Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39185   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

    Summary
    EudraCT number
    2010-020002-15
    Trial protocol
    CZ   DE   GB   NL   FI   ES   DK   SE   BG   SK   HU   AT   GR   BE  
    Global end of trial date
    22 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Jun 2017
    First version publication date
    16 Jun 2017
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    A3921061
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01163253
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 110017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    14 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long term safety and tolerability of treatment with tofacitinib (10 mg twice a day [BID] or variable dose 5 and 10 mg BID) in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Sep 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 19
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 12
    Country: Number of subjects enrolled
    Brazil: 7
    Country: Number of subjects enrolled
    Bulgaria: 56
    Country: Number of subjects enrolled
    Canada: 374
    Country: Number of subjects enrolled
    Chile: 171
    Country: Number of subjects enrolled
    Colombia: 74
    Country: Number of subjects enrolled
    Croatia: 7
    Country: Number of subjects enrolled
    Czech Republic: 41
    Country: Number of subjects enrolled
    Denmark: 30
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    France: 74
    Country: Number of subjects enrolled
    Germany: 229
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Hong Kong: 7
    Country: Number of subjects enrolled
    Hungary: 91
    Country: Number of subjects enrolled
    Japan: 49
    Country: Number of subjects enrolled
    Korea, Republic of: 29
    Country: Number of subjects enrolled
    Mexico: 30
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    Poland: 293
    Country: Number of subjects enrolled
    Puerto Rico: 17
    Country: Number of subjects enrolled
    Russian Federation: 125
    Country: Number of subjects enrolled
    Serbia: 16
    Country: Number of subjects enrolled
    Singapore: 13
    Country: Number of subjects enrolled
    Slovakia: 20
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Sweden: 17
    Country: Number of subjects enrolled
    Switzerland: 6
    Country: Number of subjects enrolled
    Taiwan: 67
    Country: Number of subjects enrolled
    Ukraine: 234
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    United States: 679
    Worldwide total number of subjects
    2867
    EEA total number of subjects
    919
    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)
    2672
    From 65 to 84 years
    195
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    A total of 2881 subjects were enrolled in this study, however 2867 subjects received treatment.

    Pre-assignment
    Screening details
    The study was conducted at 282 sites in 36 countries. The start date of the study was 17-Sep-2010 and the study completed on 22-Jun-2016.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Open-Label

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Tofacitinib 10 mg
    Arm description
    Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
    Arm type
    Experimental

    Investigational medicinal product name
    Tofacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Tofacitinib 10 mg twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

    Arm title
    Tofacitinib 5 mg or 10 mg
    Arm description
    Subjects received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, subjects received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
    Arm type
    Experimental

    Investigational medicinal product name
    Tofacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Tofacitinib 10 mg twice daily for a period of 3 months. After 3 months of treatment, subjects received twice daily dosing of tofacitinib 5 mg or 10 mg until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.

    Number of subjects in period 1
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Started
    2281
    586
    Completed
    0
    0
    Not completed
    2281
    586
         Other Unspecified
    170
    34
         Study Terminated by Sponsor
    978
    349
         Death
    17
    5
         Protocol deviation
    43
    12
         Withdrawal by Subject
    199
    50
         Insufficient Clinical Response
    423
    29
         Withdrawn Due to Pregnancy
    12
    2
         Medication Error
    1
    -
         Ongoing
    13
    4
         Adverse Event
    300
    78
         Lost to Follow-up
    125
    23

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Tofacitinib 10 mg
    Reporting group description
    Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

    Reporting group title
    Tofacitinib 5 mg or 10 mg
    Reporting group description
    Subjects received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, subjects received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.

    Reporting group values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg Total
    Number of subjects
    2281 586 2867
    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)
    2137 535 2672
        From 65-84 years
    144 51 195
        85 years and over
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    45.3 ± 12.5 47 ± 13 -
    Gender Categorical
    Units: Subjects
        Female
    640 203 843
        Male
    1641 383 2024

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Tofacitinib 10 mg
    Reporting group description
    Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

    Reporting group title
    Tofacitinib 5 mg or 10 mg
    Reporting group description
    Subjects received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, subjects received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Close Top of page
    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2281
    586
    Units: subjects
        AEs
    1876
    490
        SAEs
    304
    88
    No statistical analyses for this end point

    Primary: Number of Adverse Events by Severity

    Close Top of page
    End point title
    Number of Adverse Events by Severity [2]
    End point description
    An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant’s usual function; b) moderate: AEs interfered to some extent with participant’s usual function; c) severe: AEs interfered significantly with participant’s usual function. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2281
    586
    Units: adverse events
        Mild
    5354
    1749
        Moderate
    3268
    766
        Severe
    410
    136
    No statistical analyses for this end point

    Primary: Number of Subjects With Laboratory Abnormalities

    Close Top of page
    End point title
    Number of Subjects With Laboratory Abnormalities [3]
    End point description
    Abnormality criteria:hematology (hemoglobin,hematocrit,red blood cell <0.8*lower limit of normal [LLN];reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75*upper limit of normal[ULN];WBC<0.6*LLN,>1.5*ULN;lymphocytes,neutrophils, basophils, eosinophils,monocytes<0.8*LLN; >1.2*ULN;coagulation(prothrombin [PT], PT ratio>1.1*ULN) liver function(bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein,albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN);renal function (blood urea nitrogen, creatinine>1.3*ULN);electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN),chemistry (glucose<0.6*LLN; >1.5* ULN),urinalysis (pH <4.5;>8, glucose, ketones, protein, blood,urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).Safety analysis set.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2271
    578
    Units: subjects
    2203
    565
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Month 1

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Month 1 [4]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2277
    586
    Units: gram per deciliter (g/dL)
    arithmetic mean (standard deviation)
        Baseline (n =2277, 586)
    14.64 ± 1.27
    14.64 ± 1.24
        Change at Month 1 (n =2201, 563)
    -0.24 ± 0.83
    -0.32 ± 0.86
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Month 3

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Month 3 [5]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2198
    572
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.27 ± 0.85
    -0.39 ± 0.83
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Month 6

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Month 6 [6]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2051
    563
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.27 ± 0.88
    -0.3 ± 0.87
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Month 12

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Month 12 [7]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1759
    531
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.34 ± 0.93
    -0.3 ± 0.9
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Month 24

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Month 24 [8]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 24
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1385
    449
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.3 ± 0.96
    -0.29 ± 0.89
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Month 36

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Month 36 [9]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 36
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1114
    380
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.32 ± 0.93
    -0.37 ± 0.88
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Month 48

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Month 48 [10]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 48
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    415
    127
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.35 ± 0.97
    -0.43 ± 0.94
    No statistical analyses for this end point

    Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 1

    Close Top of page
    End point title
    Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 [11]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2275
    586
    Units: 1000 cells/mm^3
    arithmetic mean (standard deviation)
        Baseline: Lymphocyte Count (n =2275, 586)
    1.76 ± 0.57
    1.8 ± 0.56
        Baseline: Neutrophil Count (n =2275, 586)
    4.74 ± 1.68
    4.55 ± 1.7
        Change at Month 1: Lymphocyte Count (n =2182, 559)
    0.07 ± 0.52
    0.11 ± 0.56
        Change at Month 1: Neutrophil Count (n =2182, 559)
    -0.37 ± 1.65
    -0.48 ± 1.58
    No statistical analyses for this end point

    Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 3

    Close Top of page
    End point title
    Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 [12]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2183
    570
    Units: 1000 cells/mm^3
    arithmetic mean (standard deviation)
        Lymphocyte count
    0 ± 0.52
    0.02 ± 0.52
        Neutrophil Count
    -0.28 ± 1.63
    -0.28 ± 1.6
    No statistical analyses for this end point

    Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 6

    Close Top of page
    End point title
    Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 [13]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2034
    559
    Units: 1000 cells/mm^3
    arithmetic mean (standard deviation)
        Lymphocyte Count
    -0.11 ± 0.51
    -0.05 ± 0.51
        Neutrophil Count
    -0.25 ± 1.61
    -0.22 ± 1.64
    No statistical analyses for this end point

    Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 12

    Close Top of page
    End point title
    Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 [14]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1751
    530
    Units: 1000 cells/mm^3
    arithmetic mean (standard deviation)
        Lymphocyte Count
    -0.21 ± 0.52
    -0.16 ± 0.48
        Neutrophil Count
    -0.23 ± 1.61
    -0.18 ± 1.58
    No statistical analyses for this end point

    Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 24

    Close Top of page
    End point title
    Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 [15]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 24
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1377
    445
    Units: 1000 cells/mm^3
    arithmetic mean (standard deviation)
        Lymphocyte Count
    -0.28 ± 0.52
    -0.18 ± 0.54
        Neutrophil Count
    -0.19 ± 1.69
    -0.02 ± 1.59
    No statistical analyses for this end point

    Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 36

    Close Top of page
    End point title
    Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 [16]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 36
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1111
    377
    Units: 1000 cells/mm^3
    arithmetic mean (standard deviation)
        Lymphocyte Count
    -0.35 ± 0.55
    -0.24 ± 0.51
        Neutrophil Count
    -0.26 ± 1.61
    -0.11 ± 1.68
    No statistical analyses for this end point

    Primary: Change From Baseline in Lymphocyte and Neutrophil Count at Month 48

    Close Top of page
    End point title
    Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 [17]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 48
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    413
    127
    Units: 1000 cells/mm^3
    arithmetic mean (standard deviation)
        Lymphocyte Count
    -0.42 ± 0.52
    -0.27 ± 0.46
        Neutrophil Count
    -0.28 ± 1.7
    -0.07 ± 1.49
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1

    Close Top of page
    End point title
    Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 [18]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2278
    586
    Units: milligram per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Baseline: Creatinine (n =2278, 586)
    0.9 ± 0.17
    0.88 ± 0.16
        Baseline: LDL-C (n =2253, 585)
    114.14 ± 32.53
    115 ± 35.03
        Baseline: HDL-C (n =2277, 586)
    49.05 ± 13.93
    51.87 ± 17.33
        Baseline: TC (n =2277, 586)
    192.11 ± 38.1
    194.96 ± 39.79
        Change at Month 1: Creatinine (n =2204, 563)
    0.03 ± 0.1
    0.02 ± 0.1
        Change at Month 1: LDL-C (n =2125, 546)
    11.49 ± 28.77
    11.55 ± 29.55
        Change at Month 1: HDL-C (n =2203, 562)
    8.19 ± 9.89
    8.63 ± 10.5
        Change at Month 1: TC (n =2203, 562)
    21.12 ± 34.08
    22.65 ± 34.36
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3

    Close Top of page
    End point title
    Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 [19]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2211
    573
    Units: mg/dL
    arithmetic mean (standard deviation)
        Creatinine (n =2211, 573)
    0.04 ± 0.21
    0.03 ± 0.1
        LDL-C (n =2130, 559)
    11.97 ± 29.77
    10.44 ± 32.72
        HDL-C (n =2204, 573)
    7.69 ± 10.23
    7.96 ± 10.33
        TC (n =2203, 573)
    21.52 ± 35.63
    21.06 ± 38.34
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6

    Close Top of page
    End point title
    Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 [20]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2057
    564
    Units: mg/dL
    arithmetic mean (standard deviation)
        Creatinine (n =2057, 564)
    0.03 ± 0.11
    0.03 ± 0.1
        LDL-C (n =1983, 553)
    11.44 ± 30.1
    8.74 ± 33.22
        HDL-C (n =2056, 564)
    7.68 ± 10.33
    8.19 ± 11.6
        TC (n =2057, 564)
    20.91 ± 35.94
    19.17 ± 39.06
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12

    Close Top of page
    End point title
    Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 [21]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1777
    533
    Units: mg/dL
    arithmetic mean (standard deviation)
        Creatinine (n =1777, 533)
    0.04 ± 0.12
    0.04 ± 0.12
        LDL-C (n =1728, 521)
    11.31 ± 31.45
    9.65 ± 32.87
        HDL-C (n =1776, 531)
    8.13 ± 10.48
    6.88 ± 11.15
        TC (n =1776, 531)
    21.2 ± 39.15
    16.97 ± 37.84
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24

    Close Top of page
    End point title
    Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 [22]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 24
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1398
    450
    Units: mg/dL
    arithmetic mean (standard deviation)
        Creatinine (n =1398, 450)
    0.05 ± 0.11
    0.04 ± 0.11
        LDL-C (n =1353, 435)
    11.35 ± 35.33
    10.13 ± 35.67
        HDL-C (n =1397, 450)
    9.02 ± 11.62
    7.55 ± 11.94
        TC (n =1398, 450)
    21.74 ± 41.05
    19.22 ± 39.69
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36

    Close Top of page
    End point title
    Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 [23]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 36
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1122
    384
    Units: mg/dL
    arithmetic mean (standard deviation)
        Creatinine (n =1122, 384)
    0.05 ± 0.12
    0.04 ± 0.15
        LDL-C (n =1085, 375)
    10.11 ± 35.83
    7.25 ± 37.41
        HDL-C (n =1119, 384)
    8.8 ± 11.59
    6.39 ± 11.91
        TC (n =1119, 384)
    20.2 ± 41.28
    15.55 ± 43.59
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48

    Close Top of page
    End point title
    Change From Baseline in Creatinine, Low-Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 [24]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 48
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    417
    127
    Units: mg/dL
    arithmetic mean (standard deviation)
        Creatinine (n =417, 127)
    0.04 ± 0.12
    0.04 ± 0.11
        LDL-C (n =402, 123)
    12.98 ± 36.89
    6.61 ± 34.66
        HDL-C (n =417, 127)
    8.62 ± 11.36
    8.19 ± 12.72
        TC (n =417, 127)
    24.99 ± 43.35
    16.36 ± 40.99
    No statistical analyses for this end point

    Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1

    Close Top of page
    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 [25]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2278
    586
    Units: international unit per liter (IU/L)
    arithmetic mean (standard deviation)
        Baseline: AST (n =2278, 586)
    24.02 ± 12.22
    24.66 ± 10.36
        Baseline: ALT (n =2278, 586)
    28.47 ± 17.29
    28.17 ± 16.56
        Change at Month 1: AST (n =2198, 564)
    3.48 ± 15.39
    4.07 ± 12.01
        Change at Month 1: ALT (n =2199, 564)
    4.07 ± 19.04
    4.84 ± 17.5
    No statistical analyses for this end point

    Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3

    Close Top of page
    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 [26]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2201
    573
    Units: IU/L
    arithmetic mean (standard deviation)
        AST (n =2200, 573)
    4.09 ± 17.75
    5.65 ± 16.37
        ALT (n =2201, 573)
    4.86 ± 18.52
    6.86 ± 20.8
    No statistical analyses for this end point

    Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6

    Close Top of page
    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 [27]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2054
    564
    Units: IU/L
    arithmetic mean (standard deviation)
        AST (n =2052, 564)
    4.5 ± 15.6
    5.07 ± 14.9
        ALT (n =2054, 564)
    5.98 ± 19
    6.15 ± 18.4
    No statistical analyses for this end point

    Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12

    Close Top of page
    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 [28]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1774
    532
    Units: IU/L
    arithmetic mean (standard deviation)
        AST (n =1772, 531)
    4.88 ± 16.63
    7.29 ± 22.7
        ALT (n =1774, 532)
    6.68 ± 23.12
    8.91 ± 25.21
    No statistical analyses for this end point

    Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24

    Close Top of page
    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 [29]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 24
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1398
    450
    Units: IU/L
    arithmetic mean (standard deviation)
        AST (n =1397, 450)
    4.1 ± 14.64
    6.77 ± 15.74
        ALT (n =1398, 450)
    5.31 ± 19.37
    7.56 ± 18.93
    No statistical analyses for this end point

    Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36

    Close Top of page
    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 [30]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 36
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1122
    384
    Units: IU/L
    arithmetic mean (standard deviation)
        AST
    5.38 ± 20.68
    5.32 ± 15.65
        ALT
    5.46 ± 20.61
    6.56 ± 22.43
    No statistical analyses for this end point

    Primary: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48

    Close Top of page
    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 [31]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 48
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    417
    127
    Units: IU/L
    arithmetic mean (standard deviation)
        AST (n =416, 127)
    4.49 ± 14.05
    8.4 ± 26.41
        ALT (n =417, 127)
    4.92 ± 27.11
    6.92 ± 20.98
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Change From Baseline in Physical Examination

    Close Top of page
    End point title
    Number of Subjects With Clinically Significant Change From Baseline in Physical Examination [32]
    End point description
    Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion. Safety analysis set. Here, 'N' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2268
    577
    Units: subjects
    683
    191
    No statistical analyses for this end point

    Primary: Number of Subjects With Vital Sign Abnormalities

    Close Top of page
    End point title
    Number of Subjects With Vital Sign Abnormalities [33]
    End point description
    Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg); diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg; heart rate: <40 and >120 beats per minute (BPM); SBP values: maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; DBP value: maximum IFB of >=20 mmHg. Safety analysis set. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2271
    577
    Units: subjects
        Systolic BP (n =2271, 577)
    12
    6
        Diastolic BP (n =2271, 577)
    12
    1
        Heart Rate (n =2271, 577)
    3
    1
        Maximum IFB in Systolic BP (n =2267, 577)
    187
    65
        Maximum IFB in Diastolic BP (n =2267, 577)
    221
    74
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1

    Close Top of page
    End point title
    Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 [34]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2277
    586
    Units: millimeter of mercury (mmHg)
    arithmetic mean (standard deviation)
        Baseline: Systolic BP (n =2277, 586)
    126.07 ± 14.03
    126.24 ± 14.12
        Baseline: Diastolic BP (n =2277, 586)
    79.64 ± 9.42
    78.88 ± 9.27
        Change at Month 1: Systolic BP (n =2210, 564)
    -0.43 ± 11.83
    -1.31 ± 11.55
        Change at Month 1: Diastolic BP (n =2210, 564)
    -0.03 ± 8.42
    0.22 ± 8.45
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3

    Close Top of page
    End point title
    Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 [35]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2214
    575
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic BP
    -0.16 ± 11.97
    -0.95 ± 11.85
        Diastolic BP
    -0.26 ± 8.56
    0.05 ± 8.52
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6

    Close Top of page
    End point title
    Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 [36]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2061
    566
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic BP
    0.22 ± 12.18
    -0.15 ± 12.48
        Diastolic BP
    -0.05 ± 8.87
    0.55 ± 8.74
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12

    Close Top of page
    End point title
    Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 [37]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1784
    534
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic BP
    0.42 ± 11.97
    -0.2 ± 12.51
        Diastolic BP
    0.23 ± 8.89
    0.1 ± 9.1
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24

    Close Top of page
    End point title
    Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 [38]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 24
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1398
    451
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic BP
    0.84 ± 13
    -0.07 ± 13.02
        Diastolic BP
    0.36 ± 9.45
    0.35 ± 8.85
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36

    Close Top of page
    End point title
    Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 [39]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 36
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1123
    386
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic BP
    0.52 ± 13.15
    0.1 ± 13.92
        Diastolic BP
    0.33 ± 9.33
    -0.06 ± 9.24
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48

    Close Top of page
    End point title
    Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 [40]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 48
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    422
    127
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic BP
    2.35 ± 13.45
    1.13 ± 15.18
        Diastolic BP
    0.97 ± 9.52
    0.87 ± 9.8
    No statistical analyses for this end point

    Primary: Change From Baseline in Heart Rate at Month 1

    Close Top of page
    End point title
    Change From Baseline in Heart Rate at Month 1 [41]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2277
    586
    Units: beats per minute
    arithmetic mean (standard deviation)
        Baseline (n =2277, 586)
    71.81 ± 9.67
    71.46 ± 9.93
        Change at Month 1 (n =2210, 563)
    -0.82 ± 9.16
    -1.23 ± 9.03
    No statistical analyses for this end point

    Primary: Change From Baseline in Heart Rate at Month 3

    Close Top of page
    End point title
    Change From Baseline in Heart Rate at Month 3 [42]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2214
    573
    Units: beats per minute
        arithmetic mean (standard deviation)
    -0.57 ± 9.35
    -0.32 ± 9.19
    No statistical analyses for this end point

    Primary: Change From Baseline in Heart Rate at Month 6

    Close Top of page
    End point title
    Change From Baseline in Heart Rate at Month 6 [43]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2061
    565
    Units: beats per minute
        arithmetic mean (standard deviation)
    -0.73 ± 9.65
    -1.05 ± 9.18
    No statistical analyses for this end point

    Primary: Change From Baseline in Heart Rate at Month 12

    Close Top of page
    End point title
    Change From Baseline in Heart Rate at Month 12 [44]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1784
    534
    Units: beats per minute
        arithmetic mean (standard deviation)
    -1.13 ± 9.66
    -1.14 ± 9.07
    No statistical analyses for this end point

    Primary: Change From Baseline in Heart Rate at Month 24

    Close Top of page
    End point title
    Change From Baseline in Heart Rate at Month 24 [45]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 24
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1398
    451
    Units: beats per minute
        arithmetic mean (standard deviation)
    -1.07 ± 9.91
    -0.94 ± 8.89
    No statistical analyses for this end point

    Primary: Change From Baseline in Heart Rate at Month 36

    Close Top of page
    End point title
    Change From Baseline in Heart Rate at Month 36 [46]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 36
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1123
    386
    Units: beats per minute
        arithmetic mean (standard deviation)
    -1.38 ± 9.81
    -1 ± 9.26
    No statistical analyses for this end point

    Primary: Change From Baseline in Heart Rate at Month 48

    Close Top of page
    End point title
    Change From Baseline in Heart Rate at Month 48 [47]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Month 48
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    422
    127
    Units: beats per minute
        arithmetic mean (standard deviation)
    -0.91 ± 10.64
    -0.64 ± 10.64
    No statistical analyses for this end point

    Primary: Number of Subjects With Electrocardiogram (ECG) Abnormalities

    Close Top of page
    End point title
    Number of Subjects With Electrocardiogram (ECG) Abnormalities [48]
    End point description
    Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett’s Correction) and QTcF (Fridericia’s Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2281
    586
    Units: subjects
    7
    2
    No statistical analyses for this end point

    Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6

    Close Top of page
    End point title
    Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 [49]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2264
    583
    Units: milliseconds (msec)
    arithmetic mean (standard deviation)
        Baseline: QRS Complex (n =2264, 583)
    92.88 ± 9.12
    92.31 ± 9.75
        Baseline: PR Interval (n =2258, 583)
    162.32 ± 21.32
    158.91 ± 20.62
        Baseline: QT Interval (n =2264, 583)
    392.39 ± 29.12
    395.75 ± 29.7
        Baseline: QTcB Interval (n =2264, 583)
    415.7 ± 23.83
    416.91 ± 23.04
        Baseline: QTcF Interval (n =2264, 583)
    407.48 ± 20.74
    409.42 ± 20.11
        Baseline: RR Interval (n =2264, 583)
    901.27 ± 145.58
    911.59 ± 150.35
        Change at Month 6: QRS Complex (n =1995, 550)
    1.51 ± 8.28
    2.01 ± 7.5
        Change at Month 6: PR Interval (n =1986, 549)
    2.46 ± 13.79
    2.76 ± 14.81
        Change at Month 6: QT Interval (n =1995, 550)
    2.25 ± 24.49
    2.52 ± 24.39
        Change at Month 6: QTcB Interval (n =1995, 550)
    -0.84 ± 20.49
    -1.38 ± 20.31
        Change at Month 6: QTcF Interval (n =1995, 550)
    0.23 ± 17.14
    -0.03 ± 17.68
        Change at Month 6: RR Interval (n =1995, 550)
    14.35 ± 130.91
    18.77 ± 123.49
    No statistical analyses for this end point

    Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12

    Close Top of page
    End point title
    Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 [50]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1727
    516
    Units: msec
    arithmetic mean (standard deviation)
        QRS Complex (n =1726, 516)
    1.89 ± 7.93
    2.11 ± 7.53
        PR Interval (n =1717, 515)
    2.8 ± 14.32
    3.21 ± 14.31
        QT Interval (n =1726, 516)
    2.49 ± 23.26
    2.69 ± 23
        QTcB Interval (n =1726, 516)
    -1.04 ± 20.63
    -1.09 ± 20.83
        QTcF Interval (n =1726, 516)
    0.16 ± 16.71
    0.23 ± 17.2
        RR Interval (n =1727, 516)
    15.94 ± 130.6
    17.55 ± 128.16
    No statistical analyses for this end point

    Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24

    Close Top of page
    End point title
    Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 [51]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 24
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    1352
    432
    Units: msec
    arithmetic mean (standard deviation)
        QRS Complex (n =1352, 432)
    2 ± 8.55
    2.42 ± 9.13
        PR Interval (n =1346, 432)
    3.49 ± 14.55
    3.81 ± 14.67
        QT Interval (n =1352, 432)
    3.93 ± 24.93
    2.28 ± 24.8
        QTcB Interval (n =1352, 431)
    0.15 ± 20.77
    0.78 ± 21.06
        QTcF Interval (n =1352, 431)
    1.47 ± 16.86
    1.25 ± 17.72
        RR Interval (n =1352, 432)
    17.7 ± 139.47
    8.66 ± 135.06
    No statistical analyses for this end point

    Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36

    Close Top of page
    End point title
    Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 [52]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 36
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    845
    283
    Units: msec
    arithmetic mean (standard deviation)
        QRS Complex (n =845, 283)
    1.75 ± 8.47
    1.85 ± 10.37
        PR Interval (n =840, 282)
    4.18 ± 14.5
    3.25 ± 15.5
        QT Interval (n =844, 283)
    4.31 ± 24.93
    2.52 ± 22.63
        QTcB Interval (n =844, 283)
    0.44 ± 21.29
    -0.01 ± 22.21
        QTcF Interval (n =844, 283)
    1.79 ± 17.57
    0.84 ± 17.63
        RR Interval (n =845, 283)
    18.24 ± 136.44
    15.14 ± 131.42
    No statistical analyses for this end point

    Primary: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48

    Close Top of page
    End point title
    Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 [53]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Here, 'number of subjects analyzed' signifies subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 48
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    126
    55
    Units: msec
    arithmetic mean (standard deviation)
        QRS Complex (n =126, 55)
    2.37 ± 10.17
    1.31 ± 5.37
        PR Interval (n =126, 55)
    6.26 ± 12.58
    1.98 ± 13.2
        QT Interval (n =126, 55)
    6.43 ± 24.05
    1.69 ± 23.43
        QTcB Interval (n =125, 55)
    3.42 ± 20.11
    -2 ± 22.64
        QTcF Interval (n =125, 55)
    4.55 ± 15.84
    -0.87 ± 19.38
        RR Interval (n =126, 55)
    15.69 ± 143.06
    20.78 ± 119.61
    No statistical analyses for this end point

    Primary: Number of Subjects With Adjudicated Cardiovascular Events

    Close Top of page
    End point title
    Number of Subjects With Adjudicated Cardiovascular Events [54]
    End point description
    Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2281
    586
    Units: subjects
    32
    13
    No statistical analyses for this end point

    Primary: Number of Subjects With Malignancy Events

    Close Top of page
    End point title
    Number of Subjects With Malignancy Events [55]
    End point description
    Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Notes
    [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive data was planned to be reported for this endpoint
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2281
    586
    Units: subjects
    87
    26
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'

    Close Top of page
    End point title
    Percentage of Subjects Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
    End point description
    PGA of psoriasis was scored on a 5-point scale,reflecting a global consideration of the erythema (E),induration (I) and scaling (S) across all psoriatic lesions in subjects.The severity rating scores(Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders;Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. Total average was rounded to the nearest whole number score to determine the PGA.The 5-point scale for PGA was: 0= clear;1= almost clear;2= mild;3= moderate;4= severe,where higher score indicating more severity.Percentage of subjects with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported. Full analysis set (FAS).Here,‘number of subjects analyzed’ =subjects evaluable for this endpoint and ‘n’=subjects evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2200
    571
    Units: percentage of subjects
    number (confidence interval 95%)
        Month 1 (n =2196, 563)
    50.36 (48.27 to 52.46)
    77.8 (74.36 to 81.23)
        Month 3 (n =2200, 571)
    54.86 (52.78 to 56.94)
    85.29 (82.38 to 88.19)
        Month 6 (n =2052, 564)
    54.97 (52.82 to 57.12)
    82.09 (78.93 to 85.26)
        Month 12 (n =1776, 532)
    54.79 (52.47 to 57.1)
    75.19 (71.52 to 78.86)
        Month 24 (n =1397, 448)
    54.62 (52.01 to 57.23)
    79.46 (75.72 to 83.2)
        Month 36 (n =1123, 385)
    57.35 (54.45 to 60.24)
    76.36 (72.12 to 80.61)
        Month 48 (n =422, 126)
    48.58 (43.81 to 53.35)
    77.78 (70.52 to 85.04)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    Close Top of page
    End point title
    Percentage of Subjects Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease),with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=75% reduction from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2200
    566
    Units: percentage of subjects
    number (confidence interval 95%)
        Month 1 (n =2194, 555)
    51.96 (49.87 to 54.05)
    71.89 (68.15 to 75.63)
        Month 3 (n =2200, 566)
    58.45 (56.4 to 60.51)
    84.45 (81.47 to 87.44)
        Month 6 (n =2048, 557)
    61.67 (59.56 to 63.78)
    86 (83.11 to 88.88)
        Month 12 (n =1775, 525)
    65.24 (63.02 to 67.45)
    80.76 (77.39 to 84.13)
        Month 24 (n =1393, 445)
    67.26 (64.8 to 69.73)
    84.94 (81.62 to 88.27)
        Month 36 (n =1118, 380)
    70.75 (68.08 to 73.42)
    83.95 (80.26 to 87.64)
        Month 48 (n =422, 124)
    64.93 (60.38 to 69.48)
    83.06 (76.46 to 89.67)
    No statistical analyses for this end point

    Secondary: Psoriasis Area and Severity Index (PASI) Scores

    Close Top of page
    End point title
    Psoriasis Area and Severity Index (PASI) Scores
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2266
    585
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n =2266, 585)
    21.85 ± 9.48
    19.05 ± 8.89
        Month 1 (n =2198, 561)
    6.6 ± 7.14
    3.09 ± 4.81
        Month 3 (n =2205, 572)
    5.64 ± 6.33
    1.95 ± 3.25
        Month 6 (n =2051, 563)
    5.31 ± 6.31
    1.9 ± 3.25
        Month 12 (n =1779, 531)
    4.72 ± 5.29
    2.38 ± 3.57
        Month 24 (n =1397, 449)
    4.41 ± 5.08
    1.9 ± 2.65
        Month 36 (n =1121, 384)
    3.91 ± 4.66
    2.19 ± 3.23
        Month 48 (n =422, 126)
    4.75 ± 5.37
    1.85 ± 2.31
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

    Close Top of page
    End point title
    Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2201
    572
    Units: units on a scale
    arithmetic mean (standard deviation)
        Month 1 (n =2195, 561)
    -15.26 ± 9.96
    -16 ± 9.57
        Month 3 (n =2201, 572)
    -16.18 ± 9.73
    -16.99 ± 9.27
        Month 6 (n =2049, 563)
    -16.56 ± 9.54
    -17.03 ± 9.16
        Month 12 (n =1776, 531)
    -17.01 ± 9.33
    -16.45 ± 9.04
        Month 24 (n =1394, 449)
    -17.25 ± 9.35
    -16.67 ± 8.7
        Month 36 (n =1119, 384)
    -17.44 ± 9.23
    -16.49 ± 8.81
        Month 48 (n =422, 126)
    -16.16 ± 8.61
    -15.47 ± 9.04
    No statistical analyses for this end point

    Secondary: Psoriasis Area and Severity Index (PASI) Component Scores: Erythema

    Close Top of page
    End point title
    Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2266
    585
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Head/Neck (n =2266, 585)
    2.26 ± 0.99
    2.13 ± 1.08
        Month 1: Head/Neck (n =2198, 561)
    0.82 ± 0.96
    0.47 ± 0.81
        Month 3: Head/Neck (n =2205, 572)
    0.76 ± 0.95
    0.34 ± 0.65
        Month 6: Head/Neck (n =2051, 563)
    0.75 ± 0.95
    0.42 ± 0.75
        Month 12: Head/Neck (n =1779, 531)
    0.7 ± 0.92
    0.49 ± 0.82
        Month 24: Head/Neck (n =1397, 449)
    0.66 ± 0.93
    0.47 ± 0.75
        Month 36: Head/Neck (n =1121, 384)
    0.57 ± 0.88
    0.48 ± 0.79
        Month 48: Head/Neck (n =422, 126)
    0.7 ± 0.93
    0.34 ± 0.69
        Baseline: Upper Limbs (n =2266, 585)
    2.82 ± 0.74
    2.68 ± 0.86
        Month 1: Upper Limbs (n =2198, 561)
    1.29 ± 0.98
    0.71 ± 0.86
        Month 3: Upper Limbs (n =2205, 572)
    1.23 ± 1
    0.57 ± 0.79
        Month 6: Upper Limbs (n =2051, 563)
    1.2 ± 1.01
    0.58 ± 0.83
        Month 12: Upper Limbs (n =1779, 531)
    1.16 ± 1.01
    0.74 ± 0.95
        Month 24: Upper Limbs (n =1397, 449)
    1.13 ± 1.03
    0.61 ± 0.85
        Month 36: Upper Limbs (n =1121, 384)
    1.06 ± 1.01
    0.68 ± 0.86
        Month 48: Upper Limbs (n =422, 126)
    1.18 ± 1.03
    0.58 ± 0.84
        Baseline: Trunk (n =2266, 585)
    2.83 ± 0.83
    2.73 ± 0.94
        Month 1: Trunk (n =2198, 561)
    1.18 ± 1.11
    0.62 ± 0.92
        Month 3: Trunk (n =2205, 572)
    1.06 ± 1.09
    0.41 ± 0.73
        Month 6: Trunk (n =2051, 563)
    1.03 ± 1.09
    0.41 ± 0.79
        Month 12: Trunk (n =1779, 531)
    0.99 ± 1.08
    0.51 ± 0.89
        Month 24: Trunk (n =1397, 449)
    0.96 ± 1.08
    0.49 ± 0.84
        Month 36: Trunk (n =1121, 384)
    0.86 ± 1.06
    0.53 ± 0.9
        Month 48: Trunk (n =422, 126)
    1 ± 1.1
    0.5 ± 0.86
        Baseline: Lower Limbs (n =2266, 585)
    3.1 ± 0.7
    2.94 ± 0.89
        Month 1: Lower Limbs (n =2198, 561)
    1.37 ± 1.09
    0.79 ± 0.95
        Month 3: Lower Limbs (n =2205, 572)
    1.24 ± 1.08
    0.58 ± 0.84
        Month 6: Lower Limbs (n =2051, 563)
    1.2 ± 1.11
    0.52 ± 0.81
        Month 12: Lower Limbs (n =1779, 531)
    1.17 ± 1.1
    0.69 ± 0.98
        Month 24: Lower Limbs (n =1397, 449)
    1.15 ± 1.11
    0.59 ± 0.9
        Month 36: Lower Limbs (n =1121, 384)
    1.07 ± 1.11
    0.67 ± 0.96
        Month 48: Lower Limbs (n =422, 126)
    1.2 ± 1.11
    0.61 ± 0.91
    No statistical analyses for this end point

    Secondary: Psoriasis Area and Severity Index (PASI) Component Scores: Induration

    Close Top of page
    End point title
    Psoriasis Area and Severity Index (PASI) Component Scores: Induration
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2266
    585
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Head/Neck (n =2266, 585)
    1.97 ± 1.01
    1.88 ± 1.1
        Month 1: Head/Neck (n =2198, 561)
    0.65 ± 0.85
    0.35 ± 0.73
        Month 3: Head/Neck (n =2205, 572)
    0.6 ± 0.84
    0.26 ± 0.56
        Month 6: Head/Neck (n =2051, 563)
    0.59 ± 0.86
    0.31 ± 0.67
        Month 12: Head/Neck (n =1779, 531)
    0.55 ± 0.81
    0.38 ± 0.71
        Month 24: Head/Neck (n =1397, 449)
    0.53 ± 0.82
    0.37 ± 0.68
        Month 36: Head/Neck (n =1121, 384)
    0.46 ± 0.77
    0.37 ± 0.68
        Month 48: Head/Neck (n =422, 126)
    0.6 ± 0.85
    0.26 ± 0.6
        Baseline: Upper Limbs (n =2266, 585)
    2.64 ± 0.77
    2.5 ± 0.93
        Month 1: Upper Limbs (n =2198, 561)
    1.21 ± 0.99
    0.66 ± 0.88
        Month 3: Upper Limbs (n =2205, 572)
    1.17 ± 1.01
    0.53 ± 0.81
        Month 6: Upper Limbs (n =2051, 563)
    1.15 ± 1.02
    0.55 ± 0.85
        Month 12: Upper Limbs (n =1779, 531)
    1.11 ± 1.01
    0.69 ± 0.95
        Month 24: Upper Limbs (n =1397, 449)
    1.08 ± 1.02
    0.53 ± 0.84
        Month 36: Upper Limbs (n =1121, 384)
    1 ± 1.01
    0.6 ± 0.82
        Month 48: Upper Limbs (n =422, 126)
    1.09 ± 1
    0.5 ± 0.75
        Baseline: Trunk (n =2266, 585)
    2.57 ± 0.86
    2.51 ± 1.01
        Month 1: Trunk (n =2198, 561)
    1.02 ± 1.04
    0.52 ± 0.86
        Month 3: Trunk (n =2205, 572)
    0.91 ± 1.02
    0.34 ± 0.68
        Month 6: Trunk (n =2051, 563)
    0.88 ± 1
    0.34 ± 0.71
        Month 12: Trunk (n =1779, 531)
    0.87 ± 1
    0.42 ± 0.77
        Month 24: Trunk (n =1397, 449)
    0.82 ± 0.98
    0.39 ± 0.73
        Month 36: Trunk (n =1121, 384)
    0.75 ± 0.97
    0.43 ± 0.79
        Month 48: Trunk (n =422, 126)
    0.91 ± 1.05
    0.44 ± 0.8
        Baseline: Lower Limbs (n =2266, 585)
    2.85 ± 0.76
    2.77 ± 0.96
        Month 1: Lower Limbs (n =2198, 561)
    1.22 ± 1.04
    0.68 ± 0.95
        Month 3: Lower Limbs (n =2205, 572)
    1.1 ± 1.04
    0.51 ± 0.84
        Month 6: Lower Limbs (n =2051, 563)
    1.08 ± 1.06
    0.47 ± 0.82
        Month 12: Lower Limbs (n =1779, 531)
    1.05 ± 1.03
    0.61 ± 0.94
        Month 24: Lower Limbs (n =1397, 449)
    1.02 ± 1.03
    0.49 ± 0.83
        Month 36: Lower Limbs (n =1121, 384)
    0.95 ± 1.03
    0.57 ± 0.87
        Month 48: Lower Limbs (n =422, 126)
    1.07 ± 1.04
    0.48 ± 0.79
    No statistical analyses for this end point

    Secondary: Psoriasis Area and Severity Index (PASI) Component Scores: Scaling

    Close Top of page
    End point title
    Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2266
    585
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Head/Neck (n =2266, 585)
    2.22 ± 1.08
    2.1 ± 1.11
        Month 1: Head/Neck (n =2198, 561)
    0.75 ± 0.95
    0.42 ± 0.79
        Month 3: Head/Neck (n =2205, 572)
    0.71 ± 0.95
    0.32 ± 0.66
        Month 6: Head/Neck (n =2051, 563)
    0.71 ± 0.97
    0.4 ± 0.77
        Month 12: Head/Neck (n =1779, 531)
    0.67 ± 0.92
    0.48 ± 0.84
        Month 24: Head/Neck (n =1397, 449)
    0.6 ± 0.88
    0.45 ± 0.77
        Month 36: Head/Neck (n =1121, 384)
    0.55 ± 0.88
    0.47 ± 0.79
        Month 48: Head/Neck (n =422, 126)
    0.65 ± 0.93
    0.34 ± 0.72
        Baseline: Upper Limbs (n =2266, 585)
    2.65 ± 0.82
    2.52 ± 0.96
        Month 1: Upper Limbs (n =2198, 561)
    1.22 ± 1.01
    0.69 ± 0.89
        Month 3: Upper Limbs (n =2205, 572)
    1.18 ± 1.04
    0.55 ± 0.8
        Month 6: Upper Limbs (n =2051, 563)
    1.16 ± 1.05
    0.58 ± 0.87
        Month 12: Upper Limbs (n =1779, 531)
    1.12 ± 1.03
    0.72 ± 0.97
        Month 24: Upper Limbs (n =1397, 449)
    1.08 ± 1.03
    0.58 ± 0.84
        Month 36: Upper Limbs (n =1121, 384)
    1.01 ± 1.02
    0.62 ± 0.83
        Month 48: Upper Limbs (n =422, 126)
    1.13 ± 1.09
    0.53 ± 0.79
        Baseline: Trunk (n =2266, 585)
    2.55 ± 0.89
    2.47 ± 1
        Month 1: Trunk (n =2198, 561)
    0.97 ± 1.02
    0.5 ± 0.83
        Month 3: Trunk (n =2205, 572)
    0.87 ± 1
    0.33 ± 0.64
        Month 6: Trunk (n =2051, 563)
    0.85 ± 0.99
    0.33 ± 0.7
        Month 12: Trunk (n =1779, 531)
    0.83 ± 0.97
    0.4 ± 0.76
        Month 24: Trunk (n =1397, 449)
    0.78 ± 0.95
    0.39 ± 0.72
        Month 36: Trunk (n =1121, 384)
    0.71 ± 0.93
    0.42 ± 0.77
        Month 48: Trunk (n =422, 126)
    0.86 ± 0.99
    0.4 ± 0.78
        Baseline: Lower Limbs (n =2266, 585)
    2.89 ± 0.81
    2.79 ± 1
        Month 1: Lower Limbs (n =2198, 561)
    1.23 ± 1.08
    0.7 ± 0.93
        Month 3: Lower Limbs (n =2205, 572)
    1.12 ± 1.08
    0.48 ± 0.78
        Month 6: Lower Limbs (n =2051, 563)
    1.11 ± 1.1
    0.48 ± 0.83
        Month 12: Lower Limbs (n =1779, 531)
    1.07 ± 1.07
    0.64 ± 0.98
        Month 24: Lower Limbs (n =1397, 449)
    1.04 ± 1.06
    0.53 ± 0.84
        Month 36: Lower Limbs (n =1121, 384)
    0.94 ± 1.03
    0.6 ± 0.9
        Month 48: Lower Limbs (n =422, 126)
    1.09 ± 1.09
    0.48 ± 0.76
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48

    Close Top of page
    End point title
    Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2201
    572
    Units: units on a scale
    arithmetic mean (standard deviation)
        Month 1: Head/Neck (n =2195, 561)
    -1.43 ± 1.15
    -1.66 ± 1.2
        Month 3: Head/Neck (n =2201, 572)
    -1.5 ± 1.18
    -1.8 ± 1.18
        Month 6: Head/Neck (n =2049, 563)
    -1.52 ± 1.2
    -1.72 ± 1.21
        Month 12: Head/Neck (n =1776, 531)
    -1.56 ± 1.19
    -1.64 ± 1.22
        Month 24: Head/Neck (n =1394, 449)
    -1.62 ± 1.19
    -1.67 ± 1.23
        Month 36: Head/Neck (n =1119, 384)
    -1.72 ± 1.18
    -1.67 ± 1.2
        Month 48: Head/Neck (n =422, 126)
    -1.55 ± 1.19
    -1.7 ± 1.13
        Month 1: Upper Limbs (n =2195, 561)
    -1.53 ± 1.12
    -1.98 ± 1.18
        Month 3: Upper Limbs (n =2201, 572)
    -1.59 ± 1.15
    -2.12 ± 1.14
        Month 6: Upper Limbs (n =2049, 563)
    -1.62 ± 1.15
    -2.09 ± 1.13
        Month 12: Upper Limbs (n =1776, 531)
    -1.67 ± 1.15
    -1.94 ± 1.21
        Month 24: Upper Limbs (n =1394, 449)
    -1.7 ± 1.18
    -2.05 ± 1.19
        Month 36: Upper Limbs (n =1119, 384)
    -1.78 ± 1.17
    -2 ± 1.18
        Month 48: Upper Limbs (n =422, 126)
    -1.62 ± 1.16
    -1.9 ± 1.22
        Month 1: Trunk (n =2195, 561)
    -1.65 ± 1.22
    -2.12 ± 1.26
        Month 3: Trunk (n =2201, 572)
    -1.77 ± 1.24
    -2.33 ± 1.17
        Month 6: Trunk (n =2049, 563)
    -1.81 ± 1.24
    -2.32 ± 1.19
        Month 12: Trunk (n =1776, 531)
    -1.86 ± 1.24
    -2.21 ± 1.25
        Month 24: Trunk (n =1394, 449)
    -1.88 ± 1.25
    -2.22 ± 1.26
        Month 36: Trunk (n =1119, 384)
    -1.99 ± 1.26
    -2.18 ± 1.3
        Month 48: Trunk (n =422, 126)
    -1.82 ± 1.22
    -2.08 ± 1.17
        Month 1: Lower Limbs (n =2195, 561)
    -1.72 ± 1.19
    -2.16 ± 1.26
        Month 3: Lower Limbs (n =2201, 572)
    -1.87 ± 1.21
    -2.36 ± 1.21
        Month 6: Lower Limbs (n =2049, 563)
    -1.9 ± 1.22
    -2.42 ± 1.18
        Month 12: Lower Limbs (n =1776, 531)
    -1.94 ± 1.23
    -2.24 ± 1.33
        Month 24: Lower Limbs (n =1394, 449)
    -1.95 ± 1.25
    -2.32 ± 1.24
        Month 36: Lower Limbs (n =1119, 384)
    -2.04 ± 1.23
    -2.28 ± 1.3
        Month 48: Lower Limbs (n =422, 126)
    -1.87 ± 1.2
    -2.17 ± 1.21
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48

    Close Top of page
    End point title
    Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2201
    572
    Units: units on a scale
    arithmetic mean (standard deviation)
        Month 1: Head/Neck (n =2195, 561)
    -1.32 ± 1.13
    -1.53 ± 1.15
        Month 3: Head/Neck (n =2201, 572)
    -1.37 ± 1.17
    -1.63 ± 1.14
        Month 6: Head/Neck (n =2049, 563)
    -1.4 ± 1.16
    -1.57 ± 1.18
        Month 12: Head/Neck (n =1776, 531)
    -1.44 ± 1.18
    -1.49 ± 1.18
        Month 24: Head/Neck (n =1394, 449)
    -1.48 ± 1.17
    -1.51 ± 1.21
        Month 36: Head/Neck (n =1119, 384)
    -1.55 ± 1.17
    -1.51 ± 1.15
        Month 48: Head/Neck (n =422, 126)
    -1.35 ± 1.17
    -1.41 ± 1.1
        Month 1: Upper Limbs (n =2195, 561)
    -1.43 ± 1.14
    -1.85 ± 1.22
        Month 3: Upper Limbs (n =2201, 572)
    -1.47 ± 1.17
    -1.97 ± 1.16
        Month 6: Upper Limbs (n =2049, 563)
    -1.49 ± 1.15
    -1.94 ± 1.19
        Month 12: Upper Limbs (n =1776, 531)
    -1.54 ± 1.14
    -1.82 ± 1.27
        Month 24: Upper Limbs (n =1394, 449)
    -1.57 ± 1.18
    -1.97 ± 1.19
        Month 36: Upper Limbs (n =1119, 384)
    -1.65 ± 1.17
    -1.92 ± 1.18
        Month 48: Upper Limbs (n =422, 126)
    -1.53 ± 1.14
    -1.83 ± 1.14
        Month 1: Trunk (n =2195, 561)
    -1.55 ± 1.19
    -2.01 ± 1.26
        Month 3: Trunk (n =2201, 572)
    -1.65 ± 1.22
    -2.17 ± 1.18
        Month 6: Trunk (n =2049, 563)
    -1.7 ± 1.19
    -2.18 ± 1.2
        Month 12: Trunk (n =1776, 531)
    -1.71 ± 1.2
    -2.1 ± 1.24
        Month 24: Trunk (n =1394, 449)
    -1.76 ± 1.19
    -2.13 ± 1.2
        Month 36: Trunk (n =1119, 384)
    -1.85 ± 1.2
    -2.09 ± 1.23
        Month 48: Trunk (n =422, 126)
    -1.68 ± 1.17
    -1.87 ± 1.2
        Month 1: Lower Limbs (n =2195, 561)
    -1.63 ± 1.22
    -2.09 ± 1.31
        Month 3: Lower Limbs (n =2201, 572)
    -1.75 ± 1.22
    -2.26 ± 1.24
        Month 6: Lower Limbs (n =2049, 563)
    -1.78 ± 1.23
    -2.3 ± 1.23
        Month 12: Lower Limbs (n =1776, 531)
    -1.82 ± 1.2
    -2.17 ± 1.33
        Month 24: Lower Limbs (n =1394, 449)
    -1.85 ± 1.22
    -2.28 ± 1.24
        Month 36: Lower Limbs (n =1119, 384)
    -1.93 ± 1.21
    -2.22 ± 1.29
        Month 48: Lower Limbs (n =422, 126)
    -1.77 ± 1.18
    -2.07 ± 1.24
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48

    Close Top of page
    End point title
    Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2201
    572
    Units: units on a scale
    arithmetic mean (standard deviation)
        Month 1: Head/Neck (n =2195, 561)
    -1.46 ± 1.19
    -1.69 ± 1.2
        Month 3: Head/Neck (n =2201, 572)
    -1.51 ± 1.24
    -1.78 ± 1.19
        Month 6: Head/Neck (n =2049, 563)
    -1.52 ± 1.24
    -1.7 ± 1.22
        Month 12: Head/Neck (n =1776, 531)
    -1.56 ± 1.25
    -1.61 ± 1.24
        Month 24: Head/Neck (n =1394, 449)
    -1.63 ± 1.24
    -1.63 ± 1.27
        Month 36: Head/Neck (n =1119, 384)
    -1.68 ± 1.22
    -1.64 ± 1.22
        Month 48: Head/Neck (n =422, 126)
    -1.53 ± 1.24
    -1.58 ± 1.17
        Month 1: Upper Limbs (n =2195, 561)
    -1.44 ± 1.18
    -1.84 ± 1.24
        Month 3: Upper Limbs (n =2201, 572)
    -1.47 ± 1.2
    -1.97 ± 1.18
        Month 6: Upper Limbs (n =2049, 563)
    -1.49 ± 1.21
    -1.94 ± 1.26
        Month 12: Upper Limbs (n =1776, 531)
    -1.52 ± 1.21
    -1.82 ± 1.3
        Month 24: Upper Limbs (n =1394, 449)
    -1.56 ± 1.22
    -1.96 ± 1.22
        Month 36: Upper Limbs (n =1119, 384)
    -1.65 ± 1.19
    -1.93 ± 1.15
        Month 48: Upper Limbs (n =422, 126)
    -1.45 ± 1.19
    -1.78 ± 1.22
        Month 1: Trunk (n =2195, 561)
    -1.58 ± 1.2
    -1.98 ± 1.24
        Month 3: Trunk (n =2201, 572)
    -1.67 ± 1.22
    -2.14 ± 1.14
        Month 6: Trunk (n =2049, 563)
    -1.7 ± 1.19
    -2.14 ± 1.22
        Month 12: Trunk (n =1776, 531)
    -1.72 ± 1.21
    -2.08 ± 1.23
        Month 24: Trunk (n =1394, 449)
    -1.77 ± 1.2
    -2.11 ± 1.19
        Month 36: Trunk (n =1119, 384)
    -1.84 ± 1.2
    -2.06 ± 1.23
        Month 48: Trunk (n =422, 126)
    -1.62 ± 1.19
    -1.8 ± 1.18
        Month 1: Lower Limbs (n =2195, 561)
    -1.67 ± 1.24
    -2.09 ± 1.3
        Month 3: Lower Limbs (n =2201, 572)
    -1.77 ± 1.26
    -2.3 ± 1.23
        Month 6: Lower Limbs (n =2049, 563)
    -1.79 ± 1.27
    -2.3 ± 1.25
        Month 12: Lower Limbs (n =1776, 531)
    -1.83 ± 1.26
    -2.15 ± 1.36
        Month 24: Lower Limbs (n =1394, 449)
    -1.86 ± 1.27
    -2.25 ± 1.24
        Month 36: Lower Limbs (n =1119, 384)
    -1.97 ± 1.23
    -2.21 ± 1.26
        Month 48: Lower Limbs (n =422, 126)
    -1.77 ± 1.29
    -2.11 ± 1.23
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    Close Top of page
    End point title
    Percentage of Subjects Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=50% reduction from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2200
    566
    Units: percentage of subjects
    number (confidence interval 95%)
        Month 1 (n =2194, 555)
    76.53 (74.75 to 78.3)
    86.67 (83.84 to 89.49)
        Month 3 (n =2200, 566)
    81.59 (79.97 to 83.21)
    95.05 (93.27 to 96.84)
        Month 6 (n =2048, 557)
    85.64 (84.13 to 87.16)
    93.9 (91.91 to 95.88)
        Month 12 (n =1775, 525)
    87.66 (86.13 to 89.19)
    93.14 (90.98 to 95.3)
        Month 24 (n =1393, 445)
    88.87 (87.22 to 90.52)
    94.61 (92.51 to 96.71)
        Month 36 (n =1118, 380)
    90.97 (89.29 to 92.65)
    92.63 (90 to 95.26)
        Month 48 (n =422, 124)
    88.86 (85.86 to 91.86)
    97.58 (94.88 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    Close Top of page
    End point title
    Percentage of Subjects Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=90% reduction from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2200
    566
    Units: percentage of subjects
    number (confidence interval 95%)
        Month 1 (n =2194, 555)
    29.99 (28.07 to 31.91)
    56.04 (51.91 to 60.17)
        Month 3 (n =2200, 566)
    33.73 (31.75 to 35.7)
    65.37 (61.45 to 69.29)
        Month 6 (n =2048, 557)
    35.21 (33.14 to 37.27)
    65.89 (61.95 to 69.83)
        Month 12 (n =1775, 525)
    35.94 (33.71 to 38.18)
    61.71 (57.56 to 65.87)
        Month 24 (n =1393, 445)
    38.33 (35.78 to 40.89)
    62.02 (57.51 to 66.53)
        Month 36 (n =1118, 380)
    43.02 (40.12 to 45.93)
    60.53 (55.61 to 65.44)
        Month 48 (n =422, 124)
    34.36 (29.83 to 38.89)
    58.06 (49.38 to 66.75)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    Close Top of page
    End point title
    Percentage of Subjects Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores
    End point description
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of subjects with >=125% increase from baseline in PASI scores were reported. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2200
    566
    Units: percentage of subjects
    number (confidence interval 95%)
        Month 1 (n =2194, 555)
    0.96 (0.55 to 1.36)
    1.08 (0.22 to 1.94)
        Month 3 (n =2200, 566)
    1.18 (0.73 to 1.63)
    0.71 (0.02 to 1.4)
        Month 6 (n =2048, 557)
    1.27 (0.78 to 1.75)
    0.9 (0.11 to 1.68)
        Month 12 (n =1775, 525)
    0.9 (0.46 to 1.34)
    1.33 (0.35 to 2.31)
        Month 24 (n =1393, 445)
    0.93 (0.43 to 1.44)
    0.9 (0.02 to 1.78)
        Month 36 (n =1118, 380)
    0.54 (0.11 to 0.96)
    1.32 (0.17 to 2.46)
        Month 48 (n =422, 124)
    0.71 (0 to 1.51)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Itch Severity Item (ISI) Scores

    Close Top of page
    End point title
    Itch Severity Item (ISI) Scores
    End point description
    ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Subjects were asked to rate their “severity of itching’’ due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms “0=no itching” and “10=worst possible itching” at the ends. Higher scores indicated greater severity of itching. FAS included all subjects who received at least 1 dose of study drug, excluding the subjects who had compliance issues. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2197
    572
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n =2172, 566)
    5.76 ± 2.91
    5.17 ± 3
        Month 1 (n =2196, 561)
    1.88 ± 2.26
    0.92 ± 1.53
        Month 3 (n =2197, 572)
    1.83 ± 2.32
    0.72 ± 1.39
        Month 6 (n =2047, 560)
    1.87 ± 2.33
    0.82 ± 1.51
        Month 12 (n =1774, 530)
    1.79 ± 2.21
    1.08 ± 1.67
        Month 24 (n =1394, 449)
    1.83 ± 2.23
    1.01 ± 1.54
        Month 36 (n =1117, 383)
    1.69 ± 2.12
    1.21 ± 1.72
        Month 48 (n =417, 127)
    1.92 ± 2.3
    1.24 ± 1.74
    No statistical analyses for this end point

    Secondary: Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

    Close Top of page
    End point title
    Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
    End point description
    ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Subjects were asked to rate their “severity of itching’’ due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms “0=no itching” and “10=worst possible itching” at the ends. Higher scores indicated greater severity of itching. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2107
    554
    Units: units on a scale
    arithmetic mean (standard deviation)
        Month 1 (n =2107, 544)
    -3.88 ± 3.06
    -4.26 ± 3.07
        Month 3 (n =2103, 554)
    -3.94 ± 3.18
    -4.44 ± 3.06
        Month 6 (n =1958, 543)
    -3.91 ± 3.2
    -4.36 ± 3.14
        Month 12 (n =1693, 514)
    -3.9 ± 3.17
    -4.01 ± 3.3
        Month 24 (n =1340, 435)
    -3.8 ± 3.14
    -4.11 ± 3.17
        Month 36 (n =1078, 372)
    -3.95 ± 3.18
    -3.84 ± 3.06
        Month 48 (n =411, 126)
    -4.03 ± 3.19
    -3.78 ± 3.25
    No statistical analyses for this end point

    Secondary: Dermatology Life Quality Index (DLQI) Scores

    Close Top of page
    End point title
    Dermatology Life Quality Index (DLQI) Scores
    End point description
    The DLQI is a validated, self-administered, 10-item quality-of-life questionnaire that consists of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2243
    582
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n =2243, 582)
    12.73 ± 7.12
    10.95 ± 6.61
        Month 1 (n =2189, 559)
    4.11 ± 5.23
    2.14 ± 3.43
        Month 6 (n =2028, 557)
    3.68 ± 5
    1.67 ± 3.33
        Month 12 (n =1751, 528)
    3.44 ± 4.65
    1.71 ± 2.92
        Month 24 (n =1361, 441)
    3.49 ± 4.71
    1.94 ± 3.29
        Month 36 (n =1093, 372)
    2.97 ± 4.05
    1.98 ± 3.35
        Month 48 (n =407, 124)
    3.2 ± 4.39
    1.81 ± 2.98
    No statistical analyses for this end point

    Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48

    Close Top of page
    End point title
    Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
    End point description
    The DLQI is a validated, self-administered, 10-item quality-of-life questionnaire that consists of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2163
    556
    Units: units on a scale
    arithmetic mean (standard deviation)
        Month 1 (n =2163, 556)
    -8.61 ± 7
    -8.75 ± 6.56
        Month 6 (n =2005, 554)
    -9.14 ± 7.06
    -9.22 ± 6.92
        Month 12 (n =1730, 525)
    -9.23 ± 6.91
    -9.02 ± 6.68
        Month 24 (n =1345, 438)
    -9.08 ± 6.82
    -8.47 ± 6.43
        Month 36 (n =1083, 369)
    -9.47 ± 6.8
    -8.46 ± 6.14
        Month 48 (n =404, 122)
    -8.99 ± 6.74
    -7.78 ± 6.1
    No statistical analyses for this end point

    Secondary: 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores

    Close Top of page
    End point title
    36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
    End point description
    The SF-36 questionnaire, version 2 is a 36-item generic health status measure. SF-36 evaluates 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranges from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranges from 0 (worst) to 100 (best), with higher scores indicating good health condition. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2233
    580
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n =2233, 580)
    47.31 ± 9.38
    48.94 ± 9.12
        Month 6 (n =2025, 557)
    51.78 ± 8.24
    53.51 ± 7.3
        Month 12 (n =1750, 524)
    51.96 ± 8.13
    53.58 ± 7.19
        Month 24 (n =1362, 442)
    51.91 ± 7.8
    53.15 ± 7.32
        Month 36 (n =857, 286)
    52.01 ± 8.08
    53.05 ± 7.28
        Month 48 (n =124, 56)
    52.93 ± 6.79
    52.36 ± 8.39
    No statistical analyses for this end point

    Secondary: 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores

    Close Top of page
    End point title
    36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
    End point description
    The SF-36 questionnaire, version 2 is a 36-item generic health status measure. SF-36 evaluates 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranges from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranges from 0 (worst) to 100 (best), with higher scores indicating good health condition. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2233
    580
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n =2233, 580)
    43.51 ± 11.98
    43.96 ± 11.23
        Month 6 (n =2025, 557)
    48.86 ± 10.02
    50.03 ± 9.14
        Month 12 (n =1750, 524)
    49.1 ± 9.89
    49.78 ± 9.28
        Month 24 (n =1362, 442)
    49.22 ± 9.82
    49.66 ± 9.54
        Month 36 (n =857, 286)
    49.21 ± 9.95
    50.17 ± 8.2
        Month 48 (n =124, 56)
    50.14 ± 8.96
    49.6 ± 8.24
    No statistical analyses for this end point

    Secondary: Number of Subjects With Patient Global Assessment (PtGA) Response of “Clear” or “Almost Clear”

    Close Top of page
    End point title
    Number of Subjects With Patient Global Assessment (PtGA) Response of “Clear” or “Almost Clear”
    End point description
    The PtGA evaluated the overall skin disease of subjects at that point in time on a single-item. Subjects provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Subjects who provided their response as “clear (score of 0)” or “almost clear (score of 1)” in PtGA at each specified visit were reported in this endpoint. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2244
    583
    Units: subjects
        Baseline: Clear (n =2244, 583)
    1
    3
        Baseline: Almost Clear (n =2244, 583)
    25
    16
        Month 1: Clear (n =2192, 561)
    211
    127
        Month 1: Almost Clear (n =2192, 561)
    703
    246
        Month 3: Clear (n =2177, 568)
    248
    174
        Month 3: Almost Clear (n =2177, 568)
    762
    254
        Month 6: Clear (n =2030, 562)
    247
    176
        Month 6: Almost Clear (n =2030, 562)
    748
    265
        Month 12: Clear (n =1758, 530)
    209
    151
        Month 12: Almost Clear (n =1758, 530)
    662
    236
        Month 24: Clear (n =1380, 449)
    171
    111
        Month 24: Almost Clear (n =1380, 449)
    502
    202
        Month 36: Clear (n =1112, 377)
    162
    75
        Month 36: Almost Clear (n =1112, 377)
    418
    183
        Month 48: Clear (n =410, 125)
    40
    25
        Month 48: Almost Clear (n =410, 125)
    151
    60
    No statistical analyses for this end point

    Secondary: Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores

    Close Top of page
    End point title
    Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
    End point description
    EQ-5D: subject rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigns a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2242
    581
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n =2242, 581)
    0.77 ± 0.19
    0.8 ± 0.17
        Month 6 (n =2021, 559)
    0.87 ± 0.15
    0.91 ± 0.13
        Month 12 (n =1750, 523)
    0.88 ± 0.15
    0.91 ± 0.13
        Month 24 (n =1364, 443)
    0.88 ± 0.14
    0.9 ± 0.14
        Month 36 (n =857, 284)
    0.88 ± 0.14
    0.91 ± 0.12
        Month 48 (n =124, 56)
    0.9 ± 0.13
    0.89 ± 0.12
    No statistical analyses for this end point

    Secondary: Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)

    Close Top of page
    End point title
    Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
    End point description
    EQ-5D VAS was a subject rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition. FAS. Here, ‘number of subjects analyzed’= subjects evaluable for this endpoint and n reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2224
    570
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n =2224, 570)
    66.39 ± 23.2
    68.21 ± 22.91
        Month 6 (n =2026, 559)
    78.28 ± 17.11
    83.95 ± 16.18
        Month 12 (n =1749, 525)
    78.91 ± 16.95
    83.8 ± 14.85
        Month 24 (n =1365, 443)
    79.8 ± 16.98
    83.47 ± 15.55
        Month 36 (n =856, 286)
    79.43 ± 17.01
    84.62 ± 14.28
        Month 48 (n =124, 56)
    82.14 ± 14.07
    84.5 ± 16.87
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)

    Close Top of page
    End point title
    Number of Subjects Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
    End point description
    Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included subject’s interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, subjects were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this endpoint, number of subjects who answered Ps-HCRU at any specified visits were reported.Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, 3, 6, 12, 24, 36, 48
    End point values
    Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
    Number of subjects analysed
    2281
    586
    Units: subjects
        Baseline
    156
    44
        Month 1
    153
    30
        Month 3
    204
    55
        Month 6
    288
    71
        Month 12
    234
    71
        Month 24
    171
    50
        Month 36
    114
    30
        Month 48
    22
    11
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non serious in another subject, or one subject may have experienced both a serious and non serious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Tofacitinib 5 mg or 10 mg
    Reporting group description
    Subjects received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, subjects received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.

    Reporting group title
    Tofacitinib 10 mg
    Reporting group description
    Subjects received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).

    Serious adverse events
    Tofacitinib 5 mg or 10 mg Tofacitinib 10 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    88 / 586 (15.02%)
    304 / 2281 (13.33%)
         number of deaths (all causes)
    7
    22
         number of deaths resulting from adverse events
    4
    9
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    3 / 586 (0.51%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    3 / 586 (0.51%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    3 / 2281 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 586 (0.17%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 586 (0.00%)
    7 / 2281 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Skin abrasion
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haematoma
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    SEVERE REBOUND PSORIASIS - THE PATIENT’S LAST DOSE OF MEDICATION WAS 06 APR 2015 AND THE PATIENT BEG
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 586 (0.17%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 586 (0.34%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 586 (0.00%)
    3 / 2281 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 586 (0.17%)
    4 / 2281 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial flutter
         subjects affected / exposed
    0 / 586 (0.00%)
    3 / 2281 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 586 (0.00%)
    3 / 2281 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    Cardiac valve disease
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 586 (0.17%)
    5 / 2281 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery occlusion
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 586 (0.34%)
    6 / 2281 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hypertensive cardiomyopathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 586 (0.00%)
    3 / 2281 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 586 (0.17%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonia
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic stroke
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 586 (0.34%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    2 / 586 (0.34%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital fat herniation
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 586 (0.34%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn’s disease
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Noninfective sialoadenitis
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 586 (0.17%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertensive gastropathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland disorder
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 586 (0.34%)
    4 / 2281 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive uropathy
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular acidosis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythrodermic psoriasis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 586 (0.17%)
    6 / 2281 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pustular psoriasis
         subjects affected / exposed
    0 / 586 (0.00%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 586 (0.34%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 586 (0.34%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 586 (0.34%)
    5 / 2281 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament disorder
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 586 (0.00%)
    7 / 2281 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 586 (0.00%)
    3 / 2281 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal instability
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal disorder
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 586 (0.17%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid cyst
         subjects affected / exposed
    1 / 586 (0.17%)
    0 / 2281 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic nodular goitre
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 586 (0.34%)
    2 / 2281 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 586 (0.00%)
    4 / 2281 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 586 (0.00%)
    1 / 2281 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    <