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A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01163253
Recruitment Status : Terminated
First Posted : July 15, 2010
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: CP-690,550
Enrollment 2867
Recruitment Details  
Pre-assignment Details A total of 2881 participants were enrolled in this study, however 2867 participants received treatment.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description Participants 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). Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Period Title: Overall Study
Started 2281 586
Completed 0 0
Not Completed 2281 586
Reason Not Completed
Withdrawn Due to Pregnancy             12             2
Study Terminated by Sponsor             978             349
Protocol Violation             43             12
Withdrawal by Subject             199             50
Medication Error             1             0
Lost to Follow-up             125             23
Insufficient Clinical Response             423             29
Adverse Event             300             78
Death             17             5
Ongoing             13             4
Other Unspecified             170             34
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg Total
Hide Arm/Group Description Participants 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). Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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. Total of all reporting groups
Overall Number of Baseline Participants 2281 586 2867
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2281 participants 586 participants 2867 participants
45.3  (12.5) 47.0  (13.0) 45.6  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2281 participants 586 participants 2867 participants
Female
640
  28.1%
203
  34.6%
843
  29.4%
Male
1641
  71.9%
383
  65.4%
2024
  70.6%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant 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.
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2281 586
Measure Type: Number
Unit of Measure: participants
AEs 1876 490
SAEs 304 88
2.Primary Outcome
Title Number of Adverse Events (AEs) by Severity
Hide Description An AE was any untoward medical occurrence attributed to study drug in a participant 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.
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2281 586
Measure Type: Number
Unit of Measure: adverse events
Mild 5354 1749
Moderate 3268 766
Severe 410 136
3.Primary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide 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).
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2271 578
Measure Type: Number
Unit of Measure: participants
2203 565
4.Primary Outcome
Title Change From Baseline in Hemoglobin Level at Month 1
Hide Description [Not Specified]
Time Frame Baseline, Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2277 586
Mean (Standard Deviation)
Unit of Measure: gram per deciliter (g/dL)
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)
5.Primary Outcome
Title Change From Baseline in Hemoglobin Level at Month 3
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2198 572
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.27  (0.85) -0.39  (0.83)
6.Primary Outcome
Title Change From Baseline in Hemoglobin Level at Month 6
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2051 563
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.27  (0.88) -0.30  (0.87)
7.Primary Outcome
Title Change From Baseline in Hemoglobin Level at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1759 531
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.34  (0.93) -0.30  (0.90)
8.Primary Outcome
Title Change From Baseline in Hemoglobin Level at Month 24
Hide Description [Not Specified]
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1385 449
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.30  (0.96) -0.29  (0.89)
9.Primary Outcome
Title Change From Baseline in Hemoglobin Level at Month 36
Hide Description [Not Specified]
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1114 380
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.32  (0.93) -0.37  (0.88)
10.Primary Outcome
Title Change From Baseline in Hemoglobin Level at Month 48
Hide Description [Not Specified]
Time Frame Baseline, Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 415 127
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.35  (0.97) -0.43  (0.94)
11.Primary Outcome
Title Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
Hide Description [Not Specified]
Time Frame Baseline, Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2275 586
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
Baseline: Lymphocyte Count (n =2275, 586) 1.76  (0.57) 1.80  (0.56)
Baseline: Neutrophil Count (n =2275, 586) 4.74  (1.68) 4.55  (1.70)
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)
12.Primary Outcome
Title Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2183 570
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
Lymphocyte count -0.00  (0.52) 0.02  (0.52)
Neutrophil Count -0.28  (1.63) -0.28  (1.60)
13.Primary Outcome
Title Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2034 559
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
Lymphocyte Count -0.11  (0.51) -0.05  (0.51)
Neutrophil Count -0.25  (1.61) -0.22  (1.64)
14.Primary Outcome
Title Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1751 530
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
Lymphocyte Count -0.21  (0.52) -0.16  (0.48)
Neutrophil Count -0.23  (1.61) -0.18  (1.58)
15.Primary Outcome
Title Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
Hide Description [Not Specified]
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1377 445
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
Lymphocyte Count -0.28  (0.52) -0.18  (0.54)
Neutrophil Count -0.19  (1.69) -0.02  (1.59)
16.Primary Outcome
Title Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
Hide Description [Not Specified]
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1111 377
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
Lymphocyte Count -0.35  (0.55) -0.24  (0.51)
Neutrophil Count -0.26  (1.61) -0.11  (1.68)
17.Primary Outcome
Title Change From Baseline in Lymphocyte and Neutrophil Count at Month 48
Hide Description [Not Specified]
Time Frame Baseline, Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 413 127
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
Lymphocyte Count -0.42  (0.52) -0.27  (0.46)
Neutrophil Count -0.28  (1.70) -0.07  (1.49)
18.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2278 586
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline: Creatinine (n =2278, 586) 0.90  (0.17) 0.88  (0.16)
Baseline: LDL-C (n =2253, 585) 114.14  (32.53) 115.00  (35.03)
Baseline: HDL-C (n =2277, 586) 49.05  (13.93) 51.87  (17.33)
Baseline: TC (n =2277, 586) 192.11  (38.10) 194.96  (39.79)
Change at Month 1: Creatinine (n =2204, 563) 0.03  (0.10) 0.02  (0.10)
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  (10.50)
Change at Month 1: TC (n =2203, 562) 21.12  (34.08) 22.65  (34.36)
19.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2211 573
Mean (Standard Deviation)
Unit of Measure: mg/dL
Creatinine (n =2211, 573) 0.04  (0.21) 0.03  (0.10)
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)
20.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2057 564
Mean (Standard Deviation)
Unit of Measure: mg/dL
Creatinine (n =2057, 564) 0.03  (0.11) 0.03  (0.10)
LDL-C (n =1983, 553) 11.44  (30.10) 8.74  (33.22)
HDL-C (n =2056, 564) 7.68  (10.33) 8.19  (11.60)
TC (n =2057, 564) 20.91  (35.94) 19.17  (39.06)
21.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1777 533
Mean (Standard Deviation)
Unit of Measure: mg/dL
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) 21.20  (39.15) 16.97  (37.84)
22.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1398 450
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
23.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1122 384
Mean (Standard Deviation)
Unit of Measure: mg/dL
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) 8.80  (11.59) 6.39  (11.91)
TC (n =1119, 384) 20.20  (41.28) 15.55  (43.59)
24.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 417 127
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
25.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
Hide Description [Not Specified]
Time Frame Baseline, Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2278 586
Mean (Standard Deviation)
Unit of Measure: international unit per liter (IU/L)
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  (17.50)
26.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2201 573
Mean (Standard Deviation)
Unit of Measure: IU/L
AST (n =2200, 573) 4.09  (17.75) 5.65  (16.37)
ALT (n =2201, 573) 4.86  (18.52) 6.86  (20.80)
27.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2054 564
Mean (Standard Deviation)
Unit of Measure: IU/L
AST (n =2052, 564) 4.50  (15.60) 5.07  (14.90)
ALT (n =2054, 564) 5.98  (19.00) 6.15  (18.40)
28.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1774 532
Mean (Standard Deviation)
Unit of Measure: IU/L
AST (n =1772, 531) 4.88  (16.63) 7.29  (22.70)
ALT (n =1774, 532) 6.68  (23.12) 8.91  (25.21)
29.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
Hide Description [Not Specified]
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1398 450
Mean (Standard Deviation)
Unit of Measure: IU/L
AST (n =1397, 450) 4.10  (14.64) 6.77  (15.74)
ALT (n =1398, 450) 5.31  (19.37) 7.56  (18.93)
30.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
Hide Description [Not Specified]
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1122 384
Mean (Standard Deviation)
Unit of Measure: IU/L
AST 5.38  (20.68) 5.32  (15.65)
ALT 5.46  (20.61) 6.56  (22.43)
31.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
Hide Description [Not Specified]
Time Frame Baseline, Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 417 127
Mean (Standard Deviation)
Unit of Measure: IU/L
AST (n =416, 127) 4.49  (14.05) 8.40  (26.41)
ALT (n =417, 127) 4.92  (27.11) 6.92  (20.98)
32.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Hide 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.
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2268 577
Measure Type: Number
Unit of Measure: participants
683 191
33.Primary Outcome
Title Number of Participants With Vital Sign Abnormalities
Hide Description Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute.
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2271 577
Measure Type: Number
Unit of Measure: participants
SBP (n =2271, 577) 12 6
DBP (n =2271, 577) 12 1
Heart Rate (n =2271, 577) 3 1
Maximum IFB in SBP (n =2267, 577) 187 65
Maximum IFB in DBP (n =2267, 577) 221 74
34.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
Hide Description [Not Specified]
Time Frame Baseline, Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2277 586
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
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)
35.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2214 575
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP -0.16  (11.97) -0.95  (11.85)
Diastolic BP -0.26  (8.56) 0.05  (8.52)
36.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2061 566
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP 0.22  (12.18) -0.15  (12.48)
Diastolic BP -0.05  (8.87) 0.55  (8.74)
37.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1784 534
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP 0.42  (11.97) -0.20  (12.51)
Diastolic BP 0.23  (8.89) 0.10  (9.10)
38.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
Hide Description [Not Specified]
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1398 451
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP 0.84  (13.00) -0.07  (13.02)
Diastolic BP 0.36  (9.45) 0.35  (8.85)
39.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
Hide Description [Not Specified]
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1123 386
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP 0.52  (13.15) 0.10  (13.92)
Diastolic BP 0.33  (9.33) -0.06  (9.24)
40.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
Hide Description [Not Specified]
Time Frame Baseline, Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 422 127
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP 2.35  (13.45) 1.13  (15.18)
Diastolic BP 0.97  (9.52) 0.87  (9.80)
41.Primary Outcome
Title Change From Baseline in Heart Rate at Month 1
Hide Description [Not Specified]
Time Frame Baseline, Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2277 586
Mean (Standard Deviation)
Unit of Measure: beats per minute
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)
42.Primary Outcome
Title Change From Baseline in Heart Rate at Month 3
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2214 573
Mean (Standard Deviation)
Unit of Measure: beats per minute
-0.57  (9.35) -0.32  (9.19)
43.Primary Outcome
Title Change From Baseline in Heart Rate at Month 6
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2061 565
Mean (Standard Deviation)
Unit of Measure: beats per minute
-0.73  (9.65) -1.05  (9.18)
44.Primary Outcome
Title Change From Baseline in Heart Rate at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1784 534
Mean (Standard Deviation)
Unit of Measure: beats per minute
-1.13  (9.66) -1.14  (9.07)
45.Primary Outcome
Title Change From Baseline in Heart Rate at Month 24
Hide Description [Not Specified]
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1398 451
Mean (Standard Deviation)
Unit of Measure: beats per minute
-1.07  (9.91) -0.94  (8.89)
46.Primary Outcome
Title Change From Baseline in Heart Rate at Month 36
Hide Description [Not Specified]
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1123 386
Mean (Standard Deviation)
Unit of Measure: beats per minute
-1.38  (9.81) -1.00  (9.26)
47.Primary Outcome
Title Change From Baseline in Heart Rate at Month 48
Hide Description [Not Specified]
Time Frame Baseline, Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 422 127
Mean (Standard Deviation)
Unit of Measure: beats per minute
-0.91  (10.64) -0.64  (10.64)
48.Primary Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities
Hide 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.
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2281 586
Measure Type: Number
Unit of Measure: participants
7 2
49.Primary Outcome
Title Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2264 583
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
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  (29.70)
Baseline: QTcB Interval (n =2264, 583) 415.70  (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  (7.50)
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)
50.Primary Outcome
Title Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1727 516
Mean (Standard Deviation)
Unit of Measure: msec
QRS Complex (n =1726, 516) 1.89  (7.93) 2.11  (7.53)
PR Interval (n =1717, 515) 2.80  (14.32) 3.21  (14.31)
QT Interval (n =1726, 516) 2.49  (23.26) 2.69  (23.00)
QTcB Interval (n =1726, 516) -1.04  (20.63) -1.09  (20.83)
QTcF Interval (n =1726, 516) 0.16  (16.71) 0.23  (17.20)
RR Interval (n =1727, 516) 15.94  (130.60) 17.55  (128.16)
51.Primary Outcome
Title Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
Hide Description [Not Specified]
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 1352 432
Mean (Standard Deviation)
Unit of Measure: msec
QRS Complex (n =1352, 432) 2.00  (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  (24.80)
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) 17.70  (139.47) 8.66  (135.06)
52.Primary Outcome
Title Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
Hide Description [Not Specified]
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 845 283
Mean (Standard Deviation)
Unit of Measure: msec
QRS Complex (n =845, 283) 1.75  (8.47) 1.85  (10.37)
PR Interval (n =840, 282) 4.18  (14.50) 3.25  (15.50)
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)
53.Primary Outcome
Title Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
Hide Description [Not Specified]
Time Frame Baseline, Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 126 55
Mean (Standard Deviation)
Unit of Measure: msec
QRS Complex (n =126, 55) 2.37  (10.17) 1.31  (5.37)
PR Interval (n =126, 55) 6.26  (12.58) 1.98  (13.20)
QT Interval (n =126, 55) 6.43  (24.05) 1.69  (23.43)
QTcB Interval (n =125, 55) 3.42  (20.11) -2.00  (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)
54.Primary Outcome
Title Number of Participants With Adjudicated Cardiovascular Events
Hide 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.
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2281 586
Measure Type: Number
Unit of Measure: participants
32 13
55.Primary Outcome
Title Number of Participants With Malignancy Events
Hide Description Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.
Time Frame Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2281 586
Measure Type: Number
Unit of Measure: participants
87 26
56.Secondary Outcome
Title Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
Hide Description The 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 participants. 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. The 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 indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.
Time Frame Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies participants evaluable for this outcome measure and ‘n’ signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2200 571
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 (n =2196, 563)
50.36
(48.27 to 52.46)
77.80
(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 57.10)
75.19
(71.52 to 78.86)
Month 24 (n =1397, 448)
54.62
(52.01 to 57.23)
79.46
(75.72 to 83.20)
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)
57.Secondary Outcome
Title Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Hide 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 ranging 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 participants with >=75 percent (%) reduction from baseline in PASI scores were reported.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2200 566
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
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
(56.40 to 60.51)
84.45
(81.47 to 87.44)
Month 6 (n =2048, 557)
61.67
(59.56 to 63.78)
86.00
(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
(64.80 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)
58.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI) Scores
Hide 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 ranging 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2266 585
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =2266, 585) 21.85  (9.48) 19.05  (8.89)
Month 1 (n =2198, 561) 6.60  (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) 1.90  (3.25)
Month 12 (n =1779, 531) 4.72  (5.29) 2.38  (3.57)
Month 24 (n =1397, 449) 4.41  (5.08) 1.90  (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)
59.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Hide 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 ranging 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2201 572
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 (n =2195, 561) -15.26  (9.96) -16.00  (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  (8.70)
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)
60.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
Hide 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2266 585
Mean (Standard Deviation)
Unit of Measure: units on a scale
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) 0.70  (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) 0.70  (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  (1.00) 0.57  (0.79)
Month 6: Upper Limbs (n =2051, 563) 1.20  (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  (0.90)
Month 48: Trunk (n =422, 126) 1.00  (1.10) 0.50  (0.86)
Baseline: Lower Limbs (n =2266, 585) 3.10  (0.70) 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) 1.20  (1.11) 0.52  (0.81)
Month 12: Lower Limbs (n =1779, 531) 1.17  (1.10) 0.69  (0.98)
Month 24: Lower Limbs (n =1397, 449) 1.15  (1.11) 0.59  (0.90)
Month 36: Lower Limbs (n =1121, 384) 1.07  (1.11) 0.67  (0.96)
Month 48: Lower Limbs (n =422, 126) 1.20  (1.11) 0.61  (0.91)
61.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI) Component Scores: Induration
Hide 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2266 585
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Head/Neck (n =2266, 585) 1.97  (1.01) 1.88  (1.10)
Month 1: Head/Neck (n =2198, 561) 0.65  (0.85) 0.35  (0.73)
Month 3: Head/Neck (n =2205, 572) 0.60  (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) 0.60  (0.85) 0.26  (0.60)
Baseline: Upper Limbs (n =2266, 585) 2.64  (0.77) 2.50  (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) 1.00  (1.01) 0.60  (0.82)
Month 48: Upper Limbs (n =422, 126) 1.09  (1.00) 0.50  (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  (1.00) 0.34  (0.71)
Month 12: Trunk (n =1779, 531) 0.87  (1.00) 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  (0.80)
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) 1.10  (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)
62.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
Hide 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2266 585
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Head/Neck (n =2266, 585) 2.22  (1.08) 2.10  (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) 0.40  (0.77)
Month 12: Head/Neck (n =1779, 531) 0.67  (0.92) 0.48  (0.84)
Month 24: Head/Neck (n =1397, 449) 0.60  (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  (0.80)
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  (1.00)
Month 1: Trunk (n =2198, 561) 0.97  (1.02) 0.50  (0.83)
Month 3: Trunk (n =2205, 572) 0.87  (1.00) 0.33  (0.64)
Month 6: Trunk (n =2051, 563) 0.85  (0.99) 0.33  (0.70)
Month 12: Trunk (n =1779, 531) 0.83  (0.97) 0.40  (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) 0.40  (0.78)
Baseline: Lower Limbs (n =2266, 585) 2.89  (0.81) 2.79  (1.00)
Month 1: Lower Limbs (n =2198, 561) 1.23  (1.08) 0.70  (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  (1.10) 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) 0.60  (0.90)
Month 48: Lower Limbs (n =422, 126) 1.09  (1.09) 0.48  (0.76)
63.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
Hide 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2201 572
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1: Head/Neck (n =2195, 561) -1.43  (1.15) -1.66  (1.20)
Month 3: Head/Neck (n =2201, 572) -1.50  (1.18) -1.80  (1.18)
Month 6: Head/Neck (n =2049, 563) -1.52  (1.20) -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  (1.20)
Month 48: Head/Neck (n =422, 126) -1.55  (1.19) -1.70  (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) -1.70  (1.18) -2.05  (1.19)
Month 36: Upper Limbs (n =1119, 384) -1.78  (1.17) -2.00  (1.18)
Month 48: Upper Limbs (n =422, 126) -1.62  (1.16) -1.90  (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  (1.30)
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) -1.90  (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  (1.30)
Month 48: Lower Limbs (n =422, 126) -1.87  (1.20) -2.17  (1.21)
64.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48
Hide 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2201 572
Mean (Standard Deviation)
Unit of Measure: units on a scale
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) -1.40  (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  (1.10)
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) -1.70  (1.19) -2.18  (1.20)
Month 12: Trunk (n =1776, 531) -1.71  (1.20) -2.10  (1.24)
Month 24: Trunk (n =1394, 449) -1.76  (1.19) -2.13  (1.20)
Month 36: Trunk (n =1119, 384) -1.85  (1.20) -2.09  (1.23)
Month 48: Trunk (n =422, 126) -1.68  (1.17) -1.87  (1.20)
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) -2.30  (1.23)
Month 12: Lower Limbs (n =1776, 531) -1.82  (1.20) -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)
65.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48
Hide 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2201 572
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1: Head/Neck (n =2195, 561) -1.46  (1.19) -1.69  (1.20)
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) -1.70  (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  (1.20) -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  (1.30)
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  (1.20) -1.98  (1.24)
Month 3: Trunk (n =2201, 572) -1.67  (1.22) -2.14  (1.14)
Month 6: Trunk (n =2049, 563) -1.70  (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  (1.20) -2.11  (1.19)
Month 36: Trunk (n =1119, 384) -1.84  (1.20) -2.06  (1.23)
Month 48: Trunk (n =422, 126) -1.62  (1.19) -1.80  (1.18)
Month 1: Lower Limbs (n =2195, 561) -1.67  (1.24) -2.09  (1.30)
Month 3: Lower Limbs (n =2201, 572) -1.77  (1.26) -2.30  (1.23)
Month 6: Lower Limbs (n =2049, 563) -1.79  (1.27) -2.30  (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)
66.Secondary Outcome
Title Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Hide 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 ranging 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 participants with >=50% reduction from baseline in PASI scores were reported.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2200 566
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 (n =2194, 555)
76.53
(74.75 to 78.30)
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)
93.90
(91.91 to 95.88)
Month 12 (n =1775, 525)
87.66
(86.13 to 89.19)
93.14
(90.98 to 95.30)
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
(90.00 to 95.26)
Month 48 (n =422, 124)
88.86
(85.86 to 91.86)
97.58
(94.88 to 100.00)
67.Secondary Outcome
Title Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Hide 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 ranging 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 participants with >=90% reduction from baseline in PASI scores were reported.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2200 566
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
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 35.70)
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)
68.Secondary Outcome
Title Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Hide 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 ranging 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 participants with >=125% increase from baseline in PASI scores were reported.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2200 566
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
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 1.40)
Month 6 (n =2048, 557)
1.27
(0.78 to 1.75)
0.90
(0.11 to 1.68)
Month 12 (n =1775, 525)
0.90
(0.46 to 1.34)
1.33
(0.35 to 2.31)
Month 24 (n =1393, 445)
0.93
(0.43 to 1.44)
0.90
(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
(0.00 to 1.51)
0.00
(0.00 to 0.00)
69.Secondary Outcome
Title Itch Severity Item (ISI) Scores
Hide Description ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2197 572
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =2172, 566) 5.76  (2.91) 5.17  (3.00)
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  (2.30) 1.24  (1.74)
70.Secondary Outcome
Title Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Hide Description ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants 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.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2107 554
Mean (Standard Deviation)
Unit of Measure: units on a scale
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  (3.20) -4.36  (3.14)
Month 12 (n =1693, 514) -3.90  (3.17) -4.01  (3.30)
Month 24 (n =1340, 435) -3.80  (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)
71.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Scores
Hide Description The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted 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.
Time Frame Baseline, Month 1, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2243 582
Mean (Standard Deviation)
Unit of Measure: units on a scale
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  (5.00) 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) 3.20  (4.39) 1.81  (2.98)
72.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
Hide Description The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted 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.
Time Frame Baseline, Month 1, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2163 556
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 (n =2163, 556) -8.61  (7.00) -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  (6.80) -8.46  (6.14)
Month 48 (n =404, 122) -8.99  (6.74) -7.78  (6.10)
73.Secondary Outcome
Title 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
Hide Description The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 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 ranged 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: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
Time Frame Baseline, Month 6, 12, 24, 36, 48
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Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2233 580
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =2233, 580) 47.31  (9.38) 48.94  (9.12)
Month 6 (n =2025, 557) 51.78  (8.24) 53.51  (7.30)
Month 12 (n =1750, 524) 51.96  (8.13) 53.58  (7.19)
Month 24 (n =1362, 442) 51.91  (7.80) 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)
74.Secondary Outcome
Title 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
Hide Description The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 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 ranged 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 ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
Time Frame Baseline, Month 6, 12, 24, 36, 48
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Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2233 580
Mean (Standard Deviation)
Unit of Measure: units on a scale
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) 49.10  (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  (8.20)
Month 48 (n =124, 56) 50.14  (8.96) 49.60  (8.24)
75.Secondary Outcome
Title Number of Participants With Patient Global Assessment (PtGA) Response of “Clear” or “Almost Clear”
Hide Description The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants 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. Participants 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 outcome measure.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2244 583
Measure Type: Number
Unit of Measure: participants
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
76.Secondary Outcome
Title Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
Hide Description EQ-5D: participant 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 assigned 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.
Time Frame Baseline, Month 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2242 581
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =2242, 581) 0.77  (0.19) 0.80  (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) 0.90  (0.14)
Month 36 (n =857, 284) 0.88  (0.14) 0.91  (0.12)
Month 48 (n =124, 56) 0.90  (0.13) 0.89  (0.12)
77.Secondary Outcome
Title Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
Hide Description EQ-5D VAS was a participant 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.
Time Frame Baseline, Month 6, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2224 570
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n =2224, 570) 66.39  (23.20) 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) 83.80  (14.85)
Month 24 (n =1365, 443) 79.80  (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) 84.50  (16.87)
78.Secondary Outcome
Title Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
Hide 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 participant’s interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants 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 outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported.
Time Frame Baseline, Month 1, 3, 6, 12, 24, 36, 48
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Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg
Hide Arm/Group Description:
Participants 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).
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants 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.
Overall Number of Participants Analyzed 2281 586
Measure Type: Number
Unit of Measure: participants
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
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
 
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg or 10 mg