Trial Outcomes & Findings for A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis (NCT NCT01163253)

Last Updated: 2017-06-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2867 participants

Primary outcome timeframe

Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Results posted on

2017-06-26

Participant Flow

A total of 2881 participants were enrolled in this study, however 2867 participants received treatment.

Participant milestones

Participant milestones
Measure	Tofacitinib 10 mg 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).	Tofacitinib 5 mg or 10 mg 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 Study STARTED	2281	586
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2281	586

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib 10 mg 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).	Tofacitinib 5 mg or 10 mg 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 Study Withdrawn Due to Pregnancy	12	2
Overall Study Study Terminated by Sponsor	978	349
Overall Study Protocol Violation	43	12
Overall Study Withdrawal by Subject	199	50
Overall Study Medication Error	1	0
Overall Study Lost to Follow-up	125	23
Overall Study Insufficient Clinical Response	423	29
Overall Study Adverse Event	300	78
Overall Study Death	17	5
Overall Study Ongoing	13	4
Overall Study Other Unspecified	170	34

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib 10 mg n=2281 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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 n=2867 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 12.5 • n=5 Participants	47.0 years STANDARD_DEVIATION 13.0 • n=7 Participants	45.6 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	640 Participants n=5 Participants	203 Participants n=7 Participants	843 Participants n=5 Participants
Sex: Female, Male Male	1641 Participants n=5 Participants	383 Participants n=7 Participants	2024 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2281 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	1876 participants	490 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	304 participants	88 participants

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2281 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Number of Adverse Events (AEs) by Severity Mild	5354 adverse events	1749 adverse events
Number of Adverse Events (AEs) by Severity Moderate	3268 adverse events	766 adverse events
Number of Adverse Events (AEs) by Severity Severe	410 adverse events	136 adverse events

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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).

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2271 Participants 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).	Tofacitinib 5 mg or 10 mg n=578 Participants 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.
Number of Participants With Laboratory Abnormalities	2203 participants	565 participants

PRIMARY outcome

Timeframe: Baseline, Month 1

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2277 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Change From Baseline in Hemoglobin Level at Month 1 Baseline (n =2277, 586)	14.64 gram per deciliter (g/dL) Standard Deviation 1.27	14.64 gram per deciliter (g/dL) Standard Deviation 1.24
Change From Baseline in Hemoglobin Level at Month 1 Change at Month 1 (n =2201, 563)	-0.24 gram per deciliter (g/dL) Standard Deviation 0.83	-0.32 gram per deciliter (g/dL) Standard Deviation 0.86

PRIMARY outcome

Timeframe: Baseline, Month 3

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2198 Participants 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).	Tofacitinib 5 mg or 10 mg n=572 Participants 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.
Change From Baseline in Hemoglobin Level at Month 3	-0.27 g/dL Standard Deviation 0.85	-0.39 g/dL Standard Deviation 0.83

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2051 Participants 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).	Tofacitinib 5 mg or 10 mg n=563 Participants 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.
Change From Baseline in Hemoglobin Level at Month 6	-0.27 g/dL Standard Deviation 0.88	-0.30 g/dL Standard Deviation 0.87

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1759 Participants 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).	Tofacitinib 5 mg or 10 mg n=531 Participants 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.
Change From Baseline in Hemoglobin Level at Month 12	-0.34 g/dL Standard Deviation 0.93	-0.30 g/dL Standard Deviation 0.90

PRIMARY outcome

Timeframe: Baseline, Month 24

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1385 Participants 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).	Tofacitinib 5 mg or 10 mg n=449 Participants 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.
Change From Baseline in Hemoglobin Level at Month 24	-0.30 g/dL Standard Deviation 0.96	-0.29 g/dL Standard Deviation 0.89

PRIMARY outcome

Timeframe: Baseline, Month 36

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1114 Participants 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).	Tofacitinib 5 mg or 10 mg n=380 Participants 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.
Change From Baseline in Hemoglobin Level at Month 36	-0.32 g/dL Standard Deviation 0.93	-0.37 g/dL Standard Deviation 0.88

PRIMARY outcome

Timeframe: Baseline, Month 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=415 Participants 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).	Tofacitinib 5 mg or 10 mg n=127 Participants 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.
Change From Baseline in Hemoglobin Level at Month 48	-0.35 g/dL Standard Deviation 0.97	-0.43 g/dL Standard Deviation 0.94

PRIMARY outcome

Timeframe: Baseline, Month 1

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2275 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 Baseline: Lymphocyte Count (n =2275, 586)	1.76 1000 cells/mm^3 Standard Deviation 0.57	1.80 1000 cells/mm^3 Standard Deviation 0.56
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 Baseline: Neutrophil Count (n =2275, 586)	4.74 1000 cells/mm^3 Standard Deviation 1.68	4.55 1000 cells/mm^3 Standard Deviation 1.70
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 Change at Month 1: Lymphocyte Count (n =2182, 559)	0.07 1000 cells/mm^3 Standard Deviation 0.52	0.11 1000 cells/mm^3 Standard Deviation 0.56
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 Change at Month 1: Neutrophil Count (n =2182, 559)	-0.37 1000 cells/mm^3 Standard Deviation 1.65	-0.48 1000 cells/mm^3 Standard Deviation 1.58

PRIMARY outcome

Timeframe: Baseline, Month 3

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2183 Participants 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).	Tofacitinib 5 mg or 10 mg n=570 Participants 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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 Lymphocyte count	-0.00 1000 cells/mm^3 Standard Deviation 0.52	0.02 1000 cells/mm^3 Standard Deviation 0.52
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 Neutrophil Count	-0.28 1000 cells/mm^3 Standard Deviation 1.63	-0.28 1000 cells/mm^3 Standard Deviation 1.60

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2034 Participants 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).	Tofacitinib 5 mg or 10 mg n=559 Participants 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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 Lymphocyte Count	-0.11 1000 cells/mm^3 Standard Deviation 0.51	-0.05 1000 cells/mm^3 Standard Deviation 0.51
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 Neutrophil Count	-0.25 1000 cells/mm^3 Standard Deviation 1.61	-0.22 1000 cells/mm^3 Standard Deviation 1.64

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1751 Participants 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).	Tofacitinib 5 mg or 10 mg n=530 Participants 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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 Lymphocyte Count	-0.21 1000 cells/mm^3 Standard Deviation 0.52	-0.16 1000 cells/mm^3 Standard Deviation 0.48
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 Neutrophil Count	-0.23 1000 cells/mm^3 Standard Deviation 1.61	-0.18 1000 cells/mm^3 Standard Deviation 1.58

PRIMARY outcome

Timeframe: Baseline, Month 24

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1377 Participants 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).	Tofacitinib 5 mg or 10 mg n=445 Participants 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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 Lymphocyte Count	-0.28 1000 cells/mm^3 Standard Deviation 0.52	-0.18 1000 cells/mm^3 Standard Deviation 0.54
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 Neutrophil Count	-0.19 1000 cells/mm^3 Standard Deviation 1.69	-0.02 1000 cells/mm^3 Standard Deviation 1.59

PRIMARY outcome

Timeframe: Baseline, Month 36

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1111 Participants 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).	Tofacitinib 5 mg or 10 mg n=377 Participants 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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 Lymphocyte Count	-0.35 1000 cells/mm^3 Standard Deviation 0.55	-0.24 1000 cells/mm^3 Standard Deviation 0.51
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 Neutrophil Count	-0.26 1000 cells/mm^3 Standard Deviation 1.61	-0.11 1000 cells/mm^3 Standard Deviation 1.68

PRIMARY outcome

Timeframe: Baseline, Month 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=413 Participants 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).	Tofacitinib 5 mg or 10 mg n=127 Participants 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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 Lymphocyte Count	-0.42 1000 cells/mm^3 Standard Deviation 0.52	-0.27 1000 cells/mm^3 Standard Deviation 0.46
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 Neutrophil Count	-0.28 1000 cells/mm^3 Standard Deviation 1.70	-0.07 1000 cells/mm^3 Standard Deviation 1.49

PRIMARY outcome

Timeframe: Baseline, Month 1

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2278 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
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 Baseline: Creatinine (n =2278, 586)	0.90 milligram per deciliter (mg/dL) Standard Deviation 0.17	0.88 milligram per deciliter (mg/dL) Standard Deviation 0.16
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 Baseline: LDL-C (n =2253, 585)	114.14 milligram per deciliter (mg/dL) Standard Deviation 32.53	115.00 milligram per deciliter (mg/dL) Standard Deviation 35.03
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 Baseline: HDL-C (n =2277, 586)	49.05 milligram per deciliter (mg/dL) Standard Deviation 13.93	51.87 milligram per deciliter (mg/dL) Standard Deviation 17.33
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 Baseline: TC (n =2277, 586)	192.11 milligram per deciliter (mg/dL) Standard Deviation 38.10	194.96 milligram per deciliter (mg/dL) Standard Deviation 39.79
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 Change at Month 1: Creatinine (n =2204, 563)	0.03 milligram per deciliter (mg/dL) Standard Deviation 0.10	0.02 milligram per deciliter (mg/dL) Standard Deviation 0.10
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 Change at Month 1: LDL-C (n =2125, 546)	11.49 milligram per deciliter (mg/dL) Standard Deviation 28.77	11.55 milligram per deciliter (mg/dL) Standard Deviation 29.55
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 Change at Month 1: HDL-C (n =2203, 562)	8.19 milligram per deciliter (mg/dL) Standard Deviation 9.89	8.63 milligram per deciliter (mg/dL) Standard Deviation 10.50
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 Change at Month 1: TC (n =2203, 562)	21.12 milligram per deciliter (mg/dL) Standard Deviation 34.08	22.65 milligram per deciliter (mg/dL) Standard Deviation 34.36

PRIMARY outcome

Timeframe: Baseline, Month 3

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2211 Participants 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).	Tofacitinib 5 mg or 10 mg n=573 Participants 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.
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 Creatinine (n =2211, 573)	0.04 mg/dL Standard Deviation 0.21	0.03 mg/dL Standard Deviation 0.10
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 LDL-C (n =2130, 559)	11.97 mg/dL Standard Deviation 29.77	10.44 mg/dL Standard Deviation 32.72
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 HDL-C (n =2204, 573)	7.69 mg/dL Standard Deviation 10.23	7.96 mg/dL Standard Deviation 10.33
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 TC (n =2203, 573)	21.52 mg/dL Standard Deviation 35.63	21.06 mg/dL Standard Deviation 38.34

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2057 Participants 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).	Tofacitinib 5 mg or 10 mg n=564 Participants 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.
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 Creatinine (n =2057, 564)	0.03 mg/dL Standard Deviation 0.11	0.03 mg/dL Standard Deviation 0.10
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 LDL-C (n =1983, 553)	11.44 mg/dL Standard Deviation 30.10	8.74 mg/dL Standard Deviation 33.22
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 HDL-C (n =2056, 564)	7.68 mg/dL Standard Deviation 10.33	8.19 mg/dL Standard Deviation 11.60
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 TC (n =2057, 564)	20.91 mg/dL Standard Deviation 35.94	19.17 mg/dL Standard Deviation 39.06

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1777 Participants 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).	Tofacitinib 5 mg or 10 mg n=533 Participants 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.
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 Creatinine (n =1777, 533)	0.04 mg/dL Standard Deviation 0.12	0.04 mg/dL Standard Deviation 0.12
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 LDL-C (n =1728, 521)	11.31 mg/dL Standard Deviation 31.45	9.65 mg/dL Standard Deviation 32.87
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 HDL-C (n =1776, 531)	8.13 mg/dL Standard Deviation 10.48	6.88 mg/dL Standard Deviation 11.15
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 TC (n =1776, 531)	21.20 mg/dL Standard Deviation 39.15	16.97 mg/dL Standard Deviation 37.84

PRIMARY outcome

Timeframe: Baseline, Month 24

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1398 Participants 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).	Tofacitinib 5 mg or 10 mg n=450 Participants 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.
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 Creatinine (n =1398, 450)	0.05 mg/dL Standard Deviation 0.11	0.04 mg/dL Standard Deviation 0.11
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 LDL-C (n =1353, 435)	11.35 mg/dL Standard Deviation 35.33	10.13 mg/dL Standard Deviation 35.67
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 HDL-C (n =1397, 450)	9.02 mg/dL Standard Deviation 11.62	7.55 mg/dL Standard Deviation 11.94
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 TC (n =1398, 450)	21.74 mg/dL Standard Deviation 41.05	19.22 mg/dL Standard Deviation 39.69

PRIMARY outcome

Timeframe: Baseline, Month 36

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1122 Participants 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).	Tofacitinib 5 mg or 10 mg n=384 Participants 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.
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 Creatinine (n =1122, 384)	0.05 mg/dL Standard Deviation 0.12	0.04 mg/dL Standard Deviation 0.15
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 LDL-C (n =1085, 375)	10.11 mg/dL Standard Deviation 35.83	7.25 mg/dL Standard Deviation 37.41
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 HDL-C (n =1119, 384)	8.80 mg/dL Standard Deviation 11.59	6.39 mg/dL Standard Deviation 11.91
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 TC (n =1119, 384)	20.20 mg/dL Standard Deviation 41.28	15.55 mg/dL Standard Deviation 43.59

PRIMARY outcome

Timeframe: Baseline, Month 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=417 Participants 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).	Tofacitinib 5 mg or 10 mg n=127 Participants 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.
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 Creatinine (n =417, 127)	0.04 mg/dL Standard Deviation 0.12	0.04 mg/dL Standard Deviation 0.11
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 LDL-C (n =402, 123)	12.98 mg/dL Standard Deviation 36.89	6.61 mg/dL Standard Deviation 34.66
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 HDL-C (n =417, 127)	8.62 mg/dL Standard Deviation 11.36	8.19 mg/dL Standard Deviation 12.72
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 TC (n =417, 127)	24.99 mg/dL Standard Deviation 43.35	16.36 mg/dL Standard Deviation 40.99

PRIMARY outcome

Timeframe: Baseline, Month 1

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2278 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 Baseline: AST (n =2278, 586)	24.02 international unit per liter (IU/L) Standard Deviation 12.22	24.66 international unit per liter (IU/L) Standard Deviation 10.36
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 Baseline: ALT (n =2278, 586)	28.47 international unit per liter (IU/L) Standard Deviation 17.29	28.17 international unit per liter (IU/L) Standard Deviation 16.56
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 Change at Month 1: AST (n =2198, 564)	3.48 international unit per liter (IU/L) Standard Deviation 15.39	4.07 international unit per liter (IU/L) Standard Deviation 12.01
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 Change at Month 1: ALT (n =2199, 564)	4.07 international unit per liter (IU/L) Standard Deviation 19.04	4.84 international unit per liter (IU/L) Standard Deviation 17.50

PRIMARY outcome

Timeframe: Baseline, Month 3

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2201 Participants 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).	Tofacitinib 5 mg or 10 mg n=573 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 ALT (n =2201, 573)	4.86 IU/L Standard Deviation 18.52	6.86 IU/L Standard Deviation 20.80
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 AST (n =2200, 573)	4.09 IU/L Standard Deviation 17.75	5.65 IU/L Standard Deviation 16.37

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2054 Participants 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).	Tofacitinib 5 mg or 10 mg n=564 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 AST (n =2052, 564)	4.50 IU/L Standard Deviation 15.60	5.07 IU/L Standard Deviation 14.90
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 ALT (n =2054, 564)	5.98 IU/L Standard Deviation 19.00	6.15 IU/L Standard Deviation 18.40

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1774 Participants 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).	Tofacitinib 5 mg or 10 mg n=532 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 AST (n =1772, 531)	4.88 IU/L Standard Deviation 16.63	7.29 IU/L Standard Deviation 22.70
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 ALT (n =1774, 532)	6.68 IU/L Standard Deviation 23.12	8.91 IU/L Standard Deviation 25.21

PRIMARY outcome

Timeframe: Baseline, Month 24

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1398 Participants 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).	Tofacitinib 5 mg or 10 mg n=450 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 AST (n =1397, 450)	4.10 IU/L Standard Deviation 14.64	6.77 IU/L Standard Deviation 15.74
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 ALT (n =1398, 450)	5.31 IU/L Standard Deviation 19.37	7.56 IU/L Standard Deviation 18.93

PRIMARY outcome

Timeframe: Baseline, Month 36

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1122 Participants 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).	Tofacitinib 5 mg or 10 mg n=384 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 AST	5.38 IU/L Standard Deviation 20.68	5.32 IU/L Standard Deviation 15.65
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 ALT	5.46 IU/L Standard Deviation 20.61	6.56 IU/L Standard Deviation 22.43

PRIMARY outcome

Timeframe: Baseline, Month 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=417 Participants 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).	Tofacitinib 5 mg or 10 mg n=127 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 AST (n =416, 127)	4.49 IU/L Standard Deviation 14.05	8.40 IU/L Standard Deviation 26.41
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 ALT (n =417, 127)	4.92 IU/L Standard Deviation 27.11	6.92 IU/L Standard Deviation 20.98

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2268 Participants 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).	Tofacitinib 5 mg or 10 mg n=577 Participants 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.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination	683 participants	191 participants

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2271 Participants 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).	Tofacitinib 5 mg or 10 mg n=577 Participants 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.
Number of Participants With Vital Sign Abnormalities SBP (n =2271, 577)	12 participants	6 participants
Number of Participants With Vital Sign Abnormalities DBP (n =2271, 577)	12 participants	1 participants
Number of Participants With Vital Sign Abnormalities Heart Rate (n =2271, 577)	3 participants	1 participants
Number of Participants With Vital Sign Abnormalities Maximum IFB in SBP (n =2267, 577)	187 participants	65 participants
Number of Participants With Vital Sign Abnormalities Maximum IFB in DBP (n =2267, 577)	221 participants	74 participants

PRIMARY outcome

Timeframe: Baseline, Month 1

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2277 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 Baseline: Systolic BP (n =2277, 586)	126.07 millimeter of mercury (mmHg) Standard Deviation 14.03	126.24 millimeter of mercury (mmHg) Standard Deviation 14.12
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 Baseline: Diastolic BP (n =2277, 586)	79.64 millimeter of mercury (mmHg) Standard Deviation 9.42	78.88 millimeter of mercury (mmHg) Standard Deviation 9.27
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 Change at Month 1: Systolic BP (n =2210, 564)	-0.43 millimeter of mercury (mmHg) Standard Deviation 11.83	-1.31 millimeter of mercury (mmHg) Standard Deviation 11.55
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 Change at Month 1: Diastolic BP (n =2210, 564)	-0.03 millimeter of mercury (mmHg) Standard Deviation 8.42	0.22 millimeter of mercury (mmHg) Standard Deviation 8.45

PRIMARY outcome

Timeframe: Baseline, Month 3

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2214 Participants 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).	Tofacitinib 5 mg or 10 mg n=575 Participants 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.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 Systolic BP	-0.16 mmHg Standard Deviation 11.97	-0.95 mmHg Standard Deviation 11.85
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 Diastolic BP	-0.26 mmHg Standard Deviation 8.56	0.05 mmHg Standard Deviation 8.52

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2061 Participants 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).	Tofacitinib 5 mg or 10 mg n=566 Participants 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.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 Systolic BP	0.22 mmHg Standard Deviation 12.18	-0.15 mmHg Standard Deviation 12.48
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 Diastolic BP	-0.05 mmHg Standard Deviation 8.87	0.55 mmHg Standard Deviation 8.74

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1784 Participants 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).	Tofacitinib 5 mg or 10 mg n=534 Participants 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.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 Systolic BP	0.42 mmHg Standard Deviation 11.97	-0.20 mmHg Standard Deviation 12.51
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 Diastolic BP	0.23 mmHg Standard Deviation 8.89	0.10 mmHg Standard Deviation 9.10

PRIMARY outcome

Timeframe: Baseline, Month 24

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1398 Participants 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).	Tofacitinib 5 mg or 10 mg n=451 Participants 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.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 Systolic BP	0.84 mmHg Standard Deviation 13.00	-0.07 mmHg Standard Deviation 13.02
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 Diastolic BP	0.36 mmHg Standard Deviation 9.45	0.35 mmHg Standard Deviation 8.85

PRIMARY outcome

Timeframe: Baseline, Month 36

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1123 Participants 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).	Tofacitinib 5 mg or 10 mg n=386 Participants 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.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 Systolic BP	0.52 mmHg Standard Deviation 13.15	0.10 mmHg Standard Deviation 13.92
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 Diastolic BP	0.33 mmHg Standard Deviation 9.33	-0.06 mmHg Standard Deviation 9.24

PRIMARY outcome

Timeframe: Baseline, Month 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=422 Participants 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).	Tofacitinib 5 mg or 10 mg n=127 Participants 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.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 Systolic BP	2.35 mmHg Standard Deviation 13.45	1.13 mmHg Standard Deviation 15.18
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 Diastolic BP	0.97 mmHg Standard Deviation 9.52	0.87 mmHg Standard Deviation 9.80

PRIMARY outcome

Timeframe: Baseline, Month 1

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2277 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Change From Baseline in Heart Rate at Month 1 Baseline (n =2277, 586)	71.81 beats per minute Standard Deviation 9.67	71.46 beats per minute Standard Deviation 9.93
Change From Baseline in Heart Rate at Month 1 Change at Month 1 (n =2210, 563)	-0.82 beats per minute Standard Deviation 9.16	-1.23 beats per minute Standard Deviation 9.03

PRIMARY outcome

Timeframe: Baseline, Month 3

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2214 Participants 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).	Tofacitinib 5 mg or 10 mg n=573 Participants 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.
Change From Baseline in Heart Rate at Month 3	-0.57 beats per minute Standard Deviation 9.35	-0.32 beats per minute Standard Deviation 9.19

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2061 Participants 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).	Tofacitinib 5 mg or 10 mg n=565 Participants 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.
Change From Baseline in Heart Rate at Month 6	-0.73 beats per minute Standard Deviation 9.65	-1.05 beats per minute Standard Deviation 9.18

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1784 Participants 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).	Tofacitinib 5 mg or 10 mg n=534 Participants 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.
Change From Baseline in Heart Rate at Month 12	-1.13 beats per minute Standard Deviation 9.66	-1.14 beats per minute Standard Deviation 9.07

PRIMARY outcome

Timeframe: Baseline, Month 24

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1398 Participants 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).	Tofacitinib 5 mg or 10 mg n=451 Participants 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.
Change From Baseline in Heart Rate at Month 24	-1.07 beats per minute Standard Deviation 9.91	-0.94 beats per minute Standard Deviation 8.89

PRIMARY outcome

Timeframe: Baseline, Month 36

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1123 Participants 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).	Tofacitinib 5 mg or 10 mg n=386 Participants 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.
Change From Baseline in Heart Rate at Month 36	-1.38 beats per minute Standard Deviation 9.81	-1.00 beats per minute Standard Deviation 9.26

PRIMARY outcome

Timeframe: Baseline, Month 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=422 Participants 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).	Tofacitinib 5 mg or 10 mg n=127 Participants 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.
Change From Baseline in Heart Rate at Month 48	-0.91 beats per minute Standard Deviation 10.64	-0.64 beats per minute Standard Deviation 10.64

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2281 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Number of Participants With Electrocardiogram (ECG) Abnormalities	7 participants	2 participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2264 Participants 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).	Tofacitinib 5 mg or 10 mg n=583 Participants 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.
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Baseline: QRS Complex (n =2264, 583)	92.88 milliseconds (msec) Standard Deviation 9.12	92.31 milliseconds (msec) Standard Deviation 9.75
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Baseline: PR Interval (n =2258, 583)	162.32 milliseconds (msec) Standard Deviation 21.32	158.91 milliseconds (msec) Standard Deviation 20.62
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Baseline: QT Interval (n =2264, 583)	392.39 milliseconds (msec) Standard Deviation 29.12	395.75 milliseconds (msec) Standard Deviation 29.70
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Baseline: QTcB Interval (n =2264, 583)	415.70 milliseconds (msec) Standard Deviation 23.83	416.91 milliseconds (msec) Standard Deviation 23.04
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Baseline: QTcF Interval (n =2264, 583)	407.48 milliseconds (msec) Standard Deviation 20.74	409.42 milliseconds (msec) Standard Deviation 20.11
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Baseline: RR Interval (n =2264, 583)	901.27 milliseconds (msec) Standard Deviation 145.58	911.59 milliseconds (msec) Standard Deviation 150.35
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Change at Month 6: QRS Complex (n =1995, 550)	1.51 milliseconds (msec) Standard Deviation 8.28	2.01 milliseconds (msec) Standard Deviation 7.50
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Change at Month 6: PR Interval (n =1986, 549)	2.46 milliseconds (msec) Standard Deviation 13.79	2.76 milliseconds (msec) Standard Deviation 14.81
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Change at Month 6: QT Interval (n =1995, 550)	2.25 milliseconds (msec) Standard Deviation 24.49	2.52 milliseconds (msec) Standard Deviation 24.39
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Change at Month 6: QTcB Interval (n =1995, 550)	-0.84 milliseconds (msec) Standard Deviation 20.49	-1.38 milliseconds (msec) Standard Deviation 20.31
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Change at Month 6: QTcF Interval (n =1995, 550)	0.23 milliseconds (msec) Standard Deviation 17.14	-0.03 milliseconds (msec) Standard Deviation 17.68
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Change at Month 6: RR Interval (n =1995, 550)	14.35 milliseconds (msec) Standard Deviation 130.91	18.77 milliseconds (msec) Standard Deviation 123.49

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1727 Participants 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).	Tofacitinib 5 mg or 10 mg n=516 Participants 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.
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 QRS Complex (n =1726, 516)	1.89 msec Standard Deviation 7.93	2.11 msec Standard Deviation 7.53
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 PR Interval (n =1717, 515)	2.80 msec Standard Deviation 14.32	3.21 msec Standard Deviation 14.31
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 QT Interval (n =1726, 516)	2.49 msec Standard Deviation 23.26	2.69 msec Standard Deviation 23.00
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 QTcB Interval (n =1726, 516)	-1.04 msec Standard Deviation 20.63	-1.09 msec Standard Deviation 20.83
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 QTcF Interval (n =1726, 516)	0.16 msec Standard Deviation 16.71	0.23 msec Standard Deviation 17.20
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 RR Interval (n =1727, 516)	15.94 msec Standard Deviation 130.60	17.55 msec Standard Deviation 128.16

PRIMARY outcome

Timeframe: Baseline, Month 24

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=1352 Participants 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).	Tofacitinib 5 mg or 10 mg n=432 Participants 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.
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 QRS Complex (n =1352, 432)	2.00 msec Standard Deviation 8.55	2.42 msec Standard Deviation 9.13
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 PR Interval (n =1346, 432)	3.49 msec Standard Deviation 14.55	3.81 msec Standard Deviation 14.67
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 QT Interval (n =1352, 432)	3.93 msec Standard Deviation 24.93	2.28 msec Standard Deviation 24.80
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 QTcB Interval (n =1352, 431)	0.15 msec Standard Deviation 20.77	0.78 msec Standard Deviation 21.06
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 QTcF Interval (n =1352, 431)	1.47 msec Standard Deviation 16.86	1.25 msec Standard Deviation 17.72
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 RR Interval (n =1352, 432)	17.70 msec Standard Deviation 139.47	8.66 msec Standard Deviation 135.06

PRIMARY outcome

Timeframe: Baseline, Month 36

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=845 Participants 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).	Tofacitinib 5 mg or 10 mg n=283 Participants 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.
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 QRS Complex (n =845, 283)	1.75 msec Standard Deviation 8.47	1.85 msec Standard Deviation 10.37
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 PR Interval (n =840, 282)	4.18 msec Standard Deviation 14.50	3.25 msec Standard Deviation 15.50
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 QT Interval (n =844, 283)	4.31 msec Standard Deviation 24.93	2.52 msec Standard Deviation 22.63
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 QTcB Interval (n =844, 283)	0.44 msec Standard Deviation 21.29	-0.01 msec Standard Deviation 22.21
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 QTcF Interval (n =844, 283)	1.79 msec Standard Deviation 17.57	0.84 msec Standard Deviation 17.63
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 RR Interval (n =845, 283)	18.24 msec Standard Deviation 136.44	15.14 msec Standard Deviation 131.42

PRIMARY outcome

Timeframe: Baseline, Month 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=126 Participants 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).	Tofacitinib 5 mg or 10 mg n=55 Participants 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.
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 PR Interval (n =126, 55)	6.26 msec Standard Deviation 12.58	1.98 msec Standard Deviation 13.20
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 QRS Complex (n =126, 55)	2.37 msec Standard Deviation 10.17	1.31 msec Standard Deviation 5.37
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 QT Interval (n =126, 55)	6.43 msec Standard Deviation 24.05	1.69 msec Standard Deviation 23.43
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 QTcB Interval (n =125, 55)	3.42 msec Standard Deviation 20.11	-2.00 msec Standard Deviation 22.64
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 QTcF Interval (n =125, 55)	4.55 msec Standard Deviation 15.84	-0.87 msec Standard Deviation 19.38
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 RR Interval (n =126, 55)	15.69 msec Standard Deviation 143.06	20.78 msec Standard Deviation 119.61

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2281 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Number of Participants With Adjudicated Cardiovascular Events	32 participants	13 participants

PRIMARY outcome

Timeframe: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2281 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Number of Participants With Malignancy Events	87 participants	26 participants

SECONDARY outcome

Timeframe: Month 1, 3, 6, 12, 24, 36, 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2200 Participants 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).	Tofacitinib 5 mg or 10 mg n=571 Participants 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.
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Month 1 (n =2196, 563)	50.36 percentage of participants Interval 48.27 to 52.46	77.80 percentage of participants Interval 74.36 to 81.23
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Month 3 (n =2200, 571)	54.86 percentage of participants Interval 52.78 to 56.94	85.29 percentage of participants Interval 82.38 to 88.19
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Month 6 (n =2052, 564)	54.97 percentage of participants Interval 52.82 to 57.12	82.09 percentage of participants Interval 78.93 to 85.26
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Month 12 (n =1776, 532)	54.79 percentage of participants Interval 52.47 to 57.1	75.19 percentage of participants Interval 71.52 to 78.86
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Month 24 (n =1397, 448)	54.62 percentage of participants Interval 52.01 to 57.23	79.46 percentage of participants Interval 75.72 to 83.2
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Month 36 (n =1123, 385)	57.35 percentage of participants Interval 54.45 to 60.24	76.36 percentage of participants Interval 72.12 to 80.61
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Month 48 (n =422, 126)	48.58 percentage of participants Interval 43.81 to 53.35	77.78 percentage of participants Interval 70.52 to 85.04

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2200 Participants 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).	Tofacitinib 5 mg or 10 mg n=566 Participants 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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 1 (n =2194, 555)	51.96 percentage of participants Interval 49.87 to 54.05	71.89 percentage of participants Interval 68.15 to 75.63
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 3 (n =2200, 566)	58.45 percentage of participants Interval 56.4 to 60.51	84.45 percentage of participants Interval 81.47 to 87.44
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 6 (n =2048, 557)	61.67 percentage of participants Interval 59.56 to 63.78	86.00 percentage of participants Interval 83.11 to 88.88
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 12 (n =1775, 525)	65.24 percentage of participants Interval 63.02 to 67.45	80.76 percentage of participants Interval 77.39 to 84.13
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 24 (n =1393, 445)	67.26 percentage of participants Interval 64.8 to 69.73	84.94 percentage of participants Interval 81.62 to 88.27
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 36 (n =1118, 380)	70.75 percentage of participants Interval 68.08 to 73.42	83.95 percentage of participants Interval 80.26 to 87.64
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 48 (n =422, 124)	64.93 percentage of participants Interval 60.38 to 69.48	83.06 percentage of participants Interval 76.46 to 89.67

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2266 Participants 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).	Tofacitinib 5 mg or 10 mg n=585 Participants 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.
Psoriasis Area and Severity Index (PASI) Scores Baseline (n =2266, 585)	21.85 units on a scale Standard Deviation 9.48	19.05 units on a scale Standard Deviation 8.89
Psoriasis Area and Severity Index (PASI) Scores Month 1 (n =2198, 561)	6.60 units on a scale Standard Deviation 7.14	3.09 units on a scale Standard Deviation 4.81
Psoriasis Area and Severity Index (PASI) Scores Month 3 (n =2205, 572)	5.64 units on a scale Standard Deviation 6.33	1.95 units on a scale Standard Deviation 3.25
Psoriasis Area and Severity Index (PASI) Scores Month 6 (n =2051, 563)	5.31 units on a scale Standard Deviation 6.31	1.90 units on a scale Standard Deviation 3.25
Psoriasis Area and Severity Index (PASI) Scores Month 12 (n =1779, 531)	4.72 units on a scale Standard Deviation 5.29	2.38 units on a scale Standard Deviation 3.57
Psoriasis Area and Severity Index (PASI) Scores Month 24 (n =1397, 449)	4.41 units on a scale Standard Deviation 5.08	1.90 units on a scale Standard Deviation 2.65
Psoriasis Area and Severity Index (PASI) Scores Month 36 (n =1121, 384)	3.91 units on a scale Standard Deviation 4.66	2.19 units on a scale Standard Deviation 3.23
Psoriasis Area and Severity Index (PASI) Scores Month 48 (n =422, 126)	4.75 units on a scale Standard Deviation 5.37	1.85 units on a scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2201 Participants 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).	Tofacitinib 5 mg or 10 mg n=572 Participants 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.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 1 (n =2195, 561)	-15.26 units on a scale Standard Deviation 9.96	-16.00 units on a scale Standard Deviation 9.57
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 3 (n =2201, 572)	-16.18 units on a scale Standard Deviation 9.73	-16.99 units on a scale Standard Deviation 9.27
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 6 (n =2049, 563)	-16.56 units on a scale Standard Deviation 9.54	-17.03 units on a scale Standard Deviation 9.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 12 (n =1776, 531)	-17.01 units on a scale Standard Deviation 9.33	-16.45 units on a scale Standard Deviation 9.04
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 24 (n =1394, 449)	-17.25 units on a scale Standard Deviation 9.35	-16.67 units on a scale Standard Deviation 8.70
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 36 (n =1119, 384)	-17.44 units on a scale Standard Deviation 9.23	-16.49 units on a scale Standard Deviation 8.81
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 48 (n =422, 126)	-16.16 units on a scale Standard Deviation 8.61	-15.47 units on a scale Standard Deviation 9.04

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2266 Participants 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).	Tofacitinib 5 mg or 10 mg n=585 Participants 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.
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Baseline: Head/Neck (n =2266, 585)	2.26 units on a scale Standard Deviation 0.99	2.13 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 1: Head/Neck (n =2198, 561)	0.82 units on a scale Standard Deviation 0.96	0.47 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 3: Head/Neck (n =2205, 572)	0.76 units on a scale Standard Deviation 0.95	0.34 units on a scale Standard Deviation 0.65
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 6: Head/Neck (n =2051, 563)	0.75 units on a scale Standard Deviation 0.95	0.42 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 12: Head/Neck (n =1779, 531)	0.70 units on a scale Standard Deviation 0.92	0.49 units on a scale Standard Deviation 0.82
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 24: Head/Neck (n =1397, 449)	0.66 units on a scale Standard Deviation 0.93	0.47 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 36: Head/Neck (n =1121, 384)	0.57 units on a scale Standard Deviation 0.88	0.48 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 48: Head/Neck (n =422, 126)	0.70 units on a scale Standard Deviation 0.93	0.34 units on a scale Standard Deviation 0.69
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Baseline: Upper Limbs (n =2266, 585)	2.82 units on a scale Standard Deviation 0.74	2.68 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 1: Upper Limbs (n =2198, 561)	1.29 units on a scale Standard Deviation 0.98	0.71 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 3: Upper Limbs (n =2205, 572)	1.23 units on a scale Standard Deviation 1.00	0.57 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 6: Upper Limbs (n =2051, 563)	1.20 units on a scale Standard Deviation 1.01	0.58 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 12: Upper Limbs (n =1779, 531)	1.16 units on a scale Standard Deviation 1.01	0.74 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 24: Upper Limbs (n =1397, 449)	1.13 units on a scale Standard Deviation 1.03	0.61 units on a scale Standard Deviation 0.85
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 36: Upper Limbs (n =1121, 384)	1.06 units on a scale Standard Deviation 1.01	0.68 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 48: Upper Limbs (n =422, 126)	1.18 units on a scale Standard Deviation 1.03	0.58 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Baseline: Trunk (n =2266, 585)	2.83 units on a scale Standard Deviation 0.83	2.73 units on a scale Standard Deviation 0.94
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 1: Trunk (n =2198, 561)	1.18 units on a scale Standard Deviation 1.11	0.62 units on a scale Standard Deviation 0.92
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 3: Trunk (n =2205, 572)	1.06 units on a scale Standard Deviation 1.09	0.41 units on a scale Standard Deviation 0.73
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 6: Trunk (n =2051, 563)	1.03 units on a scale Standard Deviation 1.09	0.41 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 12: Trunk (n =1779, 531)	0.99 units on a scale Standard Deviation 1.08	0.51 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 24: Trunk (n =1397, 449)	0.96 units on a scale Standard Deviation 1.08	0.49 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 36: Trunk (n =1121, 384)	0.86 units on a scale Standard Deviation 1.06	0.53 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 48: Trunk (n =422, 126)	1.00 units on a scale Standard Deviation 1.10	0.50 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Baseline: Lower Limbs (n =2266, 585)	3.10 units on a scale Standard Deviation 0.70	2.94 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 1: Lower Limbs (n =2198, 561)	1.37 units on a scale Standard Deviation 1.09	0.79 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 3: Lower Limbs (n =2205, 572)	1.24 units on a scale Standard Deviation 1.08	0.58 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 6: Lower Limbs (n =2051, 563)	1.20 units on a scale Standard Deviation 1.11	0.52 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 12: Lower Limbs (n =1779, 531)	1.17 units on a scale Standard Deviation 1.10	0.69 units on a scale Standard Deviation 0.98
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 24: Lower Limbs (n =1397, 449)	1.15 units on a scale Standard Deviation 1.11	0.59 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 36: Lower Limbs (n =1121, 384)	1.07 units on a scale Standard Deviation 1.11	0.67 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Month 48: Lower Limbs (n =422, 126)	1.20 units on a scale Standard Deviation 1.11	0.61 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2266 Participants 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).	Tofacitinib 5 mg or 10 mg n=585 Participants 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.
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 12: Trunk (n =1779, 531)	0.87 units on a scale Standard Deviation 1.00	0.42 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 24: Trunk (n =1397, 449)	0.82 units on a scale Standard Deviation 0.98	0.39 units on a scale Standard Deviation 0.73
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 36: Trunk (n =1121, 384)	0.75 units on a scale Standard Deviation 0.97	0.43 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 48: Trunk (n =422, 126)	0.91 units on a scale Standard Deviation 1.05	0.44 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Baseline: Lower Limbs (n =2266, 585)	2.85 units on a scale Standard Deviation 0.76	2.77 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 1: Lower Limbs (n =2198, 561)	1.22 units on a scale Standard Deviation 1.04	0.68 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 3: Lower Limbs (n =2205, 572)	1.10 units on a scale Standard Deviation 1.04	0.51 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 6: Lower Limbs (n =2051, 563)	1.08 units on a scale Standard Deviation 1.06	0.47 units on a scale Standard Deviation 0.82
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 12: Lower Limbs (n =1779, 531)	1.05 units on a scale Standard Deviation 1.03	0.61 units on a scale Standard Deviation 0.94
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 24: Lower Limbs (n =1397, 449)	1.02 units on a scale Standard Deviation 1.03	0.49 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 36: Lower Limbs (n =1121, 384)	0.95 units on a scale Standard Deviation 1.03	0.57 units on a scale Standard Deviation 0.87
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 36: Upper Limbs (n =1121, 384)	1.00 units on a scale Standard Deviation 1.01	0.60 units on a scale Standard Deviation 0.82
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 48: Upper Limbs (n =422, 126)	1.09 units on a scale Standard Deviation 1.00	0.50 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Baseline: Trunk (n =2266, 585)	2.57 units on a scale Standard Deviation 0.86	2.51 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 1: Trunk (n =2198, 561)	1.02 units on a scale Standard Deviation 1.04	0.52 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 3: Trunk (n =2205, 572)	0.91 units on a scale Standard Deviation 1.02	0.34 units on a scale Standard Deviation 0.68
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 6: Trunk (n =2051, 563)	0.88 units on a scale Standard Deviation 1.00	0.34 units on a scale Standard Deviation 0.71
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Baseline: Head/Neck (n =2266, 585)	1.97 units on a scale Standard Deviation 1.01	1.88 units on a scale Standard Deviation 1.10
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 1: Head/Neck (n =2198, 561)	0.65 units on a scale Standard Deviation 0.85	0.35 units on a scale Standard Deviation 0.73
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 3: Head/Neck (n =2205, 572)	0.60 units on a scale Standard Deviation 0.84	0.26 units on a scale Standard Deviation 0.56
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 6: Head/Neck (n =2051, 563)	0.59 units on a scale Standard Deviation 0.86	0.31 units on a scale Standard Deviation 0.67
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 12: Head/Neck (n =1779, 531)	0.55 units on a scale Standard Deviation 0.81	0.38 units on a scale Standard Deviation 0.71
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 24: Head/Neck (n =1397, 449)	0.53 units on a scale Standard Deviation 0.82	0.37 units on a scale Standard Deviation 0.68
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 36: Head/Neck (n =1121, 384)	0.46 units on a scale Standard Deviation 0.77	0.37 units on a scale Standard Deviation 0.68
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 48: Head/Neck (n =422, 126)	0.60 units on a scale Standard Deviation 0.85	0.26 units on a scale Standard Deviation 0.60
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Baseline: Upper Limbs (n =2266, 585)	2.64 units on a scale Standard Deviation 0.77	2.50 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 1: Upper Limbs (n =2198, 561)	1.21 units on a scale Standard Deviation 0.99	0.66 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 3: Upper Limbs (n =2205, 572)	1.17 units on a scale Standard Deviation 1.01	0.53 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 6: Upper Limbs (n =2051, 563)	1.15 units on a scale Standard Deviation 1.02	0.55 units on a scale Standard Deviation 0.85
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 12: Upper Limbs (n =1779, 531)	1.11 units on a scale Standard Deviation 1.01	0.69 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 24: Upper Limbs (n =1397, 449)	1.08 units on a scale Standard Deviation 1.02	0.53 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Month 48: Lower Limbs (n =422, 126)	1.07 units on a scale Standard Deviation 1.04	0.48 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2266 Participants 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).	Tofacitinib 5 mg or 10 mg n=585 Participants 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.
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 12: Trunk (n =1779, 531)	0.83 units on a scale Standard Deviation 0.97	0.40 units on a scale Standard Deviation 0.76
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 24: Trunk (n =1397, 449)	0.78 units on a scale Standard Deviation 0.95	0.39 units on a scale Standard Deviation 0.72
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 36: Trunk (n =1121, 384)	0.71 units on a scale Standard Deviation 0.93	0.42 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 48: Trunk (n =422, 126)	0.86 units on a scale Standard Deviation 0.99	0.40 units on a scale Standard Deviation 0.78
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Baseline: Lower Limbs (n =2266, 585)	2.89 units on a scale Standard Deviation 0.81	2.79 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 1: Lower Limbs (n =2198, 561)	1.23 units on a scale Standard Deviation 1.08	0.70 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 3: Lower Limbs (n =2205, 572)	1.12 units on a scale Standard Deviation 1.08	0.48 units on a scale Standard Deviation 0.78
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 6: Lower Limbs (n =2051, 563)	1.11 units on a scale Standard Deviation 1.10	0.48 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 12: Lower Limbs (n =1779, 531)	1.07 units on a scale Standard Deviation 1.07	0.64 units on a scale Standard Deviation 0.98
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 24: Lower Limbs (n =1397, 449)	1.04 units on a scale Standard Deviation 1.06	0.53 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 36: Lower Limbs (n =1121, 384)	0.94 units on a scale Standard Deviation 1.03	0.60 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 48: Lower Limbs (n =422, 126)	1.09 units on a scale Standard Deviation 1.09	0.48 units on a scale Standard Deviation 0.76
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Baseline: Head/Neck (n =2266, 585)	2.22 units on a scale Standard Deviation 1.08	2.10 units on a scale Standard Deviation 1.11
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 1: Head/Neck (n =2198, 561)	0.75 units on a scale Standard Deviation 0.95	0.42 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 3: Head/Neck (n =2205, 572)	0.71 units on a scale Standard Deviation 0.95	0.32 units on a scale Standard Deviation 0.66
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 6: Head/Neck (n =2051, 563)	0.71 units on a scale Standard Deviation 0.97	0.40 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 12: Head/Neck (n =1779, 531)	0.67 units on a scale Standard Deviation 0.92	0.48 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 24: Head/Neck (n =1397, 449)	0.60 units on a scale Standard Deviation 0.88	0.45 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 36: Head/Neck (n =1121, 384)	0.55 units on a scale Standard Deviation 0.88	0.47 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 48: Head/Neck (n =422, 126)	0.65 units on a scale Standard Deviation 0.93	0.34 units on a scale Standard Deviation 0.72
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Baseline: Upper Limbs (n =2266, 585)	2.65 units on a scale Standard Deviation 0.82	2.52 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 1: Upper Limbs (n =2198, 561)	1.22 units on a scale Standard Deviation 1.01	0.69 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 3: Upper Limbs (n =2205, 572)	1.18 units on a scale Standard Deviation 1.04	0.55 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 6: Upper Limbs (n =2051, 563)	1.16 units on a scale Standard Deviation 1.05	0.58 units on a scale Standard Deviation 0.87
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 12: Upper Limbs (n =1779, 531)	1.12 units on a scale Standard Deviation 1.03	0.72 units on a scale Standard Deviation 0.97
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 24: Upper Limbs (n =1397, 449)	1.08 units on a scale Standard Deviation 1.03	0.58 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 36: Upper Limbs (n =1121, 384)	1.01 units on a scale Standard Deviation 1.02	0.62 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 48: Upper Limbs (n =422, 126)	1.13 units on a scale Standard Deviation 1.09	0.53 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Baseline: Trunk (n =2266, 585)	2.55 units on a scale Standard Deviation 0.89	2.47 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 1: Trunk (n =2198, 561)	0.97 units on a scale Standard Deviation 1.02	0.50 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 3: Trunk (n =2205, 572)	0.87 units on a scale Standard Deviation 1.00	0.33 units on a scale Standard Deviation 0.64
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Month 6: Trunk (n =2051, 563)	0.85 units on a scale Standard Deviation 0.99	0.33 units on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2201 Participants 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).	Tofacitinib 5 mg or 10 mg n=572 Participants 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.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Head/Neck (n =2195, 561)	-1.43 units on a scale Standard Deviation 1.15	-1.66 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Head/Neck (n =2201, 572)	-1.50 units on a scale Standard Deviation 1.18	-1.80 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Head/Neck (n =2049, 563)	-1.52 units on a scale Standard Deviation 1.20	-1.72 units on a scale Standard Deviation 1.21
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Head/Neck (n =1776, 531)	-1.56 units on a scale Standard Deviation 1.19	-1.64 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Head/Neck (n =1394, 449)	-1.62 units on a scale Standard Deviation 1.19	-1.67 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Head/Neck (n =1119, 384)	-1.72 units on a scale Standard Deviation 1.18	-1.67 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Head/Neck (n =422, 126)	-1.55 units on a scale Standard Deviation 1.19	-1.70 units on a scale Standard Deviation 1.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Upper Limbs (n =2195, 561)	-1.53 units on a scale Standard Deviation 1.12	-1.98 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Upper Limbs (n =2201, 572)	-1.59 units on a scale Standard Deviation 1.15	-2.12 units on a scale Standard Deviation 1.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Upper Limbs (n =2049, 563)	-1.62 units on a scale Standard Deviation 1.15	-2.09 units on a scale Standard Deviation 1.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Upper Limbs (n =1776, 531)	-1.67 units on a scale Standard Deviation 1.15	-1.94 units on a scale Standard Deviation 1.21
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Upper Limbs (n =1394, 449)	-1.70 units on a scale Standard Deviation 1.18	-2.05 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Upper Limbs (n =1119, 384)	-1.78 units on a scale Standard Deviation 1.17	-2.00 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Upper Limbs (n =422, 126)	-1.62 units on a scale Standard Deviation 1.16	-1.90 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Trunk (n =2195, 561)	-1.65 units on a scale Standard Deviation 1.22	-2.12 units on a scale Standard Deviation 1.26
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Trunk (n =2201, 572)	-1.77 units on a scale Standard Deviation 1.24	-2.33 units on a scale Standard Deviation 1.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Trunk (n =2049, 563)	-1.81 units on a scale Standard Deviation 1.24	-2.32 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Trunk (n =1776, 531)	-1.86 units on a scale Standard Deviation 1.24	-2.21 units on a scale Standard Deviation 1.25
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Trunk (n =1394, 449)	-1.88 units on a scale Standard Deviation 1.25	-2.22 units on a scale Standard Deviation 1.26
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Trunk (n =1119, 384)	-1.99 units on a scale Standard Deviation 1.26	-2.18 units on a scale Standard Deviation 1.30
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Trunk (n =422, 126)	-1.82 units on a scale Standard Deviation 1.22	-2.08 units on a scale Standard Deviation 1.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Lower Limbs (n =2195, 561)	-1.72 units on a scale Standard Deviation 1.19	-2.16 units on a scale Standard Deviation 1.26
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Lower Limbs (n =2201, 572)	-1.87 units on a scale Standard Deviation 1.21	-2.36 units on a scale Standard Deviation 1.21
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Lower Limbs (n =2049, 563)	-1.90 units on a scale Standard Deviation 1.22	-2.42 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Lower Limbs (n =1776, 531)	-1.94 units on a scale Standard Deviation 1.23	-2.24 units on a scale Standard Deviation 1.33
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Lower Limbs (n =1394, 449)	-1.95 units on a scale Standard Deviation 1.25	-2.32 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Lower Limbs (n =1119, 384)	-2.04 units on a scale Standard Deviation 1.23	-2.28 units on a scale Standard Deviation 1.30
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Lower Limbs (n =422, 126)	-1.87 units on a scale Standard Deviation 1.20	-2.17 units on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2201 Participants 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).	Tofacitinib 5 mg or 10 mg n=572 Participants 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.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Head/Neck (n =2195, 561)	-1.32 units on a scale Standard Deviation 1.13	-1.53 units on a scale Standard Deviation 1.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Head/Neck (n =2201, 572)	-1.37 units on a scale Standard Deviation 1.17	-1.63 units on a scale Standard Deviation 1.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Head/Neck (n =2049, 563)	-1.40 units on a scale Standard Deviation 1.16	-1.57 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Head/Neck (n =1776, 531)	-1.44 units on a scale Standard Deviation 1.18	-1.49 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Head/Neck (n =1394, 449)	-1.48 units on a scale Standard Deviation 1.17	-1.51 units on a scale Standard Deviation 1.21
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Head/Neck (n =1119, 384)	-1.55 units on a scale Standard Deviation 1.17	-1.51 units on a scale Standard Deviation 1.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Head/Neck (n =422, 126)	-1.35 units on a scale Standard Deviation 1.17	-1.41 units on a scale Standard Deviation 1.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Upper Limbs (n =2195, 561)	-1.43 units on a scale Standard Deviation 1.14	-1.85 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Upper Limbs (n =2201, 572)	-1.47 units on a scale Standard Deviation 1.17	-1.97 units on a scale Standard Deviation 1.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Upper Limbs (n =2049, 563)	-1.49 units on a scale Standard Deviation 1.15	-1.94 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Upper Limbs (n =1776, 531)	-1.54 units on a scale Standard Deviation 1.14	-1.82 units on a scale Standard Deviation 1.27
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Upper Limbs (n =1394, 449)	-1.57 units on a scale Standard Deviation 1.18	-1.97 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Upper Limbs (n =1119, 384)	-1.65 units on a scale Standard Deviation 1.17	-1.92 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Upper Limbs (n =422, 126)	-1.53 units on a scale Standard Deviation 1.14	-1.83 units on a scale Standard Deviation 1.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Trunk (n =2195, 561)	-1.55 units on a scale Standard Deviation 1.19	-2.01 units on a scale Standard Deviation 1.26
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Trunk (n =2201, 572)	-1.65 units on a scale Standard Deviation 1.22	-2.17 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Trunk (n =2049, 563)	-1.70 units on a scale Standard Deviation 1.19	-2.18 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Trunk (n =1776, 531)	-1.71 units on a scale Standard Deviation 1.20	-2.10 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Trunk (n =1394, 449)	-1.76 units on a scale Standard Deviation 1.19	-2.13 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Trunk (n =1119, 384)	-1.85 units on a scale Standard Deviation 1.20	-2.09 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Trunk (n =422, 126)	-1.68 units on a scale Standard Deviation 1.17	-1.87 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Lower Limbs (n =2195, 561)	-1.63 units on a scale Standard Deviation 1.22	-2.09 units on a scale Standard Deviation 1.31
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Lower Limbs (n =2201, 572)	-1.75 units on a scale Standard Deviation 1.22	-2.26 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Lower Limbs (n =2049, 563)	-1.78 units on a scale Standard Deviation 1.23	-2.30 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Lower Limbs (n =1776, 531)	-1.82 units on a scale Standard Deviation 1.20	-2.17 units on a scale Standard Deviation 1.33
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Lower Limbs (n =1394, 449)	-1.85 units on a scale Standard Deviation 1.22	-2.28 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Lower Limbs (n =1119, 384)	-1.93 units on a scale Standard Deviation 1.21	-2.22 units on a scale Standard Deviation 1.29
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Lower Limbs (n =422, 126)	-1.77 units on a scale Standard Deviation 1.18	-2.07 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2201 Participants 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).	Tofacitinib 5 mg or 10 mg n=572 Participants 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.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Head/Neck (n =2195, 561)	-1.46 units on a scale Standard Deviation 1.19	-1.69 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Head/Neck (n =2201, 572)	-1.51 units on a scale Standard Deviation 1.24	-1.78 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Head/Neck (n =2049, 563)	-1.52 units on a scale Standard Deviation 1.24	-1.70 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Head/Neck (n =1776, 531)	-1.56 units on a scale Standard Deviation 1.25	-1.61 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Head/Neck (n =1394, 449)	-1.63 units on a scale Standard Deviation 1.24	-1.63 units on a scale Standard Deviation 1.27
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Head/Neck (n =1119, 384)	-1.68 units on a scale Standard Deviation 1.22	-1.64 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Head/Neck (n =422, 126)	-1.53 units on a scale Standard Deviation 1.24	-1.58 units on a scale Standard Deviation 1.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Upper Limbs (n =2195, 561)	-1.44 units on a scale Standard Deviation 1.18	-1.84 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Upper Limbs (n =2201, 572)	-1.47 units on a scale Standard Deviation 1.20	-1.97 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Upper Limbs (n =2049, 563)	-1.49 units on a scale Standard Deviation 1.21	-1.94 units on a scale Standard Deviation 1.26
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Upper Limbs (n =1776, 531)	-1.52 units on a scale Standard Deviation 1.21	-1.82 units on a scale Standard Deviation 1.30
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Upper Limbs (n =1394, 449)	-1.56 units on a scale Standard Deviation 1.22	-1.96 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Upper Limbs (n =1119, 384)	-1.65 units on a scale Standard Deviation 1.19	-1.93 units on a scale Standard Deviation 1.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Upper Limbs (n =422, 126)	-1.45 units on a scale Standard Deviation 1.19	-1.78 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Trunk (n =2195, 561)	-1.58 units on a scale Standard Deviation 1.20	-1.98 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Trunk (n =2201, 572)	-1.67 units on a scale Standard Deviation 1.22	-2.14 units on a scale Standard Deviation 1.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Trunk (n =2049, 563)	-1.70 units on a scale Standard Deviation 1.19	-2.14 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Trunk (n =1776, 531)	-1.72 units on a scale Standard Deviation 1.21	-2.08 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Trunk (n =1394, 449)	-1.77 units on a scale Standard Deviation 1.20	-2.11 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Trunk (n =1119, 384)	-1.84 units on a scale Standard Deviation 1.20	-2.06 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Trunk (n =422, 126)	-1.62 units on a scale Standard Deviation 1.19	-1.80 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 1: Lower Limbs (n =2195, 561)	-1.67 units on a scale Standard Deviation 1.24	-2.09 units on a scale Standard Deviation 1.30
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 3: Lower Limbs (n =2201, 572)	-1.77 units on a scale Standard Deviation 1.26	-2.30 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 6: Lower Limbs (n =2049, 563)	-1.79 units on a scale Standard Deviation 1.27	-2.30 units on a scale Standard Deviation 1.25
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 12: Lower Limbs (n =1776, 531)	-1.83 units on a scale Standard Deviation 1.26	-2.15 units on a scale Standard Deviation 1.36
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 24: Lower Limbs (n =1394, 449)	-1.86 units on a scale Standard Deviation 1.27	-2.25 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 36: Lower Limbs (n =1119, 384)	-1.97 units on a scale Standard Deviation 1.23	-2.21 units on a scale Standard Deviation 1.26
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Month 48: Lower Limbs (n =422, 126)	-1.77 units on a scale Standard Deviation 1.29	-2.11 units on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2200 Participants 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).	Tofacitinib 5 mg or 10 mg n=566 Participants 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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 1 (n =2194, 555)	76.53 percentage of participants Interval 74.75 to 78.3	86.67 percentage of participants Interval 83.84 to 89.49
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 3 (n =2200, 566)	81.59 percentage of participants Interval 79.97 to 83.21	95.05 percentage of participants Interval 93.27 to 96.84
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 6 (n =2048, 557)	85.64 percentage of participants Interval 84.13 to 87.16	93.90 percentage of participants Interval 91.91 to 95.88
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 12 (n =1775, 525)	87.66 percentage of participants Interval 86.13 to 89.19	93.14 percentage of participants Interval 90.98 to 95.3
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 24 (n =1393, 445)	88.87 percentage of participants Interval 87.22 to 90.52	94.61 percentage of participants Interval 92.51 to 96.71
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 36 (n =1118, 380)	90.97 percentage of participants Interval 89.29 to 92.65	92.63 percentage of participants Interval 90.0 to 95.26
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 48 (n =422, 124)	88.86 percentage of participants Interval 85.86 to 91.86	97.58 percentage of participants Interval 94.88 to 100.0

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2200 Participants 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).	Tofacitinib 5 mg or 10 mg n=566 Participants 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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 1 (n =2194, 555)	29.99 percentage of participants Interval 28.07 to 31.91	56.04 percentage of participants Interval 51.91 to 60.17
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 3 (n =2200, 566)	33.73 percentage of participants Interval 31.75 to 35.7	65.37 percentage of participants Interval 61.45 to 69.29
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 6 (n =2048, 557)	35.21 percentage of participants Interval 33.14 to 37.27	65.89 percentage of participants Interval 61.95 to 69.83
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 12 (n =1775, 525)	35.94 percentage of participants Interval 33.71 to 38.18	61.71 percentage of participants Interval 57.56 to 65.87
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 24 (n =1393, 445)	38.33 percentage of participants Interval 35.78 to 40.89	62.02 percentage of participants Interval 57.51 to 66.53
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 36 (n =1118, 380)	43.02 percentage of participants Interval 40.12 to 45.93	60.53 percentage of participants Interval 55.61 to 65.44
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 48 (n =422, 124)	34.36 percentage of participants Interval 29.83 to 38.89	58.06 percentage of participants Interval 49.38 to 66.75

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2200 Participants 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).	Tofacitinib 5 mg or 10 mg n=566 Participants 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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 1 (n =2194, 555)	0.96 percentage of participants Interval 0.55 to 1.36	1.08 percentage of participants Interval 0.22 to 1.94
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 3 (n =2200, 566)	1.18 percentage of participants Interval 0.73 to 1.63	0.71 percentage of participants Interval 0.02 to 1.4
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 6 (n =2048, 557)	1.27 percentage of participants Interval 0.78 to 1.75	0.90 percentage of participants Interval 0.11 to 1.68
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 12 (n =1775, 525)	0.90 percentage of participants Interval 0.46 to 1.34	1.33 percentage of participants Interval 0.35 to 2.31
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 24 (n =1393, 445)	0.93 percentage of participants Interval 0.43 to 1.44	0.90 percentage of participants Interval 0.02 to 1.78
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 36 (n =1118, 380)	0.54 percentage of participants Interval 0.11 to 0.96	1.32 percentage of participants Interval 0.17 to 2.46
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Month 48 (n =422, 124)	0.71 percentage of participants Interval 0.0 to 1.51	0.00 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2197 Participants 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).	Tofacitinib 5 mg or 10 mg n=572 Participants 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.
Itch Severity Item (ISI) Scores Month 12 (n =1774, 530)	1.79 units on a scale Standard Deviation 2.21	1.08 units on a scale Standard Deviation 1.67
Itch Severity Item (ISI) Scores Baseline (n =2172, 566)	5.76 units on a scale Standard Deviation 2.91	5.17 units on a scale Standard Deviation 3.00
Itch Severity Item (ISI) Scores Month 1 (n =2196, 561)	1.88 units on a scale Standard Deviation 2.26	0.92 units on a scale Standard Deviation 1.53
Itch Severity Item (ISI) Scores Month 3 (n =2197, 572)	1.83 units on a scale Standard Deviation 2.32	0.72 units on a scale Standard Deviation 1.39
Itch Severity Item (ISI) Scores Month 6 (n =2047, 560)	1.87 units on a scale Standard Deviation 2.33	0.82 units on a scale Standard Deviation 1.51
Itch Severity Item (ISI) Scores Month 24 (n =1394, 449)	1.83 units on a scale Standard Deviation 2.23	1.01 units on a scale Standard Deviation 1.54
Itch Severity Item (ISI) Scores Month 36 (n =1117, 383)	1.69 units on a scale Standard Deviation 2.12	1.21 units on a scale Standard Deviation 1.72
Itch Severity Item (ISI) Scores Month 48 (n =417, 127)	1.92 units on a scale Standard Deviation 2.30	1.24 units on a scale Standard Deviation 1.74

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2107 Participants 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).	Tofacitinib 5 mg or 10 mg n=554 Participants 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.
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 1 (n =2107, 544)	-3.88 units on a scale Standard Deviation 3.06	-4.26 units on a scale Standard Deviation 3.07
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 3 (n =2103, 554)	-3.94 units on a scale Standard Deviation 3.18	-4.44 units on a scale Standard Deviation 3.06
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 6 (n =1958, 543)	-3.91 units on a scale Standard Deviation 3.20	-4.36 units on a scale Standard Deviation 3.14
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 12 (n =1693, 514)	-3.90 units on a scale Standard Deviation 3.17	-4.01 units on a scale Standard Deviation 3.30
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 24 (n =1340, 435)	-3.80 units on a scale Standard Deviation 3.14	-4.11 units on a scale Standard Deviation 3.17
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 36 (n =1078, 372)	-3.95 units on a scale Standard Deviation 3.18	-3.84 units on a scale Standard Deviation 3.06
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Month 48 (n =411, 126)	-4.03 units on a scale Standard Deviation 3.19	-3.78 units on a scale Standard Deviation 3.25

SECONDARY outcome

Timeframe: Baseline, Month 1, 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2243 Participants 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).	Tofacitinib 5 mg or 10 mg n=582 Participants 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.
Dermatology Life Quality Index (DLQI) Scores Baseline (n =2243, 582)	12.73 units on a scale Standard Deviation 7.12	10.95 units on a scale Standard Deviation 6.61
Dermatology Life Quality Index (DLQI) Scores Month 1 (n =2189, 559)	4.11 units on a scale Standard Deviation 5.23	2.14 units on a scale Standard Deviation 3.43
Dermatology Life Quality Index (DLQI) Scores Month 6 (n =2028, 557)	3.68 units on a scale Standard Deviation 5.00	1.67 units on a scale Standard Deviation 3.33
Dermatology Life Quality Index (DLQI) Scores Month 12 (n =1751, 528)	3.44 units on a scale Standard Deviation 4.65	1.71 units on a scale Standard Deviation 2.92
Dermatology Life Quality Index (DLQI) Scores Month 24 (n =1361, 441)	3.49 units on a scale Standard Deviation 4.71	1.94 units on a scale Standard Deviation 3.29
Dermatology Life Quality Index (DLQI) Scores Month 36 (n =1093, 372)	2.97 units on a scale Standard Deviation 4.05	1.98 units on a scale Standard Deviation 3.35
Dermatology Life Quality Index (DLQI) Scores Month 48 (n =407, 124)	3.20 units on a scale Standard Deviation 4.39	1.81 units on a scale Standard Deviation 2.98

SECONDARY outcome

Timeframe: Baseline, Month 1, 6, 12, 24, 36, 48

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2163 Participants 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).	Tofacitinib 5 mg or 10 mg n=556 Participants 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 Month 24 (n =1345, 438)	-9.08 units on a scale Standard Deviation 6.82	-8.47 units on a scale Standard Deviation 6.43
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 Month 36 (n =1083, 369)	-9.47 units on a scale Standard Deviation 6.80	-8.46 units on a scale Standard Deviation 6.14
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 Month 48 (n =404, 122)	-8.99 units on a scale Standard Deviation 6.74	-7.78 units on a scale Standard Deviation 6.10
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 Month 1 (n =2163, 556)	-8.61 units on a scale Standard Deviation 7.00	-8.75 units on a scale Standard Deviation 6.56
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 Month 6 (n =2005, 554)	-9.14 units on a scale Standard Deviation 7.06	-9.22 units on a scale Standard Deviation 6.92
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 Month 12 (n =1730, 525)	-9.23 units on a scale Standard Deviation 6.91	-9.02 units on a scale Standard Deviation 6.68

SECONDARY outcome

Timeframe: Baseline, Month 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2233 Participants 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).	Tofacitinib 5 mg or 10 mg n=580 Participants 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.
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores Baseline (n =2233, 580)	47.31 units on a scale Standard Deviation 9.38	48.94 units on a scale Standard Deviation 9.12
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores Month 6 (n =2025, 557)	51.78 units on a scale Standard Deviation 8.24	53.51 units on a scale Standard Deviation 7.30
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores Month 12 (n =1750, 524)	51.96 units on a scale Standard Deviation 8.13	53.58 units on a scale Standard Deviation 7.19
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores Month 24 (n =1362, 442)	51.91 units on a scale Standard Deviation 7.80	53.15 units on a scale Standard Deviation 7.32
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores Month 36 (n =857, 286)	52.01 units on a scale Standard Deviation 8.08	53.05 units on a scale Standard Deviation 7.28
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores Month 48 (n =124, 56)	52.93 units on a scale Standard Deviation 6.79	52.36 units on a scale Standard Deviation 8.39

SECONDARY outcome

Timeframe: Baseline, Month 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2233 Participants 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).	Tofacitinib 5 mg or 10 mg n=580 Participants 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.
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores Baseline (n =2233, 580)	43.51 units on a scale Standard Deviation 11.98	43.96 units on a scale Standard Deviation 11.23
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores Month 6 (n =2025, 557)	48.86 units on a scale Standard Deviation 10.02	50.03 units on a scale Standard Deviation 9.14
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores Month 12 (n =1750, 524)	49.10 units on a scale Standard Deviation 9.89	49.78 units on a scale Standard Deviation 9.28
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores Month 24 (n =1362, 442)	49.22 units on a scale Standard Deviation 9.82	49.66 units on a scale Standard Deviation 9.54
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores Month 36 (n =857, 286)	49.21 units on a scale Standard Deviation 9.95	50.17 units on a scale Standard Deviation 8.20
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores Month 48 (n =124, 56)	50.14 units on a scale Standard Deviation 8.96	49.60 units on a scale Standard Deviation 8.24

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2244 Participants 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).	Tofacitinib 5 mg or 10 mg n=583 Participants 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.
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 36: Clear (n =1112, 377)	162 participants	75 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Baseline: Clear (n =2244, 583)	1 participants	3 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Baseline: Almost Clear (n =2244, 583)	25 participants	16 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 1: Clear (n =2192, 561)	211 participants	127 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 1: Almost Clear (n =2192, 561)	703 participants	246 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 3: Clear (n =2177, 568)	248 participants	174 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 3: Almost Clear (n =2177, 568)	762 participants	254 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 6: Clear (n =2030, 562)	247 participants	176 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 6: Almost Clear (n =2030, 562)	748 participants	265 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 12: Clear (n =1758, 530)	209 participants	151 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 12: Almost Clear (n =1758, 530)	662 participants	236 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 24: Clear (n =1380, 449)	171 participants	111 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 24: Almost Clear (n =1380, 449)	502 participants	202 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 36: Almost Clear (n =1112, 377)	418 participants	183 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 48: Clear (n =410, 125)	40 participants	25 participants
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Month 48: Almost Clear (n =410, 125)	151 participants	60 participants

SECONDARY outcome

Timeframe: Baseline, Month 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2242 Participants 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).	Tofacitinib 5 mg or 10 mg n=581 Participants 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.
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores Baseline (n =2242, 581)	0.77 units on a scale Standard Deviation 0.19	0.80 units on a scale Standard Deviation 0.17
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores Month 6 (n =2021, 559)	0.87 units on a scale Standard Deviation 0.15	0.91 units on a scale Standard Deviation 0.13
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores Month 12 (n =1750, 523)	0.88 units on a scale Standard Deviation 0.15	0.91 units on a scale Standard Deviation 0.13
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores Month 24 (n =1364, 443)	0.88 units on a scale Standard Deviation 0.14	0.90 units on a scale Standard Deviation 0.14
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores Month 36 (n =857, 284)	0.88 units on a scale Standard Deviation 0.14	0.91 units on a scale Standard Deviation 0.12
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores Month 48 (n =124, 56)	0.90 units on a scale Standard Deviation 0.13	0.89 units on a scale Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline, Month 6, 12, 24, 36, 48

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2224 Participants 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).	Tofacitinib 5 mg or 10 mg n=570 Participants 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.
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) Month 48 (n =124, 56)	82.14 units on a scale Standard Deviation 14.07	84.50 units on a scale Standard Deviation 16.87
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) Baseline (n =2224, 570)	66.39 units on a scale Standard Deviation 23.20	68.21 units on a scale Standard Deviation 22.91
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) Month 6 (n =2026, 559)	78.28 units on a scale Standard Deviation 17.11	83.95 units on a scale Standard Deviation 16.18
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) Month 12 (n =1749, 525)	78.91 units on a scale Standard Deviation 16.95	83.80 units on a scale Standard Deviation 14.85
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) Month 24 (n =1365, 443)	79.80 units on a scale Standard Deviation 16.98	83.47 units on a scale Standard Deviation 15.55
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) Month 36 (n =856, 286)	79.43 units on a scale Standard Deviation 17.01	84.62 units on a scale Standard Deviation 14.28

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg n=2281 Participants 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).	Tofacitinib 5 mg or 10 mg n=586 Participants 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.
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Baseline	156 participants	44 participants
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Month 1	153 participants	30 participants
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Month 3	204 participants	55 participants
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Month 6	288 participants	71 participants
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Month 12	234 participants	71 participants
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Month 24	171 participants	50 participants
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Month 36	114 participants	30 participants
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Month 48	22 participants	11 participants

Adverse Events

Tofacitinib 10 mg

Serious events: 304 serious events

Other events: 1415 other events

Deaths: 0 deaths

Tofacitinib 5 mg or 10 mg

Serious events: 88 serious events

Other events: 394 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Tofacitinib 10 mg n=2281 participants at risk 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).	Tofacitinib 5 mg or 10 mg n=586 participants at risk 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.
Vascular disorders Hypertension	7.4% 169/2281 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.	7.5% 44/586 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.
Gastrointestinal disorders Diarrhoea	3.2% 73/2281 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.	5.5% 32/586 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.
Infections and infestations Bronchitis	5.9% 134/2281 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.	8.2% 48/586 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.
Infections and infestations Herpes zoster	6.0% 136/2281 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.	5.6% 33/586 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.
Infections and infestations Influenza	5.5% 126/2281 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.	3.9% 23/586 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.
Infections and infestations Nasopharyngitis	20.9% 476/2281 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.	20.8% 122/586 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.
Infections and infestations Upper respiratory tract infection	11.6% 264/2281 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.	8.7% 51/586 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.
Infections and infestations Urinary tract infection	6.4% 145/2281 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.	7.2% 42/586 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.
Investigations Blood cholesterol increased	3.8% 86/2281 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.	5.6% 33/586 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.
Investigations Blood creatine phosphokinase increased	12.9% 294/2281 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.	15.7% 92/586 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.
Investigations Gamma-glutamyltransferase increased	3.6% 81/2281 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.	6.5% 38/586 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.
Metabolism and nutrition disorders Dyslipidaemia	3.2% 73/2281 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.	8.9% 52/586 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.
Metabolism and nutrition disorders Hypercholesterolaemia	5.9% 134/2281 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.	5.1% 30/586 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.
Musculoskeletal and connective tissue disorders Arthralgia	7.2% 164/2281 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.	6.8% 40/586 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.
Nervous system disorders Headache	5.2% 119/2281 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.	6.5% 38/586 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.
Skin and subcutaneous tissue disorders Psoriasis	6.5% 148/2281 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.	6.7% 39/586 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.