Trial Outcomes & Findings for Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study (NCT NCT01877668)

Results Overview

ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

422 participants

Primary outcome timeframe

At end of Month 3

Results posted on

2017-07-06

Participant Flow

Of 611 participants screened for entry into the study, 422 received treatment.

Participant milestones

Participant milestones
Measure	Tofacitinib, 5 mg, Twice Daily Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo/Tofacitinib, 5 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Overall Study STARTED	107	104	106	52	53
Overall Study COMPLETED	96	96	94	44	43
Overall Study NOT COMPLETED	11	8	12	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib, 5 mg, Twice Daily Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo/Tofacitinib, 5 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Overall Study Death	0	0	0	1	0
Overall Study No longer met study criteria	1	0	1	0	0
Overall Study Insufficient clinical response	0	1	2	2	0
Overall Study Lost to Follow-up	0	2	1	0	0
Overall Study Withdrawal by Subject	2	0	3	2	2
Overall Study Other	1	1	1	1	3
Overall Study Protocol Violation	1	1	0	0	3
Overall Study Adverse event related to study drug	2	2	2	2	1
Overall Study Adverse event unrelated to study drug	4	1	2	0	1

Baseline Characteristics

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo/Tofacitinib, 5 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.	Placebo/Tofacitinib, 10 mg, Twice Daily n=53 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Total n=422 Participants Total of all reporting groups
Age, Continuous	49.4 Years STANDARD_DEVIATION 12.6 • n=5 Participants	46.9 Years STANDARD_DEVIATION 12.4 • n=7 Participants	47.4 Years STANDARD_DEVIATION 11.3 • n=5 Participants	46.1 Years STANDARD_DEVIATION 10.4 • n=4 Participants	49.3 Years STANDARD_DEVIATION 13.8 • n=21 Participants	47.9 Years STANDARD_DEVIATION 12.1 • n=10 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	62 Participants n=7 Participants	50 Participants n=5 Participants	28 Participants n=4 Participants	28 Participants n=21 Participants	225 Participants n=10 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	42 Participants n=7 Participants	56 Participants n=5 Participants	24 Participants n=4 Participants	25 Participants n=21 Participants	197 Participants n=10 Participants

PRIMARY outcome

Timeframe: At end of Month 3

Population: All participants who were randomized and received at least 1 dose of study drug.

ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=105 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3	50.47 Percentage or participants	60.58 Percentage or participants	51.89 Percentage or participants	33.33 Percentage or participants	—	—

PRIMARY outcome

Timeframe: From Baseline to Month 3

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score	-0.3499 Units on a scale Standard Error 0.04665	-0.3998 Units on a scale Standard Error 0.04716	-0.3808 Units on a scale Standard Error 0.04767	-0.1802 Units on a scale Standard Error 0.05031	—	—

SECONDARY outcome

Timeframe: From Baseline to Month 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=98 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=99 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=95 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=48 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=45 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis	0.01 Units on a scale Standard Error 0.067	-0.01 Units on a scale Standard Error 0.067	-0.07 Units on a scale Standard Error 0.069	0.00 Units on a scale Standard Error 0.094	0.09 Units on a scale Standard Error 0.099	—

SECONDARY outcome

Timeframe: At Month 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS \>0.5 from baseline.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=98 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=99 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=95 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=48 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=45 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12	4.08 Percentage of participants	5.05 Percentage of participants	2.11 Percentage of participants	4.17 Percentage of participants	8.89 Percentage of participants	—

SECONDARY outcome

Timeframe: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=53 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=105 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 2 (n=23, 34, 24, NA, NA, 8)	21.50 Percentage of participants	32.69 Percentage of participants	22.64 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	7.62 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 1 (n=13, 20,12, NA, NA, 5)	12.15 Percentage of participants	19.23 Percentage of participants	11.32 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	4.76 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Week 2 (n=7, 7, 5, NA, NA, 1)	6.54 Percentage of participants	6.73 Percentage of participants	4.72 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	0.95 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 3 (n=30, 42, 35, NA, NA, 10)	28.04 Percentage of participants	40.38 Percentage of participants	33.02 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	9.52 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 4 (n=38, 39, 34, 11, 17, NA)	35.51 Percentage of participants	37.50 Percentage of participants	32.08 Percentage of participants	21.15 Percentage of participants	32.08 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 6 (n=41, 48, 45, 17, 14, NA)	38.32 Percentage of participants	46.15 Percentage of participants	42.45 Percentage of participants	32.69 Percentage of participants	26.42 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 9 (n=45, 48, 49, 22, 23, NA)	42.06 Percentage of participants	46.15 Percentage of participants	46.23 Percentage of participants	42.31 Percentage of participants	43.40 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 12 (n=48, 50, 43, 21, 19, NA)	44.86 Percentage of participants	48.08 Percentage of participants	40.57 Percentage of participants	40.38 Percentage of participants	35.85 Percentage of participants	NA Percentage of participants Results not reported for this group.

SECONDARY outcome

Timeframe: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. .

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=53 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=105 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 9 (n=21, 31, 30, 15, 12, NA)	19.63 Percentage of participants	29.81 Percentage of participants	28.30 Percentage of participants	28.85 Percentage of participants	22.64 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Week 2 (n=0, 3, 1, NA, NA, 0)	0.00 Percentage of participants	2.88 Percentage of participants	0.94 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	0.00 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 1 (n=5, 8, 4, NA, NA, 1)	4.67 Percentage of participants	7.69 Percentage of participants	3.77 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	0.95 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 2 (n=10, 14, 13, NA, NA, 2)	9.35 Percentage of participants	13.46 Percentage of participants	12.26 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	1.90 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 3 (n=18, 15, 20, NA, NA, 5)	16.82 Percentage of participants	14.42 Percentage of participants	18.87 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	4.76 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 4 (n=24, 23, 21, 7, 8, NA)	22.43 Percentage of participants	22.12 Percentage of participants	19.81 Percentage of participants	13.46 Percentage of participants	15.09 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 6 (n=19, 33, 32, 10, 7, NA)	17.76 Percentage of participants	31.73 Percentage of participants	30.19 Percentage of participants	19.23 Percentage of participants	13.21 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 12 (n=25, 32, 31, 12, 12, NA)	23.36 Percentage of participants	30.77 Percentage of participants	29.25 Percentage of participants	23.08 Percentage of participants	22.64 Percentage of participants	NA Percentage of participants Results not reported for this group.

SECONDARY outcome

Timeframe: At Week 2 and Months 1, 2, 4, 6, 9, and 12

Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=53 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=105 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 Month 9 (n=73, 76, 73, 35, 37, NA)	68.22 Percentage of participants	73.08 Percentage of participants	68.87 Percentage of participants	67.31 Percentage of participants	69.81 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 Month 12 (n=73, 73, 64, 35, 31, NA)	68.22 Percentage of participants	70.19 Percentage of participants	60.38 Percentage of participants	67.31 Percentage of participants	58.49 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 Week 2 (n=24, 33, 23, NA, NA, 6)	22.43 Percentage of participants	31.73 Percentage of participants	21.70 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	5.71 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 Month 1 (n=37, 50, 30, NA, NA, 11)	34.58 Percentage of participants	48.08 Percentage of participants	28.30 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	10.48 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 Month 2 (n=47, 57, 62, NA, NA, 28)	43.93 Percentage of participants	54.81 Percentage of participants	58.49 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	26.67 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 Month 4 (n=65, 60, 61, 27, 28, NA)	60.75 Percentage of participants	57.69 Percentage of participants	57.55 Percentage of participants	51.92 Percentage of participants	52.83 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 Month 6 (n=63, 70, 68, 31, 30, NA)	58.88 Percentage of participants	67.31 Percentage of participants	64.15 Percentage of participants	59.62 Percentage of participants	56.60 Percentage of participants	NA Percentage of participants Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 2 (n=104, 104, 104, NA, NA, 102)	-0.2713 Units on a scale Standard Error 0.04626	-0.4009 Units on a scale Standard Error 0.04678	-0.3736 Units on a scale Standard Error 0.04719	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.1682 Units on a scale Standard Error 0.04998
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 4 (n=102, 100, 102, 50, 50, NA)	-0.4231 Units on a scale Standard Error 0.04982	-0.4407 Units on a scale Standard Error 0.05039	-0.3643 Units on a scale Standard Error 0.05069	-0.2850 Units on a scale Standard Error 0.07075	-0.3302 Units on a scale Standard Error 0.07128	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 6 (n=100, 100, 99, 48, 48, NA)	-0.4471 Units on a scale Standard Error 0.05136	-0.4611 Units on a scale Standard Error 0.05179	-0.4259 Units on a scale Standard Error 0.05227	-0.3142 Units on a scale Standard Error 0.07315	-0.3841 Units on a scale Standard Error 0.07369	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 9 (n=99, 96, 96, 47, 45, NA)	-0.5119 Units on a scale Standard Error 0.05038	-0.4847 Units on a scale Standard Error 0.05096	-0.4304 Units on a scale Standard Error 0.05143	-0.3843 Units on a scale Standard Error 0.07185	-0.4839 Units on a scale Standard Error 0.07276	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 12 (n=96, 96, 94, 44, 44, NA)	-0.5391 Units on a scale Standard Error 0.05324	-0.5104 Units on a scale Standard Error 0.05365	-0.4478 Units on a scale Standard Error 0.05426	-0.4104 Units on a scale Standard Error 0.07646	-0.4569 Units on a scale Standard Error 0.07704	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Week 2 (n=106, 102, 103, NA, NA, 102)	-0.1842 Units on a scale Standard Error 0.04131	-0.2089 Units on a scale Standard Error 0.04208	-0.2129 Units on a scale Standard Error 0.04246	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.0837 Units on a scale Standard Error 0.04549
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 1 (n=105, 103, 104, NA, NA, 103)	-0.2048 Units on a scale Standard Error 0.04363	-0.2676 Units on a scale Standard Error 0.04426	-0.3028 Units on a scale Standard Error 0.04465	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.1224 Units on a scale Standard Error 0.04755

SECONDARY outcome

Timeframe: From Baseline to end of Month 3

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels	-5.5981 mg/L Standard Error 0.80656	-6.6004 mg/L Standard Error 0.80822	-7.8955 mg/L Standard Error 0.82547	-0.8643 mg/L Standard Error 0.86304	—	—

SECONDARY outcome

Timeframe: From Baseline to end of Month 3

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (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.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=105 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain	-21.49 mm Standard Error 2.325	-27.10 mm Standard Error 2.342	-21.87 mm Standard Error 2.389	-10.22 mm Standard Error 2.499	—	—

SECONDARY outcome

Timeframe: From Baseline to end of Month 3

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Participant answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis	-20.08 mm Standard Error 2.275	-25.50 mm Standard Error 2.291	-21.47 mm Standard Error 2.328	-11.40 mm Standard Error 2.439	—	—

SECONDARY outcome

Timeframe: From Baseline to end of Month 3

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

The blinded 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 was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=103 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis	-27.44 mm Standard Error 1.998	-33.74 mm Standard Error 2.021	-29.02 mm Standard Error 2.043	-22.26 mm Standard Error 2.121	—	—

SECONDARY outcome

Timeframe: From Baseline to end of Month 3

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count	-6.5 Joints Standard Error 0.58	-7.6 Joints Standard Error 0.58	-6.5 Joints Standard Error 0.59	-4.8 Joints Standard Error 0.62	—	—

SECONDARY outcome

Timeframe: From Baseline to end of Month 3

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count	-8.7 Joints Standard Error 1.04	-11.0 Joints Standard Error 1.05	-7.6 Joints Standard Error 1.07	-6.9 Joints Standard Error 1.10	—	—

SECONDARY outcome

Timeframe: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=107 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=53 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=105 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Week 2 (n=34, 42, 23, NA, NA, 10)	31.78 Percentage of participants	40.38 Percentage of participants	21.70 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	9.52 Percentage of participants
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 1 (n=45, 51, 43, NA, NA, 23)	42.06 Percentage of participants	49.04 Percentage of participants	40.57 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	21.90 Percentage of participants
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 2 (n=54, 69, 62, NA, NA, 36)	50.47 Percentage of participants	66.35 Percentage of participants	58.49 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	34.29 Percentage of participants
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 3 (n=55, 73, 65, NA, NA, 47)	51.40 Percentage of participants	70.19 Percentage of participants	61.32 Percentage of participants	NA Percentage of participants Results not reported for this group.	NA Percentage of participants Results not reported for this group.	44.76 Percentage of participants
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 4 (n=68, 68, 71, 32, 30, NA)	63.55 Percentage of participants	65.38 Percentage of participants	66.98 Percentage of participants	61.54 Percentage of participants	56.60 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 6 (n=61, 75, 71, 35, 35, NA)	57.01 Percentage of participants	72.12 Percentage of participants	66.98 Percentage of participants	67.31 Percentage of participants	66.04 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 9 (n=75, 73, 71, 36, 37, NA)	70.09 Percentage of participants	70.19 Percentage of participants	66.98 Percentage of participants	69.23 Percentage of participants	69.81 Percentage of participants	NA Percentage of participants Results not reported for this group.
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 Month 12 (n=69, 76, 69, 39, 33, NA)	64.49 Percentage of participants	73.08 Percentage of participants	65.09 Percentage of participants	75.00 Percentage of participants	62.26 Percentage of participants	NA Percentage of participants Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO\>0 and were evaluable. n=number of participants evaluable at each visit.

The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=101 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=98 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=102 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=50 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=50 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=100 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response Month 1 (n=100, 96, 100, NA, NA, 99)	-0.7 Units on a scale Standard Error 0.07	-0.8 Units on a scale Standard Error 0.08	-0.5 Units on a scale Standard Error 0.08	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	-0.2 Units on a scale Standard Error 0.08
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response Month 3 (n=98, 97, 98, NA, NA, 98)	-1.0 Units on a scale Standard Error 0.08	-1.2 Units on a scale Standard Error 0.08	-1.0 Units on a scale Standard Error 0.09	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	-0.4 Units on a scale Standard Error 0.09
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response Month 6 (n=96, 94, 96, 46, 46, NA)	-0.9 Units on a scale Standard Error 0.09	-1.3 Units on a scale Standard Error 0.09	-1.2 Units on a scale Standard Error 0.09	-0.7 Units on a scale Standard Error 0.12	-0.9 Units on a scale Standard Error 0.13	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response Month 9 (n=95, 91, 94, 45, 44, NA)	-1.0 Units on a scale Standard Error 0.09	-1.5 Units on a scale Standard Error 0.09	-1.2 Units on a scale Standard Error 0.09	-0.7 Units on a scale Standard Error 0.12	-1.3 Units on a scale Standard Error 0.13	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response Month 12 (n=91, 90, 92, 41, 43, NA)	-1.2 Units on a scale Standard Error 0.09	-1.5 Units on a scale Standard Error 0.09	-1.2 Units on a scale Standard Error 0.09	-0.9 Units on a scale Standard Error 0.13	-1.3 Units on a scale Standard Error 0.13	NA Units on a scale Standard Error NA Results not reported for this group.

SECONDARY outcome

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

Population: All participants who were randomized and received at least 1 dose of study drug with PASI\>0 and BSA ≥3% at baseline. n=number of responders.

PASI determines psoriasis severity based on lesion severity \& percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, \& scaling, evaluated separately for head \& neck, upper limbs, trunk, \& lower limbs \& rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis \& is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score \& can vary in increments of 0.1 \& range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=82 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=70 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=77 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=42 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=40 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=82 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 Month 1 (n=19, 19, 11, NA, NA, 4)	23.17 Percentage of participants 4.66	27.14 Percentage of participants 5.32	14.29 Percentage of participants 3.99	NA Percentage of participants NA Results not reported for this group.	NA Percentage of participants NA Results not reported for this group.	4.88 Percentage of participants 2.38
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 Month 3 (n=35, 31, 30, NA, NA, 12)	42.68 Percentage of participants 5.46	44.29 Percentage of participants 5.94	38.96 Percentage of participants 5.56	NA Percentage of participants NA Results not reported for this group.	NA Percentage of participants NA Results not reported for this group.	14.63 Percentage of participants 3.90
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 Month 6 (n=38, 42, 42, 12, 17, NA)	46.34 Percentage of participants 5.51	60.00 Percentage of participants 5.86	54.55 Percentage of participants 5.67	28.57 Percentage of participants 6.97	42.50 Percentage of participants 7.82	NA Percentage of participants NA Results not reported for this group.
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 Month 9 (n=36, 48, 45, 14, 20, NA)	43.90 Percentage of participants 5.448	68.57 Percentage of participants 5.55	58.44 Percentage of participants 5.62	33.33 Percentage of participants 7.27	50.00 Percentage of participants 7.91	NA Percentage of participants NA Results not reported for this group.
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 Month 12 (n=46, 47, 43, 15, 21, NA)	56.10 Percentage of participants 5.48	67.14 Percentage of participants 5.61	55.84 Percentage of participants 5.66	35.71 Percentage of participants 7.39	52.50 Percentage of participants 7.90	NA Percentage of participants NA Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug with baseline DSS\>0 and were evaluable. n=number of participants evaluable at each visit.

Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is 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 scores for a patient is 0-60. Higher score indicates greater degree of tenderness.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=60 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=60 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=58 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=29 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=28 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=57 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Dactylitis Severity Score (DSS) Month 3 (n=58, 60 , 56, NA, NA, 55)	-3.5 Units on a scale Standard Error 0.95	-5.5 Units on a scale Standard Error 0.91	-4.0 Units on a scale Standard Error 0.97	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	-2.0 Units on a scale Standard Error 1.06
Change From Baseline in Dactylitis Severity Score (DSS) Month 1 (n=58, 59, 56, NA, NA, 56)	-1.8 Units on a scale Standard Error 0.91	-3.1 Units on a scale Standard Error 0.87	-2.1 Units on a scale Standard Error 0.93	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	0.6 Units on a scale Standard Error 1.02
Change From Baseline in Dactylitis Severity Score (DSS) Month 6 (n=58, 59, 55, 28, 25, NA)	-5.2 Units on a scale Standard Error 1.01	-6.4 Units on a scale Standard Error 0.99	-5.4 Units on a scale Standard Error 1.03	-5.9 Units on a scale Standard Error 1.45	-5.2 Units on a scale Standard Error 1.50	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in Dactylitis Severity Score (DSS) Month 9 (n=57, 59, 53, 27, 25, NA)	-7.0 Units on a scale Standard Error 0.60	-7.2 Units on a scale Standard Error 0.58	-6.5 Units on a scale Standard Error 0.63	-5.3 Units on a scale Standard Error 0.87	-7.9 Units on a scale Standard Error 0.89	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in Dactylitis Severity Score (DSS) Month 12 (n=54, 58, 52, 26, 24, NA)	-7.4 Units on a scale Standard Error 0.65	-7.5 Units on a scale Standard Error 0.62	-6.1 Units on a scale Standard Error 0.67	-6.7 Units on a scale Standard Error 0.93	-7.7 Units on a scale Standard Error 0.96	NA Units on a scale Standard Error NA Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score\>0 and were evaluable. n=number of participants evaluable at each visit.

The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is 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 indicates a greater number of sites that are affected by enthesitis.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=80 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=81 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=82 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=38 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=41 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=79 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Month 1 (n=79, 80, 80, NA, NA, 78)	-0.83 Units on a scale Standard Error 0.317	-1.27 Units on a scale Standard Error 0.321	-0.95 Units on a scale Standard Error 0.336	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	-0.58 Units on a scale Standard Error 0.355
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Month 3 (n=77, 79, 79, NA, NA, 78)	-1.84 Units on a scale Standard Error 0.363	-2.41 Units on a scale Standard Error 0.364	-1.90 Units on a scale Standard Error 0.375	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	-1.17 Units on a scale Standard Error 0.393
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Month 6 (n=76, 78, 76, 33, 39, NA)	-2.4 Units on a scale Standard Error 0.34	-2.6 Units on a scale Standard Error 0.34	-2.3 Units on a scale Standard Error 0.35	-2.4 Units on a scale Standard Error 0.50	-2.5 Units on a scale Standard Error 0.48	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Month 9 (n=75, 75, 73, 34, 37, NA)	-2.9 Units on a scale Standard Error 0.31	-2.6 Units on a scale Standard Error 0.32	-3.0 Units on a scale Standard Error 0.33	-2.8 Units on a scale Standard Error 0.46	-3.2 Units on a scale Standard Error 0.44	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Month 12 (n=72, 73, 72, 31, 37, NA)	-3.2 Units on a scale Standard Error 0.33	-3.1 Units on a scale Standard Error 0.33	-2.8 Units on a scale Standard Error 0.35	-2.5 Units on a scale Standard Error 0.49	-3.2 Units on a scale Standard Error 0.46	NA Units on a scale Standard Error NA Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug with baseline LEI\>0 and were evaluable. n=number of participants evaluable at each visit.

Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=74 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=64 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=76 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=31 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=34 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=65 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Leeds Enthesitis Index (LEI) Month 1 (n=74, 63, 75, NA, NA, 65)	-0.41 Units on a scale Standard Error 0.192	-0.57 Units on a scale Standard Error 0.213	-0.42 Units on a scale Standard Error 0.203	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	-0.26 Units on a scale Standard Error 0.219
Change From Baseline in the Leeds Enthesitis Index (LEI) Month 3 (n=70, 63, 73, NA, NA, 63)	-0.82 Units on a scale Standard Error 0.221	-1.46 Units on a scale Standard Error 0.240	-1.10 Units on a scale Standard Error 0.228	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	-0.43 Units on a scale Standard Error 0.246
Change From Baseline in the Leeds Enthesitis Index (LEI) Month 6 (n=72, 61, 71, 27, 31, NA)	-1.3 Units on a scale Standard Error 0.21	-1.2 Units on a scale Standard Error 0.23	-1.3 Units on a scale Standard Error 0.22	-1.0 Units on a scale Standard Error 0.32	-1.3 Units on a scale Standard Error 0.30	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Leeds Enthesitis Index (LEI) Month 9 (n=70, 58, 68, 27, 29, NA)	-1.4 Units on a scale Standard Error 0.20	-1.3 Units on a scale Standard Error 0.23	-1.5 Units on a scale Standard Error 0.21	-1.4 Units on a scale Standard Error 0.31	-1.7 Units on a scale Standard Error 0.30	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Leeds Enthesitis Index (LEI) Month 12 (n=67, 56, 67, 24, 29, NA)	-1.7 Units on a scale Standard Error 0.19	-1.6 Units on a scale Standard Error 0.21	-1.6 Units on a scale Standard Error 0.20	-1.4 Units on a scale Standard Error 0.30	-1.9 Units on a scale Standard Error 0.28	NA Units on a scale Standard Error NA Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 physical component summary (PCS) score and the mental component summary (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

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score Month 1 (n=105, 103,104, NA, NA, 103)	3.39 Units on a scale Standard Error 0.638	4.66 Units on a scale Standard Error 0.645	4.00 Units on a scale Standard Error 0.655	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	1.54 Units on a scale Standard Error 0.700
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score Month 3 (n=102, 103,100, NA, NA, 102)	5.51 Units on a scale Standard Error 0.733	5.69 Units on a scale Standard Error 0.735	6.23 Units on a scale Standard Error 0.748	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	2.68 Units on a scale Standard Error 0.785
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score Month 6 (n=100, 100, 98, 48, 48, NA)	6.72 Units on a scale Standard Error 0.773	6.70 Units on a scale Standard Error 0.777	6.26 Units on a scale Standard Error 0.788	5.86 Units on a scale Standard Error 1.101	6.07 Units on a scale Standard Error 1.112	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score Month 9 (n=99, 97, 95, 47, 46, NA)	7.52 Units on a scale Standard Error 0.781	7.21 Units on a scale Standard Error 0.787	6.91 Units on a scale Standard Error 0.798	6.16 Units on a scale Standard Error 1.115	7.15 Units on a scale Standard Error 1.130	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score Month 12 (n=96, 96, 94, 44, 43, NA)	7.61 Units on a scale Standard Error 0.806	7.67 Units on a scale Standard Error 0.810	6.74 Units on a scale Standard Error 0.822	5.82 Units on a scale Standard Error 1.160	5.72 Units on a scale Standard Error 1.177	NA Units on a scale Standard Error NA Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score Month 1 (n=105, 103,104,NA, NA, 103)	4.12 Units on a scale Standard Error 0.841	3.63 Units on a scale Standard Error 0.849	2.13 Units on a scale Standard Error 0.871	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	3.19 Units on a scale Standard Error 0.917
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score Month 3 (n=102, 103,100, NA, NA, 102)	4.35 Units on a scale Standard Error 0.909	4.20 Units on a scale Standard Error 0.909	3.13 Units on a scale Standard Error 0.938	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	3.27 Units on a scale Standard Error 0.976
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score Month 6 (n=100, 100, 98, 48, 48, NA)	5.70 Units on a scale Standard Error 0.927	5.51 Units on a scale Standard Error 0.930	4.58 Units on a scale Standard Error 0.955	4.50 Units on a scale Standard Error 1.319	3.62 Units on a scale Standard Error 1.331	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score Month 9 (n=99, 97, 95, 47, 46, NA)	5.07 Units on a scale Standard Error 0.974	6.20 Units on a scale Standard Error 0.982	3.68 Units on a scale Standard Error 1.005	4.61 Units on a scale Standard Error 1.391	6.03 Units on a scale Standard Error 1.409	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score Month 12 (n=96, 96, 94, 44, 43, NA)	4.82 Units on a scale Standard Error 1.012	6.26 Units on a scale Standard Error 1.016	4.81 Units on a scale Standard Error 1.039	4.51 Units on a scale Standard Error 1.455	4.43 Units on a scale Standard Error 1.474	NA Units on a scale Standard Error NA Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 physical functioning domain score represents better physical functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain Month 1 (n=105, 103,104, NA, NA, 103)	2.43 Units on a scale Standard Error 0.768	3.89 Units on a scale Standard Error 0.776	2.81 Units on a scale Standard Error 0.787	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	1.10 Units on a scale Standard Error 0.840
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain Month 3 (n=102, 103,101, NA, NA, 102)	5.17 Units on a scale Standard Error 0.846	5.23 Units on a scale Standard Error 0.848	5.22 Units on a scale Standard Error 0.862	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	2.06 Units on a scale Standard Error 0.910
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain Month 6 (n=100, 100, 99, 48, 48, NA)	7.02 Units on a scale Standard Error 0.897	6.15 Units on a scale Standard Error 0.900	6.36 Units on a scale Standard Error 0.912	5.22 Units on a scale Standard Error 1.276	5.22 Units on a scale Standard Error 1.291	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain Month 9 (n=99, 97, 96, 47, 46, NA)	7.43 Units on a scale Standard Error 0.902	6.67 Units on a scale Standard Error 0.909	7.01 Units on a scale Standard Error 0.921	5.69 Units on a scale Standard Error 1.285	6.25 Units on a scale Standard Error 1.306	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain Month 12 (n=96, 96, 94, 44, 44, NA)	7.67 Units on a scale Standard Error 0.899	7.11 Units on a scale Standard Error 0.903	6.81 Units on a scale Standard Error 0.917	6.49 Units on a scale Standard Error 1.292	4.77 Units on a scale Standard Error 1.308	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 role-physical domain score represents better role-physical functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain Month 1 (n=105, 103,104, NA, NA, 103)	4.05 Units on a scale Standard Error 0.751	3.72 Units on a scale Standard Error 0.759	4.09 Units on a scale Standard Error 0.770	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	1.98 Units on a scale Standard Error 0.820
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain Month 3 (n=102, 103, 100, NA, NA, 102)	4.45 Units on a scale Standard Error 0.801	4.79 Units on a scale Standard Error 0.803	5.21 Units on a scale Standard Error 0.820	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	3.63 Units on a scale Standard Error 0.862
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain Month 6 (n=100, 100, 99, 48, 48, NA)	6.02 Units on a scale Standard Error 0.824	5.21 Units on a scale Standard Error 0.828	5.48 Units on a scale Standard Error 0.840	4.97 Units on a scale Standard Error 1.172	5.03 Units on a scale Standard Error 1.185	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain Month 9 (n=99, 97, 96, 47, 46, NA)	6.24 Units on a scale Standard Error 0.853	6.56 Units on a scale Standard Error 0.861	5.79 Units on a scale Standard Error 0.872	4.68 Units on a scale Standard Error 1.217	6.70 Units on a scale Standard Error 1.234	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain Month 12 (n=96, 96, 94, 44, 44, NA)	6.21 Units on a scale Standard Error 0.888	7.11 Units on a scale Standard Error 0.892	6.37 Units on a scale Standard Error 0.906	2.98 Units on a scale Standard Error 1.279	5.03 Units on a scale Standard Error 1.291	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 bodily pain domain score represents less bodily pain.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain Month 1 (n=105, 103,104, NA, NA, 103)	5.53 Units on a scale Standard Error 0.777	7.16 Units on a scale Standard Error 0.786	6.42 Units on a scale Standard Error 0.802	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	3.44 Units on a scale Standard Error 0.851
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain Month 3 (n=102, 103, 101, NA, NA, 102)	7.75 Units on a scale Standard Error 0.838	8.05 Units on a scale Standard Error 0.840	7.52 Units on a scale Standard Error 0.859	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	3.77 Units on a scale Standard Error 0.903
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain Month 6 (n=100, 100, 99, 48, 48, NA)	7.76 Units on a scale Standard Error 0.985	10.65 Units on a scale Standard Error 0.989	7.76 Units on a scale Standard Error 1.004	8.55 Units on a scale Standard Error 1.405	8.98 Units on a scale Standard Error 1.425	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain Month 9 (n=99, 97, 96, 47, 46, NA)	9.03 Units on a scale Standard Error 0.953	10.13 Units on a scale Standard Error 0.960	8.59 Units on a scale Standard Error 0.977	8.46 Units on a scale Standard Error 1.362	10.81 Units on a scale Standard Error 1.389	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain Month 12 (n=96, 96, 94, 44, 43, NA)	9.15 Units on a scale Standard Error 0.961	11.38 Units on a scale Standard Error 0.965	9.18 Units on a scale Standard Error 0.984	8.59 Units on a scale Standard Error 1.384	8.61 Units on a scale Standard Error 1.413	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 general health domain score represents better general health perceptions.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain Month 1 (n=105, 103,104, NA, NA, 103)	3.29 Units on a scale Standard Error 0.610	3.87 Units on a scale Standard Error 0.616	1.96 Units on a scale Standard Error 0.625	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	2.15 Units on a scale Standard Error 0.666
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain Month 3 (n=102, 103,101, NA, NA, 102 )	4.09 Units on a scale Standard Error 0.700	3.95 Units on a scale Standard Error 0.701	4.73 Units on a scale Standard Error 0.713	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	2.64 Units on a scale Standard Error 0.748
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain Month 6 (n=100, 100, 99, 48, 48, NA)	5.96 Units on a scale Standard Error 0.720	4.12 Units on a scale Standard Error 0.722	4.81 Units on a scale Standard Error 0.733	4.39 Units on a scale Standard Error 1.022	3.92 Units on a scale Standard Error 1.033	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain Month 9 (n=99, 97, 96, 47, 46, NA)	5.93 Units on a scale Standard Error 0.773	5.18 Units on a scale Standard Error 0.778	4.09 Units on a scale Standard Error 0.788	4.72 Units on a scale Standard Error 1.102	4.85 Units on a scale Standard Error 1.117	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain Month 12 (n=96, 96, 94, 44, 44, NA)	5.70 Units on a scale Standard Error 0.811	4.63 Units on a scale Standard Error 0.815	4.21 Units on a scale Standard Error 0.825	4.50 Units on a scale Standard Error 1.164	4.12 Units on a scale Standard Error 1.175	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 vitality domain score represents better vitality.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain Month 1 (n=105, 103,104, NA, NA, 103)	3.64 Units on a scale Standard Error 0.802	4.59 Units on a scale Standard Error 0.806	2.42 Units on a scale Standard Error 0.826	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	2.16 Units on a scale Standard Error 0.877
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain Month 3 (n=102, 103, 101, NA, NA, 102)	5.50 Units on a scale Standard Error 0.889	5.90 Units on a scale Standard Error 0.887	4.93 Units on a scale Standard Error 0.909	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	3.05 Units on a scale Standard Error 0.954
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain Month 6 (n=100, 100, 99, 48, 48, NA)	6.81 Units on a scale Standard Error 0.969	7.41 Units on a scale Standard Error 0.970	5.05 Units on a scale Standard Error 0.989	5.34 Units on a scale Standard Error 1.378	4.62 Units on a scale Standard Error 1.394	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain Month 9 (n=99, 97, 96, 47, 46, NA)	6.09 Units on a scale Standard Error 1.017	7.82 Units on a scale Standard Error 1.023	5.27 Units on a scale Standard Error 1.041	6.61 Units on a scale Standard Error 1.451	6.39 Units on a scale Standard Error 1.472	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain Month 12 (n=96, 96, 94, 44, 44, NA)	7.01 Units on a scale Standard Error 1.022	7.02 Units on a scale Standard Error 1.024	5.12 Units on a scale Standard Error 1.043	5.62 Units on a scale Standard Error 1.465	5.15 Units on a scale Standard Error 1.481	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.

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 social functioning domain score represents better social functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain Month 3 (n=102, 103, 101, NA, NA, 102)	5.95 Units on a scale Standard Error 0.897	5.22 Units on a scale Standard Error 0.898	5.26 Units on a scale Standard Error 0.918	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	3.63 Units on a scale Standard Error 0.961
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain Month 1 (n=105, 103,104, NA, NA, 103)	4.51 Units on a scale Standard Error 0.827	4.46 Units on a scale Standard Error 0.838	3.34 Units on a scale Standard Error 0.852	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	2.96 Units on a scale Standard Error 0.901
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain Month 6 (n=100, 100, 99, 48, 48, NA)	6.97 Units on a scale Standard Error 0.955	7.08 Units on a scale Standard Error 0.959	7.10 Units on a scale Standard Error 0.975	5.44 Units on a scale Standard Error 1.362	6.05 Units on a scale Standard Error 1.373	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain Month 9 (n=99, 97, 96, 47, 46, NA)	7.66 Units on a scale Standard Error 0.947	7.74 Units on a scale Standard Error 0.957	5.69 Units on a scale Standard Error 0.972	5.95 Units on a scale Standard Error 1.355	8.93 Units on a scale Standard Error 1.373	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain Month 12 (n=96, 96, 94, 44, 44, NA)	6.13 Units on a scale Standard Error 0.989	8.42 Units on a scale Standard Error 0.995	6.32 Units on a scale Standard Error 1.012	6.19 Units on a scale Standard Error 1.427	6.41 Units on a scale Standard Error 1.445	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 role-emotional domain score represents better role-emotional functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain Month 1 (n=105, 103,104, NA, NA, 103)	4.77 Units on a scale Standard Error 0.960	3.87 Units on a scale Standard Error 0.971	2.93 Units on a scale Standard Error 0.991	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	4.52 Units on a scale Standard Error 1.042
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain Month 3 (n=102, 103, 100, NA, NA, 102)	4.21 Units on a scale Standard Error 1.010	4.82 Units on a scale Standard Error 1.011	3.35 Units on a scale Standard Error 1.040	NA Units on a scale Standard Error NA Results not reported for this group.	NA Units on a scale Standard Error NA Results not reported for this group.	3.68 Units on a scale Standard Error 1.083
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain Month 6 (n=100, 100, 98, 48, 48, NA)	5.67 Units on a scale Standard Error 1.024	4.68 Units on a scale Standard Error 1.027	4.77 Units on a scale Standard Error 1.051	6.34 Units on a scale Standard Error 1.458	4.56 Units on a scale Standard Error 1.473	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain Month 9 (n=99, 97, 95, 47, 46, NA)	5.13 Units on a scale Standard Error 1.021	6.13 Units on a scale Standard Error 1.030	4.87 Units on a scale Standard Error 1.052	5.89 Units on a scale Standard Error 1.456	6.52 Units on a scale Standard Error 1.478	NA Units on a scale Standard Error NA Results not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain Month 12 (n=96, 96, 94, 44, 44, NA)	5.15 Units on a scale Standard Error 1.048	6.73 Units on a scale Standard Error 1.053	6.03 Units on a scale Standard Error 1.075	4.77 Units on a scale Standard Error 1.509	4.94 Units on a scale Standard Error 1.525	NA Units on a scale Standard Error NA Results not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

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 mental health domain score represents better mental health functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain Month 1 (n=105, 103, 104, NA, NA, 103)	3.32 Units on a scale Standard Error 0.867	3.87 Units on a scale Standard Error 0.874	2.79 Units on a scale Standard Error 0.895	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	1.57 Units on a scale Standard Error 0.952
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain Month 3 (n=102, 103, 101, NA, NA, 102)	4.45 Units on a scale Standard Error 0.934	4.23 Units on a scale Standard Error 0.932	3.95 Units on a scale Standard Error 0.956	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	2.62 Units on a scale Standard Error 1.009
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain Month 6 (n=100, 100, 99, 48, 48, NA)	6.11 Units on a scale Standard Error 0.951	6.38 Units on a scale Standard Error 0.953	5.35 Units on a scale Standard Error 0.974	3.70 Units on a scale Standard Error 1.354	3.41 Units on a scale Standard Error 1.372	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain Month 9 (n=99, 97, 96, 47, 46, NA)	5.79 Units on a scale Standard Error 1.022	6.43 Units on a scale Standard Error 1.028	4.62 Units on a scale Standard Error 1.048	3.57 Units on a scale Standard Error 1.461	5.45 Units on a scale Standard Error 1.483	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain Month 12 (n=96, 96, 94, 44, 44, NA)	5.86 Units on a scale Standard Error 1.019	6.58 Units on a scale Standard Error 1.022	5.86 Units on a scale Standard Error 1.044	4.72 Units on a scale Standard Error 1.467	4.48 Units on a scale Standard Error 1.483	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility Month 3 (n=101, 103, 101, NA, NA, 102)	-0.28 Units on a scale Standard Error 0.047	-0.27 Units on a scale Standard Error 0.047	-0.29 Units on a scale Standard Error 0.048	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.11 Units on a scale Standard Error 0.050
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility Month 1 (n=105, 103, 104, NA, NA, 103)	-0.07 Units on a scale Standard Error 0.042	-0.19 Units on a scale Standard Error 0.043	-0.15 Units on a scale Standard Error 0.043	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.10 Units on a scale Standard Error 0.046
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility Month 6 (n=100, 100, 99, 48, 48, NA)	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.2 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.07	-0.2 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.07	-0.3 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility Month 12 (n=96, 96, 94, 44,44, NA)	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.07	-0.3 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=103 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care Month 1 (n=105, 102, 104, NA, NA, 103)	-0.11 Units on a scale Standard Error 0.046	-0.16 Units on a scale Standard Error 0.047	-0.16 Units on a scale Standard Error 0.047	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.09 Units on a scale Standard Error 0.050
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care Month 3 (n=101, 102, 101, NA, NA, 102)	-0.19 Units on a scale Standard Error 0.047	-0.11 Units on a scale Standard Error 0.047	-0.18 Units on a scale Standard Error 0.048	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.12 Units on a scale Standard Error 0.051
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care Month 6 (n=100, 99, 99, 48, 48, NA)	-0.2 Units on a scale Standard Error 0.04	-0.3 Units on a scale Standard Error 0.05	-0.2 Units on a scale Standard Error 0.05	-0.2 Units on a scale Standard Error 0.06	-0.3 Units on a scale Standard Error 0.06	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care Month 9 (n=99, 97, 96, 47, 46, NA)	-0.2 Units on a scale Standard Error 0.05	-0.2 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.2 Units on a scale Standard Error 0.06	-0.3 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care Month 12 (n=96, 96, 94, 44, 44, NA)	-0.2 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.07	-0.2 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=103 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities Month 1 (n=105, 102, 104, NA, NA, 103)	-0.17 Units on a scale Standard Error 0.043	-0.19 Units on a scale Standard Error 0.043	-0.21 Units on a scale Standard Error 0.044	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.06 Units on a scale Standard Error 0.047
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities Month 6 (n=100, 99, 99, 48, 47, NA)	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.07	-0.3 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities Month 3 (n=101, 102, 101, NA, NA, 102)	-0.24 Units on a scale Standard Error 0.049	-0.29 Units on a scale Standard Error 0.049	-0.29 Units on a scale Standard Error 0.049	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.17 Units on a scale Standard Error 0.052
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.07	-0.4 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities Month 12 (n=96, 96, 94, 44, 44, NA)	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.07	-0.3 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit

The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort Month 1 (n=105, 103, 104, NA, NA, 103)	-0.14 Units on a scale Standard Error 0.039	-0.25 Units on a scale Standard Error 0.040	-0.19 Units on a scale Standard Error 0.040	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.08 Units on a scale Standard Error 0.043
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort Month 3 (n=101, 103, 101, NA, NA, 102)	-0.25 Units on a scale Standard Error 0.044	-0.27 Units on a scale Standard Error 0.044	-0.28 Units on a scale Standard Error 0.045	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.08 Units on a scale Standard Error 0.047
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort Month 6 (n=100, 100, 99, 48, 48, NA)	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.07	-0.4 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.07	-0.4 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort Month 12 (n=96, 96, 94, 44, 44, NA)	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.2 Units on a scale Standard Error 0.07	-0.3 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.06	-0.2 Units on a scale Standard Error 0.08	-0.3 Units on a scale Standard Error 0.08	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression Month 1 (n=105, 103, 104, NA, NA, 103)	-0.25 Units on a scale Standard Error 0.051	-0.22 Units on a scale Standard Error 0.052	-0.27 Units on a scale Standard Error 0.053	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.21 Units on a scale Standard Error 0.056
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression Month 3 (n=101, 103, 100, NA, NA, 102)	-0.25 Units on a scale Standard Error 0.055	-0.17 Units on a scale Standard Error 0.055	-0.32 Units on a scale Standard Error 0.056	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	-0.21 Units on a scale Standard Error 0.059
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression Month 6 (n=100, 100, 99, 48, 48, NA)	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.05	-0.3 Units on a scale Standard Error 0.08	-0.2 Units on a scale Standard Error 0.08	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression Month 12 (n=96, 96, 94, 44, 44, NA)	-0.3 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.05	-0.4 Units on a scale Standard Error 0.06	-0.2 Units on a scale Standard Error 0.08	-0.3 Units on a scale Standard Error 0.08	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today Month 1 (n=105, 103, 104, NA, NA, 103)	10.75 mm Standard Error 1.859	10.81 mm Standard Error 1.880	10.27 mm Standard Error 1.917	NA mm Standard Error NA Results were not reported for this group.	NA mm Standard Error NA Results were not reported for this group.	6.59 mm Standard Error 2.027
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today Month 3 (n=101, 103, 101, NA, NA, 101)	14.00 mm Standard Error 2.100	15.83 mm Standard Error 2.092	13.10 mm Standard Error 2.138	NA mm Standard Error NA Results were not reported for this group.	NA mm Standard Error NA Results were not reported for this group.	6.37 mm Standard Error 2.242
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today Month 6 (n=100, 100, 99, 48, 48, NA)	19.5 mm Standard Error 2.08	15.7 mm Standard Error 2.09	15.5 mm Standard Error 2.12	14.7 mm Standard Error 2.97	16.6 mm Standard Error 3.00	NA mm Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today Month 9 (n=99, 97, 96, 47, 46, NA)	19.2 mm Standard Error 2.21	15.9 mm Standard Error 2.23	18.2 mm Standard Error 2.26	12.8 mm Standard Error 3.16	21.5 mm Standard Error 3.21	NA mm Standard Error NA Results were not reported for this group.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today Month 12 (n=96, 96, 94, 44, 44, NA)	20.7 mm Standard Error 2.09	19.8 mm Standard Error 2.09	16.5 mm Standard Error 2.14	16.0 mm Standard Error 3.02	19.8 mm Standard Error 3.05	NA mm Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score Month 3 (102, 102, 101, NA, NA, 102)	7.0 Units on a scale Standard Error 0.85	6.0 Units on a scale Standard Error 0.85	6.0 Units on a scale Standard Error 0.87	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	3.3 Units on a scale Standard Error 0.91
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score Month 1 (n=105, 103, 104, NA, NA, 103)	5.2 Units on a scale Standard Error 0.77	4.4 Units on a scale Standard Error 0.78	4.2 Units on a scale Standard Error 0.79	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	2.7 Units on a scale Standard Error 0.84
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score Month 6 (n=100, 100, 99,48, 48, NA)	7.9 Units on a scale Standard Error 0.89	8.0 Units on a scale Standard Error 0.89	6.5 Units on a scale Standard Error 0.91	6.5 Units on a scale Standard Error 1.26	7.2 Units on a scale Standard Error 1.28	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score Month 9 (n=99, 97, 96, 47, 46, NA)	7.9 Units on a scale Standard Error 0.92	7.4 Units on a scale Standard Error 0.92	6.5 Units on a scale Standard Error 0.94	5.5 Units on a scale Standard Error 1.31	8.4 Units on a scale Standard Error 1.33	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score Month 12 (n=96, 96, 94, 44, 44, NA)	8.5 Units on a scale Standard Error 0.95	8.4 Units on a scale Standard Error 0.95	6.9 Units on a scale Standard Error 0.97	5.7 Units on a scale Standard Error 1.36	7.6 Units on a scale Standard Error 1.38	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score Month 12 (n=96, 96, 94, 44, 44, NA)	3.9 Units on a scale Standard Error 0.44	3.7 Units on a scale Standard Error 0.44	3.2 Units on a scale Standard Error 0.45	2.7 Units on a scale Standard Error 0.63	3.4 Units on a scale Standard Error 0.63	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score Month 1 (n=105, 103, 104, NA, NA, 103)	2.4 Units on a scale Standard Error 0.35	2.1 Units on a scale Standard Error 0.35	2.1 Units on a scale Standard Error 0.36	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	1.2 Units on a scale Standard Error 0.38
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score Month 3 (n=102, 102, 101, NA, NA, 102)	3.3 Units on a scale Standard Error 0.38	2.8 Units on a scale Standard Error 0.38	2.9 Units on a scale Standard Error 0.39	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	1.6 Units on a scale Standard Error 0.41
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score Month 6 (n=100, 100, 99,48, 48, NA)	3.6 Units on a scale Standard Error 0.40	3.3 Units on a scale Standard Error 0.40	3.2 Units on a scale Standard Error 0.41	3.0 Units on a scale Standard Error 0.57	3.3 Units on a scale Standard Error 0.58	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score Month 9 (n=99, 97, 96, 47, 46, NA)	3.6 Units on a scale Standard Error 0.42	3.3 Units on a scale Standard Error 0.42	3.3 Units on a scale Standard Error 0.43	2.7 Units on a scale Standard Error 0.59	3.9 Units on a scale Standard Error 0.60	NA Units on a scale Standard Error NA Results were not reported for this group.

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=106 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=52 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=104 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score Month 9 (n=99, 97, 96, 47, 46, NA)	4.3 Units on a scale Standard Error 0.55	4.1 Units on a scale Standard Error 0.55	3.3 Units on a scale Standard Error 0.56	2.8 Units on a scale Standard Error 0.78	4.6 Units on a scale Standard Error 0.80	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score Month 12 (n=96, 96, 94, 44, 44, NA)	4.6 Units on a scale Standard Error 0.57	4.7 Units on a scale Standard Error 0.57	3.7 Units on a scale Standard Error 0.58	2.9 Units on a scale Standard Error 0.82	4.3 Units on a scale Standard Error 0.82	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score Month 6 (n=100, 100, 99,48, 48, NA)	4.3 Units on a scale Standard Error 0.53	4.7 Units on a scale Standard Error 0.53	3.4 Units on a scale Standard Error 0.54	3.5 Units on a scale Standard Error 0.75	4.0 Units on a scale Standard Error 0.76	NA Units on a scale Standard Error NA Results were not reported for this group.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score Month 1 (n=105, 103, 104, NA, NA, 103)	2.9 Units on a scale Standard Error 0.47	2.3 Units on a scale Standard Error 0.48	2.1 Units on a scale Standard Error 0.49	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	1.5 Units on a scale Standard Error 0.52
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score Month 3 (n=102, 102, 101, NA, NA, 102)	3.8 Units on a scale Standard Error 0.52	3.2 Units on a scale Standard Error 0.52	3.2 Units on a scale Standard Error 0.53	NA Units on a scale Standard Error NA Results were not reported for this group.	NA Units on a scale Standard Error NA Results were not reported for this group.	1.8 Units on a scale Standard Error 0.56

SECONDARY outcome

Timeframe: From Baseline to Months 1, 3, 6, 9, and 12

Population: All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score\>0 cm and were evaluable. n=number of participants evaluable at each visit.

BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg, Twice Daily n=24 Participants Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=21 Participants Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=10 Participants Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo n=10 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=12 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks	Placebo n=22 Participants Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) Month 3 (n=24, 21, 10, NA, NA, 22)	-1.83 cm Standard Error 0.579	-2.78 cm Standard Error 0.559	-2.93 cm Standard Error 0.753	NA cm Standard Error NA Results were not reported for this group.	NA cm Standard Error NA Results were not reported for this group.	-1.60 cm Standard Error 0.624
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) Month 6 (n=23, 21, 10, 9, 11, NA)	-2.24 cm Standard Error 0.580	-2.35 cm Standard Error 0.560	-3.58 cm Standard Error 0.758	-2.85 cm Standard Error 0.778	-3.31 cm Standard Error 0.744	NA cm Standard Error NA Results were not reported for this group.
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) Month 9 (n=23, 20, 10, 9, 9, NA)	-2.06 cm Standard Error 0.575	-2.71 cm Standard Error 0.558	2.66 cm Standard Error 0.747	-3.00 cm Standard Error 0.770	-3.35 cm Standard Error 0.761	NA cm Standard Error NA Results were not reported for this group.
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) Month 12 (n=23, 19, 10, 9, 9, NA)	-2.50 cm Standard Error 0.594	-3.30 cm Standard Error 0.587	-2.42 cm Standard Error 0.779	-2.31 cm Standard Error 0.808	-2.67 cm Standard Error 0.806	NA cm Standard Error NA Results were not reported for this group.
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) Month 1 (n=24, 21, 10, NA, NA, 22)	-1.23 cm Standard Error 0.537	-1.60 cm Standard Error 0.508	-2.30 cm Standard Error 0.673	NA cm Standard Error NA Results were not reported for this group.	NA cm Standard Error NA Results were not reported for this group.	-1.27 cm Standard Error 0.581

Adverse Events

Tofacitinib, 5 mg, Twice Daily

Serious events: 8 serious events

Other events: 31 other events

Deaths: 0 deaths

Tofacitinib, 10 mg, Twice Daily

Serious events: 4 serious events

Other events: 43 other events

Deaths: 0 deaths

Adalimumab, 40 mg, Every 2 Weeks

Serious events: 9 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo/Tofacitinib, 5 mg, Twice Daily

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo/Tofacitinib, 10 mg, Twice Daily

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tofacitinib, 5 mg, Twice Daily n=107 participants at risk Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 participants at risk Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 participants at risk Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo/Tofacitinib, 5 mg, Twice Daily n=52 participants at risk Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.	Placebo/Tofacitinib, 10 mg, Twice Daily n=53 participants at risk Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Cardiac disorders Atrial fibrillation	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Cardiac disorders Bradycardia	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Cardiac disorders Cardiac arrest	0.00% 0/107	0.00% 0/104	0.00% 0/106	1.9% 1/52	0.00% 0/53
Gastrointestinal disorders Abdominal hernia	0.00% 0/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	1.9% 1/53
Gastrointestinal disorders Chronic gastritis	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Gastrointestinal disorders Diverticulum	0.00% 0/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	1.9% 1/53
Gastrointestinal disorders Nausea	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Hepatobiliary disorders Bile duct stone	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Infections and infestations Appendicitis	0.00% 0/107	0.00% 0/104	0.00% 0/106	1.9% 1/52	0.00% 0/53
Infections and infestations Herpes simplex	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Infections and infestations Influenza	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Infections and infestations Pneumonia	0.00% 0/107	0.00% 0/104	0.00% 0/106	1.9% 1/52	0.00% 0/53
Infections and infestations Pyoderma streptococcal	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Injury, poisoning and procedural complications Joint injury	0.93% 1/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Metabolism and nutrition disorders Dehydration	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	1.9% 1/53
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vulva	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Nervous system disorders Migraine	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Nervous system disorders Transient ischaemic attack	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Renal and urinary disorders Calculus urinary	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Renal and urinary disorders Nephropathy	0.00% 0/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	1.9% 1/53
Reproductive system and breast disorders Cystocele	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Reproductive system and breast disorders Rectocele	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Reproductive system and breast disorders Uterine polyp	0.00% 0/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	1.9% 1/53
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/107	0.00% 0/104	0.94% 1/106	0.00% 0/52	0.00% 0/53
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Skin and subcutaneous tissue disorders Angioedema	0.93% 1/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53
Vascular disorders Deep vein thrombosis	0.00% 0/107	0.00% 0/104	0.00% 0/106	0.00% 0/52	1.9% 1/53
Vascular disorders Hypertension	0.00% 0/107	0.96% 1/104	0.00% 0/106	0.00% 0/52	0.00% 0/53

Other adverse events

Other adverse events
Measure	Tofacitinib, 5 mg, Twice Daily n=107 participants at risk Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Tofacitinib, 10 mg, Twice Daily n=104 participants at risk Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Adalimumab, 40 mg, Every 2 Weeks n=106 participants at risk Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Placebo/Tofacitinib, 5 mg, Twice Daily n=52 participants at risk Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.	Placebo/Tofacitinib, 10 mg, Twice Daily n=53 participants at risk Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Gastrointestinal disorders Abdominal pain	0.93% 1/107	0.96% 1/104	1.9% 2/106	0.00% 0/52	5.7% 3/53
Gastrointestinal disorders Nausea	2.8% 3/107	3.8% 4/104	5.7% 6/106	0.00% 0/52	1.9% 1/53
Infections and infestations Nasopharyngitis	7.5% 8/107	11.5% 12/104	10.4% 11/106	7.7% 4/52	7.5% 4/53
Infections and infestations Pharyngitis	4.7% 5/107	5.8% 6/104	6.6% 7/106	0.00% 0/52	5.7% 3/53
Infections and infestations Upper respiratory tract infection	9.3% 10/107	10.6% 11/104	7.5% 8/106	9.6% 5/52	9.4% 5/53
Infections and infestations Urinary tract infection	1.9% 2/107	3.8% 4/104	3.8% 4/106	1.9% 1/52	7.5% 4/53
Investigations Alanine aminotransferase increased	2.8% 3/107	2.9% 3/104	7.5% 8/106	5.8% 3/52	1.9% 1/53
Investigations Aspartate aminotransferase increased	0.00% 0/107	0.96% 1/104	6.6% 7/106	1.9% 1/52	1.9% 1/53
Investigations Blood creatine phosphokinase increased	4.7% 5/107	4.8% 5/104	2.8% 3/106	1.9% 1/52	9.4% 5/53
Musculoskeletal and connective tissue disorders Spinal pain	1.9% 2/107	0.96% 1/104	2.8% 3/106	5.8% 3/52	0.00% 0/53
Nervous system disorders Headache	4.7% 5/107	10.6% 11/104	6.6% 7/106	3.8% 2/52	7.5% 4/53

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Results disclosure agreements

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

Restriction type: OTHER