Trial Outcomes & Findings for Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis (NCT NCT01976364)

NCT ID: NCT01976364

Last Updated: 2020-05-21

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 686 participants
• Primary outcome timeframe: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
• Results posted on: 2020-05-21

Participant Flow

Eligible participants (who had previously participated in randomized psoriatic arthritis [PsA] clinical studies with tofacitinib) from qualifying studies A3921091 (NCT01877668) and A3921125 (NCT01882439) were enrolled into this current study A3921092 (NCT01976364).

This main study was a long-term extension study, which also included a sub-study (only for the purpose of efficacy, safety and tolerability of tofacitinib monotherapy as compared to tofacitinib combination therapy with methotrexate). Sub-study included eligible participants from main study who consented to take part in sub-study.

Participant milestones

Measure	Tofacitinib Participants with active psoriatic arthritis (PsA) received tofacitinib 5 milligram (mg) oral tablet, twice daily (BID) with or without allowed concomitant disease-modifying anti-rheumatic drugs (DMARDs) examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.	Tofacitinib 5 mg BID + Methotrexate (MTX) Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study (36 Months) STARTED	686	0	0
Main Study (36 Months) COMPLETED	465	0	0
Main Study (36 Months) NOT COMPLETED	221	0	0
Sub-study (12 Months) STARTED	0	89	90
Sub-study (12 Months) COMPLETED	0	83	85
Sub-study (12 Months) NOT COMPLETED	0	6	5

Reasons for withdrawal

Measure	Tofacitinib Participants with active psoriatic arthritis (PsA) received tofacitinib 5 milligram (mg) oral tablet, twice daily (BID) with or without allowed concomitant disease-modifying anti-rheumatic drugs (DMARDs) examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.	Tofacitinib 5 mg BID + Methotrexate (MTX) Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study (36 Months) Adverse Event	63	0	0
Main Study (36 Months) Withdrawn due to pregnancy	5	0	0
Main Study (36 Months) Other	13	0	0
Main Study (36 Months) No longer met eligibility criteria	2	0	0
Main Study (36 Months) Medication error	1	0	0
Main Study (36 Months) Lost to Follow-up	10	0	0
Main Study (36 Months) Lack of Efficacy	40	0	0
Main Study (36 Months) Protocol Violation	13	0	0
Main Study (36 Months) Withdrawal by Subject	69	0	0
Main Study (36 Months) Death	5	0	0
Sub-study (12 Months) Lost to Follow-up	0	1	0
Sub-study (12 Months) Withdrawal by Subject	0	0	1
Sub-study (12 Months) Protocol Violation	0	1	1
Sub-study (12 Months) Adverse Event	0	4	3

Baseline Characteristics

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Tofacitinib: All Participants n=686 Participants All enrolled participants with PsA who were part of a prior qualifying study, and received at least one dose of open-label study medication (tofacitinib) in this study.
Age, Continuous	48.8 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	370 Participants n=5 Participants
Sex: Female, Male Male	316 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	646 Participants n=5 Participants
Race (NIH/OMB) More than one race	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Population: SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	83.7 percentage of participants	—
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	16.8 percentage of participants	—

PRIMARY outcome

Timeframe: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Population: SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Number of Adverse Events (AEs) by Severity Number of adverse events: Mild	1632 adverse events	—
Number of Adverse Events (AEs) by Severity Number of adverse events: Moderate	1045 adverse events	—
Number of Adverse Events (AEs) by Severity Number of adverse events: Severe	136 adverse events	—

PRIMARY outcome

Timeframe: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Population: SAS included all participants enrolled in this study who were part of prior qualifying study, and who received at least 1 dose of open-label study medication in A3921092. Safety analysis include cumulative data for main and sub-study as pre-specified in protocol.Overall number of participants analyzed=participants evaluable for this measure.

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=683 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Number of Participants With Abnormal Clinical Laboratory Values	646 Participants	—

PRIMARY outcome

Timeframe: Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)

Population: SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values	9 Participants	—

PRIMARY outcome

Timeframe: Sub-study: Baseline (Day 1), Month 6

Population: FAS of sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6	0.0174 units on a scale Standard Error 0.02775	0.0428 units on a scale Standard Error 0.02714

PRIMARY outcome

Timeframe: Sub-study: Baseline (Day 1), Month 6

Population: FAS of sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6	0.138 units on a scale Standard Error 0.0805	0.229 units on a scale Standard Error 0.0786

SECONDARY outcome

Timeframe: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.

Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 1	66.12 percentage of participants Interval 62.55 to 69.7	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 3	68.79 percentage of participants Interval 65.25 to 72.32	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 6	70.66 percentage of participants Interval 67.12 to 74.21	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 9	71.48 percentage of participants Interval 67.87 to 75.08	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 12	74.18 percentage of participants Interval 70.62 to 77.74	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 15	78.04 percentage of participants Interval 74.58 to 81.5	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 18	77.65 percentage of participants Interval 74.13 to 81.18	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 21	77.00 percentage of participants Interval 73.4 to 80.59	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 24	76.13 percentage of participants Interval 72.43 to 79.82	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 27	78.18 percentage of participants Interval 74.54 to 81.82	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 30	80.79 percentage of participants Interval 77.27 to 84.32	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 33	77.88 percentage of participants Interval 74.05 to 81.7	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 36	77.02 percentage of participants Interval 72.81 to 81.24	—

SECONDARY outcome

Timeframe: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.

Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 1	45.70 percentage of participants Interval 41.94 to 49.46	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 3	43.27 percentage of participants Interval 39.49 to 47.04	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 6	47.08 percentage of participants Interval 43.19 to 50.97	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 9	50.41 percentage of participants Interval 46.43 to 54.4	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 12	50.26 percentage of participants Interval 46.19 to 54.32	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 15	55.42 percentage of participants Interval 51.28 to 59.55	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 18	55.10 percentage of participants Interval 50.9 to 59.3	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 21	55.41 percentage of participants Interval 51.16 to 59.65	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 24	57.34 percentage of participants Interval 53.05 to 61.63	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 27	56.05 percentage of participants Interval 51.68 to 60.42	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 30	60.46 percentage of participants Interval 56.08 to 64.84	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 33	57.96 percentage of participants Interval 53.41 to 62.52	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Month 36	58.85 percentage of participants Interval 53.93 to 63.78	—

SECONDARY outcome

Timeframe: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.

Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 1	24.85 percentage of participants Interval 21.59 to 28.11	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 3	26.13 percentage of participants Interval 22.79 to 29.48	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 6	30.50 percentage of participants Interval 26.92 to 34.08	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 9	30.81 percentage of participants Interval 27.13 to 34.48	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 12	32.13 percentage of participants Interval 28.34 to 35.92	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 15	33.87 percentage of participants Interval 29.94 to 37.81	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 18	36.25 percentage of participants Interval 32.18 to 40.31	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 21	34.35 percentage of participants Interval 30.29 to 38.4	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 24	35.94 percentage of participants Interval 31.78 to 40.09	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 27	38.10 percentage of participants Interval 33.83 to 42.38	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 30	41.60 percentage of participants Interval 37.17 to 46.02	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 33	38.19 percentage of participants Interval 33.72 to 42.66	—
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Month 36	37.76 percentage of participants Interval 32.91 to 42.61	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.

HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 1	-0.4373 units on a scale Standard Deviation 0.55677	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 3	-0.4559 units on a scale Standard Deviation 0.55104	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 6	-0.4755 units on a scale Standard Deviation 0.57468	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 9	-0.4841 units on a scale Standard Deviation 0.58294	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 12	-0.4782 units on a scale Standard Deviation 0.60163	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 15	-0.5108 units on a scale Standard Deviation 0.58277	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 18	-0.5116 units on a scale Standard Deviation 0.59401	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 21	-0.5211 units on a scale Standard Deviation 0.59568	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 24	-0.5068 units on a scale Standard Deviation 0.62016	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 27	-0.5219 units on a scale Standard Deviation 0.60833	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 30	-0.5356 units on a scale Standard Deviation 0.61316	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 33	-0.5276 units on a scale Standard Deviation 0.63803	—
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 36	-0.5476 units on a scale Standard Deviation 0.65226	—

SECONDARY outcome

Timeframe: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.

PsARC is comprised of 4 clinical improvement criteria: greater than or equal to (>=) 20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 1	68.46 percentage of participants Interval 64.94 to 71.98	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 3	69.56 percentage of participants Interval 66.04 to 73.08	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 6	73.14 percentage of participants Interval 69.69 to 76.6	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 9	74.46 percentage of participants Interval 70.97 to 77.95	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 12	76.08 percentage of participants Interval 72.6 to 79.56	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 15	79.52 percentage of participants Interval 76.14 to 82.91	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 18	80.15 percentage of participants Interval 76.77 to 83.53	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 21	79.50 percentage of participants Interval 76.04 to 82.96	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 24	77.51 percentage of participants Interval 73.88 to 81.15	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 27	80.16 percentage of participants Interval 76.65 to 83.68	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 30	82.11 percentage of participants Interval 78.66 to 85.55	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 33	80.85 percentage of participants Interval 77.21 to 84.49	—
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 36	77.17 percentage of participants Interval 72.95 to 81.38	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline PGA-PsO score \>0. Number analyzed =participants evaluable for this outcome measure at specified time points.

The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=660 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 30	-1.3 units on a scale Standard Deviation 1.05	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 1	-1.1 units on a scale Standard Deviation 1.04	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 3	-1.1 units on a scale Standard Deviation 1.04	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 6	-1.2 units on a scale Standard Deviation 1.03	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 9	-1.2 units on a scale Standard Deviation 1.06	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 12	-1.1 units on a scale Standard Deviation 1.06	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 15	-1.2 units on a scale Standard Deviation 1.07	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 18	-1.2 units on a scale Standard Deviation 1.05	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 21	-1.2 units on a scale Standard Deviation 1.06	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 24	-1.3 units on a scale Standard Deviation 1.02	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 27	-1.3 units on a scale Standard Deviation 1.02	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 33	-1.3 units on a scale Standard Deviation 1.02	—
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 36	-1.2 units on a scale Standard Deviation 1.02	—

SECONDARY outcome

Timeframe: Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline BSA \>=3% and baseline PASI score \>0. Number analyzed =participants evaluable for this outcome measure at specified time points.

PASI: combined assessment of lesion severity and body area affected into single score; range =0 (no disease) -72 (maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0 (0%) - 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1 =slight, 2 =moderate, 3 =marked, 4 =very marked. Final PASI =sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=474 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 1	55.05 percentage of participants Interval 50.53 to 59.58	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 3	57.96 percentage of participants Interval 53.41 to 62.52	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 6	60.74 percentage of participants Interval 56.14 to 65.34	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 9	61.07 percentage of participants Interval 56.36 to 65.78	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 12	63.16 percentage of participants Interval 58.42 to 67.89	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 15	65.71 percentage of participants Interval 60.95 to 70.47	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 18	65.22 percentage of participants Interval 60.35 to 70.08	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 21	69.72 percentage of participants Interval 64.98 to 74.47	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 24	71.47 percentage of participants Interval 66.72 to 76.22	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 27	70.85 percentage of participants Interval 66.04 to 75.66	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 30	68.58 percentage of participants Interval 63.58 to 73.58	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 33	70.10 percentage of participants Interval 65.01 to 75.18	—
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Month 36	68.08 percentage of participants Interval 62.41 to 73.74	—

SECONDARY outcome

Timeframe: Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline BSA\>=3% and baseline PASI score \>0. Number analyzed =participants evaluable for this outcome measure at specified time points.

PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=474 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 1	-64.09 percent change Standard Deviation 57.473	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 3	-66.98 percent change Standard Deviation 43.647	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 6	-68.58 percent change Standard Deviation 44.568	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 9	-70.42 percent change Standard Deviation 40.617	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 12	-71.58 percent change Standard Deviation 42.515	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 15	-73.13 percent change Standard Deviation 43.653	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 18	-73.51 percent change Standard Deviation 40.527	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 21	-75.15 percent change Standard Deviation 44.182	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 24	-78.36 percent change Standard Deviation 34.808	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 27	-78.37 percent change Standard Deviation 34.405	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 30	-78.28 percent change Standard Deviation 30.270	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 33	-77.47 percent change Standard Deviation 43.952	—
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 At Month 36	-76.85 percent change Standard Deviation 31.973	—

SECONDARY outcome

Timeframe: Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline BSA\>=3% and baseline PASI Score \>0. Number analyzed =participants evaluable for this outcome measure at specified time points.

PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=474 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 1	-62.60 percent change Standard Deviation 62.288	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 3	-66.92 percent change Standard Deviation 46.898	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 6	-68.63 percent change Standard Deviation 46.644	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 9	-70.33 percent change Standard Deviation 41.960	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 12	-70.81 percent change Standard Deviation 48.439	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 15	-72.49 percent change Standard Deviation 48.644	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 18	-73.16 percent change Standard Deviation 40.801	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 21	-74.34 percent change Standard Deviation 47.617	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 24	-78.45 percent change Standard Deviation 36.534	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 27	-77.85 percent change Standard Deviation 34.297	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 30	-78.55 percent change Standard Deviation 31.187	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 33	-77.09 percent change Standard Deviation 42.305	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Induration: At Month 36	-76.11 percent change Standard Deviation 35.000	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 1	-63.60 percent change Standard Deviation 67.818	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 3	-66.69 percent change Standard Deviation 43.013	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 6	-67.17 percent change Standard Deviation 46.756	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 9	-69.75 percent change Standard Deviation 42.882	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 12	-70.45 percent change Standard Deviation 46.575	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 15	-71.55 percent change Standard Deviation 50.406	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 18	-73.12 percent change Standard Deviation 45.194	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 21	-75.06 percent change Standard Deviation 45.993	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 24	-77.40 percent change Standard Deviation 38.093	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 27	-77.83 percent change Standard Deviation 33.877	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 30	-77.04 percent change Standard Deviation 33.478	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 33	-75.17 percent change Standard Deviation 53.782	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Erythema: At Month 36	-75.72 percent change Standard Deviation 34.823	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 1	-64.26 percent change Standard Deviation 55.848	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 3	-66.15 percent change Standard Deviation 52.568	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 6	-68.66 percent change Standard Deviation 49.145	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 9	-69.09 percent change Standard Deviation 48.506	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 12	-72.48 percent change Standard Deviation 45.755	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 15	-73.83 percent change Standard Deviation 42.528	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 18	-74.62 percent change Standard Deviation 39.708	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 21	-75.11 percent change Standard Deviation 44.570	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 24	-77.86 percent change Standard Deviation 38.041	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 27	-79.34 percent change Standard Deviation 31.825	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 30	-77.23 percent change Standard Deviation 37.819	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 33	-77.94 percent change Standard Deviation 41.688	—
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Scaling: At Month 36	-78.10 percent change Standard Deviation 30.391	—

SECONDARY outcome

Timeframe: Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline DSS \>0. Number analyzed =participants evaluable for this outcome measure at specified time points.

Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis severity score for a participant was 0-60. Higher score indicated greater severity.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=366 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 1	-6.7 units on a scale Standard Deviation 7.65	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 3	-6.8 units on a scale Standard Deviation 7.71	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 6	-7.2 units on a scale Standard Deviation 7.89	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 9	-7.4 units on a scale Standard Deviation 7.29	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 12	-7.6 units on a scale Standard Deviation 7.70	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 15	-7.7 units on a scale Standard Deviation 7.44	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 18	-7.7 units on a scale Standard Deviation 7.50	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 21	-7.8 units on a scale Standard Deviation 7.89	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 24	-7.9 units on a scale Standard Deviation 7.76	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 27	-8.1 units on a scale Standard Deviation 7.59	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 30	-8.0 units on a scale Standard Deviation 7.65	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 33	-8.1 units on a scale Standard Deviation 7.75	—
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 36	-7.7 units on a scale Standard Deviation 7.88	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline LEI \>0. Number analyzed =participants evaluable for this outcome measure at specified time points.

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=458 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 1	-1.5 units on a scale Standard Deviation 1.88	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 3	-1.6 units on a scale Standard Deviation 1.79	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 6	-1.7 units on a scale Standard Deviation 1.78	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 9	-1.8 units on a scale Standard Deviation 1.80	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 12	-1.7 units on a scale Standard Deviation 1.82	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 15	-2.0 units on a scale Standard Deviation 1.76	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 18	-1.9 units on a scale Standard Deviation 1.79	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 21	-1.9 units on a scale Standard Deviation 1.81	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 24	-2.0 units on a scale Standard Deviation 1.72	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 27	-2.0 units on a scale Standard Deviation 1.73	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 30	-2.0 units on a scale Standard Deviation 1.76	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 33	-2.0 units on a scale Standard Deviation 1.75	—
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 36	-2.1 units on a scale Standard Deviation 1.76	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline SPARCC enthesitis index \>0. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness was recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=525 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 1	-2.8 units on a scale Standard Deviation 3.60	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 3	-3.0 units on a scale Standard Deviation 3.61	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 6	-3.2 units on a scale Standard Deviation 3.72	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 9	-3.4 units on a scale Standard Deviation 3.69	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 12	-3.5 units on a scale Standard Deviation 3.46	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 15	-3.7 units on a scale Standard Deviation 3.55	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 18	-3.5 units on a scale Standard Deviation 3.45	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 21	-3.6 units on a scale Standard Deviation 3.60	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 24	-3.7 units on a scale Standard Deviation 3.62	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 27	-3.7 units on a scale Standard Deviation 3.56	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 30	-3.8 units on a scale Standard Deviation 3.49	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 33	-3.9 units on a scale Standard Deviation 3.39	—
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 36	-3.9 units on a scale Standard Deviation 3.69	—

SECONDARY outcome

Timeframe: Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 with presence of spondylitis at screening and baseline BASDAI Score\>0 cm. Number analyzed =participants evaluable for this outcome measure at specified time points.

BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=124 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 1	-2.26 centimeter Standard Deviation 2.367	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 3	-2.10 centimeter Standard Deviation 2.278	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 6	-2.40 centimeter Standard Deviation 2.371	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 9	-2.35 centimeter Standard Deviation 2.254	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 12	-2.41 centimeter Standard Deviation 2.371	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 15	-2.35 centimeter Standard Deviation 2.547	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 18	-2.41 centimeter Standard Deviation 2.640	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 21	-2.28 centimeter Standard Deviation 2.582	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 24	-2.47 centimeter Standard Deviation 2.640	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 27	-2.65 centimeter Standard Deviation 2.658	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 30	-2.95 centimeter Standard Deviation 2.672	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 33	-2.85 centimeter Standard Deviation 2.671	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 36	-2.88 centimeter Standard Deviation 2.521	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Population: Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with presence of spondylitis at screening and baseline BASDAI score \>=4 cm. Number analyzed =participants evaluable for this outcome measure at specified time points.

BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=106 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 1	-2.59 centimeter Standard Deviation 2.324	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 3	-2.41 centimeter Standard Deviation 2.227	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 6	-2.74 centimeter Standard Deviation 2.350	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 9	-2.63 centimeter Standard Deviation 2.175	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 12	-2.65 centimeter Standard Deviation 2.364	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 15	-2.65 centimeter Standard Deviation 2.487	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 18	-2.65 centimeter Standard Deviation 2.652	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 21	-2.47 centimeter Standard Deviation 2.602	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 24	-2.72 centimeter Standard Deviation 2.616	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 27	-2.90 centimeter Standard Deviation 2.640	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 30	-3.27 centimeter Standard Deviation 2.596	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 33	-3.17 centimeter Standard Deviation 2.589	—
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Change at Month 36	-3.08 centimeter Standard Deviation 2.459	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	6.44 units on a scale Standard Deviation 8.285	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	6.71 units on a scale Standard Deviation 8.496	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	7.23 units on a scale Standard Deviation 8.257	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	7.44 units on a scale Standard Deviation 8.729	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	7.79 units on a scale Standard Deviation 9.055	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	8.06 units on a scale Standard Deviation 8.899	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	7.77 units on a scale Standard Deviation 9.074	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	4.72 units on a scale Standard Deviation 10.480	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	4.98 units on a scale Standard Deviation 11.052	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	5.25 units on a scale Standard Deviation 11.072	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	5.53 units on a scale Standard Deviation 11.055	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	5.79 units on a scale Standard Deviation 11.122	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	5.82 units on a scale Standard Deviation 11.726	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	6.18 units on a scale Standard Deviation 11.284	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	6.06 units on a scale Standard Deviation 9.425	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	6.44 units on a scale Standard Deviation 9.834	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	7.00 units on a scale Standard Deviation 9.472	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	7.31 units on a scale Standard Deviation 9.891	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	7.69 units on a scale Standard Deviation 10.280	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	7.96 units on a scale Standard Deviation 10.146	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	7.80 units on a scale Standard Deviation 10.703	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	6.19 units on a scale Standard Deviation 9.545	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	6.56 units on a scale Standard Deviation 9.650	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	6.61 units on a scale Standard Deviation 9.293	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	7.07 units on a scale Standard Deviation 10.050	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	7.46 units on a scale Standard Deviation 10.094	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	7.64 units on a scale Standard Deviation 10.041	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	7.40 units on a scale Standard Deviation 9.996	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	8.52 units on a scale Standard Deviation 10.033	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	9.29 units on a scale Standard Deviation 9.777	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	8.36 units on a scale Standard Deviation 9.797	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	10.21 units on a scale Standard Deviation 10.645	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	10.45 units on a scale Standard Deviation 10.627	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	9.70 units on a scale Standard Deviation 10.271	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	9.95 units on a scale Standard Deviation 10.980	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	3.89 units on a scale Standard Deviation 8.033	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	4.09 units on a scale Standard Deviation 8.640	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	4.68 units on a scale Standard Deviation 8.652	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	4.76 units on a scale Standard Deviation 8.386	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	4.89 units on a scale Standard Deviation 8.608	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	4.81 units on a scale Standard Deviation 8.590	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	4.36 units on a scale Standard Deviation 8.847	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represents better vitality.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	5.92 units on a scale Standard Deviation 10.160	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	6.03 units on a scale Standard Deviation 10.546	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	6.72 units on a scale Standard Deviation 10.367	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	6.67 units on a scale Standard Deviation 10.147	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	7.10 units on a scale Standard Deviation 10.828	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	7.62 units on a scale Standard Deviation 10.808	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	7.65 units on a scale Standard Deviation 10.403	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	6.08 units on a scale Standard Deviation 11.028	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	6.51 units on a scale Standard Deviation 10.923	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	7.16 units on a scale Standard Deviation 10.932	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	6.76 units on a scale Standard Deviation 11.272	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	7.28 units on a scale Standard Deviation 11.487	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	7.64 units on a scale Standard Deviation 11.597	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	7.83 units on a scale Standard Deviation 11.977	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	6.71 units on a scale Standard Deviation 12.647	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	5.40 units on a scale Standard Deviation 11.962	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	5.39 units on a scale Standard Deviation 12.445	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	5.73 units on a scale Standard Deviation 12.235	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	6.82 units on a scale Standard Deviation 12.154	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	6.54 units on a scale Standard Deviation 12.843	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	6.95 units on a scale Standard Deviation 12.859	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	4.85 units on a scale Standard Deviation 10.306	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	5.39 units on a scale Standard Deviation 10.893	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	5.56 units on a scale Standard Deviation 10.781	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	5.82 units on a scale Standard Deviation 10.730	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	6.09 units on a scale Standard Deviation 11.247	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	6.18 units on a scale Standard Deviation 11.278	—
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	6.37 units on a scale Standard Deviation 11.199	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this outcome measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	-0.30 units on a scale Standard Deviation 0.538	—
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	-0.31 units on a scale Standard Deviation 0.545	—
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	-0.30 units on a scale Standard Deviation 0.526	—
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	-0.32 units on a scale Standard Deviation 0.555	—
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	-0.24 units on a scale Standard Deviation 0.529	—
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	-0.30 units on a scale Standard Deviation 0.540	—
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	-0.28 units on a scale Standard Deviation 0.511	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	-0.19 units on a scale Standard Deviation 0.547	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	-0.20 units on a scale Standard Deviation 0.530	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	-0.19 units on a scale Standard Deviation 0.532	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	-0.21 units on a scale Standard Deviation 0.522	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	-0.21 units on a scale Standard Deviation 0.534	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	-0.23 units on a scale Standard Deviation 0.533	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	-0.24 units on a scale Standard Deviation 0.589	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	-0.32 units on a scale Standard Deviation 0.579	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	-0.36 units on a scale Standard Deviation 0.547	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	-0.35 units on a scale Standard Deviation 0.594	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	-0.27 units on a scale Standard Deviation 0.588	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	-0.30 units on a scale Standard Deviation 0.539	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	-0.33 units on a scale Standard Deviation 0.547	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	-0.34 units on a scale Standard Deviation 0.571	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	-0.36 units on a scale Standard Deviation 0.568	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	-0.40 units on a scale Standard Deviation 0.584	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	-0.41 units on a scale Standard Deviation 0.602	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	-0.41 units on a scale Standard Deviation 0.601	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	-0.31 units on a scale Standard Deviation 0.557	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	-0.32 units on a scale Standard Deviation 0.570	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	-0.40 units on a scale Standard Deviation 0.613	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this outcome measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	-0.26 units on a scale Standard Deviation 0.623	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	-0.23 units on a scale Standard Deviation 0.600	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	-0.25 units on a scale Standard Deviation 0.594	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	-0.26 units on a scale Standard Deviation 0.604	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	-0.29 units on a scale Standard Deviation 0.605	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	-0.31 units on a scale Standard Deviation 0.608	—
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	-0.29 units on a scale Standard Deviation 0.651	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	14.12 millimeter Standard Deviation 24.928	—
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	15.71 millimeter Standard Deviation 25.871	—
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	16.00 millimeter Standard Deviation 24.896	—
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	16.68 millimeter Standard Deviation 24.746	—
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	17.43 millimeter Standard Deviation 25.226	—
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	17.87 millimeter Standard Deviation 25.363	—
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	18.07 millimeter Standard Deviation 25.185	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	7.0 units on a scale Standard Deviation 9.78	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	7.7 units on a scale Standard Deviation 10.13	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	7.8 units on a scale Standard Deviation 9.70	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	8.1 units on a scale Standard Deviation 10.06	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	8.3 units on a scale Standard Deviation 10.61	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	8.7 units on a scale Standard Deviation 10.93	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	9.1 units on a scale Standard Deviation 11.05	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 12	3.5 units on a scale Standard Deviation 4.48	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 1	3.1 units on a scale Standard Deviation 4.47	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 6	3.4 units on a scale Standard Deviation 4.61	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 18	3.6 units on a scale Standard Deviation 4.63	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 24	3.7 units on a scale Standard Deviation 4.93	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 30	3.9 units on a scale Standard Deviation 5.02	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Change at Month 36	4.0 units on a scale Standard Deviation 4.90	—

SECONDARY outcome

Timeframe: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36

Population: FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.

FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=686 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 1	3.9 units on a scale Standard Deviation 5.98	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 6	4.2 units on a scale Standard Deviation 6.19	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 12	4.4 units on a scale Standard Deviation 5.88	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 18	4.5 units on a scale Standard Deviation 6.05	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 24	4.6 units on a scale Standard Deviation 6.34	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 30	4.8 units on a scale Standard Deviation 6.46	—
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Change at Month 36	5.0 units on a scale Standard Deviation 6.77	—

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least 1 dose of (tofacitinib, MTX or placebo).

HAQ-DI assessed the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12 Change at Month 1	-0.0164 units on a scale Standard Error 0.02438	0.0322 units on a scale Standard Error 0.02411
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12 Change at Month 3	0.0057 units on a scale Standard Error 0.02512	0.0381 units on a scale Standard Error 0.02474
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12 Change at Month 9	0.0720 units on a scale Standard Error 0.03195	0.0663 units on a scale Standard Error 0.03125
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12 Change at Month 12	0.0467 units on a scale Standard Error 0.02998	0.0563 units on a scale Standard Error 0.02941

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least 1 dose of (tofacitinib, MTX or placebo).

PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in mm, swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), SF-36 physical component summary (norm-based domain score were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and CRP in mg/L. PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12 Change at Month 12	0.194 units on a scale Standard Error 0.0898	0.133 units on a scale Standard Error 0.0882
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12 Change at Month 1	0.000 units on a scale Standard Error 0.0701	0.032 units on a scale Standard Error 0.0696
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12 Change at Month 3	0.188 units on a scale Standard Error 0.0869	0.165 units on a scale Standard Error 0.0868
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12 Change at Month 9	0.158 units on a scale Standard Error 0.0934	0.371 units on a scale Standard Error 0.0912

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

PsARC was comprised of 4 clinical improvement criteria: >=20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12 Month 1	12.36 percentage of participants	12.22 percentage of participants
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12 Month 3	11.24 percentage of participants	6.67 percentage of participants
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12 Month 6	12.36 percentage of participants	6.67 percentage of participants
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12 Month 9	12.36 percentage of participants	10.00 percentage of participants
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12 Month 12	13.48 percentage of participants	3.33 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline PGA-PsO score\>0.

The PGA-PsO is a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=41 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=33 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.3 units on a scale Standard Error 0.13	0.2 units on a scale Standard Error 0.13
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12 Change at Month 12	0.0 units on a scale Standard Error 0.15	0.3 units on a scale Standard Error 0.15
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.1 units on a scale Standard Error 0.10	0.2 units on a scale Standard Error 0.11
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.1 units on a scale Standard Error 0.12	0.1 units on a scale Standard Error 0.14
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.1 units on a scale Standard Error 0.11	0.2 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline BSA \>0%. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage (Head and neck = 10 handprints [1 handprint =10%], upper extremities = 20 handprints [1 handprint =5%], Trunk (including axillae and groin) = 30 handprints [1 handprint =3.33%], lower extremities (including buttocks) = 40 handprints [1 handprint =2.5%]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=47 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=42 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12 At Month 1	28.47 percent change Standard Error 13.497	9.04 percent change Standard Error 13.972
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12 At Month 3	43.58 percent change Standard Error 18.679	13.47 percent change Standard Error 19.348
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12 At Month 6	41.51 percent change Standard Error 20.745	17.19 percent change Standard Error 21.157
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12 At Month 9	35.36 percent change Standard Error 17.309	23.72 percent change Standard Error 17.691
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12 At Month 12	34.74 percent change Standard Error 19.909	41.75 percent change Standard Error 20.333

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline DSS \>0. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=7 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=1 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.4 units on a scale Standard Deviation 0.79	0.0 units on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.3 units on a scale Standard Deviation 0.52	-1.0 units on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.3 units on a scale Standard Deviation 0.52	-1.0 units on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.3 units on a scale Standard Deviation 0.52	-1.0 units on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.3 units on a scale Standard Deviation 0.52	-1.0 units on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.

SECONDARY outcome

Timeframe: Sub-study: Months 1, 3, 6, 9 and 12

Population: Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline DSS \>0.

Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=7 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=1 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Month 1	14.29 percentage of participants	0.0 percentage of participants
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Month 3	14.29 percentage of participants	0.0 percentage of participants
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Month 6	14.29 percentage of participants	0.0 percentage of participants
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Month 9	14.29 percentage of participants	0.0 percentage of participants
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Month 12	14.29 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) and with baseline Leeds enthesitis index \>0. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=15 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=16 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.2 units on a scale Standard Error 0.25	-0.4 units on a scale Standard Error 0.24
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.3 units on a scale Standard Error 0.23	-0.5 units on a scale Standard Error 0.23
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.5 units on a scale Standard Error 0.29	-0.7 units on a scale Standard Error 0.28
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.3 units on a scale Standard Error 0.29	0.0 units on a scale Standard Error 0.28
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.5 units on a scale Standard Error 0.28	-0.3 units on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: Sub-study: Months 1, 3, 6, 9 and 12

Population: Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline LEI =0. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=74 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=74 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12 Month 3	0.2 units on a scale Standard Deviation 0.56	0.0 units on a scale Standard Deviation 0.24
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12 Month 1	0.2 units on a scale Standard Deviation 0.64	0.1 units on a scale Standard Deviation 0.58
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12 Month 6	0.2 units on a scale Standard Deviation 0.76	0.2 units on a scale Standard Deviation 0.82
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12 Month 9	0.1 units on a scale Standard Deviation 0.24	0.1 units on a scale Standard Deviation 0.46
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12 Month 12	0.2 units on a scale Standard Deviation 0.67	0.1 units on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: Sub-study: Months 1, 3, 6, 9 and 12

Population: Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline LEI \>0.

Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=15 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=16 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Month 1	13.33 percentage of participants	25.00 percentage of participants
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Month 3	13.33 percentage of participants	43.75 percentage of participants
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Month 6	26.67 percentage of participants	56.25 percentage of participants
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Month 9	13.33 percentage of participants	37.50 percentage of participants
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Month 12	26.67 percentage of participants	43.75 percentage of participants

SECONDARY outcome

Timeframe: Sub-study: Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

A psoriatic arthritis participant was considered with minimal disease activity if participant had >= 5 of 7 criteria: 1) tender/painful joint count less than or equals to (<=) 1; (2) swollen joint count <=1; (3) BSA <=3%; (4) Patient Assessment of Arthritis Pain (VAS) <=15 mm; (5) PtGA (VAS) <=20 mm; (6) HAQ-DI score <=0.5; (7) tender entheseal points (using LEI) <=1.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12 Month 12	41.57 percentage of participants	44.44 percentage of participants
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12 Month 1	50.56 percentage of participants	55.56 percentage of participants
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12 Month 3	50.56 percentage of participants	54.44 percentage of participants
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12 Month 6	46.07 percentage of participants	48.89 percentage of participants
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12 Month 9	42.70 percentage of participants	46.67 percentage of participants

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

68 joints were assessed to determine joints that are considered tender or painful. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints). The 68 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 3	1.3 tender/painful joints Standard Error 0.44	0.9 tender/painful joints Standard Error 0.44
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 1	0.7 tender/painful joints Standard Error 0.37	0.3 tender/painful joints Standard Error 0.37
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 6	0.5 tender/painful joints Standard Error 0.37	0.5 tender/painful joints Standard Error 0.37
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 9	0.4 tender/painful joints Standard Error 0.33	0.4 tender/painful joints Standard Error 0.32
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 12	0.3 tender/painful joints Standard Error 0.32	0.5 tender/painful joints Standard Error 0.32

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

Joints were assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Sixty-six (66) joints were assessed for swelling. The 66 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.1 swollen joints Standard Error 0.14	0.0 swollen joints Standard Error 0.14
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 3	0.3 swollen joints Standard Error 0.21	0.3 swollen joints Standard Error 0.21
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 6	0.1 swollen joints Standard Error 0.16	0.1 swollen joints Standard Error 0.15
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 9	0.0 swollen joints Standard Error 0.17	0.2 swollen joints Standard Error 0.17
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12 Change at Month 12	0.1 swollen joints Standard Error 0.14	0.0 swollen joints Standard Error 0.14

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and independent of the PtGA and Patient Assessment of Arthritis Pain. The investigator's response was recorded using a 100 mm VAS where 0 =PSA not active at all and 100 =PSA extremely active. Higher score indicated more PSA.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.42 millimeter Standard Error 0.992	-0.17 millimeter Standard Error 0.981
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12 Change at Month 3	1.98 millimeter Standard Error 1.225	2.76 millimeter Standard Error 1.216
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12 Change at Month 6	1.18 millimeter Standard Error 0.983	1.65 millimeter Standard Error 0.966
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12 Change at Month 9	1.18 millimeter Standard Error 1.316	3.35 millimeter Standard Error 1.287
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12 Change at Month 12	0.86 millimeter Standard Error 1.127	0.75 millimeter Standard Error 1.111

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participant's response were recorded using a 0 - 100 mm VAS where 0 =not affected at all and 100 =extremely affected. Higher score indicated worse condition due to PSA.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12 Change at Month 1	1.35 millimeter Standard Error 1.277	-0.68 millimeter Standard Error 1.264
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12 Change at Month 3	2.11 millimeter Standard Error 1.537	1.68 millimeter Standard Error 1.516
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12 Change at Month 6	3.17 millimeter Standard Error 1.725	4.45 millimeter Standard Error 1.690
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12 Change at Month 9	2.63 millimeter Standard Error 1.691	3.27 millimeter Standard Error 1.655
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12 Change at Month 12	2.77 millimeter Standard Error 1.629	2.65 millimeter Standard Error 1.602

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

Participants assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. Higher score indicated more severe pain.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.05 millimeter Standard Error 1.383	-1.16 millimeter Standard Error 1.370
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12 Change at Month 3	1.59 millimeter Standard Error 1.394	0.36 millimeter Standard Error 1.380
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12 Change at Month 6	3.12 millimeter Standard Error 1.709	4.07 millimeter Standard Error 1.674
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12 Change at Month 9	2.44 millimeter Standard Error 1.780	4.45 millimeter Standard Error 1.741
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12 Change at Month 12	2.69 millimeter Standard Error 1.692	3.35 millimeter Standard Error 1.664

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.1005 mg/L Standard Error 0.78650	0.2667 mg/L Standard Error 0.77230
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.1171 mg/L Standard Error 0.71654	-0.2706 mg/L Standard Error 0.70892
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.3625 mg/L Standard Error 0.48088	-0.9285 mg/L Standard Error 0.47675
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12 Change at Month 6	0.5354 mg/L Standard Error 0.79954	-0.2637 mg/L Standard Error 0.78002
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.3217 mg/L Standard Error 0.59271	-0.2591 mg/L Standard Error 0.57983

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.55 units on a scale Standard Error 0.424	-0.22 units on a scale Standard Error 0.419
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.90 units on a scale Standard Error 0.492	-0.57 units on a scale Standard Error 0.487
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.65 units on a scale Standard Error 0.480	-1.42 units on a scale Standard Error 0.466
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-1.09 units on a scale Standard Error 0.607	-1.85 units on a scale Standard Error 0.593
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-1.52 units on a scale Standard Error 0.533	-1.00 units on a scale Standard Error 0.523

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 1	0.35 units on a scale Standard Error 0.630	-0.11 units on a scale Standard Error 0.622
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 3	0.09 units on a scale Standard Error 0.642	-0.77 units on a scale Standard Error 0.634
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.23 units on a scale Standard Error 0.733	-0.89 units on a scale Standard Error 0.713
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.71 units on a scale Standard Error 0.749	0.06 units on a scale Standard Error 0.731
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.38 units on a scale Standard Error 0.694	-0.47 units on a scale Standard Error 0.681

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.37 units on a scale Standard Error 0.472	-0.15 units on a scale Standard Error 0.467
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.50 units on a scale Standard Error 0.562	-0.33 units on a scale Standard Error 0.556
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.27 units on a scale Standard Error 0.586	-0.80 units on a scale Standard Error 0.571
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-1.43 units on a scale Standard Error 0.657	-1.11 units on a scale Standard Error 0.643
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-1.01 units on a scale Standard Error 0.676	-1.02 units on a scale Standard Error 0.664

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.27 units on a scale Standard Error 0.561	0.22 units on a scale Standard Error 0.555
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-1.04 units on a scale Standard Error 0.626	0.21 units on a scale Standard Error 0.619
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-1.57 units on a scale Standard Error 0.585	-0.87 units on a scale Standard Error 0.569
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.64 units on a scale Standard Error 0.638	-0.44 units on a scale Standard Error 0.624
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-1.85 units on a scale Standard Error 0.646	-0.12 units on a scale Standard Error 0.635

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.77 units on a scale Standard Error 0.617	-0.06 units on a scale Standard Error 0.609
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-1.59 units on a scale Standard Error 0.661	-1.24 units on a scale Standard Error 0.652
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.61 units on a scale Standard Error 0.686	-2.42 units on a scale Standard Error 0.669
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-1.29 units on a scale Standard Error 0.808	-3.05 units on a scale Standard Error 0.790
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-1.69 units on a scale Standard Error 0.719	-1.99 units on a scale Standard Error 0.706

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	0.20 units on a scale Standard Error 0.492	-0.48 units on a scale Standard Error 0.487
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	0.34 units on a scale Standard Error 0.516	-0.79 units on a scale Standard Error 0.511
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	0.24 units on a scale Standard Error 0.493	-0.57 units on a scale Standard Error 0.481
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.48 units on a scale Standard Error 0.562	-0.46 units on a scale Standard Error 0.551
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.32 units on a scale Standard Error 0.539	-0.29 units on a scale Standard Error 0.530

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represented better vitality.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.04 units on a scale Standard Error 0.614	-0.39 units on a scale Standard Error 0.607
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.26 units on a scale Standard Error 0.593	-1.12 units on a scale Standard Error 0.586
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	0.01 units on a scale Standard Error 0.705	-1.70 units on a scale Standard Error 0.687
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.80 units on a scale Standard Error 0.645	-1.27 units on a scale Standard Error 0.632
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-1.04 units on a scale Standard Error 0.640	-0.09 units on a scale Standard Error 0.629

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.99 units on a scale Standard Error 0.734	-0.22 units on a scale Standard Error 0.726
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.80 units on a scale Standard Error 0.750	-1.18 units on a scale Standard Error 0.740
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-1.16 units on a scale Standard Error 0.776	-1.74 units on a scale Standard Error 0.757
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-1.50 units on a scale Standard Error 0.753	-1.22 units on a scale Standard Error 0.737
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-1.81 units on a scale Standard Error 0.758	-1.28 units on a scale Standard Error 0.746

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.33 units on a scale Standard Error 0.835	-1.11 units on a scale Standard Error 0.820
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	1.14 units on a scale Standard Error 0.716	-0.53 units on a scale Standard Error 0.707
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	0.24 units on a scale Standard Error 0.807	-0.38 units on a scale Standard Error 0.797
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.72 units on a scale Standard Error 0.788	-0.82 units on a scale Standard Error 0.769
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.78 units on a scale Standard Error 0.803	-0.06 units on a scale Standard Error 0.782

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.30 units on a scale Standard Error 0.676	0.63 units on a scale Standard Error 0.669
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.42 units on a scale Standard Error 0.661	-0.31 units on a scale Standard Error 0.653
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.01 units on a scale Standard Error 0.780	-0.26 units on a scale Standard Error 0.762
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.72 units on a scale Standard Error 0.724	0.35 units on a scale Standard Error 0.710
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.37 units on a scale Standard Error 0.723	0.01 units on a scale Standard Error 0.711

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-1.9 units on a scale Standard Error 0.61	-1.1 units on a scale Standard Error 0.61
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-1.8 units on a scale Standard Error 0.59	-1.3 units on a scale Standard Error 0.58
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-1.3 units on a scale Standard Error 0.61	-2.0 units on a scale Standard Error 0.60
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-2.1 units on a scale Standard Error 0.65	-1.0 units on a scale Standard Error 0.64
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-1.4 units on a scale Standard Error 0.66	-0.7 units on a scale Standard Error 0.64

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-0.9 units on a scale Standard Error 0.29	-0.5 units on a scale Standard Error 0.29
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-0.8 units on a scale Standard Error 0.31	-0.9 units on a scale Standard Error 0.30
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.5 units on a scale Standard Error 0.29	-1.3 units on a scale Standard Error 0.28
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-0.7 units on a scale Standard Error 0.31	-0.8 units on a scale Standard Error 0.30
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.5 units on a scale Standard Error 0.31	-0.5 units on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 12	-0.9 units on a scale Standard Error 0.40	-0.1 units on a scale Standard Error 0.40
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 1	-1.1 units on a scale Standard Error 0.39	-0.6 units on a scale Standard Error 0.39
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 3	-1.1 units on a scale Standard Error 0.35	-0.4 units on a scale Standard Error 0.35
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 6	-0.8 units on a scale Standard Error 0.41	-0.7 units on a scale Standard Error 0.40
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12 Change at Month 9	-1.4 units on a scale Standard Error 0.42	-0.2 units on a scale Standard Error 0.41

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12 Change at Month 1	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12 Change at Month 3	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12 Change at Month 6	0.0 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12 Change at Month 9	0.0 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12 Change at Month 12	0.0 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12 Change at Month 1	0.0 units on a scale Standard Error 0.03	0.0 units on a scale Standard Error 0.03
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12 Change at Month 3	0.0 units on a scale Standard Error 0.03	0.0 units on a scale Standard Error 0.03
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12 Change at Month 6	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.03
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12 Change at Month 9	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12 Change at Month 12	0.0 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12 Change at Month 1	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12 Change at Month 3	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12 Change at Month 6	0.0 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12 Change at Month 9	0.1 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12 Change at Month 12	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain Change at Month 1	0.1 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain Change at Month 3	0.1 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain Change at Month 6	0.1 units on a scale Standard Error 0.04	0.1 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain Change at Month 9	0.1 units on a scale Standard Error 0.05	0.1 units on a scale Standard Error 0.05
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain Change at Month 12	0.1 units on a scale Standard Error 0.05	0.2 units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this measure.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12 Change at Month 1	0.1 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12 Change at Month 3	0.0 units on a scale Standard Error 0.05	0.0 units on a scale Standard Error 0.04
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12 Change at Month 6	0.1 units on a scale Standard Error 0.05	0.0 units on a scale Standard Error 0.05
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12 Change at Month 9	0.1 units on a scale Standard Error 0.05	0.0 units on a scale Standard Error 0.05
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12 Change at Month 12	0.1 units on a scale Standard Error 0.05	0.0 units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Population: FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).

The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard verticle 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.

Outcome measures

Measure	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 Participants Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 Participants Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12 Change at Month 1	2.0 millimeter Standard Error 1.19	-0.9 millimeter Standard Error 1.16
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12 Change at Month 3	0.5 millimeter Standard Error 1.54	-1.1 millimeter Standard Error 1.52
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12 Change at Month 6	4.4 millimeter Standard Error 1.41	-1.9 millimeter Standard Error 1.38
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12 Change at Month 9	2.5 millimeter Standard Error 1.59	-0.4 millimeter Standard Error 1.56
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12 Change at Month 12	3.0 millimeter Standard Error 1.82	-1.9 millimeter Standard Error 1.78

Adverse Events

All Tofacitinib

Serious events: 115 serious events

Other events: 457 other events

Deaths: 6 deaths

Tofacitinib 5 mg BID + Methotrexate (MTX)

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Tofacitinib 5 mg BID + Placebo

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Tofacitinib n=686 participants at risk Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 participants at risk Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 participants at risk Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Gastrointestinal disorders Inguinal hernia	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Blood and lymphatic system disorders Lymphadenitis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Angina pectoris	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Angina unstable	0.44% 3/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Cardiac failure acute	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Cardiovascular insufficiency	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Coronary artery disease	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Coronary artery stenosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Myocardial infarction	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Myocardial ischaemia	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Prinzmetal angina	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Cardiac disorders Stress cardiomyopathy	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Ear and labyrinth disorders Deafness neurosensory	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Endocrine disorders Goitre	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Eye disorders Chorioretinopathy	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Abdominal adhesions	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Abdominal pain	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Crohn's disease	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Gastritis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Haematemesis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Hiatus hernia	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Incarcerated umbilical hernia	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Melaena	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Pancreatitis acute	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Rectal prolapse	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
General disorders Chest pain	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
General disorders Nodule	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
General disorders Non-cardiac chest pain	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
General disorders Pyrexia	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Hepatobiliary disorders Cholecystitis acute	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Hepatobiliary disorders Cholelithiasis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Hepatobiliary disorders Hepatic failure	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Appendicitis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Cellulitis	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Diarrhoea infectious	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Epiglottitis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Erysipelas	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Gastroenteritis	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Gastroenteritis viral	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations HIV infection	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Herpes zoster	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Influenza	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Neurosyphilis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Otitis media acute	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Pneumonia	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Post procedural infection	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Pyoderma	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Serratia sepsis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Upper respiratory tract infection	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Ankle fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Cartilage injury	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Chemical poisoning	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Contusion	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Facial bones fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Fall	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Fractured sacrum	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Hand fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Humerus fracture	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Joint injury	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Ligament injury	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Meniscus injury	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Procedural pain	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Rib fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Skin laceration	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Spinal compression fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Tendon rupture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Tibia fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Investigations Heart rate decreased	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Metabolism and nutrition disorders Cardiometabolic syndrome	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Arthralgia	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Arthritis	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Back pain	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Foot deformity	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.58% 4/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Reproductive system and breast disorders Endometriosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Joint swelling	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 7/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Spinal pain	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Synovial cyst	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Reproductive system and breast disorders Ovarian cyst	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Carotid artery stenosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Carpal tunnel syndrome	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Headache	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Ischaemic stroke	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Loss of consciousness	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Paraesthesia	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Presyncope	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Transient global amnesia	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Transient ischaemic attack	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Product Issues Device loosening	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Psychiatric disorders Bipolar I disorder	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Psychiatric disorders Bipolar disorder	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Renal and urinary disorders Renal colic	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Renal and urinary disorders Urinary retention	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Reproductive system and breast disorders Breast disorder female	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Apnoea	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.29% 2/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Vascular disorders Hypertension	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Pneumonia herpes viral	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Forearm fracture	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Immune system disorders Hypersensitivity	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Device related sepsis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Vertebral lateral recess stenosis	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic adenoma	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Gastrointestinal disorder	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Meconium aspiration syndrome	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Social circumstances Miscarriage of partner	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Vascular disorders Post thrombotic syndrome	0.15% 1/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.

Other adverse events

Measure	All Tofacitinib n=686 participants at risk Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.	Tofacitinib 5 mg BID + Methotrexate (MTX) n=89 participants at risk Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.	Tofacitinib 5 mg BID + Placebo n=90 participants at risk Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Blood and lymphatic system disorders Anaemia	2.2% 15/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Diarrhoea	3.6% 25/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	3.3% 3/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Abdominal pain upper	2.5% 17/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Dyspepsia	2.2% 15/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Gastrointestinal disorders Nausea	3.9% 27/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
General disorders Oedema peripheral	2.0% 14/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Bronchitis	9.8% 67/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	3.3% 3/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Influenza	2.8% 19/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Gastroenteritis	2.8% 19/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Nasopharyngitis	15.2% 104/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	3.3% 3/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Pharyngitis	5.5% 38/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	3.4% 3/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	3.3% 3/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Respiratory tract infection	2.5% 17/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Sinusitis	4.8% 33/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Upper respiratory tract infection	18.1% 124/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	6.7% 6/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	4.4% 4/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Urinary tract infection	9.6% 66/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	3.4% 3/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	4.4% 4/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Herpes zoster	3.8% 26/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Infections and infestations Oral herpes	2.8% 19/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Injury, poisoning and procedural complications Fall	3.5% 24/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Investigations Alanine aminotransferase increased	5.0% 34/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Investigations Aspartate aminotransferase increased	3.1% 21/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Investigations Blood creatine phosphokinase increased	5.2% 36/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Investigations Gamma-glutamyltransferase increased	3.2% 22/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Investigations Hepatic enzyme increased	2.2% 15/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Metabolism and nutrition disorders Hypercholesterolaemia	2.0% 14/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 32/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Back pain	4.5% 31/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	6.4% 44/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	3.4% 3/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Dizziness	2.9% 20/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Headache	4.7% 32/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Nervous system disorders Sciatica	2.8% 19/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 17/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 14/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	0.00% 0/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Skin and subcutaneous tissue disorders Psoriasis	4.7% 32/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	1.1% 1/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.
Vascular disorders Hypertension	7.3% 50/686 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/89 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.	2.2% 2/90 • Baseline (Day 1) up to last dose of main study (maximum up to 36 months) if not enrolled into sub-study or from baseline up to last dose of sub-study (maximum up to 48 months) if enrolled into sub-study Analysis performed on safety analysis set. As pre-specified in protocol/SAP, safety data were planned to be assessed as a single group (without regard to tofacitinib doses) in the main study. For the main study report, the analysis of the safety data included cumulative safety data from both the main and the sub-study as a single group. In addition, the safety data collected in the sub-study was analyzed for tofacitinib 5 mg BID + MTX and tofacitinib 5 mg BID + placebo, separately.

Additional Information

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