Trial Outcomes & Findings for Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors (NCT NCT01882439)

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

395 participants

Primary outcome timeframe

Month 3

Results posted on

2017-09-15

Participant Flow

Data through End of Study (Month 6)

Of 546 participants screened for entry into the study, 395 were enrolled and randomized, 394 received treatment.

Participant milestones

Participant milestones
Measure	Tofacitinib, 5 mg Twice Daily Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily Participants received two 5 mg tofacitinib tablets, twice daily.	Placebo/Tofacitinib, 5 mg, Twice Daily Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.
Overall Study STARTED	131	132	66	65
Overall Study COMPLETED	122	111	56	56
Overall Study NOT COMPLETED	9	21	10	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib, 5 mg Twice Daily Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily Participants received two 5 mg tofacitinib tablets, twice daily.	Placebo/Tofacitinib, 5 mg, Twice Daily Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.
Overall Study Adverse event related to study drug	3	8	1	2
Overall Study Pregnancy	0	1	0	0
Overall Study Protocol Violation	2	2	0	1
Overall Study No longer willing to participate	1	4	2	3
Overall Study Medication error with no associated AE	0	0	2	0
Overall Study Insufficient clinical response	1	4	4	2
Overall Study Adverse event unrelated to study drug	2	2	1	1

Baseline Characteristics

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib, 5 mg Twice Daily n=131 Participants Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets, twice daily.	Placebo/Tofacitinib, 5 mg, Twice Daily n=66 Participants Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.	Placebo/Tofacitinib, 10 mg, Twice Daily n=65 Participants Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.	Total n=394 Participants Total of all reporting groups
Age, Continuous	49.5 Years STANDARD_DEVIATION 12.3 • n=5 Participants	51.3 Years STANDARD_DEVIATION 10.9 • n=7 Participants	48.7 Years STANDARD_DEVIATION 11.2 • n=5 Participants	49.3 Years STANDARD_DEVIATION 14.0 • n=4 Participants	50.0 Years STANDARD_DEVIATION 12.0 • n=21 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	74 Participants n=7 Participants	38 Participants n=5 Participants	42 Participants n=4 Participants	218 Participants n=21 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	58 Participants n=7 Participants	28 Participants n=5 Participants	23 Participants n=4 Participants	176 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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=131 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3	49.62 Percentage of participants Interval 14.72 to 37.19	46.97 Percentage of participants Interval 12.1 to 34.51	23.66 Percentage of participants Interval -14.72 to 9.43	—	—

PRIMARY outcome

Timeframe: 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 patient 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. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=129 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3	-0.3920 Units on a scale Standard Error 0.04544	-0.3540 Units on a scale Standard Error 0.04579	-0.1391 Units on a scale Standard Error 0.04573	—	—

SECONDARY outcome

Timeframe: Week 2 and Months 1, 2, 3, 4, and 6

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

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. n=number of responders.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=131 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=66 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=65 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 Month 1 (n=23,14,NA,NA,8)	17.56 Percentage of participants	10.61 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	6.11 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 Month 2 (n=33,30,NA,NA,14)	25.19 Percentage of participants	22.73 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	10.69 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 Month 3 (n=39,37,NA,NA,19)	29.77 Percentage of participants	28.03 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	14.50 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 Month 4 (n=50,38,15,21,NA)	38.17 Percentage of participants	28.79 Percentage of participants	22.73 Percentage of participants	32.31 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 Month 6 (n=50,39,21,23,NA)	38.17 Percentage of participants	29.55 Percentage of participants	31.82 Percentage of participants	35.38 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 Week 2 (n=8,13,NA,NA,4)	6.11 Percentage of participants	9.85 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	3.05 Percentage of participants

SECONDARY outcome

Timeframe: Week 2 and Months 1, 2, 3, 4, and 6

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

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. n=number of responders.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=131 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=66 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=65 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 Week 2 (n=2,3,NA,NA,1)	1.53 Percentage of participants	2.27 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	0.76 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 Month 2 (n=17,13,NA,NA,6)	12.98 Percentage of participants	9.85 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	4.58 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 Month 1 (n=7,5,NA,NA,3)	5.34 Percentage of participants	3.79 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	2.29 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 Month 3 (n=22,19,NA,NA,13)	16.79 Percentage of participants	14.39 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	9.92 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 Month 4 (n=24,20,6,14,NA)	18.32 Percentage of participants	15.15 Percentage of participants	9.09 Percentage of participants	21.54 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 Month 6 (n=28,19,10,12,NA)	21.37 Percentage of participants	14.39 Percentage of participants	15.15 Percentage of participants	18.46 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.

SECONDARY outcome

Timeframe: Week 2 and Months 1, 2, 4, and 6

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, HAQ-DI, and CRP. n=number of responders.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=131 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=66 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=65 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6 Month 4 (n=78,69,30,33,NA)	59.54 Percentage of participants	52.27 Percentage of participants	45.45 Percentage of participants	50.77 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6 Week 2 (n=35,38,NA,NA,17)	26.72 Percentage of participants	28.79 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	12.98 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6 Month 1 (n=45,56,NA,NA,29)	34.35 Percentage of participants	42.42 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	22.14 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6 Month 2 (n=63,63,NA,NA,34)	48.09 Percentage of participants	47.73 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	25.95 Percentage of participants
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6 Month 6 (n=78,65,33,35,NA)	59.54 Percentage of participants	49.24 Percentage of participants	50.00 Percentage of participants	53.85 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.

SECONDARY outcome

Timeframe: Week 2 and Months 1, 2, 4, and 6

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

The HAQ-DI assesses the difficulty a patient 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. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. n=number of participants evaluable at each visit.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=129 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=66 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=65 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6 Week 2 (129,130,NA,NA,128)	-0.2198 Units on scale Standard Error 0.03145	-0.1652 Units on scale Standard Error 0.03160	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-0.0655 Units on scale Standard Error 0.03133
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6 Month 1 (128,129,NA,NA,130)	-0.3229 Units on scale Standard Error 0.04074	-0.2279 Units on scale Standard Error 0.04073	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-0.1481 Units on scale Standard Error 0.04038
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6 Month 2 (125,126,NA,NA,121)	-0.4114 Units on scale Standard Error 0.04311	-0.3131 Units on scale Standard Error 0.04316	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-0.1620 Units on scale Standard Error 0.04317
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6 Month 4 (125,121,57,58,NA)	-0.4455 Units on scale Standard Error 0.04489	-0.3305 Units on scale Standard Error 0.04523	-0.3836 Units on scale Standard Error 0.06443	-0.3918 Units on scale Standard Error 0.06418	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6 Month 6 (122,112,56,56,NA)	-0.4365 Units on scale Standard Error 0.04642	-0.3397 Units on scale Standard Error 0.04720	-0.4808 Units on scale Standard Error 0.06680	-0.4157 Units on scale Standard Error 0.06665	NA Units on scale Standard Error NA Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.

SECONDARY outcome

Timeframe: 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=130 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3	-5.4657 mg/L Standard Error 1.80096	-5.9156 mg/L Standard Error 1.83181	1.0233 mg/L Standard Error 1.82879	—	—

SECONDARY outcome

Timeframe: 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=129 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3	-21.66 mm Standard Error 2.162	-20.88 mm Standard Error 2.188	-7.72 mm Standard Error 2.184	—	—

SECONDARY outcome

Timeframe: Month 3

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

Participants 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=129 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3	-21.59 mm Standard Error 2.228	-19.88 mm Standard Error 2.248	-7.14 mm Standard Error 2.247	—	—

SECONDARY outcome

Timeframe: 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=128 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=130 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=128 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3	-27.25 mm Standard Error 1.893	-28.95 mm Standard Error 1.916	-15.88 mm Standard Error 1.929	—	—

SECONDARY outcome

Timeframe: 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=130 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3	-7.6 Joints Standard Error 0.59	-6.7 Joints Standard Error 0.60	-2.7 Joints Standard Error 0.60	—	—

SECONDARY outcome

Timeframe: 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=130 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3	-9.9 Joints Standard Error 0.97	-9.7 Joints Standard Error 0.98	-4.5 Joints Standard Error 0.98	—	—

SECONDARY outcome

Timeframe: Week 2, Months 1, 2, 3, 4, and 6

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

The PsARC covers 4 measures: Tender 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. n=number of responders.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=131 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=132 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=66 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=65 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=131 Participants Participants received two placebo tablets twice daily up to 3 months.
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 Week 2 (n=43,45,NA,NA,23)	32.82 Percentage of participants	34.09 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	17.56 Percentage of participants
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 Month 3 (n=77,64,NA,NA,38)	58.78 Percentage of participants	48.48 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	29.01 Percentage of participants
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 Month 4 (n=74,75,34,38.NA)	56.49 Percentage of participants	56.82 Percentage of participants	51.52 Percentage of participants	58.46 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 Month 6 (n=77,68,34,36,NA)	58.78 Percentage of participants	51.52 Percentage of participants	51.52 Percentage of participants	55.38 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 Month 1 (n=56,66,NA,NA,45)	42.75 Percentage of participants	50.00 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	34.35 Percentage of participants
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 Month 2 (n=67,72,NA,NA,43)	51.15 Percentage of participants	54.55 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	32.82 Percentage of participants

SECONDARY outcome

Timeframe: Months 1, 3, and 6

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

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 the PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). n=number of participants evaluable at each visit.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=121 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=124 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=63 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=62 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=125 Participants Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6 Month 3 (n=112,116,NA,NA,112)	-0.7 Units on a scale Standard Error 0.08	-1.1 Units on a scale Standard Error 0.08	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-0.4 Units on a scale Standard Error 0.08
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6 Month 6 (n=116,108,55,51,NA)	-0.9 Units on a scale Standard Error 0.08	-1.1 Units on a scale Standard Error 0.09	-1.0 Units on a scale Standard Error 0.12	-1.0 Units on a scale Standard Error 0.13	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6 Month 1 (n=120,122,NA,NA,125)	-0.5 Units on a scale Standard Error 0.07	-0.8 Units on a scale Standard Error 0.07	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-0.2 Units on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Months 1, 3, and 6

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

PASI determines psoriasis severity based on lesion severity and percentage of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, and scaling evaluated separately for the head and neck, upper limbs, trunk, and lower limbs and then 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 and is assigned a numerical score: 0=no involvement; 1=0% to 9%; 2=10% to 29%; 3=30% to 49%; 4=50% to 69%; 5=70% to 89%; 6=90% to 100%. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this 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 the numbers obtained for each of the 4 body areas is the PASI. PASI75 is defined as a 75% reduction from baseline in PASI. n=number of responders.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=80 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=81 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=42 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=44 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=86 Participants Participants received two placebo tablets twice daily up to 3 months.
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6 Month 6 (n=27,37,11,14,NA)	33.75 Percentage of participants	45.68 Percentage of participants	26.19 Percentage of participants	31.82 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6 Month 1 (n=12,15,NA,NA,5)	15.00 Percentage of participants	18.52 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	5.81 Percentage of participants
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6 Month 3 (n=17,35,NA,NA,12)	21.25 Percentage of participants	43.21 Percentage of participants	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Percentage of participants Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	13.95 Percentage of participants

SECONDARY outcome

Timeframe: Months 1, 3, and 6

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

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=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. n=number of participants evaluable at each visit.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=65 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=64 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=29 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=33 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=62 Participants Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6 Month 1 (n=65,64,NA,NA,62)	-2.8 Units on a scale Standard Error 0.63	-4.0 Units on a scale Standard Error 0.65	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-1.1 Units on a scale Standard Error 0.64
Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6 Month 3 (n=64,58,NA,NA,55)	-5.2 Units on a scale Standard Error 0.73	-5.4 Units on a scale Standard Error 0.78	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-1.9 Units on a scale Standard Error 0.78
Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6 Month 6 (n=61,55,25,26,NA)	-6.0 Units on a scale Standard Error 0.84	-6.0 Units on a scale Standard Error 0.90	-5.4 Units on a scale Standard Error 1.33	-5.2 Units on a scale Standard Error 1.26	NA Units on a scale Standard Error NA Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.

SECONDARY outcome

Timeframe: Months 1, 3, and 6

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

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. n=number of participants evaluable at each visit.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=95 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=105 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=47 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=51 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=98 Participants Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6 Month 3 (n=92,96,NA,NA,87)	-2.5 Units of scale Standard Error 0.34	-2.8 Units of scale Standard Error 0.33	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-1.3 Units of scale Standard Error 0.34
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6 Month 6 (n=91,93,40,43,NA)	-2.6 Units of scale Standard Error 0.36	-3.1 Units of scale Standard Error 0.35	-2.6 Units of scale Standard Error 0.53	-2.4 Units of scale Standard Error 0.51	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6 Month 1 (n=94,104,NA,NA,98)	-1.9 Units of scale Standard Error 0.31	-1.9 Units of scale Standard Error 0.30	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-1.0 Units of scale Standard Error 0.30

SECONDARY outcome

Timeframe: Months 1, 3, and 6

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

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 a total score of 0-6. Higher score indicates greater severity of enthesitis. n=number of participants evaluable at each visit.

Outcome measures

Outcome measures
Measure	Tofacitinib, 5 mg Twice Daily n=82 Participants Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.	Tofacitinib, 10 mg, Twice Daily n=96 Participants Participants received two 5 mg tofacitinib tablets twice daily.	Placebo n=45 Participants Participants received two placebo tablets twice daily up to 3 months.	Placebo/Tofacitinib, 10 mg, Twice Daily n=46 Participants Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.	Placebo n=91 Participants Participants received two placebo tablets twice daily up to 3 months.
Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6 Month 1 (n=82,95,NA,NA,91)	-1.0 Units of scale Standard Error 0.19	-0.8 Units of scale Standard Error 0.18	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-0.5 Units of scale Standard Error 0.18
Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6 Month 3 (n=79,86,NA,NA,82)	-1.3 Units of scale Standard Error 0.19	-1.3 Units of scale Standard Error 0.18	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.	-0.5 Units of scale Standard Error 0.19
Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6 Month 6 (n=77,84,38,41,NA)	-1.5 Units of scale Standard Error 0.19	-1.6 Units of scale Standard Error 0.18	-1.4 Units of scale Standard Error 0.26	-1.3 Units of scale Standard Error 0.26	NA Units of scale Standard Error NA Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.

SECONDARY outcome

Timeframe: Months 1, 3, 6

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

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. n=number of participants evaluable at each visit.