
    2.6 ( 1.43 )
        Week 16
    1.0 ( 1.33 )
    1.9 ( 1.64 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    LEI difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 -0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29

    Secondary: Leeds Dactylitis Index (LDI)

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    End point title
    		 Leeds Dactylitis Index (LDI)
    End point description
    The LDI measured the ratio of the circumference of the affected digit to the circumference of the digit on the contralateral hand or foot using a Leeds Dactylometer. LDI score of a dactylitic finger/toe = {[(A/B)-1] x 100} × C Where:  A = circumference of the dactylitic finger/toe (mm)  B = circumference of the contralateral digit (mm)  C = tenderness score (0 = no tenderness, 1 = tender) If both ipsilateral and contralateral digits were thought to be dactylitic, then the reference value was used as the comparator (ie, B in the above formula). Binary tenderness score was used in LDI score calculation. The total LDI score equaled to the sum of the nonnegative individual LDI scores across all fingers and toes. End point values are reported for the subgroup of patients who had dactylitis at baseline according to the LDI. This index has no bounds and higher scores indicate more severe disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    19
    29
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    40.8 ( 36.06 )
    39.3 ( 24.66 )
        Week 16
    3.6 ( 7.60 )
    13.8 ( 46.50 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    LDI difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.316
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -10.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.8
         upper limit
    		 10.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.48

    Secondary: Health Assessment Questionnaire-Disability Index (HAQ-DI)

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    End point title
    		 Health Assessment Questionnaire-Disability Index (HAQ-DI)
    End point description
    HAQ-DI scores included the following 3 parts: - Eight domain scores: getting dressed, arising, eating, hygiene, walking, reaching, gripping, and activities. - HAQ-DI total score, ranging from 0 to 3, with higher scores indicating greater dysfunction. - Two VAS scores (which are not part of the HAQ-DI total score).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    1.43 ( 0.514 )
    1.36 ( 0.622 )
        Week 16
    0.86 ( 0.597 )
    1.09 ( 0.626 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    HAQ-DI difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0009
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 -0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Secondary: Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue)

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    End point title
    		 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue)
    End point description
    There were a total of 13 items for the FACIT-Fatigue scale. The FACIT-Fatigue scale and scoring guidelines are presented in the protocol and SAP. The FACIT-Fatigue scale ranges from 0 to 52. A higher score indicated a better quality of life.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    27.8 ( 9.62 )
    26.8 ( 11.13 )
        Week 16
    36.0 ( 8.81 )
    32.2 ( 9.89 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    FACIT-Fatigue difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0086
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    3.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 5.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.19

    Secondary: 36-Item Short-Form Health Survey (SF-36)

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    End point title
    		 36-Item Short-Form Health Survey (SF-36)
    End point description
    The validated scoring algorithm of the SF-36 (version 2) scale was applied, which did the rescoring as well as dealt with missing items. This validated scoring algorithm resulted in standardized (0 to 100) mental and physical component scores (MCS and PCS) as well as 8 domain scores including physical functioning, physical role functioning, general health perceptions, bodily pain, vitality, social role functioning, emotional role functioning, and mental health. A higher SF-36 score indicated a better health status.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: score on a scale
    arithmetic mean (standard deviation)
        MCS - Baseline
    42.9 ( 11.59 )
    42.8 ( 11.39 )
        MCS - Week 16
    47.3 ( 11.04 )
    45.9 ( 12.26 )
        PCS - Baseline
    35.2 ( 5.87 )
    36.3 ( 6.97 )
        PCS - Week 16
    42.6 ( 7.27 )
    38.6 ( 6.84 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    SF-36 (MCS) difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4128
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 4.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.44
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    SF-36 (PCS) difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-squares mean difference
    Point estimate
    4.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.58
         upper limit
    		 6.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.06

    Secondary: Psoriatic Arthritis Impact of Disease (PsAID)

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    End point title
    		 Psoriatic Arthritis Impact of Disease (PsAID)
    End point description
    PsAID was calculated using the following formula: PsAID − 9 = PsAID1 (pain) NRS × 0.174 + PsAID2 (fatigue) NRS × 0.131 + PsAID3 (skin) NRS × 0.121 + PsAID4 (work and/or leisure activities) NRS × 0.110 + PsAID5 (function) NRS × 0.107 + PsAID6 (discomfort) NRS × 0.098 + PsAID7 (sleep) NRS × 0.089 + PsAID8 (coping) NRS × 0.087 + PsAID9 (anxiety) NRS × 0.085 Each of the 9 items was on a scale of 0 to 10, so the PsAID score also gave a number between 0 and 10. A higher score on the PsAID indicated more impact of the disease.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.8 ( 1.62 )
    5.7 ( 1.95 )
        Week 16
    3.5 ( 2.00 )
    4.9 ( 2.18 )
    Statistical analysis title
    		 Treatment Difference (Filgotinib 200 mg - Placebo)
    Statistical analysis description
    PsAID difference in change from baseline at Week 16 (LOCF)
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.12
         upper limit
    		 -0.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.32

    Secondary: Safety - TEAE (Treatment Emergent Adverse Events)

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    End point title
    		 Safety - TEAE (Treatment Emergent Adverse Events)
    End point description
    The number of subjects with treatment-emergent adverse events (TEAEs). An analysis of the TEAEs was performed. Laboratory assessments, 12-lead ECG and vital signs were analyzed descriptively.
    End point type
    Secondary
    End point timeframe
    From first study drug administration until the last follow-up visit.
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    65
    66
    Units: Subjects
        Any TEAE
    37
    39
        Severe TEAE
    1
    5
        Serious TEAE
    1
    1
        Treatment related TEAE
    11
    9
        Discontinuation due to AE
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of study drug treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Filgotinib
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Filgotinib Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 66 (1.52%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Filgotinib Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 65 (56.92%)
    39 / 66 (59.09%)
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    5 / 65 (7.69%)
    0 / 66 (0.00%)
         occurrences all number
    5
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 65 (6.15%)
    0 / 66 (0.00%)
         occurrences all number
    4
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 66 (1.52%)
         occurrences all number
    2
    1
    Blood glucose increased
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 66 (1.52%)
         occurrences all number
    2
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 66 (3.03%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 65 (4.62%)
    5 / 66 (7.58%)
         occurrences all number
    4
    7
    Dizziness
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 66 (3.03%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 66 (3.03%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 66 (3.03%)
         occurrences all number
    3
    2
    Abdominal pain
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 66 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 66 (0.00%)
         occurrences all number
    4
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 66 (4.55%)
         occurrences all number
    3
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 66 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 65 (12.31%)
    10 / 66 (15.15%)
         occurrences all number
    10
    11
    Urinary tract infection
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 66 (3.03%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 66 (0.00%)
         occurrences all number
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 66 (3.03%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2017
    The protocol was updated with current clinical information around serious infections and lymphoma and other malignancies in the benefit/risk assessment in accordance with the most current version of the Investigator’s Brochure (Edition v 12, dated (22 May 2017). Also, an additional optional sub study in which urine and stool samples will be collected for biomarker analysis was added.

    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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