Trial Outcomes & Findings for Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis (NCT NCT03486457)

NCT ID: NCT03486457

Last Updated: 2024-02-08

Results Overview

ACR50 response: greater than or equal to (≥) 50% improvement in tender (TJC) and swollen joint counts (SJC) and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: patient (PtGA) and physician global assessments (PhyGA), pain, disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\], scored from 0 to 3), and an acute-phase reactant (C-reactive protein \[CRP\]). TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 millimeter (mm).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 204 participants
• Primary outcome timeframe: Month 3
• Results posted on: 2024-02-08

Participant Flow

Three hundred and forty five participants were screened and a total of 204 participants assigned to study treatment were treated (136 in the tofacitinib 5 mg BID group and 68 in the placebo → tofacitinib 5 mg twice a day [BID] group). Safety data was planned to be collected and reported for both: from Baseline to Month 3 and from Baseline to Month 6.

Participant milestones

Measure	Tofacitinib Participants received Tofacitinib 5 milligram (mg) twice daily (BID) for 6 months.	Placebo Then Tofacitinib Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Up to Month 3 STARTED	136	68
Up to Month 3 COMPLETED	129	63
Up to Month 3 NOT COMPLETED	7	5
Month 3 to Month 6 STARTED	129	63
Month 3 to Month 6 COMPLETED	126	61
Month 3 to Month 6 NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Tofacitinib Participants received Tofacitinib 5 milligram (mg) twice daily (BID) for 6 months.	Placebo Then Tofacitinib Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Up to Month 3 Adverse Event	2	5
Up to Month 3 Lack of Efficacy	1	0
Up to Month 3 Withdrawal by Subject	1	0
Up to Month 3 Failure to Meet Randomization Criteria	2	0
Up to Month 3 Other	1	0
Month 3 to Month 6 Adverse Event	2	0
Month 3 to Month 6 Lost to Follow-up	0	1
Month 3 to Month 6 Pregnancy	0	1
Month 3 to Month 6 Other	1	0

Baseline Characteristics

Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Tofacitinib n=136 Participants Participants received Tofacitinib 5 milligram (mg) twice daily (BID) for 6 months.	Placebo Then Tofacitinib n=68 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).	Total n=204 Participants Total of all reporting groups
Age, Continuous	45.3 Years STANDARD_DEVIATION 11.59 • n=5 Participants	43.9 Years STANDARD_DEVIATION 10.40 • n=7 Participants	44.8 Years STANDARD_DEVIATION 11.20 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	26 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	42 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=5 Participants	68 Participants n=7 Participants	204 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	136 Participants n=5 Participants	68 Participants n=7 Participants	204 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Missing response (MR) was considered to be non-response (NR) (MR=NR).

ACR50 response: greater than or equal to (≥) 50% improvement in tender (TJC) and swollen joint counts (SJC) and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: patient (PtGA) and physician global assessments (PhyGA), pain, disability (Health Assessment Questionnaire - Disability Index [HAQ-DI], scored from 0 to 3), and an acute-phase reactant (C-reactive protein [CRP]). TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 millimeter (mm).

Outcome measures

Measure	Tofacitinib n=136 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=68 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3	38.24 Percentage of participants	5.88 Percentage of participants

SECONDARY outcome

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

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). MR was considered to be NR (MR=NR).

ACR20 response:≥20% improvement in TJC and SJC and ≥20% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.

Outcome measures

Measure	Tofacitinib n=136 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=68 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6 Week 2	22.79 Percentage of participants	7.35 Percentage of participants
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 1	38.97 Percentage of participants	8.82 Percentage of participants
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 2	61.76 Percentage of participants	10.29 Percentage of participants
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 3	64.71 Percentage of participants	27.94 Percentage of participants
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 4	69.85 Percentage of participants	45.59 Percentage of participants
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 6	72.79 Percentage of participants	58.82 Percentage of participants

SECONDARY outcome

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

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). MR was considered to be NR (MR=NR).

ACR70 response:≥70% improvement in TJC and SJC and ≥70% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.

Outcome measures

Measure	Tofacitinib n=136 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=68 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6 Week 2	1.47 Percentage of participants	0 Percentage of participants
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 1	2.21 Percentage of participants	0 Percentage of participants
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 2	8.82 Percentage of participants	1.47 Percentage of participants
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 3	14.71 Percentage of participants	1.47 Percentage of participants
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 4	20.59 Percentage of participants	7.35 Percentage of participants
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6 Month 6	36.76 Percentage of participants	23.53 Percentage of participants

SECONDARY outcome

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

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). MR was considered to be NR (MR=NR).

ACR50 response:≥50% improvement in TJC and SJC and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhyGA, pain, disability (HAQ-DI, scored from 0 to 3), and a CRP. TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 mm.

Outcome measures

Measure	Tofacitinib n=136 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=68 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6 Week 2	4.41 Percentage of participants	1.47 Percentage of participants
Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6 Month 1	9.56 Percentage of participants	1.47 Percentage of participants
Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6 Month 2	30.15 Percentage of participants	2.94 Percentage of participants
Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6 Month 4	41.18 Percentage of participants	19.12 Percentage of participants
Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6 Month 6	55.15 Percentage of participants	36.76 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If >2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.

Outcome measures

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-0.14 unit on a scale Standard Error 0.025	-0.03 unit on a scale Standard Error 0.036
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-0.18 unit on a scale Standard Error 0.026	-0.05 unit on a scale Standard Error 0.037
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-0.28 unit on a scale Standard Error 0.028	-0.07 unit on a scale Standard Error 0.039
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-0.30 unit on a scale Standard Error 0.031	-0.08 unit on a scale Standard Error 0.044
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-0.32 unit on a scale Standard Error 0.026	-0.23 unit on a scale Standard Error 0.038
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-0.38 unit on a scale Standard Error 0.025	-0.31 unit on a scale Standard Error 0.036

SECONDARY outcome

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

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline HAQ-DI ≥0.30. MR was considered to be NR (MR=NR).

Rate was measured in terms of percentage of participants with HAQ-DI response. The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If >2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.

Outcome measures

Measure	Tofacitinib n=83 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=39 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6 Week 2	36.14 Percentage of participants	23.08 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6 Month 1	37.35 Percentage of participants	33.33 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6 Month 2	60.24 Percentage of participants	38.46 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6 Month 3	65.06 Percentage of participants	41.03 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6 Month 4	63.86 Percentage of participants	51.28 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6 Month 6	73.49 Percentage of participants	66.67 Percentage of participants

SECONDARY outcome

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

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline HAQ-DI ≥0.35. MR was considered to be NR (MR=NR).

Rate was measured in terms of percentage of participants with HAQ-DI response. The HAQ-DI assessed the degree of difficulty a participant had experienced during 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". The HAQ-DI score was the average of the non-missing domain scores. If >2 domain scores were missing, HAQ-DI score was considered missing. A higher score represented a more limited physical functional status/ability.

Outcome measures

Measure	Tofacitinib n=83 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=39 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6 Week 2	36.14 Percentage of participants	23.08 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6 Month 1	37.35 Percentage of participants	33.33 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6 Month 2	60.24 Percentage of participants	38.46 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6 Month 3	65.06 Percentage of participants	41.03 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6 Month 4	63.86 Percentage of participants	51.28 Percentage of participants
HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6 Month 6	73.49 Percentage of participants	66.67 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

Swollen joint count was an assessment on 66 joints (temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, distal interphalangeals, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined). Artificial joints were not assessed. Each joint was assessed for swelling as: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints).

Outcome measures

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-3.04 Joint count Standard Error 0.367	-0.34 Joint count Standard Error 0.516
Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-4.06 Joint count Standard Error 0.409	-0.27 Joint count Standard Error 0.582
Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-5.55 Joint count Standard Error 0.437	-0.66 Joint count Standard Error 0.622
Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-6.42 Joint count Standard Error 0.489	-0.57 Joint count Standard Error 0.697
Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-7.28 Joint count Standard Error 0.336	-4.08 Joint count Standard Error 0.476
Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-8.07 Joint count Standard Error 0.386	-5.48 Joint count Standard Error 0.545

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

Tender/painful joint count was an assessment on 68 joints (temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, distal interphalangeals, hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined). Artificial joints were not assessed. Each joint was assessed for tenderness/pain as: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints).

Outcome measures

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-3.19 Joint count Standard Error 0.585	0.21 Joint count Standard Error 0.825
Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-5.38 Joint count Standard Error 0.589	-0.35 Joint count Standard Error 0.838
Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-7.44 Joint count Standard Error 0.588	-1.76 Joint count Standard Error 0.837
Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-8.90 Joint count Standard Error 0.637	-1.89 Joint count Standard Error 0.910
Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-10.15 Joint count Standard Error 0.617	-6.19 Joint count Standard Error 0.878
Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-11.91 Joint count Standard Error 0.638	-9.51 Joint count Standard Error 0.906

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

Participants were assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain).

Outcome measures

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-29.37 mm Standard Error 1.692	-26.27 mm Standard Error 2.435
Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-9.7 mm Standard Error 1.429	-3.13 mm Standard Error 2.025
Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-14.07 mm Standard Error 1.421	-2.37 mm Standard Error 2.038
Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-18.80 mm Standard Error 1.606	-2.66 mm Standard Error 2.286
Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-23.07 mm Standard Error 1.735	-1.20 mm Standard Error 2.478
Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-24.79 mm Standard Error 1.641	-17.84 mm Standard Error 2.346

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

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

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-13.67 mm Standard Error 1.521	-7.52 mm Standard Error 2.157
Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-17.89 mm Standard Error 1.593	-4.80 mm Standard Error 2.283
Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-22.49 mm Standard Error 1.679	-9.33 mm Standard Error 2.392
Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-26.02 mm Standard Error 1.825	-7.25 mm Standard Error 2.606
Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-28.68 mm Standard Error 1.613	-21.67 mm Standard Error 2.316
Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-33.49 mm Standard Error 1.669	-28.35 mm Standard Error 2.404

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

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 should be 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

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-11.94 mm Standard Error 1.126	-2.30 mm Standard Error 1.579
Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-17.10 mm Standard Error 1.324	-7.58 mm Standard Error 1.887
Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-25.16 mm Standard Error 1.419	-8.19 mm Standard Error 2.024
Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-29.45 mm Standard Error 1.436	-11.03 mm Standard Error 2.053
Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-33.33 mm Standard Error 1.413	-26.11 mm Standard Error 2.004
Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-38.79 mm Standard Error 1.307	-31.13 mm Standard Error 1.851

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

Blood samples were collected at each visit (except follow-up) for analysis of CRP using an assay by the central laboratory. The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.

Outcome measures

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-8.63 mg/L Standard Error 0.641	-1.42 mg/L Standard Error 0.904
Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-9.37 mg/L Standard Error 0.673	-1.50 mg/L Standard Error 0.958
Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-9.24 mg/L Standard Error 0.679	-1.83 mg/L Standard Error 0.967
Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-9.78 mg/L Standard Error 0.700	-1.98 mg/L Standard Error 1.001
Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-10.28 mg/L Standard Error 0.354	-10.58 mg/L Standard Error 0.503
Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-10.24 mg/L Standard Error 0.445	-8.95 mg/L Standard Error 0.638

SECONDARY outcome

Timeframe: Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline PGA-PsO ≥2. MR was considered to be NR (MR=NR).

PGA-PsO response : PGA-PsO = 0 or 1 and decrease from baseline in PGA-PsO ≥2. Rate was measured in terms of percentage of participants with PGA-PsO response. The PGA-PsO was 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 were scored 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 scores were summed and averaged after which the total average was rounded to the nearest whole number score to determine the PGA-PsO score.

Outcome measures

Measure	Tofacitinib n=106 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=51 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Physician's Global Assessment of Psoriasis (PGA-PsO) Response Rates for Participants With Baseline PGA-PsO ≥2 at Month 1, 3 and 6 Month 1	0.94 Percentage of participants	0.00 Percentage of participants
Physician's Global Assessment of Psoriasis (PGA-PsO) Response Rates for Participants With Baseline PGA-PsO ≥2 at Month 1, 3 and 6 Month 3	9.43 Percentage of participants	1.96 Percentage of participants
Physician's Global Assessment of Psoriasis (PGA-PsO) Response Rates for Participants With Baseline PGA-PsO ≥2 at Month 1, 3 and 6 Month 6	10.38 Percentage of participants	21.57 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline PGA-PsO \>0. Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The PGA-PsO was 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 were scored 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 scores were summed and averaged after which the total average was rounded to the nearest whole number score to determine the PGA-PsO score.

Outcome measures

Measure	Tofacitinib n=130 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=63 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in PGA-PsO for Participants With Baseline PGA-PsO>0 at Month 1, 3 and 6 Month 6	-1.25 Unit on a scale Standard Error 0.089	-1.26 Unit on a scale Standard Error 0.128
Change From Baseline in PGA-PsO for Participants With Baseline PGA-PsO>0 at Month 1, 3 and 6 Month 1	-0.66 Unit on a scale Standard Error 0.064	-0.31 Unit on a scale Standard Error 0.091
Change From Baseline in PGA-PsO for Participants With Baseline PGA-PsO>0 at Month 1, 3 and 6 Month 3	-1.12 Unit on a scale Standard Error 0.080	-0.52 Unit on a scale Standard Error 0.114

SECONDARY outcome

Timeframe: Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline BSA ≥3% and Baseline PASI \>0. MR was considered to be NR (MR=NR).

PASI75 response: ≥75% improvement from baseline in PASI. Rate was measured in terms of percentage of participants with PASI75 response. PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI score ranged from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI was only performed if ≥3% of participant's BSA was affected at baseline.

Outcome measures

Measure	Tofacitinib n=75 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=27 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Psoriasis Area and Severity Index (PASI) 75 Response Rates at Month 1, 3 and 6 in Participants With Baseline Psoriatic Body Surface Area (BSA) ≥3% and Baseline PASI >0 Month 1	18.67 Percentage of participants	3.70 Percentage of participants
Psoriasis Area and Severity Index (PASI) 75 Response Rates at Month 1, 3 and 6 in Participants With Baseline Psoriatic Body Surface Area (BSA) ≥3% and Baseline PASI >0 Month 3	36.00 Percentage of participants	11.11 Percentage of participants
Psoriasis Area and Severity Index (PASI) 75 Response Rates at Month 1, 3 and 6 in Participants With Baseline Psoriatic Body Surface Area (BSA) ≥3% and Baseline PASI >0 Month 6	41.33 Percentage of participants	59.26 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: The unit of Percentage is for percent change from baseline: (change from baseline / baseline value)\*100% FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline BSA ≥3% and Baseline PASI \>0. Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percentage of BSA affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI score ranged from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI was only performed if ≥3% of participant's BSA was affected at baseline.

Outcome measures

Measure	Tofacitinib n=72 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=25 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percent Change From Baseline in PASI Score at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 6	-62.72 Percentage Standard Error 5.617	-68.03 Percentage Standard Error 9.065
Percent Change From Baseline in PASI Score at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 1	-42.23 Percentage Standard Error 4.021	-16.34 Percentage Standard Error 6.750
Percent Change From Baseline in PASI Score at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 3	-60.86 Percentage Standard Error 4.660	-25.95 Percentage Standard Error 7.637

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: The unit of Percentage is for percent change from baseline: (change from baseline / baseline value)\*100% FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline BSA ≥3% and Baseline PASI \>0. Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

PASI quantified the severity of a participant's psoriasis based on both lesion severity and the percentage of BSA affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI was only performed if ≥3% of participant's BSA was affected at baseline. The PASI clinical component scores (erythema, induration and scaling) range from 0.0 to 24.0, with higher scores representing increasing severity of psoriasis.

Outcome measures

Measure	Tofacitinib n=72 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=25 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 1: Erythema	-44.53 Percentage Standard Error 5.553	-4.89 Percentage Standard Error 9.335
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 1: Induration	-39.91 Percentage Standard Error 4.329	-14.73 Percentage Standard Error 7.261
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 1: Scaling	-37.25 Percentage Standard Error 5.331	-15.94 Percentage Standard Error 8.954
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 3: Erythema	-63.49 Percentage Standard Error 5.471	-14.38 Percentage Standard Error 8.993
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 3: Induration	-58.71 Percentage Standard Error 4.935	-29.01 Percentage Standard Error 8.082
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 3: Scaling	-56.91 Percentage Standard Error 5.575	-20.13 Percentage Standard Error 9.153
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 6: Erythema	-61.40 Percentage Standard Error 5.543	-68.43 Percentage Standard Error 8.911
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 6: Induration	-60.47 Percentage Standard Error 6.468	-69.63 Percentage Standard Error 10.430
Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 Month 6: Scaling	-63.20 Percentage Standard Error 6.088	-63.89 Percentage Standard Error 9.803

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: The unit of Percentage is for percent change from baseline: (change from baseline / baseline value)\*100% FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline BSA \>0%. Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

Assessment of BSA with psoriasis was performed separately for four body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The BSA with psoriasis (%) was the sum of the numbers of the handpoints across the 4 body regions.

Outcome measures

Measure	Tofacitinib n=131 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=63 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percent Change From Baseline in BSA at Month 1, 3 and 6 for Participants With Baseline BSA >0% Month 1	-34.82 Percentage Standard Error 4.781	-6.13 Percentage Standard Error 6.878
Percent Change From Baseline in BSA at Month 1, 3 and 6 for Participants With Baseline BSA >0% Month 3	-51.91 Percentage Standard Error 6.142	-5.44 Percentage Standard Error 8.671
Percent Change From Baseline in BSA at Month 1, 3 and 6 for Participants With Baseline BSA >0% Month 6	-67.68 Percentage Standard Error 6.225	-40.91 Percentage Standard Error 8.792

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The blinded investigator or qualified assessor assessed how the participant's overall PsA appeared at the time of the visit. The investigator's response was recorded using a 100 mm VAS (Not active at all to Extremely active).

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=65 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Physician's Global Assessment of Psoriatic Arthritis (PGA-PsA) (VAS) at Month 1, 3 and 6 Month 3	-30.29 mm Standard Error 1.479	-10.84 mm Standard Error 2.108
Change From Baseline in Physician's Global Assessment of Psoriatic Arthritis (PGA-PsA) (VAS) at Month 1, 3 and 6 Month 1	-17.94 mm Standard Error 1.376	-7.19 mm Standard Error 1.965
Change From Baseline in Physician's Global Assessment of Psoriatic Arthritis (PGA-PsA) (VAS) at Month 1, 3 and 6 Month 6	-38.75 mm Standard Error 1.315	-32.05 mm Standard Error 1.873

SECONDARY outcome

Timeframe: Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline DSS \>0. MR was considered to be NR (MR=NR).

Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitis digits.

Resolution rate of dactylitis was defined as achieving DSS =0. Rate was measured in terms of percentage of participants with resolution of dactylitis.

Dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet. DSS was the sum of the severity of the 20 evaluated digits. The range of total dactylitis scores for a participant would be 0-60 (with a higher score indicating more severe dactylitis).

Outcome measures

Measure	Tofacitinib n=93 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=41 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Resolution Rate of Dactylitis at Month 1, 3 and 6 for Participants With Baseline Dactylitis Severity Score (DSS) >0 Month 1	21.51 Percentage of participants	7.32 Percentage of participants
Resolution Rate of Dactylitis at Month 1, 3 and 6 for Participants With Baseline Dactylitis Severity Score (DSS) >0 Month 3	45.16 Percentage of participants	19.51 Percentage of participants
Resolution Rate of Dactylitis at Month 1, 3 and 6 for Participants With Baseline Dactylitis Severity Score (DSS) >0 Month 6	64.52 Percentage of participants	41.46 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline DSS \>0. Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitis digits.

Dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet. DSS was the sum of the severity of the 20 evaluated digits. The range of total dactylitis scores for a participant would be 0-60 (with a higher score indicating more severe dactylitis).

Outcome measures

Measure	Tofacitinib n=91 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=40 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in DSS for Participant With Baseline DSS >0 at Month 1, 3 and 6 Month 1	-4.26 Unit on a scale Standard Error 0.691	-1.17 Unit on a scale Standard Error 1.052
Change From Baseline in DSS for Participant With Baseline DSS >0 at Month 1, 3 and 6 Month 3	-6.55 Unit on a scale Standard Error 0.543	-2.49 Unit on a scale Standard Error 0.826
Change From Baseline in DSS for Participant With Baseline DSS >0 at Month 1, 3 and 6 Month 6	-7.80 Unit on a scale Standard Error 0.190	-6.83 Unit on a scale Standard Error 0.289

SECONDARY outcome

Timeframe: Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline LEI \>0. MR was considered to be NR (MR=NR).

Resolution rate of enthesitis was defined as percentage of participants achieving enthesitis score (using LEI) =0.

Rate was measured in terms of percentage of participants with resolution of enthesitis.

Enthesitis score based upon presence/absence of enthesitis at 6 sites using LEI. Six sites, including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion, were assessed for enthesitis. LEI was the number of sites with presence of enthesitis.

Outcome measures

Measure	Tofacitinib n=71 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=28 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Resolution Rate of Enthesitis at Month 1, 3 and 6 for Participants With Baseline Leeds Enthesitis Index (LEI) >0 Month 1	38.03 Percentage of participants	25.00 Percentage of participants
Resolution Rate of Enthesitis at Month 1, 3 and 6 for Participants With Baseline Leeds Enthesitis Index (LEI) >0 Month 3	49.30 Percentage of participants	25.00 Percentage of participants
Resolution Rate of Enthesitis at Month 1, 3 and 6 for Participants With Baseline Leeds Enthesitis Index (LEI) >0 Month 6	64.79 Percentage of participants	60.71 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline LEI \>0. Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

Enthesitis score based upon presence/absence of enthesitis at 6 sites using LEI. Six sites, including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion, were assessed for enthesitis. LEI was the number of sites with presence of enthesitis.

Outcome measures

Measure	Tofacitinib n=69 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=27 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in LEI for Participant With Baseline LEI >0 at Month 1, 3 and 6 Month 1	-1.04 Unit on a scale Standard Error 0.142	-0.74 Unit on a scale Standard Error 0.231
Change From Baseline in LEI for Participant With Baseline LEI >0 at Month 1, 3 and 6 Month 3	-1.36 Unit on a scale Standard Error 0.155	-0.99 Unit on a scale Standard Error 0.251
Change From Baseline in LEI for Participant With Baseline LEI >0 at Month 1, 3 and 6 Month 6	-1.87 Unit on a scale Standard Error 0.127	-1.61 Unit on a scale Standard Error 0.203

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Analysis only included participants in FAS with Baseline NAPSI \>0. Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

A target finger nail was evaluated using NAPSI scale. Each quadrant of the target nail was graded for nail matrix psoriasis and nail bed psoriasis, giving that 1 target nail a score of 0-8. At the baseline visit, the worst case fingernail was chosen and the same nail evaluated consistently through the entire study.

Outcome measures

Measure	Tofacitinib n=96 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=53 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Month 1, 3 and 6 for Participants With Baseline NAPSI >0 Month 1	-0.26 Unit on a scale Standard Error 0.108	-0.25 Unit on a scale Standard Error 0.146
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Month 1, 3 and 6 for Participants With Baseline NAPSI >0 Month 3	-1.03 Unit on a scale Standard Error 0.175	-0.80 Unit on a scale Standard Error 0.235
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Month 1, 3 and 6 for Participants With Baseline NAPSI >0 Month 6	-2.43 Unit on a scale Standard Error 0.189	-2.10 Unit on a scale Standard Error 0.251

SECONDARY outcome

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

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). MR was considered to be NR (MR=NR).

The PsARC consisted of 4 measurements: Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (VAS) (0-100 mm), Patient's Global Assessment of Arthritis (VAS) (0-100 mm). In order to be a 'PsARC responder', participant must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, without worsening in any measure.

Outcome measures

Measure	Tofacitinib n=136 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=68 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6 Week 2	33.09 Percentage of participants	11.76 Percentage of participants
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6 Month 1	56.62 Percentage of participants	20.59 Percentage of participants
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6 Month 2	65.44 Percentage of participants	13.24 Percentage of participants
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6 Month 3	69.12 Percentage of participants	29.41 Percentage of participants
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6 Month 4	69.85 Percentage of participants	51.47 Percentage of participants
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6 Month 6	79.41 Percentage of participants	63.24 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Month 1, 2, 3, 4, and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The DAS was a derived measurement with differential weighting given to each component. The components of the DAS 28-3 arthritis assessment were: Tender/Painful Joint Count (28), Swollen Joint Count (28), CRP (refer to above OMs for more details of these components). DAS28 scores range from 0 to 9.4. A DAS28-3 (CRP) score higher than 5.1 indicates high disease activity, a DAS28-3 (CRP) score less than 3.2 indicates low disease activity, and a DAS28-3 (CRP) score less than 2.6 indicates clinical remission. A higher score represented a more severe disease activity, and a negative change from baseline indicates improvement.

DAS28-3(CRP)=[0.56*sqrt(TJC28)+0.28*sqrt(SJC28)+0.36*ln(CRP+1)]*1.10+1.15, where sqrt() refers to the square root, and ln() refers to the natural logarithm.

Outcome measures

Measure	Tofacitinib n=135 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=67 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6 Week 2	-0.68 Unit on a scale Standard Error 0.046	-0.05 Unit on a scale Standard Error 0.065
Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6 Month 1	-0.92 Unit on a scale Standard Error 0.054	-0.12 Unit on a scale Standard Error 0.077
Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6 Month 2	-1.13 Unit on a scale Standard Error 0.060	-0.26 Unit on a scale Standard Error 0.086
Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6 Month 3	-1.34 Unit on a scale Standard Error 0.070	-0.30 Unit on a scale Standard Error 0.100
Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6 Month 4	-1.59 Unit on a scale Standard Error 0.074	-1.16 Unit on a scale Standard Error 0.105
Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6 Month 6	-1.85 Unit on a scale Standard Error 0.083	-1.63 Unit on a scale Standard Error 0.119

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The SF 36 v.2 (Acute) was a 36 item generic health status measure. It measured 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were summarized as physical and mental component summary scores. The score range for the physical and mental health scores was 0-100 (100=highest level of functioning).

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=65 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Role-Physical Domain	5.94 Unit on a scale Standard Error 0.705	1.52 Unit on a scale Standard Error 1.004
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Physical Functioning Domain	3.53 Unit on a scale Standard Error 0.570	-0.19 Unit on a scale Standard Error 0.819
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Role-Physical Domain	3.93 Unit on a scale Standard Error 0.630	0.75 Unit on a scale Standard Error 0.903
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Bodily Pain Domain	5.58 Unit on a scale Standard Error 0.492	2.47 Unit on a scale Standard Error 0.706
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: General Health Domain	3.33 Unit on a scale Standard Error 0.537	-0.21 Unit on a scale Standard Error 0.770
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Vitality Domain	3.12 Unit on a scale Standard Error 0.687	0.08 Unit on a scale Standard Error 0.987
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Social Function Domain	2.65 Unit on a scale Standard Error 0.637	0.07 Unit on a scale Standard Error 0.915
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Role-Emotional Domain	3.19 Unit on a scale Standard Error 0.763	1.15 Unit on a scale Standard Error 1.095
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Mental Health Domain	1.77 Unit on a scale Standard Error 0.669	-0.14 Unit on a scale Standard Error 0.960
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Physical Component Summary	4.52 Unit on a scale Standard Error 0.437	0.76 Unit on a scale Standard Error 0.626
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 1: Mental Component Summary	1.85 Unit on a scale Standard Error 0.671	0.07 Unit on a scale Standard Error 0.964
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Physical Functioning Domain	4.33 Unit on a scale Standard Error 0.705	1.80 Unit on a scale Standard Error 1.001
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Bodily Pain Domain	7.60 Unit on a scale Standard Error 0.614	2.30 Unit on a scale Standard Error 0.874
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: General Health Domain	5.11 Unit on a scale Standard Error 0.725	-0.16 Unit on a scale Standard Error 1.032
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Vitality Domain	3.81 Unit on a scale Standard Error 0.784	1.71 Unit on a scale Standard Error 1.116
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Social Function Domain	4.75 Unit on a scale Standard Error 0.681	0.42 Unit on a scale Standard Error 0.969
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Role-Emotional Domain	5.30 Unit on a scale Standard Error 0.795	1.86 Unit on a scale Standard Error 1.132
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Mental Health Domain	2.90 Unit on a scale Standard Error 0.728	-0.58 Unit on a scale Standard Error 1.036
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Physical Component Summary	6.02 Unit on a scale Standard Error 0.567	1.85 Unit on a scale Standard Error 0.806
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 3: Mental Component Summary	3.38 Unit on a scale Standard Error 0.715	0.11 Unit on a scale Standard Error 1.019
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Physical Functioning Domain	6.35 Unit on a scale Standard Error 0.600	5.96 Unit on a scale Standard Error 0.860
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Role-Physical Domain	6.88 Unit on a scale Standard Error 0.705	5.84 Unit on a scale Standard Error 1.011
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Bodily Pain Domain	10.68 Unit on a scale Standard Error 0.678	10.31 Unit on a scale Standard Error 0.973
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: General Health Domain	5.54 Unit on a scale Standard Error 0.762	4.32 Unit on a scale Standard Error 1.091
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Vitality Domain	5.60 Unit on a scale Standard Error 0.868	3.61 Unit on a scale Standard Error 1.246
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Social Function Domain	5.58 Unit on a scale Standard Error 0.691	5.30 Unit on a scale Standard Error 0.991
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Role-Emotional Domain	6.35 Unit on a scale Standard Error 0.782	4.12 Unit on a scale Standard Error 1.121
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Mental Health Domain	3.68 Unit on a scale Standard Error 0.795	2.97 Unit on a scale Standard Error 1.141
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Physical Component Summary	7.94 Unit on a scale Standard Error 0.580	7.55 Unit on a scale Standard Error 0.831
Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 Month 6: Mental Component Summary	3.99 Unit on a scale Standard Error 0.812	2.20 Unit on a scale Standard Error 1.166

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

On the EQ-5D (participant version, 3 categories of response per question), 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) were assessed. The status of each dimension had three possible responses with the corresponding scores of 1 (no problem), 2 (some problems) and 3 (severe problems).

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=65 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 1: Pain/Discomfort	-0.28 Unit on a scale Standard Error 0.037	-0.15 Unit on a scale Standard Error 0.054
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 1: Mobility	-0.14 Unit on a scale Standard Error 0.038	-0.02 Unit on a scale Standard Error 0.055
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 1: Self-Care	-0.15 Unit on a scale Standard Error 0.031	0.01 Unit on a scale Standard Error 0.045
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 1: Usual Activities	-0.19 Unit on a scale Standard Error 0.039	-0.05 Unit on a scale Standard Error 0.056
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 1: Anxiety/Depression	-0.19 Unit on a scale Standard Error 0.036	-0.11 Unit on a scale Standard Error 0.051
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 3: Mobility	-0.24 Unit on a scale Standard Error 0.037	0.01 Unit on a scale Standard Error 0.053
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 3: Self-Care	-0.16 Unit on a scale Standard Error 0.033	0.02 Unit on a scale Standard Error 0.047
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 3: Usual Activities	-0.32 Unit on a scale Standard Error 0.040	0.01 Unit on a scale Standard Error 0.057
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 3: Pain/Discomfort	-0.38 Unit on a scale Standard Error 0.042	-0.10 Unit on a scale Standard Error 0.059
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 3: Anxiety/Depression	-0.23 Unit on a scale Standard Error 0.036	-0.12 Unit on a scale Standard Error 0.052
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 6: Mobility	-0.32 Unit on a scale Standard Error 0.032	-0.22 Unit on a scale Standard Error 0.046
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 6: Self-Care	-0.22 Unit on a scale Standard Error 0.028	-0.19 Unit on a scale Standard Error 0.040
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 6: Usual Activities	-0.36 Unit on a scale Standard Error 0.037	-0.25 Unit on a scale Standard Error 0.053
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 6: Pain/Discomfort	-0.56 Unit on a scale Standard Error 0.046	-0.56 Unit on a scale Standard Error 0.065
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 Month 6: Anxiety/Depression	-0.22 Unit on a scale Standard Error 0.038	-0.28 Unit on a scale Standard Error 0.055

SECONDARY outcome

Timeframe: Baseline, Month 1, 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The EQ-VAS recorded the patient's self-rated health on a vertical visual analogue scale where the endpoint was labelled 'Best imaginable health state' and 'Worst imaginable health state'. Based on the patient's mark on the VAS form a score ranging from 0 to 100 mm was recorded.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=65 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Month 1, 3 and 6 Month 1	9.88 mm Standard Error 1.191	3.87 mm Standard Error 1.710
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Month 1, 3 and 6 Month 3	12.48 mm Standard Error 1.484	1.68 mm Standard Error 2.108
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Month 1, 3 and 6 Month 6	18.52 mm Standard Error 1.398	17.60 mm Standard Error 2.002

SECONDARY outcome

Timeframe: Baseline, Month 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The WPAI-PsA was a 6-item questionnaire that measured absenteeism (work time missed), presenteesism (impairment at work/reduced on -the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and activity impairment. WPAI-PsA outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

Outcome measures

Measure	Tofacitinib n=63 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=34 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment Month 3: Work Time Missed	-1.01 Percentage Standard Error 1.422	-1.86 Percentage Standard Error 1.933
Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment Month 3: Impairment While Working	-16.11 Percentage Standard Error 2.703	-9.77 Percentage Standard Error 3.673
Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment Month 3: Overall Work Impairment	-16.67 Percentage Standard Error 2.789	-10.45 Percentage Standard Error 3.790
Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment Month 6: Work Time Missed	-1.09 Percentage Standard Error 1.451	-0.01 Percentage Standard Error 2.132
Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment Month 6: Impairment While Working	-21.11 Percentage Standard Error 2.819	-18.73 Percentage Standard Error 4.014
Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment Month 6: Overall Work Impairment	-20.91 Percentage Standard Error 3.031	-18.28 Percentage Standard Error 4.389

SECONDARY outcome

Timeframe: Baseline, Month 3 and 6

Population: FAS: included all participants randomized and who have received at least one dose of randomized study drug (tofacitinib or placebo). Here "Number of Participants Analyzed" indicates participants included in the MMRM. Here "Number analyzed" signifies participants evaluable for this OM at the specific visit.

The WPAI-PsA was a 6-item questionnaire that measured absenteeism (work time missed), presenteesism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and activity impairment. WPAI-PsA outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

Outcome measures

Measure	Tofacitinib n=129 Participants Participants received Tofacitinib 5 mg BID for 6 months.	Placebo Then Tofacitinib n=64 Participants Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months (up to Month 6).
Change From Baseline in WPAI-PsA at Month 3 and 6: Activity Impairment Month 3: Activity Impairment	-17.20 Percentage Standard Error 1.778	-4.39 Percentage Standard Error 2.525
Change From Baseline in WPAI-PsA at Month 3 and 6: Activity Impairment Month 6: Activity Impairment	-21.91 Percentage Standard Error 1.805	-22.97 Percentage Standard Error 2.589

Adverse Events

Tofacitinib: Up to Month 3

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Placebo: Up to Month 3

Serious events: 3 serious events

Other events: 16 other events

Deaths: 1 deaths

Tofacitinib: Up to Month 6

Serious events: 2 serious events

Other events: 94 other events

Deaths: 0 deaths

Placebo Then Tofacitinib: Up to Month 6

Serious events: 5 serious events

Other events: 37 other events

Deaths: 1 deaths

Serious adverse events

Measure	Tofacitinib: Up to Month 3 n=136 participants at risk Participants received Tofacitinib 5 mg tablets BID for 3 months.	Placebo: Up to Month 3 n=68 participants at risk Participants received tofacitinib matching placebo tablets BID for 3 months	Tofacitinib: Up to Month 6 n=136 participants at risk Participants received tofacitinib 5 mg tablets twice daily for 6 months.	Placebo Then Tofacitinib: Up to Month 6 n=68 participants at risk Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months.
Cardiac disorders Atrial tachycardia	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Cardiac disorders Supraventricular extrasystoles	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Injury, poisoning and procedural complications Accident	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Injury, poisoning and procedural complications Limb injury	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Injury, poisoning and procedural complications Tendon injury	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Infections and infestations Pneumonia	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Renal and urinary disorders Nephrolithiasis	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).

Other adverse events

Measure	Tofacitinib: Up to Month 3 n=136 participants at risk Participants received Tofacitinib 5 mg tablets BID for 3 months.	Placebo: Up to Month 3 n=68 participants at risk Participants received tofacitinib matching placebo tablets BID for 3 months	Tofacitinib: Up to Month 6 n=136 participants at risk Participants received tofacitinib 5 mg tablets twice daily for 6 months.	Placebo Then Tofacitinib: Up to Month 6 n=68 participants at risk Participants received tofacitinib matching placebo tablets BID for 3 months, followed by tofacitinib tablets 5 mg BID for next 3 months.
Gastrointestinal disorders Abdominal discomfort	6.6% 9/136 • Number of events 13 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	6.6% 9/136 • Number of events 16 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 2/68 • Number of events 2 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Gastrointestinal disorders Diarrhoea	6.6% 9/136 • Number of events 12 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 2/68 • Number of events 2 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	8.8% 12/136 • Number of events 16 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 2/68 • Number of events 4 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Infections and infestations Upper respiratory tract infection	18.4% 25/136 • Number of events 27 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	10.3% 7/68 • Number of events 9 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	26.5% 36/136 • Number of events 45 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	10.3% 7/68 • Number of events 9 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Alanine aminotransferase increased	5.1% 7/136 • Number of events 7 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.9% 4/68 • Number of events 4 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	8.1% 11/136 • Number of events 12 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	7.4% 5/68 • Number of events 7 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Blood creatine phosphokinase increased	6.6% 9/136 • Number of events 10 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	14.7% 20/136 • Number of events 21 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 2/68 • Number of events 2 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Metabolism and nutrition disorders Hyperlipidaemia	6.6% 9/136 • Number of events 9 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 2/68 • Number of events 2 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	10.3% 14/136 • Number of events 15 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	8.8% 6/68 • Number of events 8 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Nervous system disorders Dizziness	5.1% 7/136 • Number of events 8 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.1% 7/136 • Number of events 8 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 1 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Blood and lymphatic system disorders Leukopenia	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.1% 7/136 • Number of events 7 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 1/68 • Number of events 2 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	8.8% 12/136 • Number of events 12 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	4.4% 3/68 • Number of events 3 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Infections and infestations Urinary tract infection	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 4/136 • Number of events 4 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	7.4% 5/68 • Number of events 5 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Aspartate aminotransferase increased	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	8.1% 11/136 • Number of events 11 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.9% 4/68 • Number of events 5 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Blood triglycerides increased	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	3.7% 5/136 • Number of events 7 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.9% 4/68 • Number of events 5 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Low density lipoprotein increased	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.9% 8/136 • Number of events 9 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 2/68 • Number of events 2 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Lymphocyte count decreased	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	6.6% 9/136 • Number of events 15 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	4.4% 3/68 • Number of events 3 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Red blood cell count decreased	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 2/136 • Number of events 2 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.9% 4/68 • Number of events 4 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/136 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	8.1% 11/136 • Number of events 11 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/68 • For "Tofacitinib: Up to Month 3" arm and "Placebo: Up to Month 3" arm: From the baseline to Month 3. For "Tofacitinib: Up to Month 6" arm and "Placebo Then Tofacitinib: Up to Month 6" arm: From the baseline to up to 42 days after the last dose of the study treatment (up to 7.5 months). Same event may appear as AE and serious AE. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).

Additional Information

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• 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.
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Restriction type: OTHER