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).

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 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.

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.

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.

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 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.

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 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.

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 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).

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.

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 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.

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 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.

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 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).

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 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).

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. 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).

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 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.

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 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.

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%.

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 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).

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). Percentage of participants with each PGA score is reported.

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 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.

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.

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.

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.

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.

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.

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.

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.

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. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI50 response is reported.

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.

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. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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