Trial Outcomes & Findings for A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis (NCT NCT01815424)

NCT ID: NCT01815424

Last Updated: 2019-04-16

Results Overview

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 266 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	Tofacitinib 10 mg Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).	Placebo to Tofacitinib 10 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Week 0 to 16 STARTED	90	88	88	0	0
Week 0 to 16 COMPLETED	83	84	77	0	0
Week 0 to 16 NOT COMPLETED	7	4	11	0	0
Week 16 to 52 STARTED	83	84	0	38	39
Week 16 to 52 COMPLETED	81	79	0	35	36
Week 16 to 52 NOT COMPLETED	2	5	0	3	3

Reasons for withdrawal

Measure	Tofacitinib 10 mg Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).	Placebo to Tofacitinib 10 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Week 0 to 16 Adverse Event	1	3	3	0	0
Week 0 to 16 Does Not Meet Entrance Criteria	2	0	0	0	0
Week 0 to 16 Lost to Follow-up	0	1	0	0	0
Week 0 to 16 Withdrawal by Subject	0	0	1	0	0
Week 0 to 16 Other	1	0	3	0	0
Week 0 to 16 Protocol Violation	1	0	0	0	0
Week 0 to 16 Insufficient Clinical Response	2	0	4	0	0
Week 16 to 52 Other	0	1	0	0	0
Week 16 to 52 Adverse Event	0	0	0	0	1
Week 16 to 52 Insufficient Clinical Response	1	0	0	1	1
Week 16 to 52 Lost to Follow-up	0	2	0	2	1
Week 16 to 52 Withdrawal by Subject	1	2	0	0	0

Baseline Characteristics

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis

Baseline characteristics by cohort

Measure	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).	Total n=266 Participants Total of all reporting groups
Age, Continuous	41.0 years STANDARD_DEVIATION 12.0 • n=5 Participants	40.7 years STANDARD_DEVIATION 11.3 • n=7 Participants	41.7 years STANDARD_DEVIATION 13.7 • n=5 Participants	41.1 years STANDARD_DEVIATION 12.3 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	72 Participants n=4 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	65 Participants n=7 Participants	62 Participants n=5 Participants	194 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16	—	75.56 percentage of participants	52.27 percentage of participants	19.32 percentage of participants

PRIMARY outcome

Timeframe: Week 16

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to Baseline.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16	—	81.11 percentage of participants	54.55 percentage of participants	12.50 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed was the evaluable participants for the specific criteria.

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

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=84 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=84 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=77 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16	—	-73.81 percent change Standard Error 5.903	-54.39 percent change Standard Error 5.838	-2.27 percent change Standard Error 6.061

SECONDARY outcome

Timeframe: Week 16

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90% reduction in PASI relative to Baseline.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16	—	60.00 percentage of participants 5.903	35.23 percentage of participants 5.838	3.41 percentage of participants 6.061

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed was the evaluable participants for the specific criteria.

The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=84 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=84 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=77 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in DLQI Total Score at Week 16	—	-9.10 scores on a scale Standard Error 0.635	-7.03 scores on a scale Standard Error 0.627	-1.57 scores on a scale Standard Error 0.655

SECONDARY outcome

Timeframe: Week 4

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4	—	37.78 percentage of participants 0.497	19.32 percentage of participants 0.493	1.14 percentage of participants 0.504

SECONDARY outcome

Timeframe: Week 4

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants Achieving PASI75 Response at Week 4	—	24.44 percentage of participants	4.55 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed was the evaluable participants for the specific criteria.

The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=86 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=83 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in DLQI Total Score at Week 4	—	-6.03 scores on a scale Standard Error 0.497	-5.14 scores on a scale Standard Error 0.493	-0.94 scores on a scale Standard Error 0.504

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed signifies those participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure..

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represent more severe psoriasis.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=38 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=38 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=29 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline	—	-33.32 percent change Standard Error 10.518	-14.98 percent change Standard Error 10.566	7.91 percent change Standard Error 12.025

SECONDARY outcome

Timeframe: Week 16 to Week 52

Population: Patients in the full analysis population and those who had PGA response at Week 16 and non-missing post Week 16 data were included. Patients initially treated with placebo were not included as they were advanced to tofacitinib and this maintaining response at Week 52 was not relevant.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among patients achieving PGA response at Week 16 is reported. This is a key secondary endpoint. Percentage of participants maintaining the response and the 95% confidence interval (CI) were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=68 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=46 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16	—	75.00 percentage of participants 95% Confidence Interval 0.497 • Interval 62.91 to 83.65	73.63 percentage of participants 95% Confidence Interval 0.493 • Interval 58.24 to 84.08	—

SECONDARY outcome

Timeframe: Week 16 to Week 52

Population: Patients in the full analysis population and those who had PASI75 response at Week 16 and non-missing post Week 16 data were included. Patients initially treated with placebo were not included as they were advanced to tofacitinib and this maintaining response at Week 52 was not relevant.

The PASI quantifies severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response=at least 75% reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among patients achieving PASI75 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=73 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=48 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16	—	84.93 percentage of participants 95% Confidence Interval 0.497 • Interval 74.44 to 91.36	76.82 percentage of participants 95% Confidence Interval 0.493 • Interval 62.04 to 86.44	—

SECONDARY outcome

Timeframe: Week 16 to Week 52

Population: Patients in the full analysis population and those who had PASI90 response at Week 16 and non-missing post Week 16 data were included. Patients initially treated with placebo were not included as they were advanced to tofacitinib and this maintaining response at Week 52 was not relevant.

The PASI quantifies severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response=at least 90% reduction in PASI relative to Baseline. Maintenance of PASI90 response at Week 52 among patients achieving PASI90 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=54 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=31 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16	—	74.07 percentage of participants 95% Confidence Interval 0.497 • Interval 60.19 to 83.75	70.45 percentage of participants 95% Confidence Interval 0.493 • Interval 50.85 to 83.41	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Participants with non-missing post-baseline response data in the full analysis population (all participants who were randomized to the study and received at least 1 dose of study drug) were included.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if less than 50% of participants had PGA response by Week 16.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=88 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=86 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Time to PGA Response up to Week 16	—	8.0 weeks Interval 4.0 to 8.0	14.0 weeks Interval 12.0 to Upper limit of the CI is not estimable. The time frame from Baseline to Week 16 is insufficient to observe the required number of responders for the upper limit.	NA weeks Not estimable. Less than half of the participants are responders by Week 16 (ie. censoring percent is \>50%).

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Participants with non-missing post-baseline responses data in the full analysis population (all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo) were included.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if less than 50% of participants had PASI50 response by Week 16.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=88 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=86 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Time to PASI75 Response up to Week 16	—	8.0 weeks Interval 8.0 to 12.0	16.0 weeks Interval 12.0 to Upper limit of the CI is not estimable. The time frame from Baseline to Week 16 is insufficient to observe the required number of responders for the upper limit.	NA weeks Not estimable. Less than half of the participants are responders by Week 16 (ie. censoring percent is \>50%).

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Participants with non-missing post-baseline responses data in the full analysis population (all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo) were included.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=88 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=86 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Time to PASI50 Response up to Week 16	—	4.0 weeks Interval 4.0 to 8.0	8.0 weeks Interval 8.0 to 12.0	NA weeks Not estimable. Less than half of the participants are responders by Week 16 (ie. censoring percent is \>50%).

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 2	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	3.33 percentage of participants Interval 0.0 to 7.04	2.27 percentage of participants Interval 0.0 to 5.39	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 4	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	37.78 percentage of participants Interval 27.76 to 47.79	19.32 percentage of participants Interval 11.07 to 27.57	2.27 percentage of participants Interval 0.0 to 6.68
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 8	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	57.78 percentage of participants Interval 47.57 to 67.98	38.64 percentage of participants Interval 28.46 to 48.81	11.36 percentage of participants Interval 1.99 to 20.74
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 12	6.82 percentage of participants Interval 0.0 to 14.27	74.44 percentage of participants Interval 65.43 to 83.46	50.00 percentage of participants Interval 39.55 to 60.45	25.00 percentage of participants Interval 12.21 to 37.79
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 16	9.09 percentage of participants Interval 0.6 to 17.59	75.56 percentage of participants Interval 66.68 to 84.43	52.27 percentage of participants Interval 41.84 to 62.71	29.55 percentage of participants Interval 16.06 to 43.03
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 20	47.73 percentage of participants Interval 32.97 to 62.49	75.56 percentage of participants Interval 66.68 to 84.43	54.55 percentage of participants Interval 44.14 to 64.95	59.09 percentage of participants Interval 44.56 to 73.62
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 32	52.27 percentage of participants Interval 37.51 to 67.03	73.33 percentage of participants Interval 64.2 to 82.47	53.41 percentage of participants Interval 42.99 to 63.83	68.18 percentage of participants Interval 54.42 to 81.94
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 40	54.55 percentage of participants Interval 39.83 to 69.26	72.22 percentage of participants Interval 62.97 to 81.48	55.68 percentage of participants Interval 45.3 to 66.06	65.91 percentage of participants Interval 51.9 to 79.92
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 Week 52	50.00 percentage of participants Interval 35.23 to 64.77	67.78 percentage of participants Interval 58.12 to 77.43	54.55 percentage of participants Interval 44.14 to 64.95	59.09 percentage of participants Interval 44.56 to 73.62

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; n=number of evaluable participants at the specified time point.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 20: Moderate (n=84,84,38,39)	7.7 percentage of participants	7.1 percentage of participants	13.1 percentage of participants	13.2 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 32: Almost Clear (n=83,83,38,37)	32.4 percentage of participants	27.7 percentage of participants	25.3 percentage of participants	34.2 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 32: Severe (n=83,83,38,37)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 16: Moderate (n=84,84,38,39)	51.3 percentage of participants	9.5 percentage of participants	23.8 percentage of participants	34.2 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 16: Severe (n=84,84,38,39)	7.7 percentage of participants	0 percentage of participants	0 percentage of participants	5.3 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 20: Clear (n=84,84,38,39)	2.6 percentage of participants	50.0 percentage of participants	25.0 percentage of participants	15.8 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Baseline: Clear (n=90,88,44,44)	0 percentage of participants	0 percentage of participants Interval 95.67 to 100.0	0 percentage of participants Interval 83.16 to 99.45	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Baseline: Almost Clear (n=90,88,44,44)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Baseline: Mild (n=90,88,44,44)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Baseline: Moderate (n=90,88,44,44)	70.5 percentage of participants	85.6 percentage of participants	87.5 percentage of participants	81.8 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Baseline: Severe (n=90,88,44,44)	29.5 percentage of participants	14.4 percentage of participants	12.5 percentage of participants	18.2 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 2: Clear (n=88,86,44,42)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 2: Almost Clear (n=88,86,44,42)	0 percentage of participants	3.4 percentage of participants	2.3 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 2: Mild (n=88,86,44,42)	4.8 percentage of participants	47.7 percentage of participants	36.0 percentage of participants	11.4 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 2: Moderate (n=88,86,44,42)	71.4 percentage of participants	40.9 percentage of participants	55.8 percentage of participants	75.0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 2: Severe (n=88,86,44,42)	23.8 percentage of participants	8.0 percentage of participants	5.8 percentage of participants	13.6 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 4: Almost Clear (n=87,88,43,42)	0 percentage of participants	36.8 percentage of participants	18.2 percentage of participants	2.3 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 4: Mild (n=87,88,43,42)	14.3 percentage of participants	29.9 percentage of participants	39.8 percentage of participants	23.3 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 4: Moderate (n=87,88,43,42)	69.0 percentage of participants	27.6 percentage of participants	36.4 percentage of participants	53.5 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 8: Clear (n=85,88,40,39)	0 percentage of participants	23.5 percentage of participants	3.4 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 8: Almost Clear (n=85,88,40,39)	0 percentage of participants	37.6 percentage of participants	35.2 percentage of participants	12.5 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 12: Severe (n=84,88,40,39)	10.3 percentage of participants	2.4 percentage of participants	0 percentage of participants	5.0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 8: Mild (n=85,88,40,39)	25.6 percentage of participants	20.0 percentage of participants	28.4 percentage of participants	30.0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 8: Moderate (n=85,88,40,39)	61.5 percentage of participants	17.6 percentage of participants	30.7 percentage of participants	42.5 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 8: Severe (n=85,88,40,39)	12.8 percentage of participants	1.2 percentage of participants	2.3 percentage of participants	15.0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 12: Clear (n=84,88,40,39)	0 percentage of participants	34.5 percentage of participants	12.5 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 12: Almost Clear (n=84,88,40,39)	7.7 percentage of participants	45.2 percentage of participants	37.5 percentage of participants	27.5 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 12: Mild (n=84,88,40,39)	30.8 percentage of participants	11.9 percentage of participants	27.3 percentage of participants	30.0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 12: Moderate (n=84,88,40,39)	51.3 percentage of participants	6.0 percentage of participants	22.7 percentage of participants	37.5 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 16: Clear (n=84,84,38,39)	0 percentage of participants	42.9 percentage of participants	16.7 percentage of participants	5.3 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 16: Almost Clear (n=84,84,38,39)	10.3 percentage of participants	38.1 percentage of participants	38.1 percentage of participants	28.9 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 16: Mild (n=84,84,38,39)	30.8 percentage of participants	9.5 percentage of participants	21.4 percentage of participants	26.3 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 40: Moderate (n=81,81,37,36)	13.9 percentage of participants	6.2 percentage of participants	13.6 percentage of participants	8.1 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 20: Almost Clear (n=84,84,38,39)	51.3 percentage of participants	31.0 percentage of participants	32.1 percentage of participants	52.6 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 20: Mild (n=84,84,38,39)	38.5 percentage of participants	11.9 percentage of participants	29.8 percentage of participants	18.4 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 20: Severe (n=84,84,38,39)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 32: Clear (n=83,83,38,37)	29.7 percentage of participants	51.8 percentage of participants	31.3 percentage of participants	44.7 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 32: Mild (n=83,83,38,37)	32.4 percentage of participants	13.3 percentage of participants	26.5 percentage of participants	18.4 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 32: Moderate (n=83,83,38,37)	5.4 percentage of participants	7.2 percentage of participants	16.9 percentage of participants	2.6 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 40: Clear (n=81,81,37,36)	36.1 percentage of participants	53.1 percentage of participants	29.6 percentage of participants	48.6 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 40: Almost Clear (n=81,81,37,36)	30.6 percentage of participants	27.2 percentage of participants	30.9 percentage of participants	29.7 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 40: Mild (n=81,81,37,36)	19.4 percentage of participants	13.6 percentage of participants	25.9 percentage of participants	13.5 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 40: Severe (n=81,81,37,36)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 52: Clear (n=80,78,36,36)	30.6 percentage of participants	45.0 percentage of participants	25.6 percentage of participants	50.0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 52: Almost Clear (n=80,78,36,36)	30.6 percentage of participants	31.3 percentage of participants	35.9 percentage of participants	22.2 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 52: Mild (n=80,78,36,36)	30.6 percentage of participants	16.3 percentage of participants	19.2 percentage of participants	16.7 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 52: Moderate (n=80,78,36,36)	8.3 percentage of participants	7.5 percentage of participants	17.9 percentage of participants	11.1 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 52: Severe (n=80,78,36,36)	0 percentage of participants	0 percentage of participants	1.3 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 4: Clear (n=87,88,43,42)	0 percentage of participants	2.3 percentage of participants	1.1 percentage of participants	0 percentage of participants
Percentage of Participants in Each PGA Category Over Time Through Week 52 Week 4: Severe (n=87,88,43,42)	16.7 percentage of participants	3.4 percentage of participants	4.5 percentage of participants	20.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 32	65.91 percentage of participants Interval 51.9 to 79.92	81.11 percentage of participants Interval 73.02 to 89.2	59.09 percentage of participants Interval 48.82 to 69.36	75.00 percentage of participants Interval 62.21 to 87.79
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 2	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	1.11 percentage of participants Interval 0.0 to 3.28	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 4	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	24.44 percentage of participants Interval 15.57 to 33.32	4.55 percentage of participants Interval 0.19 to 8.9	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 8	2.27 percentage of participants Interval 0.0 to 6.68	51.11 percentage of participants Interval 40.78 to 61.44	31.82 percentage of participants Interval 22.09 to 41.55	2.27 percentage of participants Interval 0.0 to 6.68
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 16	4.55 percentage of participants Interval 0.0 to 10.7	81.11 percentage of participants Interval 73.02 to 89.2	54.55 percentage of participants Interval 44.14 to 64.95	20.45 percentage of participants Interval 8.54 to 32.37
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 20	27.27 percentage of participants Interval 14.11 to 40.43	83.33 percentage of participants Interval 75.63 to 91.03	54.55 percentage of participants Interval 44.14 to 64.95	52.27 percentage of participants Interval 37.51 to 67.03
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 12	2.27 percentage of participants Interval 0.0 to 6.68	72.22 percentage of participants Interval 62.97 to 81.48	47.73 percentage of participants Interval 37.29 to 58.16	11.36 percentage of participants Interval 1.99 to 20.74
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 40	65.91 percentage of participants Interval 51.9 to 79.92	80.00 percentage of participants Interval 71.74 to 88.26	56.82 percentage of participants Interval 46.47 to 67.17	68.18 percentage of participants Interval 54.42 to 81.94
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 Week 52	59.09 percentage of participants Interval 44.56 to 73.62	76.67 percentage of participants Interval 67.93 to 85.4	59.09 percentage of participants Interval 48.82 to 69.36	63.64 percentage of participants Interval 49.42 to 77.85

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Actual PASI Scores Over Time Through Week 52 Baseline (n=90,88,44,44)	26.51 percentage of participants Standard Deviation 8.525	25.34 percentage of participants Standard Deviation 9.106 • Interval 0.0 to 3.28	25.32 percentage of participants Standard Deviation 10.185	25.62 percentage of participants Standard Deviation 10.429
Actual PASI Scores Over Time Through Week 52 Week 2 (n=88,86,44,42)	26.34 percentage of participants Standard Deviation 9.456	19.03 percentage of participants Standard Deviation 9.392 • Interval 15.57 to 33.32	21.23 percentage of participants Standard Deviation 9.979 • Interval 0.19 to 8.9	25.72 percentage of participants Standard Deviation 10.582
Actual PASI Scores Over Time Through Week 52 Week 4 (n=87,88,43,42)	24.65 percentage of participants Standard Deviation 9.433 • Interval 0.0 to 6.68	13.81 percentage of participants Standard Deviation 9.826 • Interval 40.78 to 61.44	17.41 percentage of participants Standard Deviation 10.565 • Interval 22.09 to 41.55	24.81 percentage of participants Standard Deviation 12.081 • Interval 0.0 to 6.68
Actual PASI Scores Over Time Through Week 52 Week 8 (n=85,88,40,39)	22.46 percentage of participants Standard Deviation 8.966 • Interval 0.0 to 6.68	8.18 percentage of participants Standard Deviation 9.075 • Interval 62.97 to 81.48	12.56 percentage of participants Standard Deviation 10.623 • Interval 37.29 to 58.16	21.38 percentage of participants Standard Deviation 11.689 • Interval 1.99 to 20.74
Actual PASI Scores Over Time Through Week 52 Week 12 (n=84,88,40,39)	21.35 percentage of participants Standard Deviation 9.477 • Interval 0.0 to 10.7	4.56 percentage of participants Standard Deviation 6.979 • Interval 73.02 to 89.2	10.10 percentage of participants Standard Deviation 9.858 • Interval 44.14 to 64.95	17.83 percentage of participants Standard Deviation 10.503 • Interval 8.54 to 32.37
Actual PASI Scores Over Time Through Week 52 Week 16 (n=84,84,38,39)	20.64 percentage of participants Standard Deviation 9.738 • Interval 14.11 to 40.43	3.48 percentage of participants Standard Deviation 6.722 • Interval 75.63 to 91.03	8.42 percentage of participants Standard Deviation 9.800 • Interval 44.14 to 64.95	15.27 percentage of participants Standard Deviation 11.441 • Interval 37.51 to 67.03
Actual PASI Scores Over Time Through Week 52 Week 20 (84,84,38,39)	10.43 percentage of participants Standard Deviation 7.612 • Interval 51.9 to 79.92	2.75 percentage of participants Standard Deviation 5.610 • Interval 73.02 to 89.2	7.13 percentage of participants Standard Deviation 8.280 • Interval 48.82 to 69.36	6.52 percentage of participants Standard Deviation 6.512 • Interval 62.21 to 87.79
Actual PASI Scores Over Time Through Week 52 Week 32 (n=83,83,38,37)	4.82 percentage of participants Standard Deviation 5.517 • Interval 51.9 to 79.92	2.15 percentage of participants Standard Deviation 3.810 • Interval 71.74 to 88.26	6.23 percentage of participants Standard Deviation 7.817 • Interval 46.47 to 67.17	3.09 percentage of participants Standard Deviation 5.434 • Interval 54.42 to 81.94
Actual PASI Scores Over Time Through Week 52 Week 40 (n=81,81,37,36)	3.74 percentage of participants Standard Deviation 4.540 • Interval 44.56 to 73.62	2.04 percentage of participants Standard Deviation 3.553 • Interval 67.93 to 85.4	5.74 percentage of participants Standard Deviation 6.415 • Interval 48.82 to 69.36	2.79 percentage of participants Standard Deviation 4.458 • Interval 49.42 to 77.85
Actual PASI Scores Over Time Through Week 52 Week 52 (n=80,78,36,36)	4.69 percentage of participants Standard Deviation 4.607	2.82 percentage of participants Standard Deviation 4.674	6.00 percentage of participants Standard Deviation 7.313	3.11 percentage of participants Standard Deviation 5.027

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in PASI Over Time Through Week 52 Week 40 (n=81,81,37,36)	-22.94 units on a scale Standard Deviation 9.512 • Interval 44.56 to 73.62	-23.47 units on a scale Standard Deviation 9.702 • Interval 67.93 to 85.4	-20.11 units on a scale Standard Deviation 10.292 • Interval 48.82 to 69.36	-22.80 units on a scale Standard Deviation 11.268 • Interval 49.42 to 77.85
Change From Baseline in PASI Over Time Through Week 52 Week 2 (n=88,86,44,42)	-0.04 units on a scale Standard Deviation 3.676	-6.40 units on a scale Standard Deviation 6.724 • Interval 15.57 to 33.32	-4.26 units on a scale Standard Deviation 5.231 • Interval 0.19 to 8.9	0.10 units on a scale Standard Deviation 4.715
Change From Baseline in PASI Over Time Through Week 52 Week 4 (n=87,88,43,42)	-1.72 units on a scale Standard Deviation 3.799 • Interval 0.0 to 6.68	-11.74 units on a scale Standard Deviation 8.528 • Interval 40.78 to 61.44	-7.91 units on a scale Standard Deviation 7.053 • Interval 22.09 to 41.55	-0.76 units on a scale Standard Deviation 7.423 • Interval 0.0 to 6.68
Change From Baseline in PASI Over Time Through Week 52 Week 8 (n=85,88,40,39)	-4.51 units on a scale Standard Deviation 6.130 • Interval 0.0 to 6.68	-17.25 units on a scale Standard Deviation 10.244 • Interval 62.97 to 81.48	-12.76 units on a scale Standard Deviation 10.033 • Interval 37.29 to 58.16	-4.25 units on a scale Standard Deviation 8.996 • Interval 1.99 to 20.74
Change From Baseline in PASI Over Time Through Week 52 Week 12 (n=84,88,40,39)	-5.62 units on a scale Standard Deviation 7.169 • Interval 0.0 to 10.7	-20.98 units on a scale Standard Deviation 9.612 • Interval 73.02 to 89.2	-15.22 units on a scale Standard Deviation 11.214 • Interval 44.14 to 64.95	-7.71 units on a scale Standard Deviation 10.717 • Interval 8.54 to 32.37
Change From Baseline in PASI Over Time Through Week 52 Week 16 (n=84,84,38,39)	-6.33 units on a scale Standard Deviation 8.973 • Interval 14.11 to 40.43	-22.07 units on a scale Standard Deviation 10.127 • Interval 75.63 to 91.03	-17.12 units on a scale Standard Deviation 11.711 • Interval 44.14 to 64.95	-10.03 units on a scale Standard Deviation 12.976 • Interval 37.51 to 67.03
Change From Baseline in PASI Over Time Through Week 52 Week 20 (n=84,84,38,39)	-16.54 units on a scale Standard Deviation 8.732 • Interval 51.9 to 79.92	-22.79 units on a scale Standard Deviation 9.675 • Interval 73.02 to 89.2	-18.42 units on a scale Standard Deviation 10.955 • Interval 48.82 to 69.36	-18.79 units on a scale Standard Deviation 12.428 • Interval 62.21 to 87.79
Change From Baseline in PASI Over Time Through Week 52 Week 32 (n=83,83,38,37)	-21.86 units on a scale Standard Deviation 9.283 • Interval 51.9 to 79.92	-23.45 units on a scale Standard Deviation 9.369 • Interval 71.74 to 88.26	-19.45 units on a scale Standard Deviation 10.312 • Interval 46.47 to 67.17	-22.22 units on a scale Standard Deviation 11.550 • Interval 54.42 to 81.94
Change From Baseline in PASI Over Time Through Week 52 Week 52 (n=80,78,36,36)	-22.00 units on a scale Standard Deviation 9.429	-22.71 units on a scale Standard Deviation 10.655	-20.04 units on a scale Standard Deviation 10.819	-22.54 units on a scale Standard Deviation 12.368

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
PASI Component Scores Over Time Through Week 52 Week 16: Induration (Lower Limbs) n=84,84,38,39	2.46 units on a scale Standard Deviation 0.969	0.54 units on a scale Standard Deviation 0.798	1.24 units on a scale Standard Deviation 1.115	1.95 units on a scale Standard Deviation 1.138
PASI Component Scores Over Time Through Week 52 Baseline: Scaling (Head/Neck) n=90,88,44,44	2.34 units on a scale Standard Deviation 0.987	2.40 units on a scale Standard Deviation 0.946	2.01 units on a scale Standard Deviation 1.011	2.25 units on a scale Standard Deviation 1.184
PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Head/Neck) n=84,84,38,39	1.72 units on a scale Standard Deviation 0.999	0.57 units on a scale Standard Deviation 0.811	0.76 units on a scale Standard Deviation 1.025	1.21 units on a scale Standard Deviation 1.018
PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Head/Neck) n=88,86,44,42	2.50 units on a scale Standard Deviation 0.834 • Interval 0.0 to 6.68	1.74 units on a scale Standard Deviation 0.903 • Interval 40.78 to 61.44	1.77 units on a scale Standard Deviation 1.037 • Interval 22.09 to 41.55	2.05 units on a scale Standard Deviation 1.033 • Interval 0.0 to 6.68
PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Head/Neck) n=84,88,40,39	1.97 units on a scale Standard Deviation 1.038 • Interval 14.11 to 40.43	0.68 units on a scale Standard Deviation 0.867 • Interval 75.63 to 91.03	0.94 units on a scale Standard Deviation 1.065 • Interval 44.14 to 64.95	1.75 units on a scale Standard Deviation 1.171 • Interval 37.51 to 67.03
PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Head/Neck) n=84,84,38,39	1.82 units on a scale Standard Deviation 1.073 • Interval 51.9 to 79.92	0.58 units on a scale Standard Deviation 0.839 • Interval 73.02 to 89.2	0.82 units on a scale Standard Deviation 1.032 • Interval 48.82 to 69.36	1.47 units on a scale Standard Deviation 1.156 • Interval 62.21 to 87.79
PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Head/Neck) n=84,84,38,39	1.08 units on a scale Standard Deviation 0.839 • Interval 51.9 to 79.92	0.50 units on a scale Standard Deviation 0.784 • Interval 71.74 to 88.26	0.82 units on a scale Standard Deviation 0.971 • Interval 46.47 to 67.17	0.76 units on a scale Standard Deviation 0.883 • Interval 54.42 to 81.94
PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Head/Neck) n=83,83,38,37	0.84 units on a scale Standard Deviation 1.041 • Interval 44.56 to 73.62	0.58 units on a scale Standard Deviation 0.885 • Interval 67.93 to 85.4	0.73 units on a scale Standard Deviation 0.989 • Interval 48.82 to 69.36	0.45 units on a scale Standard Deviation 0.860 • Interval 49.42 to 77.85
PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Head/Neck) n=81,81,37,36	0.64 units on a scale Standard Deviation 0.899	0.51 units on a scale Standard Deviation 0.882	0.74 units on a scale Standard Deviation 0.946	0.43 units on a scale Standard Deviation 0.728
PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Head/Neck) n=80,78,36,36	0.78 units on a scale Standard Deviation 0.929	0.58 units on a scale Standard Deviation 0.925	0.72 units on a scale Standard Deviation 0.966	0.47 units on a scale Standard Deviation 0.774
PASI Component Scores Over Time Through Week 52 Baseline: Erythema (Upper Limbs) n=90,88,44,44	2.73 units on a scale Standard Deviation 0.624	2.70 units on a scale Standard Deviation 0.694	2.78 units on a scale Standard Deviation 0.686	2.66 units on a scale Standard Deviation 0.805
PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Upper Limbs) n=88,86,44,42	2.90 units on a scale Standard Deviation 0.692	2.06 units on a scale Standard Deviation 0.793	2.28 units on a scale Standard Deviation 0.792	2.68 units on a scale Standard Deviation 0.829
PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Upper Limbs) n=87,88,43,42	2.71 units on a scale Standard Deviation 0.673	1.61 units on a scale Standard Deviation 0.826	1.88 units on a scale Standard Deviation 0.920	2.53 units on a scale Standard Deviation 0.960
PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Upper Limbs) n=85,88,40,39	2.51 units on a scale Standard Deviation 0.823	1.05 units on a scale Standard Deviation 0.937	1.47 units on a scale Standard Deviation 0.982	2.35 units on a scale Standard Deviation 1.075
PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Upper Limbs) n=84,88,40,39	2.36 units on a scale Standard Deviation 0.873	0.60 units on a scale Standard Deviation 0.778	1.17 units on a scale Standard Deviation 1.074	2.13 units on a scale Standard Deviation 1.067
PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Upper Limbs) n=84,84,38,39	2.33 units on a scale Standard Deviation 0.927	0.51 units on a scale Standard Deviation 0.784	0.99 units on a scale Standard Deviation 1.024	1.71 units on a scale Standard Deviation 1.137
PASI Component Scores Over Time Through Week 52 Baseline: Erythema (Trunk) n=90,88,44,44	2.93 units on a scale Standard Deviation 0.625	2.86 units on a scale Standard Deviation 0.696	2.81 units on a scale Standard Deviation 0.658	2.86 units on a scale Standard Deviation 0.510
PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Trunk) n=88,86,44,42	3.05 units on a scale Standard Deviation 0.697	2.28 units on a scale Standard Deviation 0.830	2.44 units on a scale Standard Deviation 0.776	2.84 units on a scale Standard Deviation 0.568
PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Trunk) n=87,88,43,42	2.83 units on a scale Standard Deviation 0.660	1.82 units on a scale Standard Deviation 0.922	2.05 units on a scale Standard Deviation 0.883	2.72 units on a scale Standard Deviation 0.734
PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Trunk) n=83,83,38,37	0.70 units on a scale Standard Deviation 0.968	0.58 units on a scale Standard Deviation 0.952	1.02 units on a scale Standard Deviation 1.137	0.53 units on a scale Standard Deviation 0.893
PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Trunk) n=81,81,37,36	0.67 units on a scale Standard Deviation 0.862	0.48 units on a scale Standard Deviation 0.823	0.96 units on a scale Standard Deviation 1.078	0.43 units on a scale Standard Deviation 0.835
PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Upper Limbs) n=81,81,37,36	0.83 units on a scale Standard Deviation 0.910	0.40 units on a scale Standard Deviation 0.801	0.96 units on a scale Standard Deviation 1.006	0.41 units on a scale Standard Deviation 0.686
PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Trunk) n=84,84,38,39	2.64 units on a scale Standard Deviation 0.811	0.63 units on a scale Standard Deviation 0.929	1.21 units on a scale Standard Deviation 1.173	1.87 units on a scale Standard Deviation 1.234
PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Upper Limbs) n=80,78,36,36	0.92 units on a scale Standard Deviation 1.052	0.48 units on a scale Standard Deviation 0.763	0.95 units on a scale Standard Deviation 0.979	0.61 units on a scale Standard Deviation 0.871
PASI Component Scores Over Time Through Week 52 Baseline: Scaling (Trunk) n=90,88,44,44	2.93 units on a scale Standard Deviation 0.789	2.72 units on a scale Standard Deviation 0.765	2.73 units on a scale Standard Deviation 0.784	2.77 units on a scale Standard Deviation 0.677
PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Head/Neck) n=87,88,43,42	2.24 units on a scale Standard Deviation 0.726 • Interval 0.0 to 6.68	1.37 units on a scale Standard Deviation 0.978 • Interval 62.97 to 81.48	1.44 units on a scale Standard Deviation 1.015 • Interval 37.29 to 58.16	1.91 units on a scale Standard Deviation 1.065 • Interval 1.99 to 20.74
PASI Component Scores Over Time Through Week 52 Week 32: Induration (Head/Neck) n=83,83,38,37	0.62 units on a scale Standard Deviation 0.794	0.49 units on a scale Standard Deviation 0.755	0.57 units on a scale Standard Deviation 0.814	0.32 units on a scale Standard Deviation 0.702
PASI Component Scores Over Time Through Week 52 Week 40: Induration (Head/Neck) n=81,81,37,36	0.53 units on a scale Standard Deviation 0.810	0.44 units on a scale Standard Deviation 0.742	0.60 units on a scale Standard Deviation 0.801	0.35 units on a scale Standard Deviation 0.633
PASI Component Scores Over Time Through Week 52 Week 8: Induration (Trunk) n=85,88,40,39	2.54 units on a scale Standard Deviation 0.969	1.13 units on a scale Standard Deviation 1.142	1.51 units on a scale Standard Deviation 1.061	2.25 units on a scale Standard Deviation 1.080
PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Trunk) n=80,78,36,36	0.92 units on a scale Standard Deviation 0.937	0.59 units on a scale Standard Deviation 0.924	0.99 units on a scale Standard Deviation 1.099	0.64 units on a scale Standard Deviation 1.073
PASI Component Scores Over Time Through Week 52 Baseline: Erythema (Lower Limbs) n=90,88,44,44	3.16 units on a scale Standard Deviation 0.608	3.03 units on a scale Standard Deviation 0.678	2.98 units on a scale Standard Deviation 0.660	3.05 units on a scale Standard Deviation 0.746
PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Lower Limbs) n=88,86,44,42	3.24 units on a scale Standard Deviation 0.576	2.53 units on a scale Standard Deviation 0.870	2.60 units on a scale Standard Deviation 0.830	3.05 units on a scale Standard Deviation 0.776
PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Lower Limbs) n=87,88,43,42	3.07 units on a scale Standard Deviation 0.677	1.97 units on a scale Standard Deviation 0.946	2.23 units on a scale Standard Deviation 0.854	2.93 units on a scale Standard Deviation 0.856
PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Lower Limbs) n=85,88,40,39	2.92 units on a scale Standard Deviation 0.739	1.33 units on a scale Standard Deviation 1.051	1.78 units on a scale Standard Deviation 1.077	2.70 units on a scale Standard Deviation 0.939
PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Lower Limbs) n=84,88,40,39	2.82 units on a scale Standard Deviation 0.756	0.79 units on a scale Standard Deviation 0.865	1.53 units on a scale Standard Deviation 1.082	2.48 units on a scale Standard Deviation 1.012
PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Lower Limbs) n=84,84,38,39	2.77 units on a scale Standard Deviation 0.810	0.67 units on a scale Standard Deviation 0.883	1.44 units on a scale Standard Deviation 1.155	2.13 units on a scale Standard Deviation 1.166
PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Lower Limbs) n=84,84,38,39	1.77 units on a scale Standard Deviation 0.842	0.54 units on a scale Standard Deviation 0.870	1.26 units on a scale Standard Deviation 1.043	1.16 units on a scale Standard Deviation 0.945
PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Lower Limbs) n=83,83,38,37	1.11 units on a scale Standard Deviation 1.100	0.47 units on a scale Standard Deviation 0.860	1.13 units on a scale Standard Deviation 1.197	0.66 units on a scale Standard Deviation 0.909
PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Lower Limbs) n=81,81,37,36	0.81 units on a scale Standard Deviation 0.889	0.52 units on a scale Standard Deviation 0.963	1.14 units on a scale Standard Deviation 1.159	0.70 units on a scale Standard Deviation 0.968
PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Lower Limbs) n=80,78,36,36	0.94 units on a scale Standard Deviation 1.068	0.70 units on a scale Standard Deviation 1.024	1.24 units on a scale Standard Deviation 1.281	0.78 units on a scale Standard Deviation 1.198
PASI Component Scores Over Time Through Week 52 Baseline: Induration (Head/Neck) n=90,88,44,44	2.20 units on a scale Standard Deviation 0.930	2.23 units on a scale Standard Deviation 0.937	1.94 units on a scale Standard Deviation 0.998	2.07 units on a scale Standard Deviation 1.065
PASI Component Scores Over Time Through Week 52 Week 2: Induration (Head/Neck) n=88,86,44,42	2.19 units on a scale Standard Deviation 0.943	1.63 units on a scale Standard Deviation 0.998	1.67 units on a scale Standard Deviation 1.011	2.00 units on a scale Standard Deviation 1.100
PASI Component Scores Over Time Through Week 52 Week 4: Induration (Head/Neck) n=87,88,43,42	2.10 units on a scale Standard Deviation 0.932	1.16 units on a scale Standard Deviation 1.022	1.35 units on a scale Standard Deviation 1.073	1.74 units on a scale Standard Deviation 1.071
PASI Component Scores Over Time Through Week 52 Week 8: Induration (Head/Neck) n=85,88,40,39	1.92 units on a scale Standard Deviation 1.010	0.84 units on a scale Standard Deviation 1.010	1.08 units on a scale Standard Deviation 1.074	1.55 units on a scale Standard Deviation 0.959
PASI Component Scores Over Time Through Week 52 Week 12: Induration (Head/Neck) n=84,88,40,39	1.72 units on a scale Standard Deviation 0.972	0.63 units on a scale Standard Deviation 0.847	0.86 units on a scale Standard Deviation 1.008	1.40 units on a scale Standard Deviation 0.900
PASI Component Scores Over Time Through Week 52 Week 16: Induration (Head/Neck) n=84,84,38,39	1.56 units on a scale Standard Deviation 0.995	0.51 units on a scale Standard Deviation 0.736	0.73 units on a scale Standard Deviation 0.974	1.29 units on a scale Standard Deviation 0.984
PASI Component Scores Over Time Through Week 52 Week 20: Induration (Head/Neck) n=84,84,38,39	0.90 units on a scale Standard Deviation 0.718	0.40 units on a scale Standard Deviation 0.642	0.67 units on a scale Standard Deviation 0.910	0.58 units on a scale Standard Deviation 0.683
PASI Component Scores Over Time Through Week 52 Week 52: Induration (Head/Neck) n=80,78,36,36	0.61 units on a scale Standard Deviation 0.871	0.53 units on a scale Standard Deviation 0.871	0.60 units on a scale Standard Deviation 0.888	0.44 units on a scale Standard Deviation 0.735
PASI Component Scores Over Time Through Week 52 Baseline: Induration (Upper Limbs) n=90,88,44,44	2.77 units on a scale Standard Deviation 0.677	2.71 units on a scale Standard Deviation 0.738	2.59 units on a scale Standard Deviation 0.783	2.57 units on a scale Standard Deviation 0.925
PASI Component Scores Over Time Through Week 52 Week 2: Induration (Upper Limbs) n=88,86,44,42	2.74 units on a scale Standard Deviation 0.798	2.02 units on a scale Standard Deviation 0.884	2.16 units on a scale Standard Deviation 0.919	2.52 units on a scale Standard Deviation 0.876
PASI Component Scores Over Time Through Week 52 Week 4: Induration (Upper Limbs) n=87,88,43,42	2.62 units on a scale Standard Deviation 0.795	1.54 units on a scale Standard Deviation 1.054	1.82 units on a scale Standard Deviation 1.012	2.35 units on a scale Standard Deviation 1.021
PASI Component Scores Over Time Through Week 52 Week 12: Induration (Trunk) n=84,88,40,39	2.33 units on a scale Standard Deviation 0.898	0.73 units on a scale Standard Deviation 1.034	1.35 units on a scale Standard Deviation 1.115	2.00 units on a scale Standard Deviation 1.109
PASI Component Scores Over Time Through Week 52 Week 8: Induration (Upper Limbs) n=85,88,40,39	2.36 units on a scale Standard Deviation 0.903	1.01 units on a scale Standard Deviation 1.029	1.40 units on a scale Standard Deviation 1.078	2.03 units on a scale Standard Deviation 1.050
PASI Component Scores Over Time Through Week 52 Week 16: Induration (Trunk) n=84,84,38,39	2.18 units on a scale Standard Deviation 0.942	0.56 units on a scale Standard Deviation 0.961	1.15 units on a scale Standard Deviation 1.156	1.79 units on a scale Standard Deviation 1.298
PASI Component Scores Over Time Through Week 52 Week 12: Induration (Upper Limbs) n=84,88,40,39	2.23 units on a scale Standard Deviation 0.842	0.55 units on a scale Standard Deviation 0.813	1.13 units on a scale Standard Deviation 1.081	1.78 units on a scale Standard Deviation 1.000
PASI Component Scores Over Time Through Week 52 Week 16: Induration (Upper Limbs) n=84,84,38,39	2.08 units on a scale Standard Deviation 0.870	0.39 units on a scale Standard Deviation 0.761	1.05 units on a scale Standard Deviation 1.108	1.55 units on a scale Standard Deviation 1.083
PASI Component Scores Over Time Through Week 52 Week 20: Induration (Upper Limbs) n=84,84,38,39	1.18 units on a scale Standard Deviation 0.823	0.37 units on a scale Standard Deviation 0.818	0.90 units on a scale Standard Deviation 1.013	0.89 units on a scale Standard Deviation 0.924
PASI Component Scores Over Time Through Week 52 Week 20: Induration (Trunk) n=84,84,38,39	1.13 units on a scale Standard Deviation 0.833	0.50 units on a scale Standard Deviation 0.976	1.01 units on a scale Standard Deviation 1.070	0.97 units on a scale Standard Deviation 0.972
PASI Component Scores Over Time Through Week 52 Week 32: Induration (Trunk) n=83,83,38,37	0.70 units on a scale Standard Deviation 0.939	0.49 units on a scale Standard Deviation 0.846	0.96 units on a scale Standard Deviation 1.087	0.50 units on a scale Standard Deviation 0.980
PASI Component Scores Over Time Through Week 52 Week 32: Induration (Upper Limbs) n=83,83,38,37	0.78 units on a scale Standard Deviation 0.917	0.42 units on a scale Standard Deviation 0.798	0.96 units on a scale Standard Deviation 1.064	0.58 units on a scale Standard Deviation 0.919
PASI Component Scores Over Time Through Week 52 Week 40: Induration (Trunk) n=81,81,37,36	0.81 units on a scale Standard Deviation 1.091	0.49 units on a scale Standard Deviation 0.910	0.89 units on a scale Standard Deviation 1.037	0.38 units on a scale Standard Deviation 0.861
PASI Component Scores Over Time Through Week 52 Week 52: Induration (Trunk) n=80,78,36,36	0.97 units on a scale Standard Deviation 1.028	0.55 units on a scale Standard Deviation 0.899	0.83 units on a scale Standard Deviation 1.012	0.50 units on a scale Standard Deviation 0.941
PASI Component Scores Over Time Through Week 52 Baseline: Induration (Lower Limbs) n=90,88,44,44	3.16 units on a scale Standard Deviation 0.680	3.03 units on a scale Standard Deviation 0.678	2.88 units on a scale Standard Deviation 0.708	3.02 units on a scale Standard Deviation 0.821
PASI Component Scores Over Time Through Week 52 Week 40: Induration (Upper Limbs) n=81,81,37,36	0.75 units on a scale Standard Deviation 0.841	0.47 units on a scale Standard Deviation 0.867	0.94 units on a scale Standard Deviation 1.041	0.49 units on a scale Standard Deviation 0.768
PASI Component Scores Over Time Through Week 52 Week 2: Induration (Lower Limbs) n=88,86,44,42	3.00 units on a scale Standard Deviation 0.826	2.39 units on a scale Standard Deviation 0.915	2.43 units on a scale Standard Deviation 0.888	2.93 units on a scale Standard Deviation 0.846
PASI Component Scores Over Time Through Week 52 Week 52: Induration (Upper Limbs) n=80,78,36,36	0.81 units on a scale Standard Deviation 0.951	0.53 units on a scale Standard Deviation 0.886	0.90 units on a scale Standard Deviation 0.988	0.58 units on a scale Standard Deviation 0.874
PASI Component Scores Over Time Through Week 52 Baseline: Induration (Trunk) n=90,88,44,44	2.93 units on a scale Standard Deviation 0.695	2.90 units on a scale Standard Deviation 0.619	2.74 units on a scale Standard Deviation 0.703	2.91 units on a scale Standard Deviation 0.772
PASI Component Scores Over Time Through Week 52 Week 2: Induration (Trunk) n=88,86,44,42	2.90 units on a scale Standard Deviation 0.759	2.25 units on a scale Standard Deviation 0.913	2.33 units on a scale Standard Deviation 0.804	2.89 units on a scale Standard Deviation 0.689
PASI Component Scores Over Time Through Week 52 Week 4: Induration (Trunk) n=87,88,43,42	2.71 units on a scale Standard Deviation 0.742	1.71 units on a scale Standard Deviation 1.109	1.95 units on a scale Standard Deviation 0.970	2.67 units on a scale Standard Deviation 0.919
PASI Component Scores Over Time Through Week 52 Week 4: Induration (Lower Limbs) n=87,88,43,42	2.93 units on a scale Standard Deviation 0.808	1.83 units on a scale Standard Deviation 1.102	2.09 units on a scale Standard Deviation 0.978	2.81 units on a scale Standard Deviation 0.932
PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Head/Neck) n=84,88,40,39	1.82 units on a scale Standard Deviation 0.914	0.64 units on a scale Standard Deviation 0.887	0.85 units on a scale Standard Deviation 1.012	1.38 units on a scale Standard Deviation 1.030
PASI Component Scores Over Time Through Week 52 Week 8: Induration (Lower Limbs) n=85,88,40,39	2.67 units on a scale Standard Deviation 0.927	1.22 units on a scale Standard Deviation 1.138	1.61 units on a scale Standard Deviation 1.044	2.43 units on a scale Standard Deviation 1.035
PASI Component Scores Over Time Through Week 52 Week 12: Induration (Lower Limbs) n=84,88,40,39	2.49 units on a scale Standard Deviation 0.970	0.69 units on a scale Standard Deviation 0.878	1.36 units on a scale Standard Deviation 1.063	2.15 units on a scale Standard Deviation 0.975
PASI Component Scores Over Time Through Week 52 Week 20: Induration (Lower Limbs) n=84,84,38,39	1.41 units on a scale Standard Deviation 0.785	0.44 units on a scale Standard Deviation 0.827	1.07 units on a scale Standard Deviation 1.027	1.05 units on a scale Standard Deviation 1.012
PASI Component Scores Over Time Through Week 52 Week 32: Induration (Lower Limbs) n=83,83,38,37	0.97 units on a scale Standard Deviation 1.013	0.40 units on a scale Standard Deviation 0.826	1.01 units on a scale Standard Deviation 1.088	0.58 units on a scale Standard Deviation 0.976
PASI Component Scores Over Time Through Week 52 Week 40: Induration (Lower Limbs) n=81,81,37,36	0.78 units on a scale Standard Deviation 0.898	0.46 units on a scale Standard Deviation 0.791	0.95 units on a scale Standard Deviation 1.011	0.68 units on a scale Standard Deviation 1.029
PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Head/Neck) n=88,86,44,42	2.40 units on a scale Standard Deviation 0.939	1.67 units on a scale Standard Deviation 1.003	1.71 units on a scale Standard Deviation 1.004	2.11 units on a scale Standard Deviation 1.185
PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Head/Neck) n=87,88,43,42	2.24 units on a scale Standard Deviation 0.906	1.24 units on a scale Standard Deviation 1.131	1.41 units on a scale Standard Deviation 1.068	1.84 units on a scale Standard Deviation 1.214
PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Head/Neck) n=84,84,38,39	0.85 units on a scale Standard Deviation 0.812	0.43 units on a scale Standard Deviation 0.664	0.67 units on a scale Standard Deviation 0.841	0.58 units on a scale Standard Deviation 0.758
PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Head/Neck) n=83,83,38,37	0.70 units on a scale Standard Deviation 0.878	0.48 units on a scale Standard Deviation 0.739	0.61 units on a scale Standard Deviation 0.809	0.29 units on a scale Standard Deviation 0.654
PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Head/Neck) n=85,88,40,39	2.03 units on a scale Standard Deviation 1.013	0.80 units on a scale Standard Deviation 0.986	1.02 units on a scale Standard Deviation 1.039	1.48 units on a scale Standard Deviation 1.109
PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Head/Neck) n=81,81,37,36	0.67 units on a scale Standard Deviation 0.956	0.51 units on a scale Standard Deviation 0.839	0.67 units on a scale Standard Deviation 0.894	0.35 units on a scale Standard Deviation 0.716
PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Head/Neck) n=80,78,36,36	0.72 units on a scale Standard Deviation 0.914	0.58 units on a scale Standard Deviation 0.897	0.63 units on a scale Standard Deviation 0.884	0.36 units on a scale Standard Deviation 0.723
PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Head/Neck) n=85,88,40,39	2.05 units on a scale Standard Deviation 1.075 • Interval 0.0 to 10.7	0.93 units on a scale Standard Deviation 0.997 • Interval 73.02 to 89.2	1.14 units on a scale Standard Deviation 1.052 • Interval 44.14 to 64.95	1.93 units on a scale Standard Deviation 1.141 • Interval 8.54 to 32.37
PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Upper Limbs) n=84,84,38,39	1.38 units on a scale Standard Deviation 0.877	0.40 units on a scale Standard Deviation 0.793	0.93 units on a scale Standard Deviation 0.967	0.97 units on a scale Standard Deviation 0.788
PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Upper Limbs) n=83,83,38,37	0.86 units on a scale Standard Deviation 1.004	0.40 units on a scale Standard Deviation 0.697	0.96 units on a scale Standard Deviation 1.087	0.55 units on a scale Standard Deviation 0.760
PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Upper Limbs) n=81,81,37,36	0.78 units on a scale Standard Deviation 0.866	0.44 units on a scale Standard Deviation 0.791	0.93 units on a scale Standard Deviation 1.034	0.59 units on a scale Standard Deviation 0.927
PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Upper Limbs) n=80,78,36,36	0.89 units on a scale Standard Deviation 1.063	0.56 units on a scale Standard Deviation 0.939	0.95 units on a scale Standard Deviation 1.031	0.69 units on a scale Standard Deviation 0.980
PASI Component Scores Over Time Through Week 52 Week 52: Induration (Lower Limbs) n=80,78,36,36	1.03 units on a scale Standard Deviation 1.134	0.61 units on a scale Standard Deviation 0.907	1.03 units on a scale Standard Deviation 1.069	0.67 units on a scale Standard Deviation 1.069
PASI Component Scores Over Time Through Week 52 Baseline: Scaling (Upper Limbs) n=90,88,44,44	2.82 units on a scale Standard Deviation 0.724	2.72 units on a scale Standard Deviation 0.779	2.60 units on a scale Standard Deviation 0.796	2.55 units on a scale Standard Deviation 0.848
PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Upper Limbs) n=88,86,44,42	2.62 units on a scale Standard Deviation 0.764	2.00 units on a scale Standard Deviation 0.922	2.19 units on a scale Standard Deviation 0.952	2.43 units on a scale Standard Deviation 0.900
PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Upper Limbs) n=87,88,43,42	2.52 units on a scale Standard Deviation 0.804	1.41 units on a scale Standard Deviation 1.106	1.77 units on a scale Standard Deviation 1.047	2.28 units on a scale Standard Deviation 1.031
PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Upper Limbs) n=85,88,40,39	2.28 units on a scale Standard Deviation 0.887	0.89 units on a scale Standard Deviation 0.939	1.35 units on a scale Standard Deviation 1.018	1.93 units on a scale Standard Deviation 1.118
PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Upper Limbs) n=84,88,40,39	2.23 units on a scale Standard Deviation 0.810	0.56 units on a scale Standard Deviation 0.841	1.14 units on a scale Standard Deviation 1.106	1.60 units on a scale Standard Deviation 1.033
PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Upper Limbs) n=84,84,38,39	1.97 units on a scale Standard Deviation 0.903	0.40 units on a scale Standard Deviation 0.793	0.99 units on a scale Standard Deviation 1.070	1.50 units on a scale Standard Deviation 1.033
PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Upper Limbs) n=84,84,38,39	1.21 units on a scale Standard Deviation 0.833	0.39 units on a scale Standard Deviation 0.807	0.86 units on a scale Standard Deviation 0.907	0.82 units on a scale Standard Deviation 0.834
PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Upper Limbs) n=83,83,38,37	0.81 units on a scale Standard Deviation 0.967	0.36 units on a scale Standard Deviation 0.708	0.93 units on a scale Standard Deviation 1.010	0.42 units on a scale Standard Deviation 0.642
PASI Component Scores Over Time Through Week 52 Baseline: Erythema (Head/Neck) n=90,88,44,44	2.39 units on a scale Standard Deviation 0.868	2.31 units on a scale Standard Deviation 0.830 • Interval 15.57 to 33.32	2.18 units on a scale Standard Deviation 0.977 • Interval 0.19 to 8.9	2.18 units on a scale Standard Deviation 1.018
PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Trunk) n=85,88,40,39	2.64 units on a scale Standard Deviation 0.778	1.20 units on a scale Standard Deviation 1.056	1.65 units on a scale Standard Deviation 1.006	2.50 units on a scale Standard Deviation 0.987
PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Trunk) n=84,88,40,39	2.54 units on a scale Standard Deviation 0.790	0.81 units on a scale Standard Deviation 1.024	1.44 units on a scale Standard Deviation 1.133	2.20 units on a scale Standard Deviation 1.137
PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Trunk) n=84,84,38,39	1.31 units on a scale Standard Deviation 0.800	0.62 units on a scale Standard Deviation 1.005	1.12 units on a scale Standard Deviation 1.080	1.08 units on a scale Standard Deviation 0.997
PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Trunk) n=88,86,44,42	2.76 units on a scale Standard Deviation 0.759	2.03 units on a scale Standard Deviation 0.928	2.27 units on a scale Standard Deviation 0.938	2.66 units on a scale Standard Deviation 0.745
PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Trunk) n=87,88,43,42	2.57 units on a scale Standard Deviation 0.770	1.52 units on a scale Standard Deviation 1.109	1.92 units on a scale Standard Deviation 0.997	2.49 units on a scale Standard Deviation 0.883
PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Trunk) n=85,88,40,39	2.38 units on a scale Standard Deviation 0.815	0.95 units on a scale Standard Deviation 1.057	1.48 units on a scale Standard Deviation 1.039	2.10 units on a scale Standard Deviation 1.008
PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Trunk) n=84,88,40,39	2.28 units on a scale Standard Deviation 0.857	0.69 units on a scale Standard Deviation 1.006	1.27 units on a scale Standard Deviation 1.132	1.73 units on a scale Standard Deviation 1.037
PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Trunk) n=84,84,38,39	2.10 units on a scale Standard Deviation 0.882	0.52 units on a scale Standard Deviation 0.938	1.02 units on a scale Standard Deviation 1.097	1.58 units on a scale Standard Deviation 1.106
PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Trunk) n=84,84,38,37	1.13 units on a scale Standard Deviation 0.894	0.49 units on a scale Standard Deviation 0.871	0.96 units on a scale Standard Deviation 0.987	0.82 units on a scale Standard Deviation 0.955
PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Trunk) n=83,83,38,37	0.68 units on a scale Standard Deviation 0.852	0.46 units on a scale Standard Deviation 0.754	0.92 units on a scale Standard Deviation 0.953	0.39 units on a scale Standard Deviation 0.823
PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Trunk) n=81,81,37,36	0.78 units on a scale Standard Deviation 0.989	0.49 units on a scale Standard Deviation 0.882	0.91 units on a scale Standard Deviation 0.938	0.38 units on a scale Standard Deviation 0.861
PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Trunk) n=80,78,36,36	0.89 units on a scale Standard Deviation 0.887	0.55 units on a scale Standard Deviation 0.855	0.82 units on a scale Standard Deviation 0.818	0.53 units on a scale Standard Deviation 0.971
PASI Component Scores Over Time Through Week 52 Baseline: Scaling (Lower Limbs) n=90,88,44,44	3.20 units on a scale Standard Deviation 0.765	2.94 units on a scale Standard Deviation 0.709	2.92 units on a scale Standard Deviation 0.776	2.84 units on a scale Standard Deviation 0.834
PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Lower Limbs) n=88,86,44,42	2.98 units on a scale Standard Deviation 0.841	2.24 units on a scale Standard Deviation 1.017	2.40 units on a scale Standard Deviation 0.911	2.66 units on a scale Standard Deviation 0.888
PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Lower Limbs) n=87,88,43,42	2.76 units on a scale Standard Deviation 0.906	1.72 units on a scale Standard Deviation 1.117	2.08 units on a scale Standard Deviation 0.997	2.49 units on a scale Standard Deviation 0.960
PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Lower Limbs) n=85,88,40,39	2.54 units on a scale Standard Deviation 0.884	1.15 units on a scale Standard Deviation 1.129	1.52 units on a scale Standard Deviation 1.093	2.20 units on a scale Standard Deviation 1.018
PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Lower Limbs) n=84,88,40,39	2.51 units on a scale Standard Deviation 0.885	0.67 units on a scale Standard Deviation 0.896	1.32 units on a scale Standard Deviation 1.120	2.03 units on a scale Standard Deviation 0.920
PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Lower Limbs) n=84,84,38,39	2.38 units on a scale Standard Deviation 0.815	0.46 units on a scale Standard Deviation 0.783	1.20 units on a scale Standard Deviation 1.106	1.82 units on a scale Standard Deviation 1.062
PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Lower Limbs) n=84,84,38,39	1.41 units on a scale Standard Deviation 0.751	0.45 units on a scale Standard Deviation 0.870	1.14 units on a scale Standard Deviation 1.020	0.95 units on a scale Standard Deviation 0.868
PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Lower Limbs) n=83,83,38,37	1.03 units on a scale Standard Deviation 1.013	0.37 units on a scale Standard Deviation 0.760	1.08 units on a scale Standard Deviation 1.118	0.47 units on a scale Standard Deviation 0.797
PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Lower Limbs) n=81,81,37,36	0.83 units on a scale Standard Deviation 1.056	0.53 units on a scale Standard Deviation 0.976	1.06 units on a scale Standard Deviation 1.041	0.51 units on a scale Standard Deviation 0.731
PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Lower Limbs) n=80,78,36,36	1.06 units on a scale Standard Deviation 1.120	0.61 units on a scale Standard Deviation 0.921	1.08 units on a scale Standard Deviation 1.042	0.67 units on a scale Standard Deviation 1.069

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Induration (Trunk) n=81,81,37,36	-2.08 units on a scale Standard Deviation 1.360	-2.41 units on a scale Standard Deviation 1.058	-1.84 units on a scale Standard Deviation 1.145	-2.57 units on a scale Standard Deviation 1.068
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Induration (Trunk) n=80,78,36,36	-1.92 units on a scale Standard Deviation 1.339	-2.36 units on a scale Standard Deviation 1.070	-1.90 units on a scale Standard Deviation 1.180	-2.47 units on a scale Standard Deviation 1.207
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Induration (Lower Limbs) n=88,86,44,42	-0.14 units on a scale Standard Deviation 0.417	-0.65 units on a scale Standard Deviation 0.803	-0.43 units on a scale Standard Deviation 0.660	-0.09 units on a scale Standard Deviation 0.421
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Induration (Lower Limbs) n=87,88,43,42	-0.21 units on a scale Standard Deviation 0.415	-1.22 units on a scale Standard Deviation 0.993	-0.78 units on a scale Standard Deviation 0.809	-0.21 units on a scale Standard Deviation 0.773
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Induration (Lower Limbs) n=85,88,40,39	-0.49 units on a scale Standard Deviation 0.683	-1.82 units on a scale Standard Deviation 1.002	-1.26 units on a scale Standard Deviation 0.977	-0.60 units on a scale Standard Deviation 0.955
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Induration (Lower Limbs) n=84,88,40,39	-0.67 units on a scale Standard Deviation 0.772	-2.36 units on a scale Standard Deviation 0.845	-1.51 units on a scale Standard Deviation 1.093	-0.85 units on a scale Standard Deviation 0.975
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Induration (Lower Limbs) n=84,84,38,39	-0.69 units on a scale Standard Deviation 0.766	-2.51 units on a scale Standard Deviation 0.814	-1.63 units on a scale Standard Deviation 1.159	-1.08 units on a scale Standard Deviation 1.148
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Induration (Lower Limbs) n=84,84,38,39	-1.74 units on a scale Standard Deviation 0.818	-2.61 units on a scale Standard Deviation 0.865	-1.80 units on a scale Standard Deviation 1.039	-1.97 units on a scale Standard Deviation 1.026
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Induration (Lower Limbs) n=83,83,38,37	-2.14 units on a scale Standard Deviation 1.058	-2.64 units on a scale Standard Deviation 0.957	-1.86 units on a scale Standard Deviation 1.106	-2.45 units on a scale Standard Deviation 1.083
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Induration (Lower Limbs) n=81,81,37,36	-2.31 units on a scale Standard Deviation 1.064	-2.57 units on a scale Standard Deviation 0.974	-1.93 units on a scale Standard Deviation 1.022	-2.35 units on a scale Standard Deviation 1.033
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Induration (Lower Limbs) n=80,78,36,36	-2.06 units on a scale Standard Deviation 1.194	-2.43 units on a scale Standard Deviation 1.041	-1.85 units on a scale Standard Deviation 1.140	-2.39 units on a scale Standard Deviation 1.178
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Head/Neck) n=88,86,44,42	0.05 units on a scale Standard Deviation 0.379	-0.72 units on a scale Standard Deviation 0.802	-0.28 units on a scale Standard Deviation 0.587	-0.14 units on a scale Standard Deviation 0.594
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Head/Neck) n=87,88,43,42	-0.12 units on a scale Standard Deviation 0.633	-1.16 units on a scale Standard Deviation 1.077	-0.60 units on a scale Standard Deviation 0.766	-0.40 units on a scale Standard Deviation 0.955
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Head/Neck) n=85,88,40,39	-0.38 units on a scale Standard Deviation 0.963	-1.60 units on a scale Standard Deviation 1.157	-0.99 units on a scale Standard Deviation 1.000	-0.75 units on a scale Standard Deviation 1.296
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Head/Neck) n=84,88,40,39	-0.59 units on a scale Standard Deviation 0.993	-1.76 units on a scale Standard Deviation 1.137	-1.16 units on a scale Standard Deviation 1.103	-0.83 units on a scale Standard Deviation 1.338
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Head/Neck) n=84,84,38,39	-0.69 units on a scale Standard Deviation 0.977	-1.83 units on a scale Standard Deviation 1.160	-1.31 units on a scale Standard Deviation 1.151	-0.97 units on a scale Standard Deviation 1.404
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Head/Neck) n=84,84,38,39	-1.56 units on a scale Standard Deviation 1.021	-1.98 units on a scale Standard Deviation 1.075	-1.40 units on a scale Standard Deviation 1.110	-1.61 units on a scale Standard Deviation 1.366
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Head/Neck) n=83,83,38,37	-1.70 units on a scale Standard Deviation 1.266	-1.92 units on a scale Standard Deviation 1.073	-1.47 units on a scale Standard Deviation 1.162	-1.89 units on a scale Standard Deviation 1.290
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Trunk) n=87,88,43,42	-0.12 units on a scale Standard Deviation 0.550	-1.05 units on a scale Standard Deviation 0.888	-0.76 units on a scale Standard Deviation 0.844	-0.14 units on a scale Standard Deviation 0.774
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Induration (Head/Neck) n=85,88,40,39	-0.33 units on a scale Standard Deviation 0.927	-1.38 units on a scale Standard Deviation 1.080	-0.86 units on a scale Standard Deviation 0.937	-0.50 units on a scale Standard Deviation 1.086
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Head/Neck) n=81,81,37,36	-1.78 units on a scale Standard Deviation 1.267	-1.88 units on a scale Standard Deviation 1.198	-1.41 units on a scale Standard Deviation 1.138	-1.78 units on a scale Standard Deviation 1.250
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Head/Neck) n=80,78,36,36	-1.72 units on a scale Standard Deviation 1.233	-1.81 units on a scale Standard Deviation 1.192	-1.45 units on a scale Standard Deviation 1.202	-1.78 units on a scale Standard Deviation 1.456
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Induration (Head/Neck) n=88,86,44,42	-0.02 units on a scale Standard Deviation 0.468	-0.59 units on a scale Standard Deviation 0.705	-0.27 units on a scale Standard Deviation 0.602	-0.07 units on a scale Standard Deviation 0.398
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Head/Neck) n=88,86,44,42)	0.10 units on a scale Standard Deviation 0.532 • Interval 0.0 to 6.68	-0.56 units on a scale Standard Deviation 0.676 • Interval 40.78 to 61.44	-0.41 units on a scale Standard Deviation 0.757 • Interval 22.09 to 41.55	-0.14 units on a scale Standard Deviation 0.594 • Interval 0.0 to 6.68
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Head/Neck) n=87,88,43,42)	-0.17 units on a scale Standard Deviation 0.621 • Interval 0.0 to 6.68	-0.94 units on a scale Standard Deviation 0.854 • Interval 62.97 to 81.48	-0.74 units on a scale Standard Deviation 0.890 • Interval 37.29 to 58.16	-0.26 units on a scale Standard Deviation 0.727 • Interval 1.99 to 20.74
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Upper Limbs) n=88,86,44,42	-0.19 units on a scale Standard Deviation 0.634	-0.72 units on a scale Standard Deviation 0.843	-0.41 units on a scale Standard Deviation 0.602	-0.11 units on a scale Standard Deviation 0.579
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Head/Neck) n=85,88,40,39	-0.38 units on a scale Standard Deviation 0.935 • Interval 0.0 to 10.7	-1.36 units on a scale Standard Deviation 0.962 • Interval 73.02 to 89.2	-1.05 units on a scale Standard Deviation 1.038 • Interval 44.14 to 64.95	-0.20 units on a scale Standard Deviation 1.114 • Interval 8.54 to 32.37
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Head/Neck) n=84,88,40,39	-0.46 units on a scale Standard Deviation 0.942 • Interval 14.11 to 40.43	-1.61 units on a scale Standard Deviation 0.957 • Interval 75.63 to 91.03	-1.24 units on a scale Standard Deviation 1.135 • Interval 44.14 to 64.95	-0.38 units on a scale Standard Deviation 1.295 • Interval 37.51 to 67.03
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Head/Neck) n=84,84,38,39	-0.62 units on a scale Standard Deviation 0.907 • Interval 51.9 to 79.92	-1.70 units on a scale Standard Deviation 1.015 • Interval 73.02 to 89.2	-1.43 units on a scale Standard Deviation 1.175 • Interval 48.82 to 69.36	-0.66 units on a scale Standard Deviation 1.361 • Interval 62.21 to 87.79
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Head/Neck) n=84,84,38,39	-1.36 units on a scale Standard Deviation 1.158 • Interval 51.9 to 79.92	-1.79 units on a scale Standard Deviation 0.945 • Interval 71.74 to 88.26	-1.43 units on a scale Standard Deviation 1.185 • Interval 46.47 to 67.17	-1.37 units on a scale Standard Deviation 1.172 • Interval 54.42 to 81.94
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Head/Neck) n=83,83,38,37	-1.59 units on a scale Standard Deviation 1.257 • Interval 44.56 to 73.62	-1.71 units on a scale Standard Deviation 1.030 • Interval 67.93 to 85.4	-1.51 units on a scale Standard Deviation 1.203 • Interval 48.82 to 69.36	-1.68 units on a scale Standard Deviation 1.254 • Interval 49.42 to 77.85
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Head/Neck) n=81,81,37,36	-1.81 units on a scale Standard Deviation 1.191	-1.78 units on a scale Standard Deviation 1.084	-1.51 units on a scale Standard Deviation 1.195	-1.68 units on a scale Standard Deviation 1.132
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Head/Neck) n=80,78,36,36	-1.67 units on a scale Standard Deviation 1.265	-1.73 units on a scale Standard Deviation 1.079	-1.53 units on a scale Standard Deviation 1.181	-1.61 units on a scale Standard Deviation 1.225
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Upper Limbs) n=88,86,44,42	0.14 units on a scale Standard Deviation 0.417	-0.64 units on a scale Standard Deviation 0.698	-0.51 units on a scale Standard Deviation 0.609	0.02 units on a scale Standard Deviation 0.403
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Upper Limbs) n=87,88,43,42	-0.05 units on a scale Standard Deviation 0.582	-1.09 units on a scale Standard Deviation 0.858	-0.91 units on a scale Standard Deviation 0.839	-0.12 units on a scale Standard Deviation 0.697
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Upper Limbs) n=85,88,40,39	-0.26 units on a scale Standard Deviation 0.677	-1.65 units on a scale Standard Deviation 0.984	-1.32 units on a scale Standard Deviation 0.977	-0.28 units on a scale Standard Deviation 0.784
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Upper Limbs) n=84,88,40,39	-0.41 units on a scale Standard Deviation 0.818	-2.08 units on a scale Standard Deviation 0.908	-1.61 units on a scale Standard Deviation 1.159	-0.50 units on a scale Standard Deviation 0.877
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Upper Limbs) n=84,84,38,39	-0.44 units on a scale Standard Deviation 0.852	-2.17 units on a scale Standard Deviation 1.004	-1.81 units on a scale Standard Deviation 1.092	-0.92 units on a scale Standard Deviation 0.941
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Upper Limbs) n=84,84,38,39	-1.38 units on a scale Standard Deviation 1.042	-2.27 units on a scale Standard Deviation 1.057	-1.87 units on a scale Standard Deviation 1.117	-1.66 units on a scale Standard Deviation 0.966
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Upper Limbs) n=83,83,38,37	-1.89 units on a scale Standard Deviation 0.994	-2.29 units on a scale Standard Deviation 0.957	-1.83 units on a scale Standard Deviation 1.257	-2.08 units on a scale Standard Deviation 1.148
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Upper Limbs) n=81,81,37,36	-1.94 units on a scale Standard Deviation 1.094	-2.26 units on a scale Standard Deviation 1.081	-1.89 units on a scale Standard Deviation 1.151	-2.05 units on a scale Standard Deviation 1.153
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Upper Limbs) n=80,78,36,36	-1.83 units on a scale Standard Deviation 1.183	-2.14 units on a scale Standard Deviation 1.111	-1.85 units on a scale Standard Deviation 1.185	-1.94 units on a scale Standard Deviation 1.286
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Trunk) n=88,86,44,42	0.10 units on a scale Standard Deviation 0.370	-0.57 units on a scale Standard Deviation 0.724	-0.41 units on a scale Standard Deviation 0.639	-0.02 units on a scale Standard Deviation 0.457
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Trunk) n=85,88,40,39	-0.28 units on a scale Standard Deviation 0.560	-1.66 units on a scale Standard Deviation 1.041	-1.16 units on a scale Standard Deviation 0.969	-0.35 units on a scale Standard Deviation 0.949
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Trunk) n=84,88,40,39	-0.38 units on a scale Standard Deviation 0.711	-2.04 units on a scale Standard Deviation 1.092	-1.36 units on a scale Standard Deviation 1.176	-0.65 units on a scale Standard Deviation 1.167
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Trunk) n=84,84,38,39	-0.28 units on a scale Standard Deviation 0.793	-2.21 units on a scale Standard Deviation 1.054	-1.61 units on a scale Standard Deviation 1.203	-0.97 units on a scale Standard Deviation 1.262
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Trunk) n=84,84,38,39	-1.62 units on a scale Standard Deviation 1.091	-2.23 units on a scale Standard Deviation 1.134	-1.70 units on a scale Standard Deviation 1.200	-1.76 units on a scale Standard Deviation 1.025
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Trunk) n=83,83,38,37	-2.22 units on a scale Standard Deviation 1.004	-2.25 units on a scale Standard Deviation 1.034	-1.80 units on a scale Standard Deviation 1.276	-2.32 units on a scale Standard Deviation 1.016
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Trunk) n=81,81,37,36	-2.22 units on a scale Standard Deviation 1.072	-2.36 units on a scale Standard Deviation 1.028	-1.86 units on a scale Standard Deviation 1.212	-2.43 units on a scale Standard Deviation 0.929
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Trunk) n=80,78,36,36	-1.97 units on a scale Standard Deviation 1.158	-2.24 units on a scale Standard Deviation 1.082	-1.82 units on a scale Standard Deviation 1.256	-2.22 units on a scale Standard Deviation 1.174
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Erythema (Lower Limbs) n=88,86,44,42	0.05 units on a scale Standard Deviation 0.379	-0.50 units on a scale Standard Deviation 0.587	-0.38 units on a scale Standard Deviation 0.722	0.00 units on a scale Standard Deviation 0.374
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Erythema (Lower Limbs) n=87,88,43,42	-0.12 units on a scale Standard Deviation 0.593	-1.07 units on a scale Standard Deviation 0.860	-0.75 units on a scale Standard Deviation 0.820	-0.12 units on a scale Standard Deviation 0.625
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Erythema (Lower Limbs) n=85,88,40,39	-0.26 units on a scale Standard Deviation 0.637	-1.71 units on a scale Standard Deviation 1.010	-1.19 units on a scale Standard Deviation 1.123	-0.33 units on a scale Standard Deviation 0.764
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Erythema (Lower Limbs) n=84,88,40,39	-0.36 units on a scale Standard Deviation 0.778	-2.24 units on a scale Standard Deviation 0.965	-1.44 units on a scale Standard Deviation 1.183	-0.58 units on a scale Standard Deviation 0.958
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Erythema (Lower Limbs) n=84,84,38,39	-0.41 units on a scale Standard Deviation 0.818	-2.36 units on a scale Standard Deviation 1.014	-1.55 units on a scale Standard Deviation 1.255	-0.89 units on a scale Standard Deviation 1.085
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Erythema (Lower Limbs) n=84,84,38,39	-1.41 units on a scale Standard Deviation 0.993	-2.49 units on a scale Standard Deviation 1.000	-1.73 units on a scale Standard Deviation 1.274	-1.87 units on a scale Standard Deviation 0.991
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Erythema (Lower Limbs) n=83,83,38,37	-2.05 units on a scale Standard Deviation 1.129	-2.54 units on a scale Standard Deviation 1.028	-1.86 units on a scale Standard Deviation 1.372	-2.37 units on a scale Standard Deviation 1.025
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Erythema (Lower Limbs) n=81,81,37,36	-2.33 units on a scale Standard Deviation 1.121	-2.52 units on a scale Standard Deviation 1.062	-1.86 units on a scale Standard Deviation 1.243	-2.32 units on a scale Standard Deviation 1.082
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Erythema (Lower Limbs) n=80,78,36,36	-2.19 units on a scale Standard Deviation 1.215	-2.33 units on a scale Standard Deviation 1.077	-1.74 units on a scale Standard Deviation 1.400	-2.25 units on a scale Standard Deviation 1.251
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Induration (Head/Neck) n=87,88,43,42	-0.12 units on a scale Standard Deviation 0.670	-1.07 units on a scale Standard Deviation 0.974	-0.59 units on a scale Standard Deviation 0.892	-0.30 units on a scale Standard Deviation 0.708
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Induration (Head/Neck) n=84,88,40,39	-0.54 units on a scale Standard Deviation 0.913	-1.58 units on a scale Standard Deviation 1.032	-1.08 units on a scale Standard Deviation 1.031	-0.65 units on a scale Standard Deviation 1.075
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Induration (Head/Neck) n=84,84,38,39	-0.69 units on a scale Standard Deviation 0.863	-1.70 units on a scale Standard Deviation 1.106	-1.24 units on a scale Standard Deviation 1.060	-0.76 units on a scale Standard Deviation 1.240
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Induration (Head/Neck) n=84,84,38,39	-1.36 units on a scale Standard Deviation 0.903	-1.81 units on a scale Standard Deviation 1.058	-1.30 units on a scale Standard Deviation 1.084	-1.47 units on a scale Standard Deviation 1.133
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Induration (Head/Neck) n=83,83,38,37	-1.65 units on a scale Standard Deviation 1.160	-1.71 units on a scale Standard Deviation 1.121	-1.41 units on a scale Standard Deviation 1.094	-1.74 units on a scale Standard Deviation 1.155
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Induration (Head/Neck) n=81,81,37,36	-1.78 units on a scale Standard Deviation 1.198	-1.75 units on a scale Standard Deviation 1.124	-1.37 units on a scale Standard Deviation 1.066	-1.68 units on a scale Standard Deviation 1.056
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Induration (Upper Limbs) n=81,81,37,36	-1.97 units on a scale Standard Deviation 1.108	-2.25 units on a scale Standard Deviation 1.067	-1.65 units on a scale Standard Deviation 1.266	-2.11 units on a scale Standard Deviation 1.100
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Induration (Upper Limbs) n=80,78,36,36	-1.92 units on a scale Standard Deviation 1.204	-2.20 units on a scale Standard Deviation 1.107	-1.69 units on a scale Standard Deviation 1.282	-2.03 units on a scale Standard Deviation 1.183
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Induration (Head/Neck) n=80,78,36,36	-1.69 units on a scale Standard Deviation 1.215	-1.68 units on a scale Standard Deviation 1.178	-1.36 units on a scale Standard Deviation 1.139	-1.58 units on a scale Standard Deviation 1.228
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Induration (Upper Limbs) n=88,86,44,42	-0.07 units on a scale Standard Deviation 0.407	-0.68 units on a scale Standard Deviation 0.766	-0.42 units on a scale Standard Deviation 0.727	-0.05 units on a scale Standard Deviation 0.526
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Induration (Upper Limbs) n=87,88,43,42	-0.19 units on a scale Standard Deviation 0.707	-1.17 units on a scale Standard Deviation 1.048	-0.77 units on a scale Standard Deviation 0.867	-0.21 units on a scale Standard Deviation 0.833
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Induration (Upper Limbs) n=85,88,40,39	-0.41 units on a scale Standard Deviation 0.751	-1.69 units on a scale Standard Deviation 1.024	-1.19 units on a scale Standard Deviation 1.092	-0.55 units on a scale Standard Deviation 1.011
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Induration (Upper Limbs) n=84,88,40,39	-0.54 units on a scale Standard Deviation 0.822	-2.17 units on a scale Standard Deviation 0.862	-1.47 units on a scale Standard Deviation 1.231	-0.80 units on a scale Standard Deviation 1.091
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Induration (Upper Limbs) n=84,84,38,39	-0.69 units on a scale Standard Deviation 0.977	-2.32 units on a scale Standard Deviation 0.867	-1.52 units on a scale Standard Deviation 1.217	-1.05 units on a scale Standard Deviation 1.293
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Induration (Upper Limbs) n=84,84,38,39	-1.59 units on a scale Standard Deviation 1.093	-2.35 units on a scale Standard Deviation 1.012	-1.67 units on a scale Standard Deviation 1.186	-1.71 units on a scale Standard Deviation 1.250
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Induration (Upper Limbs) n=83,83,38,37	-1.97 units on a scale Standard Deviation 1.093	-2.29 units on a scale Standard Deviation 1.018	-1.61 units on a scale Standard Deviation 1.296	-2.03 units on a scale Standard Deviation 1.150
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Induration (Trunk) n=88,86,44,42	-0.05 units on a scale Standard Deviation 0.439	-0.65 units on a scale Standard Deviation 0.728	-0.43 units on a scale Standard Deviation 0.660	-0.02 units on a scale Standard Deviation 0.457
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Induration (Trunk) n=87,88,43,42	-0.24 units on a scale Standard Deviation 0.576	-1.20 units on a scale Standard Deviation 1.044	-0.78 units on a scale Standard Deviation 0.850	-0.23 units on a scale Standard Deviation 0.812
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Upper Limbs) n=87,88,43,42	-0.29 units on a scale Standard Deviation 0.742	-1.31 units on a scale Standard Deviation 1.154	-0.83 units on a scale Standard Deviation 0.847	-0.26 units on a scale Standard Deviation 0.848
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Induration (Trunk) n=85,88,40,39	-0.38 units on a scale Standard Deviation 0.673	-1.78 units on a scale Standard Deviation 1.084	-1.23 units on a scale Standard Deviation 1.003	-0.68 units on a scale Standard Deviation 1.071
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Induration (Trunk) n=84,88,40,39	-0.59 units on a scale Standard Deviation 0.637	-2.19 units on a scale Standard Deviation 1.035	-1.39 units on a scale Standard Deviation 1.129	-0.90 units on a scale Standard Deviation 1.194
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Induration (Trunk) n=84,84,38,39	-0.74 units on a scale Standard Deviation 0.785	-2.36 units on a scale Standard Deviation 0.965	-1.57 units on a scale Standard Deviation 1.154	-1.13 units on a scale Standard Deviation 1.398
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Upper Limbs) n=85,88,40,39	-0.56 units on a scale Standard Deviation 0.940	-1.84 units on a scale Standard Deviation 1.078	-1.25 units on a scale Standard Deviation 0.950	-0.63 units on a scale Standard Deviation 1.030
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Induration (Trunk) n=84,84,38,39	-1.79 units on a scale Standard Deviation 1.031	-2.42 units on a scale Standard Deviation 0.984	-1.71 units on a scale Standard Deviation 1.071	-1.95 units on a scale Standard Deviation 1.138
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Upper Limbs) n=84,88,40,39	-0.62 units on a scale Standard Deviation 1.016	-2.18 units on a scale Standard Deviation 0.894	-1.47 units on a scale Standard Deviation 1.114	-0.93 units on a scale Standard Deviation 1.023
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Induration (Trunk) n=83,83,38,37	-2.22 units on a scale Standard Deviation 1.158	-2.41 units on a scale Standard Deviation 0.938	-1.76 units on a scale Standard Deviation 1.122	-2.42 units on a scale Standard Deviation 1.222
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Upper Limbs) n=84,84,38,39	-0.87 units on a scale Standard Deviation 1.105	-2.33 units on a scale Standard Deviation 0.998	-1.62 units on a scale Standard Deviation 1.040	-1.00 units on a scale Standard Deviation 1.115
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Upper Limbs) n=84,84,38,39	-1.64 units on a scale Standard Deviation 1.112	-2.35 units on a scale Standard Deviation 1.047	-1.75 units on a scale Standard Deviation 1.005	-1.68 units on a scale Standard Deviation 1.093
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Upper Limbs) n=83,83,38,37	-2.03 units on a scale Standard Deviation 1.258	-2.37 units on a scale Standard Deviation 1.009	-1.67 units on a scale Standard Deviation 1.025	-2.08 units on a scale Standard Deviation 0.997
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Upper Limbs) n=81,81,37,36	-2.00 units on a scale Standard Deviation 1.195	-2.32 units on a scale Standard Deviation 1.127	-1.65 units on a scale Standard Deviation 1.153	-2.08 units on a scale Standard Deviation 1.064
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Upper Limbs) n=80,78,36,36	-1.92 units on a scale Standard Deviation 1.381	-2.25 units on a scale Standard Deviation 1.175	-1.68 units on a scale Standard Deviation 1.201	-1.89 units on a scale Standard Deviation 1.282
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Trunk) n=88,86,44,42	-0.17 units on a scale Standard Deviation 0.490	-0.68 units on a scale Standard Deviation 0.810	-0.49 units on a scale Standard Deviation 0.682	-0.11 units on a scale Standard Deviation 0.655
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Trunk) n=87,88,43,42	-0.36 units on a scale Standard Deviation 0.692	-1.22 units on a scale Standard Deviation 1.104	-0.81 units on a scale Standard Deviation 0.842	-0.28 units on a scale Standard Deviation 0.934
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Trunk) n=85,88,40,39	-0.54 units on a scale Standard Deviation 0.790	-1.79 units on a scale Standard Deviation 1.124	-1.25 units on a scale Standard Deviation 0.997	-0.70 units on a scale Standard Deviation 1.018
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Trunk) n=84,88,40,39	-0.64 units on a scale Standard Deviation 0.932	-2.06 units on a scale Standard Deviation 1.045	-1.45 units on a scale Standard Deviation 1.174	-1.05 units on a scale Standard Deviation 1.154
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Trunk) n=84,84,38,39	-0.82 units on a scale Standard Deviation 0.970	-2.23 units on a scale Standard Deviation 1.090	-1.71 units on a scale Standard Deviation 1.136	-1.21 units on a scale Standard Deviation 1.255
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Trunk) n=84,84,38,39	-1.79 units on a scale Standard Deviation 1.174	-2.26 units on a scale Standard Deviation 1.088	-1.77 units on a scale Standard Deviation 1.090	-1.97 units on a scale Standard Deviation 1.219
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Trunk) n=83,83,38,37	-2.22 units on a scale Standard Deviation 1.250	-2.28 units on a scale Standard Deviation 0.992	-1.82 units on a scale Standard Deviation 1.049	-2.39 units on a scale Standard Deviation 1.054
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Trunk) n=81,81,37,36	-2.11 units on a scale Standard Deviation 1.410	-2.22 units on a scale Standard Deviation 1.173	-1.83 units on a scale Standard Deviation 1.160	-2.43 units on a scale Standard Deviation 1.042
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Trunk) n=80,78,36,36	-2.00 units on a scale Standard Deviation 1.352	-2.18 units on a scale Standard Deviation 1.188	-1.94 units on a scale Standard Deviation 1.049	-2.31 units on a scale Standard Deviation 1.215
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 2: Scaling (Lower Limbs) n=88,86,44,42	-0.21 units on a scale Standard Deviation 0.565	-0.70 units on a scale Standard Deviation 0.846	-0.51 units on a scale Standard Deviation 0.778	-0.18 units on a scale Standard Deviation 0.657
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 4: Scaling (Lower Limbs) n=87,88,43,42	-0.43 units on a scale Standard Deviation 0.668	-1.22 units on a scale Standard Deviation 1.016	-0.84 units on a scale Standard Deviation 0.933	-0.35 units on a scale Standard Deviation 0.997
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 8: Scaling (Lower Limbs) n=85,88,40,39	-0.69 units on a scale Standard Deviation 0.863	-1.80 units on a scale Standard Deviation 1.044	-1.40 units on a scale Standard Deviation 1.078	-0.63 units on a scale Standard Deviation 1.125
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 12: Scaling (Lower Limbs) n=84,88,40,39	-0.72 units on a scale Standard Deviation 0.916	-2.30 units on a scale Standard Deviation 0.915	-1.60 units on a scale Standard Deviation 1.160	-0.75 units on a scale Standard Deviation 1.080
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 16: Scaling (Lower Limbs) n=84,84,38,39	-0.85 units on a scale Standard Deviation 1.014	-2.50 units on a scale Standard Deviation 0.912	-1.74 units on a scale Standard Deviation 1.173	-0.95 units on a scale Standard Deviation 1.293
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 20: Scaling (Lower Limbs) n=84,84,38,39	-1.82 units on a scale Standard Deviation 1.023	-2.51 units on a scale Standard Deviation 0.963	-1.80 units on a scale Standard Deviation 1.138	-1.82 units on a scale Standard Deviation 1.136
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 32: Scaling (Lower Limbs) n=83,83,38,37	-2.16 units on a scale Standard Deviation 1.236	-2.58 units on a scale Standard Deviation 0.964	-1.86 units on a scale Standard Deviation 1.128	-2.29 units on a scale Standard Deviation 1.160
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 40: Scaling (Lower Limbs) n=81,81,37,36	-2.33 units on a scale Standard Deviation 1.331	-2.40 units on a scale Standard Deviation 1.190	-1.89 units on a scale Standard Deviation 1.118	-2.22 units on a scale Standard Deviation 1.004
Change From Baseline in PASI Component Scores Over Time Through Week 52 Week 52: Scaling (Lower Limbs) n=80,78,36,36	-2.11 units on a scale Standard Deviation 1.326	-2.33 units on a scale Standard Deviation 1.111	-1.88 units on a scale Standard Deviation 1.151	-2.08 units on a scale Standard Deviation 1.360

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 40 (n=81,81,37,36)	-83.64 percent change Standard Error 3.368	-90.18 percent change Standard Error 2.264	-77.29 percent change Standard Error 2.258	-87.73 percent change Standard Error 3.332
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 2 (n=88,86,44,42)	-0.35 percent change Standard Error 3.473	-24.93 percent change Standard Error 2.399 • Interval 15.57 to 33.32	-16.28 percent change Standard Error 2.409 • Interval 0.19 to 8.9	1.37 percent change Standard Error 3.392
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 4 (n=87,88,43,42)	-7.31 percent change Standard Error 4.527	-46.24 percent change Standard Error 3.135	-32.47 percent change Standard Error 3.127	-1.98 percent change Standard Error 4.444
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 8 (n=85,88,40,39)	-16.18 percent change Standard Error 5.488	-66.96 percent change Standard Error 3.769	-51.24 percent change Standard Error 3.739	-13.17 percent change Standard Error 5.384
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 12 (n=84,88,40,39)	-20.40 percent change Standard Error 5.304	-80.64 percent change Standard Error 3.631	-59.73 percent change Standard Error 3.585	-25.13 percent change Standard Error 5.205
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 16 (n=84,84,38,39)	-21.63 percent change Standard Error 5.721	-84.35 percent change Standard Error 3.912	-66.69 percent change Standard Error 3.874	-32.79 percent change Standard Error 5.651
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 20 (n=84,84,38,39)	-60.85 percent change Standard Error 4.423	-87.89 percent change Standard Error 3.024	-71.93 percent change Standard Error 3.002	-69.85 percent change Standard Error 4.399
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 32 (n=83,83,38,37)	-81.43 percent change Standard Error 3.622	-90.47 percent change Standard Error 2.444	-76.06 percent change Standard Error 2.437	-86.63 percent change Standard Error 3.584
Percent Change From Baseline in PASI Scores Over Time Through Week 52 Week 52 (n=80,78,36,36)	-79.27 percent change Standard Error 4.101	-86.05 percent change Standard Error 2.763	-75.55 percent change Standard Error 2.764	-84.65 percent change Standard Error 4.066

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

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

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Actual BSA Over Time Through Week 52 Week 4 (n=87,88,43,42)	36.30 percent BSA Standard Deviation 16.916	27.82 percent BSA Standard Deviation 18.599	32.75 percent BSA Standard Deviation 18.314	38.32 percent BSA Standard Deviation 19.355
Actual BSA Over Time Through Week 52 Week 12 (n=84,88,40,39)	34.06 percent BSA Standard Deviation 17.142	10.59 percent BSA Standard Deviation 15.486	20.45 percent BSA Standard Deviation 20.462	33.15 percent BSA Standard Deviation 20.483
Actual BSA Over Time Through Week 52 Baseline (n=90,88,44,44)	36.25 percent BSA Standard Deviation 16.018	36.36 percent BSA Standard Deviation 18.035 • Interval 15.57 to 33.32	37.41 percent BSA Standard Deviation 19.614 • Interval 0.19 to 8.9	35.29 percent BSA Standard Deviation 18.294
Actual BSA Over Time Through Week 52 Week 2 (n=88,86,44,44)	36.38 percent BSA Standard Deviation 16.592	33.95 percent BSA Standard Deviation 17.537	36.56 percent BSA Standard Deviation 19.363	36.84 percent BSA Standard Deviation 18.808
Actual BSA Over Time Through Week 52 Week 8 (n=85,88,40,39)	34.99 percent BSA Standard Deviation 16.182	17.62 percent BSA Standard Deviation 18.411	24.38 percent BSA Standard Deviation 19.583	36.75 percent BSA Standard Deviation 19.817
Actual BSA Over Time Through Week 52 Week 16 (n=84,84,38,39)	34.54 percent BSA Standard Deviation 18.293	7.57 percent BSA Standard Deviation 13.395	16.52 percent BSA Standard Deviation 18.899	28.57 percent BSA Standard Deviation 21.645
Actual BSA Over Time Through Week 52 Week 20 (n=84,84,38,39)	24.83 percent BSA Standard Deviation 19.044	5.05 percent BSA Standard Deviation 10.041	13.69 percent BSA Standard Deviation 16.976	15.50 percent BSA Standard Deviation 16.522
Actual BSA Over Time Through Week 52 Week 32 (n=83,83,38,37)	9.03 percent BSA Standard Deviation 11.781	3.22 percent BSA Standard Deviation 5.894	11.47 percent BSA Standard Deviation 16.304	6.95 percent BSA Standard Deviation 10.262
Actual BSA Over Time Through Week 52 Week 40 (n=81,81,37,36)	6.35 percent BSA Standard Deviation 9.462	2.56 percent BSA Standard Deviation 5.412	10.32 percent BSA Standard Deviation 13.077	5.88 percent BSA Standard Deviation 8.351
Actual BSA Over Time Through Week 52 Week 52 (n=80,78,36,36)	7.87 percent BSA Standard Deviation 9.584	3.83 percent BSA Standard Deviation 7.908	10.94 percent BSA Standard Deviation 15.255	5.00 percent BSA Standard Deviation 7.686

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

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

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percent Change From Baseline in BSA Over Time Through Week 52 Week 40 (n=81,81,37,36)	-79.91 percent change Standard Error 4.786	-90.00 percent change Standard Error 3.213	-73.00 percent change Standard Error 3.207	-79.48 percent change Standard Error 4.743
Percent Change From Baseline in BSA Over Time Through Week 52 Week 52 (n=80,78,36,36)	-74.02 percent change Standard Error 5.737	-84.16 percent change Standard Error 3.867	-72.28 percent change Standard Error 3.868	-81.70 percent change Standard Error 5.681
Percent Change From Baseline in BSA Over Time Through Week 52 Week 20 (n=84,84,38,39)	-28.86 percent change Standard Error 6.530	-82.65 percent change Standard Error 4.459	-62.35 percent change Standard Error 4.419	-49.35 percent change Standard Error 6.495
Percent Change From Baseline in BSA Over Time Through Week 52 Week 2 (n=88,86,44,44)	2.14 percent change Standard Error 3.016	-5.58 percent change Standard Error 2.083	-2.53 percent change Standard Error 2.093	4.79 percent change Standard Error 2.947
Percent Change From Baseline in BSA Over Time Through Week 52 Week 4 (n=87,88,43,42)	2.28 percent change Standard Error 4.622	-21.90 percent change Standard Error 3.202	-10.98 percent change Standard Error 3.193	10.29 percent change Standard Error 4.541
Percent Change From Baseline in BSA Over Time Through Week 52 Week 8 (n=85,88,40,39)	-0.42 percent change Standard Error 7.155	-46.98 percent change Standard Error 4.909	-33.22 percent change Standard Error 4.870	8.73 percent change Standard Error 7.017
Percent Change From Baseline in BSA Over Time Through Week 52 Week 12 (n=84,88,40,39)	0.48 percent change Standard Error 8.086	-65.97 percent change Standard Error 5.536	-44.44 percent change Standard Error 5.471	0.41 percent change Standard Error 7.928
Percent Change From Baseline in BSA Over Time Through Week 52 Week 16 (n=84,84,38,39)	4.13 percent change Standard Error 8.632	-73.80 percent change Standard Error 5.903	-54.41 percent change Standard Error 5.839	-8.85 percent change Standard Error 8.511
Percent Change From Baseline in BSA Over Time Through Week 52 Week 32 (n=83,83,38,37)	-73.95 percent change Standard Error 5.235	-87.55 percent change Standard Error 3.531	-70.55 percent change Standard Error 3.521	-74.83 percent change Standard Error 5.186

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI50 response is reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 2	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	21.11 percentage of participants Interval 12.68 to 29.54	5.68 percentage of participants Interval 0.85 to 10.52	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 4	4.55 percentage of participants Interval 0.0 to 10.7	48.89 percentage of participants Interval 38.56 to 59.22	27.27 percentage of participants Interval 17.97 to 36.58	4.55 percentage of participants Interval 0.0 to 10.7
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 8	4.55 percentage of participants Interval 0.0 to 10.7	74.44 percentage of participants Interval 65.43 to 83.46	55.68 percentage of participants Interval 45.3 to 66.06	13.64 percentage of participants Interval 3.5 to 23.78
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 12	9.09 percentage of participants Interval 0.6 to 17.59	81.11 percentage of participants Interval 73.02 to 89.2	64.77 percentage of participants Interval 54.79 to 74.75	27.27 percentage of participants Interval 14.11 to 40.43
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 16	18.18 percentage of participants Interval 6.79 to 29.58	86.67 percentage of participants Interval 79.64 to 93.69	71.59 percentage of participants Interval 62.17 to 81.01	40.91 percentage of participants Interval 26.38 to 55.44
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 20	63.64 percentage of participants Interval 49.42 to 77.85	85.56 percentage of participants Interval 78.29 to 92.82	72.73 percentage of participants Interval 63.42 to 82.03	68.18 percentage of participants Interval 54.42 to 81.94
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 32	75.00 percentage of participants Interval 62.21 to 87.79	88.89 percentage of participants Interval 82.4 to 95.38	78.41 percentage of participants Interval 69.81 to 87.01	79.55 percentage of participants Interval 67.63 to 91.46
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 40	72.73 percentage of participants Interval 59.57 to 85.89	87.78 percentage of participants Interval 81.01 to 94.54	80.68 percentage of participants Interval 72.43 to 88.93	79.55 percentage of participants Interval 67.63 to 91.46
Percentage of Participants With PASI50 Response Over Time Through Week 52 Week 52	75.00 percentage of participants Interval 62.21 to 87.79	83.33 percentage of participants Interval 75.63 to 91.03	73.86 percentage of participants Interval 64.68 to 83.04	77.27 percentage of participants Interval 64.89 to 89.66

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI90 response up to Week 52 is reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 2	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 4	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	7.78 percentage of participants Interval 2.24 to 13.31	2.27 percentage of participants Interval 0.0 to 5.39	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 8	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	27.78 percentage of participants Interval 18.52 to 37.03	13.64 percentage of participants Interval 6.47 to 20.81	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 12	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	51.11 percentage of participants Interval 40.78 to 61.44	29.55 percentage of participants Interval 20.01 to 39.08	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 16	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	60.00 percentage of participants Interval 49.88 to 70.12	35.23 percentage of participants Interval 25.25 to 45.21	6.82 percentage of participants Interval 0.0 to 14.27
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 20	9.09 percentage of participants Interval 0.6 to 17.59	71.11 percentage of participants Interval 61.75 to 80.48	35.23 percentage of participants Interval 25.25 to 45.21	25.00 percentage of participants Interval 12.21 to 37.79
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 32	40.91 percentage of participants Interval 26.38 to 55.44	65.56 percentage of participants Interval 55.74 to 75.37	42.05 percentage of participants Interval 31.73 to 52.36	56.82 percentage of participants Interval 42.18 to 71.45
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 40	45.45 percentage of participants Interval 30.74 to 60.17	66.67 percentage of participants Interval 56.93 to 76.41	35.23 percentage of participants Interval 25.25 to 45.21	56.82 percentage of participants Interval 42.18 to 71.45
Percentage of Participants With PASI90 Response Over Time Through Week 52 Week 52	36.36 percentage of participants Interval 22.15 to 50.58	56.67 percentage of participants Interval 46.43 to 66.9	38.64 percentage of participants Interval 28.46 to 48.81	56.82 percentage of participants Interval 42.18 to 71.45

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With PASI125 Over Time Through Week 52 Week 2 (n=88,86,44,42)	4.76 percentage of participants Interval 0.0 to 11.2	2.27 percentage of participants Interval 0.0 to 5.39	1.16 percentage of participants Interval 0.0 to 3.43	4.55 percentage of participants Interval 0.0 to 10.7
Percentage of Participants With PASI125 Over Time Through Week 52 Week 4 (n=87,88,43,42)	2.38 percentage of participants Interval 0.0 to 6.99	2.30 percentage of participants Interval 0.0 to 5.45	1.14 percentage of participants Interval 0.0 to 3.35	13.95 percentage of participants Interval 3.6 to 24.31
Percentage of Participants With PASI125 Over Time Through Week 52 Week 8 (n=85,88,40,39)	2.56 percentage of participants Interval 0.0 to 7.52	2.35 percentage of participants Interval 0.0 to 5.58	1.14 percentage of participants Interval 0.0 to 3.35	17.50 percentage of participants Interval 5.72 to 29.28
Percentage of Participants With PASI125 Over Time Through Week 52 Week 12 (n=84,88,40,39)	5.13 percentage of participants Interval 0.0 to 12.05	1.19 percentage of participants Interval 0.0 to 3.51	1.14 percentage of participants Interval 0.0 to 3.35	7.50 percentage of participants Interval 0.0 to 15.66
Percentage of Participants With PASI125 Over Time Through Week 52 Week 16 (n=84,84,38,39)	7.69 percentage of participants Interval 0.0 to 16.06	1.19 percentage of participants Interval 0.0 to 3.51	2.38 percentage of participants Interval 0.0 to 5.64	10.53 percentage of participants Interval 0.77 to 20.28
Percentage of Participants With PASI125 Over Time Through Week 52 Week 20 (n=84,84,38,39)	2.56 percentage of participants Interval 0.0 to 7.52	1.19 percentage of participants Interval 0.0 to 3.51	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI125 Over Time Through Week 52 Week 32 (n=83,83,38,37)	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI125 Over Time Through Week 52 Week 40 (n=81,81,37,36)	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With PASI125 Over Time Through Week 52 Week 52 (n=80,78,36,36)	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	1.25 percentage of participants Interval 0.0 to 3.68	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 20, 32, 40, and 52

Population: Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=18 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=40 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=38 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=18 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Baseline (n=40,38,18,18)	25.2 units on a scale Standard Deviation 16.37 • Interval 0.0 to 7.52	25.8 units on a scale Standard Deviation 20.58 • Interval 0.0 to 5.58	26.2 units on a scale Standard Deviation 16.97 • Interval 0.0 to 3.35	28.7 units on a scale Standard Deviation 21.90 • Interval 5.72 to 29.28
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 8 (n=39,38,15,15)	30.7 units on a scale Standard Deviation 18.48 • Interval 0.0 to 16.06	23.0 units on a scale Standard Deviation 19.45 • Interval 0.0 to 3.51	23.6 units on a scale Standard Deviation 17.29 • Interval 0.0 to 5.64	28.6 units on a scale Standard Deviation 23.66 • Interval 0.77 to 20.28
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 16 (n=38,38,14,15)	28.9 units on a scale Standard Deviation 20.54 • Interval 0.0 to 7.52	17.2 units on a scale Standard Deviation 19.14 • Interval 0.0 to 3.51	19.8 units on a scale Standard Deviation 18.30	30.3 units on a scale Standard Deviation 23.86
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 20 (n=37,38,14,15)	30.1 units on a scale Standard Deviation 19.08	13.9 units on a scale Standard Deviation 18.70	17.2 units on a scale Standard Deviation 16.94	28.6 units on a scale Standard Deviation 24.02
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 32 (n=37,37,14,14)	17.1 units on a scale Standard Deviation 12.69	12.6 units on a scale Standard Deviation 19.59	15.5 units on a scale Standard Deviation 16.69	16.2 units on a scale Standard Deviation 18.48
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 40 (n=36,36,13,13)	14.5 units on a scale Standard Deviation 13.93	9.6 units on a scale Standard Deviation 18.65 • Interval 0.0 to 3.68	14.9 units on a scale Standard Deviation 16.01	15.7 units on a scale Standard Deviation 15.82
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 52 (n=31,34,12,13)	10.5 units on a scale Standard Deviation 12.67	10.0 units on a scale Standard Deviation 20.22	13.2 units on a scale Standard Deviation 17.96	13.8 units on a scale Standard Deviation 18.54

SECONDARY outcome

Timeframe: Baseline and weeks 8, 16, 20, 32, 40, and 52

Population: Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail was divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=18 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=40 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=38 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=18 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 16 (n=38,38,14,15)	0.84 units on a scale Standard Error 3.082 • Interval 0.0 to 7.52	-9.38 units on a scale Standard Error 1.927 • Interval 0.0 to 3.51	-6.63 units on a scale Standard Error 1.936	2.04 units on a scale Standard Error 3.151
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 20 (n=37,38,14,15)	2.04 units on a scale Standard Error 2.999	-12.68 units on a scale Standard Error 1.886	-9.18 units on a scale Standard Error 1.884	0.48 units on a scale Standard Error 3.079
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 8 (n=39,38,15,15)	2.64 units on a scale Standard Error 2.283 • Interval 0.0 to 16.06	-3.60 units on a scale Standard Error 1.416 • Interval 0.0 to 3.51	-2.76 units on a scale Standard Error 1.434 • Interval 0.0 to 5.64	2.17 units on a scale Standard Error 2.282 • Interval 0.77 to 20.28
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 32 (n=37,37,14,14)	-12.61 units on a scale Standard Error 3.788	-14.02 units on a scale Standard Error 2.350	-11.31 units on a scale Standard Error 2.350	-11.81 units on a scale Standard Error 3.834
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 40 (n=36,36,13,13)	-14.19 units on a scale Standard Error 3.842	-16.31 units on a scale Standard Error 2.365 • Interval 0.0 to 3.68	-11.94 units on a scale Standard Error 2.359	-13.42 units on a scale Standard Error 3.876
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline Week 52 (n=31,34,12,13)	-17.89 units on a scale Standard Error 4.315	-17.13 units on a scale Standard Error 2.689	-13.55 units on a scale Standard Error 2.651	-15.08 units on a scale Standard Error 4.387

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 20, 32, 40, and 52

Population: Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.

Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported. The total number of affected FINGER nails was reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=18 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=40 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=38 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=18 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 Baseline (n=40,38,18,18)	7.4 nails Standard Deviation 3.45 • Interval 0.0 to 16.06	7.6 nails Standard Deviation 3.06 • Interval 0.0 to 3.51	7.3 nails Standard Deviation 3.21 • Interval 0.0 to 5.64	8.1 nails Standard Deviation 2.97 • Interval 0.77 to 20.28
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 Week 8 (n=39,38,15,15)	7.9 nails Standard Deviation 3.20 • Interval 0.0 to 7.52	7.2 nails Standard Deviation 3.07 • Interval 0.0 to 3.51	7.2 nails Standard Deviation 3.61	7.3 nails Standard Deviation 3.58
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 Week 16 (n=38,38,14,15)	7.6 nails Standard Deviation 3.56	6.1 nails Standard Deviation 3.53	6.6 nails Standard Deviation 3.57	7.9 nails Standard Deviation 3.82
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 Week 20 (n=37,38,14,15)	7.9 nails Standard Deviation 3.08	5.1 nails Standard Deviation 3.84	6.0 nails Standard Deviation 3.84	7.4 nails Standard Deviation 3.93
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 Week 32 (n=37,37,14,14)	7.6 nails Standard Deviation 3.72	3.8 nails Standard Deviation 3.92 • Interval 0.0 to 3.68	5.5 nails Standard Deviation 3.85	6.1 nails Standard Deviation 3.95
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 Week 40 (n=36,36,13,13)	5.8 nails Standard Deviation 4.28	3.0 nails Standard Deviation 3.60	5.4 nails Standard Deviation 4.08	6.3 nails Standard Deviation 4.39
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 Week 52 (n=31,34,12,13)	4.4 nails Standard Deviation 3.75	3.0 nails Standard Deviation 3.67	4.4 nails Standard Deviation 4.23	4.6 nails Standard Deviation 4.12

SECONDARY outcome

Timeframe: Baseline and weeks 8, 16, 20, 32, 40, and 52

Population: Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=18 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=40 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=38 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=18 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percent Change From Baseline in NAPSI Over Time Through Week 52 Week 8 (n=39,38,15,15)	25.40 percent change Standard Error 13.662 • Interval 0.0 to 7.52	-9.59 percent change Standard Error 8.473 • Interval 0.0 to 3.51	-8.81 percent change Standard Error 8.585	5.28 percent change Standard Error 13.661
Percent Change From Baseline in NAPSI Over Time Through Week 52 Week 16 (n=38,38,14,15)	18.43 percent change Standard Error 16.869	-33.31 percent change Standard Error 10.552	-14.91 percent change Standard Error 10.600	-3.26 percent change Standard Error 17.257
Percent Change From Baseline in NAPSI Over Time Through Week 52 Week 20 (n=37,38,14,15)	13.72 percent change Standard Error 13.869	-51.97 percent change Standard Error 8.748	-25.10 percent change Standard Error 8.715	-8.87 percent change Standard Error 14.276
Percent Change From Baseline in NAPSI Over Time Through Week 52 Week 32 (n=37,37,14,14)	-45.83 percent change Standard Error 16.481	-58.44 percent change Standard Error 10.256 • Interval 0.0 to 3.68	-25.27 percent change Standard Error 10.247	-50.20 percent change Standard Error 16.734
Percent Change From Baseline in NAPSI Over Time Through Week 52 Week 40 (n=36,36,13,13)	-58.60 percent change Standard Error 14.988	-68.68 percent change Standard Error 9.243	-37.40 percent change Standard Error 9.208	-47.17 percent change Standard Error 15.143
Percent Change From Baseline in NAPSI Over Time Through Week 52 Week 52 (n=31,34,12,13)	-45.67 percent change Standard Error 17.192	-71.40 percent change Standard Error 10.891	-51.71 percent change Standard Error 10.636	-56.08 percent change Standard Error 17.621

SECONDARY outcome

Timeframe: Weeks 8, 16, 20, 32, 40, and 52

Population: Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=18 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=40 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=38 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=18 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With NAPSI75 Response Over Time Through Week 52 Week 8	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	10.53 percentage of participants Interval 0.77 to 20.28	5.56 percentage of participants Interval 0.0 to 16.14
Percentage of Participants With NAPSI75 Response Over Time Through Week 52 Week 16	5.56 percentage of participants Interval 0.0 to 16.14	20.00 percentage of participants Interval 7.6 to 32.4	15.79 percentage of participants Interval 4.2 to 27.38	11.11 percentage of participants Interval 0.0 to 25.63
Percentage of Participants With NAPSI75 Response Over Time Through Week 52 Week 20	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	30.00 percentage of participants Interval 15.8 to 44.2	13.16 percentage of participants Interval 2.41 to 23.91	11.11 percentage of participants Interval 0.0 to 25.63
Percentage of Participants With NAPSI75 Response Over Time Through Week 52 Week 32	16.67 percentage of participants Interval 0.0 to 33.88	52.50 percentage of participants Interval 37.02 to 67.98	28.95 percentage of participants Interval 14.53 to 43.37	27.78 percentage of participants Interval 7.09 to 48.47
Percentage of Participants With NAPSI75 Response Over Time Through Week 52 Week 40	33.33 percentage of participants Interval 11.56 to 55.11	65.00 percentage of participants Interval 50.22 to 79.78	34.21 percentage of participants Interval 19.13 to 49.29	33.33 percentage of participants Interval 11.56 to 55.11
Percentage of Participants With NAPSI75 Response Over Time Through Week 52 Week 52	38.89 percentage of participants Interval 16.37 to 61.41	52.50 percentage of participants Interval 37.02 to 67.98	47.37 percentage of participants Interval 31.49 to 63.24	38.89 percentage of participants Interval 16.37 to 61.41

SECONDARY outcome

Timeframe: Weeks 8, 16, 20, 32, 40, and 52

Population: Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=18 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=40 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=38 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=18 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With NAPSI100 Response Over Time Through Week 52 Week 8	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	5.26 percentage of participants Interval 0.0 to 12.36	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With NAPSI100 Response Over Time Through Week 52 Week 16	5.56 percentage of participants Interval 0.0 to 16.14	5.00 percentage of participants Interval 0.0 to 11.75	5.26 percentage of participants Interval 0.0 to 12.36	11.11 percentage of participants Interval 0.0 to 25.63
Percentage of Participants With NAPSI100 Response Over Time Through Week 52 Week 20	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	17.50 percentage of participants Interval 5.72 to 29.28	10.53 percentage of participants Interval 0.77 to 20.28	11.11 percentage of participants Interval 0.0 to 25.63
Percentage of Participants With NAPSI100 Response Over Time Through Week 52 Week 32	5.56 percentage of participants Interval 0.0 to 16.14	27.50 percentage of participants Interval 13.66 to 41.34	13.16 percentage of participants Interval 2.41 to 23.91	11.11 percentage of participants Interval 0.0 to 25.63
Percentage of Participants With NAPSI100 Response Over Time Through Week 52 Week 40	16.67 percentage of participants Interval 0.0 to 33.88	30.00 percentage of participants Interval 15.8 to 44.2	15.79 percentage of participants Interval 4.2 to 27.38	11.11 percentage of participants Interval 0.0 to 25.63
Percentage of Participants With NAPSI100 Response Over Time Through Week 52 Week 52	16.67 percentage of participants Interval 0.0 to 33.88	30.00 percentage of participants Interval 15.8 to 44.2	31.58 percentage of participants Interval 16.8 to 46.36	16.67 percentage of participants Interval 0.0 to 33.88

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Baseline (n=88,88,44,44)	5.75 units on a scale Standard Deviation 2.679	5.66 units on a scale Standard Deviation 2.586	5.10 units on a scale Standard Deviation 2.679 • Interval 0.0 to 12.36	5.22 units on a scale Standard Deviation 2.501
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 2 (n=87,86,44,42)	4.95 units on a scale Standard Deviation 2.731 • Interval 0.0 to 16.14	2.97 units on a scale Standard Deviation 2.043 • Interval 0.0 to 11.75	3.49 units on a scale Standard Deviation 2.669 • Interval 0.0 to 12.36	5.45 units on a scale Standard Deviation 2.791 • Interval 0.0 to 25.63
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 4 (n=88,88,43,42)	5.12 units on a scale Standard Deviation 2.491	2.13 units on a scale Standard Deviation 2.061 • Interval 5.72 to 29.28	2.68 units on a scale Standard Deviation 2.322 • Interval 0.77 to 20.28	5.23 units on a scale Standard Deviation 2.715 • Interval 0.0 to 25.63
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 8 (n=85,88,40,39)	4.97 units on a scale Standard Deviation 2.978 • Interval 0.0 to 16.14	1.47 units on a scale Standard Deviation 1.900 • Interval 13.66 to 41.34	2.41 units on a scale Standard Deviation 2.283 • Interval 2.41 to 23.91	4.75 units on a scale Standard Deviation 2.677 • Interval 0.0 to 25.63
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 12 (n=84,88,40,39)	5.00 units on a scale Standard Deviation 2.938 • Interval 0.0 to 33.88	1.24 units on a scale Standard Deviation 1.565 • Interval 15.8 to 44.2	2.13 units on a scale Standard Deviation 2.323 • Interval 4.2 to 27.38	4.00 units on a scale Standard Deviation 2.621 • Interval 0.0 to 25.63
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 16 (n=84,84,38,39)	5.13 units on a scale Standard Deviation 2.811 • Interval 0.0 to 33.88	1.17 units on a scale Standard Deviation 1.782 • Interval 15.8 to 44.2	2.01 units on a scale Standard Deviation 2.367 • Interval 16.8 to 46.36	3.89 units on a scale Standard Deviation 2.391 • Interval 0.0 to 33.88
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 20 (n=83,84,38,38)	2.11 units on a scale Standard Deviation 2.227	1.06 units on a scale Standard Deviation 1.564	2.01 units on a scale Standard Deviation 2.326	1.95 units on a scale Standard Deviation 2.253
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 32 (n=838238,37	1.51 units on a scale Standard Deviation 2.388	0.88 units on a scale Standard Deviation 1.273	2.07 units on a scale Standard Deviation 2.382	1.24 units on a scale Standard Deviation 1.747
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 40 (n=81,81,37,36)	1.53 units on a scale Standard Deviation 2.158	0.96 units on a scale Standard Deviation 1.145	2.30 units on a scale Standard Deviation 2.283	1.49 units on a scale Standard Deviation 2.181
Actual Itch Severity Item (ISI) Score Over Time Through Week 52 Week 52 (n=80,78,36,36)	2.36 units on a scale Standard Deviation 2.380	1.45 units on a scale Standard Deviation 2.074	2.55 units on a scale Standard Deviation 2.516	1.89 units on a scale Standard Deviation 2.482

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in ISI Score Over Time Through Week 52 Week 20 (n=82,84,38,38)	-3.36 units on a scale Standard Error 0.320	-4.32 units on a scale Standard Error 0.219	-3.28 units on a scale Standard Error 0.216	-3.22 units on a scale Standard Error 0.318
Change From Baseline in ISI Score Over Time Through Week 52 Week 2 (n=86,86,44,42)	-0.64 units on a scale Standard Error 0.314 • Interval 0.0 to 16.14	-2.50 units on a scale Standard Error 0.219 • Interval 0.0 to 11.75	-1.76 units on a scale Standard Error 0.218 • Interval 0.0 to 12.36	0.12 units on a scale Standard Error 0.306 • Interval 0.0 to 25.63
Change From Baseline in ISI Score Over Time Through Week 52 Week 4 (n=87,88,43,42)	-0.47 units on a scale Standard Error 0.325	-3.33 units on a scale Standard Error 0.226 • Interval 5.72 to 29.28	-2.60 units on a scale Standard Error 0.224 • Interval 0.77 to 20.28	-0.03 units on a scale Standard Error 0.319 • Interval 0.0 to 25.63
Change From Baseline in ISI Score Over Time Through Week 52 Week 8 (n=84,88,40,39)	-0.46 units on a scale Standard Error 0.337 • Interval 0.0 to 16.14	-3.93 units on a scale Standard Error 0.232 • Interval 13.66 to 41.34	-2.88 units on a scale Standard Error 0.228 • Interval 2.41 to 23.91	-0.50 units on a scale Standard Error 0.331 • Interval 0.0 to 25.63
Change From Baseline in ISI Score Over Time Through Week 52 Week 12 (n=83,88,40,39)	-0.44 units on a scale Standard Error 0.344 • Interval 0.0 to 33.88	-4.10 units on a scale Standard Error 0.237 • Interval 15.8 to 44.2	-3.16 units on a scale Standard Error 0.233 • Interval 4.2 to 27.38	-1.15 units on a scale Standard Error 0.338 • Interval 0.0 to 25.63
Change From Baseline in ISI Score Over Time Through Week 52 Week 16 (n=83,84,38,39)	-0.33 units on a scale Standard Error 0.337 • Interval 0.0 to 33.88	-4.21 units on a scale Standard Error 0.232 • Interval 15.8 to 44.2	-3.28 units on a scale Standard Error 0.229 • Interval 16.8 to 46.36	-1.30 units on a scale Standard Error 0.335 • Interval 0.0 to 33.88
Change From Baseline in ISI Score Over Time Through Week 52 Week 32 (n=82,82,38,37)	-4.04 units on a scale Standard Error 0.325	-4.51 units on a scale Standard Error 0.220	-3.17 units on a scale Standard Error 0.219	-4.01 units on a scale Standard Error 0.322
Change From Baseline in ISI Score Over Time Through Week 52 Week 40 (n=80,81,37,36)	-3.89 units on a scale Standard Error 0.331	-4.39 units on a scale Standard Error 0.224	-2.98 units on a scale Standard Error 0.222	-3.81 units on a scale Standard Error 0.328
Change From Baseline in ISI Score Over Time Through Week 52 Week 52 (n=79,78,36,36)	-3.11 units on a scale Standard Error 0.403	-3.91 units on a scale Standard Error 0.272	-2.71 units on a scale Standard Error 0.272	-3.47 units on a scale Standard Error 0.401

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Baseline (n=90,88,44,44)	12.1 units on a scale Standard Deviation 6.92 • Interval 0.0 to 16.14	14.1 units on a scale Standard Deviation 7.17 • Interval 0.0 to 11.75	13.5 units on a scale Standard Deviation 7.29 • Interval 0.0 to 12.36	12.5 units on a scale Standard Deviation 6.82 • Interval 0.0 to 25.63
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 2 (n=88,86,44,42)	10.4 units on a scale Standard Deviation 5.97	9.5 units on a scale Standard Deviation 5.31 • Interval 5.72 to 29.28	10.0 units on a scale Standard Deviation 6.20 • Interval 0.77 to 20.28	12.6 units on a scale Standard Deviation 7.34 • Interval 0.0 to 25.63
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 4 (n=86,88,42,41)	10.3 units on a scale Standard Deviation 5.39 • Interval 0.0 to 16.14	7.6 units on a scale Standard Deviation 5.00 • Interval 13.66 to 41.34	8.2 units on a scale Standard Deviation 5.46 • Interval 2.41 to 23.91	12.4 units on a scale Standard Deviation 7.99 • Interval 0.0 to 25.63
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 8 (n=85,88,40,39)	9.9 units on a scale Standard Deviation 6.66 • Interval 0.0 to 33.88	5.9 units on a scale Standard Deviation 5.49 • Interval 15.8 to 44.2	7.5 units on a scale Standard Deviation 5.89 • Interval 4.2 to 27.38	11.2 units on a scale Standard Deviation 7.25 • Interval 0.0 to 25.63
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 12 (n=84,88,39,39)	10.2 units on a scale Standard Deviation 6.86 • Interval 0.0 to 33.88	4.6 units on a scale Standard Deviation 4.47 • Interval 15.8 to 44.2	6.7 units on a scale Standard Deviation 6.16 • Interval 16.8 to 46.36	11.1 units on a scale Standard Deviation 7.11 • Interval 0.0 to 33.88
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 16 (n=84,84,38,39)	10.5 units on a scale Standard Deviation 6.77	4.3 units on a scale Standard Deviation 4.70	6.2 units on a scale Standard Deviation 5.62	10.7 units on a scale Standard Deviation 7.20
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 20 (n=82,84,38,39)	6.4 units on a scale Standard Deviation 5.17	3.8 units on a scale Standard Deviation 4.46	5.4 units on a scale Standard Deviation 5.50	6.2 units on a scale Standard Deviation 4.80
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 32 (n=83,82,38,37)	5.0 units on a scale Standard Deviation 6.03	3.2 units on a scale Standard Deviation 4.39	5.1 units on a scale Standard Deviation 5.31	4.7 units on a scale Standard Deviation 5.42
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 40 (n=81,81,37,36)	4.1 units on a scale Standard Deviation 4.03	3.7 units on a scale Standard Deviation 4.37	5.9 units on a scale Standard Deviation 5.44	4.6 units on a scale Standard Deviation 5.07
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 Week 52 (n=80,78,35,36)	6.0 units on a scale Standard Deviation 5.68	4.6 units on a scale Standard Deviation 5.83	6.5 units on a scale Standard Deviation 6.25	4.7 units on a scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in DLQI Score Over Time Through Week 52 Week 16 (n=84,84,38,39)	-2.22 units on a scale Standard Error 0.905 • Interval 0.0 to 33.88	-9.03 units on a scale Standard Error 0.618 • Interval 15.8 to 44.2	-7.00 units on a scale Standard Error 0.611 • Interval 16.8 to 46.36	-1.15 units on a scale Standard Error 0.899 • Interval 0.0 to 33.88
Change From Baseline in DLQI Score Over Time Through Week 52 Week 2 (n=88,86,44,42)	-2.27 units on a scale Standard Error 0.659 • Interval 0.0 to 16.14	-3.98 units on a scale Standard Error 0.455 • Interval 0.0 to 11.75	-3.26 units on a scale Standard Error 0.458 • Interval 0.0 to 12.36	-0.20 units on a scale Standard Error 0.644 • Interval 0.0 to 25.63
Change From Baseline in DLQI Score Over Time Through Week 52 Week 4 (n=86,88,44,42)	-2.26 units on a scale Standard Error 0.712	-5.96 units on a scale Standard Error 0.492 • Interval 5.72 to 29.28	-5.11 units on a scale Standard Error 0.488 • Interval 0.77 to 20.28	0.17 units on a scale Standard Error 0.700 • Interval 0.0 to 25.63
Change From Baseline in DLQI Score Over Time Through Week 52 Week 8 (n=85,88,40,39)	-2.70 units on a scale Standard Error 0.868 • Interval 0.0 to 16.14	-7.52 units on a scale Standard Error 0.594 • Interval 13.66 to 41.34	-5.83 units on a scale Standard Error 0.587 • Interval 2.41 to 23.91	-1.00 units on a scale Standard Error 0.852 • Interval 0.0 to 25.63
Change From Baseline in DLQI Score Over Time Through Week 52 Week 12 (n=84,88,39,39)	-2.44 units on a scale Standard Error 0.904 • Interval 0.0 to 33.88	-8.59 units on a scale Standard Error 0.618 • Interval 15.8 to 44.2	-6.64 units on a scale Standard Error 0.609 • Interval 4.2 to 27.38	-0.76 units on a scale Standard Error 0.891 • Interval 0.0 to 25.63
Change From Baseline in DLQI Score Over Time Through Week 52 Week 20 (n=82,84,38,39)	-6.30 units on a scale Standard Error 0.821	-9.36 units on a scale Standard Error 0.562	-7.78 units on a scale Standard Error 0.555	-5.84 units on a scale Standard Error 0.819
Change From Baseline in DLQI Score Over Time Through Week 52 Week 32 (n=83,82,38,37)	-7.94 units on a scale Standard Error 0.837	-10.05 units on a scale Standard Error 0.565	-8.07 units on a scale Standard Error 0.562	-7.44 units on a scale Standard Error 0.828
Change From Baseline in DLQI Score Over Time Through Week 52 Week 40 (n=81,81,37,36)	-8.28 units on a scale Standard Error 0.836	-9.56 units on a scale Standard Error 0.563	-7.32 units on a scale Standard Error 0.559	-7.61 units on a scale Standard Error 0.826
Change From Baseline in DLQI Score Over Time Through Week 52 Week 52 (n=80,78,35,36)	-6.37 units on a scale Standard Error 1.010	-8.63 units on a scale Standard Error 0.679	-6.63 units on a scale Standard Error 0.681	-7.42 units on a scale Standard Error 1.012

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.

The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe). the percentage of participants with scores of 0 (clear) and 1 (almost clear) are reported.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 2	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 4	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	7.78 percentage of participants Interval 2.24 to 13.31	5.68 percentage of participants Interval 0.85 to 10.52	2.27 percentage of participants Interval 0.0 to 6.68
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 8	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	32.22 percentage of participants Interval 22.57 to 41.88	19.32 percentage of participants Interval 11.07 to 27.57	2.27 percentage of participants Interval 0.0 to 6.68
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 12	0.00 percentage of participants It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.	45.56 percentage of participants Interval 35.27 to 55.84	27.27 percentage of participants Interval 17.97 to 36.58	2.27 percentage of participants Interval 0.0 to 6.68
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 16	4.55 percentage of participants Interval 0.0 to 10.7	55.56 percentage of participants Interval 45.29 to 65.82	34.09 percentage of participants Interval 24.19 to 43.99	9.09 percentage of participants Interval 0.6 to 17.59
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 20	13.64 percentage of participants Interval 3.5 to 23.78	52.22 percentage of participants Interval 41.9 to 62.54	31.82 percentage of participants Interval 22.09 to 41.55	18.18 percentage of participants Interval 6.79 to 29.58
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 32	31.82 percentage of participants Interval 18.06 to 45.58	56.67 percentage of participants Interval 46.43 to 66.9	34.09 percentage of participants Interval 24.19 to 43.99	45.45 percentage of participants Interval 30.74 to 60.17
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 40	40.91 percentage of participants Interval 26.38 to 55.44	52.22 percentage of participants Interval 41.9 to 62.54	34.09 percentage of participants Interval 24.19 to 43.99	50.00 percentage of participants Interval 35.23 to 64.77
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 Week 52	29.55 percentage of participants Interval 16.06 to 43.03	51.11 percentage of participants Interval 40.78 to 61.44	26.14 percentage of participants Interval 16.96 to 35.32	47.73 percentage of participants Interval 32.97 to 62.49

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 32, 40, 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a worse health state.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 Week 52 (n=80,78,35,36)	0.887 units on a scale Standard Deviation 0.1626 • Interval 0.0 to 10.7	0.938 units on a scale Standard Deviation 0.1303 • Interval 45.29 to 65.82	0.893 units on a scale Standard Deviation 0.1719 • Interval 24.19 to 43.99	0.941 units on a scale Standard Deviation 0.1118 • Interval 0.6 to 17.59
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 Baseline (n=90,88,44,44)	0.741 units on a scale Standard Deviation 0.2183	0.784 units on a scale Standard Deviation 0.2088	0.797 units on a scale Standard Deviation 0.1991	0.779 units on a scale Standard Deviation 0.1803
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 Week 16 (n=84,83,38,39)	0.817 units on a scale Standard Deviation 0.2108	0.957 units on a scale Standard Deviation 0.0778 • Interval 2.24 to 13.31	0.930 units on a scale Standard Deviation 0.1226 • Interval 0.85 to 10.52	0.905 units on a scale Standard Deviation 0.1191 • Interval 0.0 to 6.68
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 Week 32 (n=83,82,38,37)	0.917 units on a scale Standard Deviation 0.1477	0.955 units on a scale Standard Deviation 0.0796 • Interval 22.57 to 41.88	0.904 units on a scale Standard Deviation 0.1368 • Interval 11.07 to 27.57	0.960 units on a scale Standard Deviation 0.0739 • Interval 0.0 to 6.68
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 Week 40 (n=81,81,37,36)	0.938 units on a scale Standard Deviation 0.1125	0.950 units on a scale Standard Deviation 0.0940 • Interval 35.27 to 55.84	0.918 units on a scale Standard Deviation 0.1177 • Interval 17.97 to 36.58	0.954 units on a scale Standard Deviation 0.0776 • Interval 0.0 to 6.68

SECONDARY outcome

Timeframe: Baseline and weeks 16, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a worse health state.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 Week 32 (n=83,82,38,37)	0.173 units on a scale Standard Deviation 0.2202	0.170 units on a scale Standard Deviation 0.2092 • Interval 22.57 to 41.88	0.109 units on a scale Standard Deviation 0.2347 • Interval 11.07 to 27.57	0.160 units on a scale Standard Deviation 0.1904 • Interval 0.0 to 6.68
Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 Week 16 (n=84,83,38,39)	0.074 units on a scale Standard Deviation 0.2391	0.172 units on a scale Standard Deviation 0.2164 • Interval 2.24 to 13.31	0.128 units on a scale Standard Deviation 0.2108 • Interval 0.85 to 10.52	0.105 units on a scale Standard Deviation 0.1824 • Interval 0.0 to 6.68
Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 Week 40 (n=81,81,37,36)	0.192 units on a scale Standard Deviation 0.2103	0.168 units on a scale Standard Deviation 0.2159 • Interval 35.27 to 55.84	0.120 units on a scale Standard Deviation 0.2322 • Interval 17.97 to 36.58	0.159 units on a scale Standard Deviation 0.1937 • Interval 0.0 to 6.68
Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 Week 52 (n=80,78,35,36)	0.142 units on a scale Standard Deviation 0.2328 • Interval 0.0 to 10.7	0.156 units on a scale Standard Deviation 0.2071 • Interval 45.29 to 65.82	0.101 units on a scale Standard Deviation 0.2477 • Interval 24.19 to 43.99	0.147 units on a scale Standard Deviation 0.2136 • Interval 0.6 to 17.59

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 Baseline (n=90,88,44,44)	67.4 units on a scale Standard Deviation 21.92	65.8 units on a scale Standard Deviation 24.90	69.5 units on a scale Standard Deviation 19.84	66.4 units on a scale Standard Deviation 23.09
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 Week 16 (n=84,83,38,39)	68.4 units on a scale Standard Deviation 20.20	83.7 units on a scale Standard Deviation 15.30 • Interval 2.24 to 13.31	78.9 units on a scale Standard Deviation 15.41 • Interval 0.85 to 10.52	72.3 units on a scale Standard Deviation 22.04 • Interval 0.0 to 6.68
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 Week 32 (n=83,82,38,37)	81.7 units on a scale Standard Deviation 17.25	84.5 units on a scale Standard Deviation 16.17 • Interval 22.57 to 41.88	82.4 units on a scale Standard Deviation 16.00 • Interval 11.07 to 27.57	85.2 units on a scale Standard Deviation 14.36 • Interval 0.0 to 6.68
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 Week 40 (n=81,81,37,36)	81.9 units on a scale Standard Deviation 16.03	85.5 units on a scale Standard Deviation 14.45 • Interval 35.27 to 55.84	83.0 units on a scale Standard Deviation 14.35 • Interval 17.97 to 36.58	83.5 units on a scale Standard Deviation 16.86 • Interval 0.0 to 6.68
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 Week 52 (n=80,78,35,36)	80.7 units on a scale Standard Deviation 19.20 • Interval 0.0 to 10.7	82.5 units on a scale Standard Deviation 17.13 • Interval 45.29 to 65.82	80.0 units on a scale Standard Deviation 18.40 • Interval 24.19 to 43.99	85.0 units on a scale Standard Deviation 13.58 • Interval 0.6 to 17.59

SECONDARY outcome

Timeframe: Baseline and weeks 16, 32, 40, and 52

Population: The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 Week 16 (n=84,83,38,39)	-0.6 units on a scale Standard Deviation 21.16	17.5 units on a scale Standard Deviation 25.23 • Interval 2.24 to 13.31	8.8 units on a scale Standard Deviation 21.15 • Interval 0.85 to 10.52	2.6 units on a scale Standard Deviation 22.17 • Interval 0.0 to 6.68
Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 Week 32 (n=83,82,38,37)	12.2 units on a scale Standard Deviation 23.99	18.4 units on a scale Standard Deviation 25.92	13.1 units on a scale Standard Deviation 22.36	15.4 units on a scale Standard Deviation 23.50
Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 Week 40 (n=81,81,37,36)	11.8 units on a scale Standard Deviation 24.46	19.9 units on a scale Standard Deviation 27.07	13.3 units on a scale Standard Deviation 22.31	14.3 units on a scale Standard Deviation 23.19
Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 Week 52 (n=80,78,35,36)	10.7 units on a scale Standard Deviation 21.16	16.1 units on a scale Standard Deviation 26.08	9.9 units on a scale Standard Deviation 24.54	15.2 units on a scale Standard Deviation 22.96

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 16

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 Number of Participants with AEs(All Causalities)	—	61 participants	57 participants	43 participants
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 Number of Participants with SAEs(All Causalities)	—	0 participants	2 participants	0 participants
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 Number of Participants Discontinued due to AEs	—	1 participants	3 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 Number of Participants with AEs (All Causalities)	33 participants	76 participants	74 participants	35 participants
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 Number of Participants with SAEs(All Causalities)	0 participants	2 participants	4 participants	1 participants
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 Number of Participants Discontinued due to AEs	1 participants	1 participants	3 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 16

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

Study drugs were to be discontinued and the participant withdrawn for: 2 sequential absolute neutrophil counts (ANC) <1.0 X 10^9/L (1000/mm^3); 2 sequential absolute lymphocyte counts <0.5 X 10^9/L; 2 sequential hemoglobin values <9.0 g/dL and/or decreases of >30% from baseline value; 2 sequential platelet counts <75 X 10^9/L; 2 sequential AST or ALT elevations ≥3X ULN with at least 1 total bilirubin value ≥2X ULN (reason #1); 2 sequential AST or ALT elevations ≥5X ULN regardless of total bilirubin or accompanying signs or symptoms (reason #2); 2 sequential increases in serum creatinine >50% and an increase in serum creatinine >0.5 mg/dL over the average of screening and baseline values; 2 sequential CK elevations >10X ULN.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 Sequential absolute neutrophil count	—	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 Sequential absolute lymphocyte count	—	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 Sequential hemoglobin	—	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 Sequential platelet count	—	2 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 Sequential AST or ALT reason #1	—	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 Sequential AST or ALT reason #2	—	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 Sequential serum creatinine	—	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 2 sequential creatine kinase	—	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

Study drugs were to be discontinued and the participant withdrawn for: 2 sequential absolute neutrophil counts (ANC) <1.0 X 10^9/L (1000/mm^3); 2 sequential absolute lymphocyte counts <0.5 X 10^9/L; 2 sequential hemoglobin values <9.0 g/dL and/or decreases of >30% from baseline value; 2 sequential platelet counts <75 X 10^9/L; 2 sequential AST or ALT elevations ≥3X ULN with at least 1 total bilirubin value ≥2X ULN (reason #1); 2 sequential AST or ALT elevations ≥5X ULN regardless of total bilirubin or accompanying signs or symptoms (reason #2); 2 sequential increases in serum creatinine >50% and an increase in serum creatinine >0.5 mg/dL over the average of screening and baseline values; 2 sequential CK elevations >10X ULN.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 Sequential absolute neutrophil count	0 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 Sequential absolute lymphocyte count	0 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 Sequential hemoglobin	0 participants	1 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 Sequential platelet count	1 participants	2 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 Sequential AST or ALT reason #1	0 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 Sequential AST or ALT reason #2	0 participants	0 participants	1 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 Sequential serum creatinine	0 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 2 sequential creatine kinase	0 participants	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 16

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo; n=number of participants evaluated against criteria.

Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), heart rate less than (<)40 or greater than (>)120 bpm; sitting systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or sitting SBP <90 mmHg, sitting diastolic blood pressure (DBP) >=20 mmHg change from baseline or sitting DBP <50 mmHg.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Sitting SBP <90 mmHg (n=87,88,86)	—	1 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Sitting DBP <50 mmHg (n=87,88,86)	—	0 participants	0 participants	1 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Heart Rate <40 or >120 bpm (n=73,74,68)	—	0 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Pulse Rate <40 or >120 bpm (n=84,85,82)	—	0 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Sitting SBP max Increase >=30 Hg(n=87,88,86)	—	1 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Sitting DBP max Increase >=20 mmHg(n=87,88,86)	—	0 participants	1 participants	1 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Sitting SBP max Decrease >=30 mmHg(n=87,88,86)	—	3 participants	2 participants	2 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 Sitting DBP max Decrease >=20 mmHg(n=87,88,86)	—	2 participants	5 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo; n=number of evaluable participants at the specified time point.

Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), heart rate less than (<)40 or greater than (>)120 bpm; sitting systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or sitting SBP <90 mmHg, sitting diastolic blood pressure (DBP) >=20 mmHg change from baseline or sitting DBP <50 mmHg.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Sitting SBP <90 mmHg (n=87,88,44,42)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Sitting DBP <50 mmHg (n=87,88,44,42)	1 participants	0 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Heart Rate <40 or >120 bpm (n=74,75,35,34)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Pulse Rate <40 or >120 bpm (n=86,85,42,40)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Sitting SBP max Increase >=30 Hg(n=87,88,44,42)	2 participants	5 participants	1 participants	1 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Sitting DBP max Increase >=20 mmHg(n=87,88,44,42)	1 participants	5 participants	4 participants	2 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Sitting SBP max Decrease >=30 mmHg(n=87,88,44,42)	1 participants	4 participants	3 participants	2 participants
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 Sitting DBP max Decrease >=20 mmHg(n=87,88,44,42)	1 participants	3 participants	8 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 16

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

CV event categories included: cerebrovascular accident (CVA), coronary revascularization procedure (percutaneous transluminal coronary angioplasty [PTCA], percutaneous coronary intervention [PCI], coronary bypass grafting [CABG], heart failure, major adverse cardiac events (MACE), myocardial infarction (MI), new ischemic heart disease, peripheral vascular disease (first diagnosis). MACE included any MI, CVA (stroke or transient ischemic attack), or CV death.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 Cerebrovascular Accident	—	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 Coronary Revascularization Procedure	—	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 Heart Failure	—	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 MACE	—	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 Myocardial Infarction	—	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 New Ischemic Heart Disease	—	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 Peripheral Vascular Disease	—	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 Non-CV Death	—	0 participants	1 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 52

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

CV event categories included: cerebrovascular accident (CVA), coronary revascularization procedure (percutaneous transluminal coronary angioplasty [PTCA], percutaneous coronary intervention [PCI], coronary bypass grafting [CABG], heart failure, major adverse cardiac events (MACE), myocardial infarction (MI), new ischemic heart disease, peripheral vascular disease (first diagnosis). MACE included any MI, CVA (stroke or transient ischemic attack), or CV death.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 Cerebrovascular Accident	0 participants	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 Coronary Revascularization Procedure	0 participants	0 participants	1 participants	1 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 Heart Failure	0 participants	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 MACE	0 participants	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 Myocardial Infarction	0 participants	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 New Ischemic Heart Disease	0 participants	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 Peripheral Vascular Disease	0 participants	0 participants	0 participants	0 participants
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 Non-CV Death	0 participants	0 participants	1 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 16

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=88 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16	—	0 participants	1 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.

As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.

Outcome measures

Measure	Placebo to Tofacitinib 5 mg n=44 Participants Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Tofacitinib 10 mg n=90 Participants Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 Participants Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo n=44 Participants Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52	0 participants	1 participants	1 participants	0 participants

Adverse Events

Tofacitinib 10 mg

Serious events: 2 serious events

Other events: 59 other events

Deaths: 0 deaths

Tofacitinib 5 mg

Serious events: 4 serious events

Other events: 60 other events

Deaths: 0 deaths

Placebo to Tofacitinib 10 mg

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo to Tofacitinib 5 mg

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tofacitinib 10 mg n=90 participants at risk Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 participants at risk Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo to Tofacitinib 10 mg n=44 participants at risk Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.	Placebo to Tofacitinib 5 mg n=44 participants at risk Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Placebo n=88 participants at risk Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Infections and infestations Urinary tract infection	0.00% 0/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	1.1% 1/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	1.1% 1/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Infections and infestations Bronchopneumonia	1.1% 1/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	1.1% 1/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	1.1% 1/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	1.1% 1/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.

Other adverse events

Measure	Tofacitinib 10 mg n=90 participants at risk Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Tofacitinib 5 mg n=88 participants at risk Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.	Placebo to Tofacitinib 10 mg n=44 participants at risk Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.	Placebo to Tofacitinib 5 mg n=44 participants at risk Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.	Placebo n=88 participants at risk Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
Injury, poisoning and procedural complications Maternal exposure during pregnancy	0.00% 0/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.3% 1/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	7.1% 1/14 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/12 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/26 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Alanine aminotransferase increased	10.0% 9/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 4/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Aspartate aminotransferase increased	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	3.4% 3/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Gastrointestinal disorders Diarrhoea	7.8% 7/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 6/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 2/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Infections and infestations Nasopharyngitis	12.2% 11/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	13.6% 12/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	13.6% 6/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	20.5% 9/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	3.4% 3/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Infections and infestations Upper respiratory tract infection	12.2% 11/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	20.5% 18/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	11.4% 5/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	15.9% 7/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	3.4% 3/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Blood cholesterol increased	16.7% 15/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	10.2% 9/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 2/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Blood triglycerides increased	8.9% 8/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	12.5% 11/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	9.1% 4/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 2/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 2/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Metabolism and nutrition disorders Hyperlipidaemia	16.7% 15/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	14.8% 13/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	18.2% 8/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	15.9% 7/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	10.2% 9/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Reproductive system and breast disorders Hypomenorrhoea	0.00% 0/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	8.7% 2/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/14 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/12 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/26 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 6/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 4/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	11.4% 5/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	11.4% 5/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	5.7% 5/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Skin and subcutaneous tissue disorders Psoriasis	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	1.1% 1/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	5.7% 5/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Gastrointestinal disorders Toothache	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	1.1% 1/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Infections and infestations Folliculitis	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Infections and infestations Herpes zoster	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	3.4% 3/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 2/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Infections and infestations Influenza	2.2% 2/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 2/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Blood creatine phosphokinase increased	7.8% 7/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	5.7% 5/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 2/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Gamma-glutamyltransferase increased	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 4/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Hepatic enzyme increased	6.7% 6/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 2/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	2.3% 1/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Low density lipoprotein increased	8.9% 8/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 6/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 2/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Investigations Protein urine present	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 4/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	4.5% 2/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 5/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	3.4% 3/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Reproductive system and breast disorders Menstruation irregular	4.3% 1/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	8.7% 2/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/14 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	8.3% 1/12 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/26 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/23 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/14 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	8.3% 1/12 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/26 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Psychiatric disorders Insomnia	0.00% 0/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Renal and urinary disorders Proteinuria	2.2% 2/90 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	1.1% 1/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	6.8% 3/44 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.	0.00% 0/88 • Baseline up to Week 52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER