Psoriasis
Conditions
Keywords
Tofacitinib, CP-690, 550, Xeljanz, Jak-Inhibitor, Oral Treatment, Psoriasis vulgaris, Pruritus, Itch, DLQI, moderate, severe, chronic, plaque psoriasis
Brief summary
The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Interventions
DRUGplacebo
placebo BID for 16 weeks and then re-randomized into active groups
DRUGCP-690,550
CP-690,550 5mg BID for 52 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to the first screening procedure. * Have a PASI score of 12 or greater AND a PGA score of 3 (moderate) or 4 (severe) at Baseline (Day 1). * Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).
Exclusion criteria
* Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed. * Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium. * Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 16 | Week 16 | 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). |
| Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Weeks 8, 16, 20, 32, 40, and 52 | 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. |
| Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Weeks 8, 16, 20, 32, 40, and 52 | 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. |
| Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Change From Baseline in ISI Score Over Time Through Week 52 | Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Change From Baseline in DLQI Score Over Time Through Week 52 | Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Baseline, Weeks 16, 32, 40, 52 | 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. |
| Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Baseline and weeks 16, 32, 40, and 52 | 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. |
| Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Baseline and Weeks 16, 32, 40, and 52 | 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. |
| Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Baseline and weeks 16, 32, 40, and 52 | 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. |
| Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 | Baseline to Week 16 | 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. |
| Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16 | Week 16 | 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. |
| Change From Baseline in DLQI Total Score at Week 16 | Baseline to Week 16 | 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. |
| Percentage of Participants With PGA Score of Clear or Almost Clear at Week 4 | Week 4 | 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). |
| Percentage of Participants Achieving PASI75 Response at Week 4 | Week 4 | 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. |
| Change From Baseline in DLQI Total Score at Week 4 | Baseline to Week 4 | 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. |
| Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline | Baseline to Week 16 | 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. |
| Percentage of Participants Maintaining PGA Score of Clear or Almost Clear at Week 52 Among Participants Achieving PGA Response at Week 16 | Week 16 to Week 52 | 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). |
| Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16 | Week 16 to Week 52 | 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). |
| Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16 | Week 16 to Week 52 | 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). |
| Time to PGA Response up to Week 16 | Baseline to Week 16 | 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. |
| Time to PASI75 Response up to Week 16 | Baseline up to Week 16 | 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. |
| Time to PASI50 Response up to Week 16 | Baseline up to Week 16 | 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%. |
| Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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). |
| Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Actual PASI Scores Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52 | 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. |
| Change From Baseline in PASI Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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 Component Scores Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Change From Baseline in PASI Component Scores Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Actual BSA Over Time Through Week 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Percent Change From Baseline in BSA Over Time Through Week 52 | Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Percentage of Participants With PASI50 Response Over Time Through Week 52 | Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Percentage of Participants With PASI90 Response Over Time Through Week 52 | Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Percentage of Participants With PASI125 Over Time Through Week 52 | Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52 | 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. |
| Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Baseline and Weeks 8, 16, 20, 32, 40, and 52 | 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. |
| Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Baseline and weeks 8, 16, 20, 32, 40, and 52 | 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 Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Baseline and Weeks 8, 16, 20, 32, 40, and 52 | 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. |
| Percent Change From Baseline in NAPSI Over Time Through Week 52 | Baseline and weeks 8, 16, 20, 32, 40, and 52 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | Baseline up to Week 52 | 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. |
| Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16 | Baseline to Week 16 | 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. |
| Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52 | Baseline to Week 52 | 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. |
| Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Baseline to Week 16 | 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. |
| Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Baseline up to Week 52 | 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. |
| Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16 | Baseline to Week 16 | As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee. |
| Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52 | Baseline to Week 52 | As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee. |
| Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Baseline to Week 16 | 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. |
| Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | Baseline to Week 16 | 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. |
| Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Baseline to Week 52 | 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. |
Countries
China, South Korea, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib 10 mg Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52. | 90 |
| Tofacitinib 5 mg Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52. | 88 |
| 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). | 88 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| 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 | Insufficient Clinical Response | 2 | 0 | 4 | 0 | 0 |
| Week 0 to 16 | Lost to Follow-up | 0 | 1 | 0 | 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 | Withdrawal by Subject | 0 | 0 | 1 | 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 | Other | 0 | 1 | 0 | 0 | 0 |
| Week 16 to 52 | Withdrawal by Subject | 1 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Tofacitinib 10 mg | Tofacitinib 5 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 12 | 40.7 years STANDARD_DEVIATION 11.3 | 41.7 years STANDARD_DEVIATION 13.7 | 41.1 years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 26 Participants | 72 Participants |
| Sex: Female, Male Male | 67 Participants | 65 Participants | 62 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 59 / 90 | 60 / 88 | 25 / 44 | 31 / 44 | 23 / 88 |
| serious Total, serious adverse events | 2 / 90 | 4 / 88 | 1 / 44 | 0 / 44 | 0 / 88 |
Outcome results
Primary
Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 | 81.11 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 | 54.55 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 | 12.50 percentage of participants |
Comparison: For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [14.84, 151.11]Cochran-Mantel-Haenszel
Comparison: For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [4.06, 25.17]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 16
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 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 |
| Tofacitinib 5 mg | Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 16 | 52.27 percentage of participants |
| Placebo | Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 16 | 19.32 percentage of participants |
Comparison: For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [6.03, 32.77]Cochran-Mantel-Haenszel
Comparison: For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [2.46, 11.86]Cochran-Mantel-Haenszel
Secondary
Actual BSA Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 27.82 percent BSA | Standard Deviation 18.599 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 3.22 percent BSA | Standard Deviation 5.894 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Baseline (n=90,88,44,44) | 36.36 percent BSA | Standard Deviation 18.035 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 10.59 percent BSA | Standard Deviation 15.486 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 17.62 percent BSA | Standard Deviation 18.411 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 2 (n=88,86,44,44) | 33.95 percent BSA | Standard Deviation 17.537 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 5.05 percent BSA | Standard Deviation 10.041 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 2.56 percent BSA | Standard Deviation 5.412 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 7.57 percent BSA | Standard Deviation 13.395 |
| Tofacitinib 10 mg | Actual BSA Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 3.83 percent BSA | Standard Deviation 7.908 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 24.38 percent BSA | Standard Deviation 19.583 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 10.32 percent BSA | Standard Deviation 13.077 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Baseline (n=90,88,44,44) | 37.41 percent BSA | Standard Deviation 19.614 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 10.94 percent BSA | Standard Deviation 15.255 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 32.75 percent BSA | Standard Deviation 18.314 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 11.47 percent BSA | Standard Deviation 16.304 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 20.45 percent BSA | Standard Deviation 20.462 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 16.52 percent BSA | Standard Deviation 18.899 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 13.69 percent BSA | Standard Deviation 16.976 |
| Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 2 (n=88,86,44,44) | 36.56 percent BSA | Standard Deviation 19.363 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 38.32 percent BSA | Standard Deviation 19.355 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 5.00 percent BSA | Standard Deviation 7.686 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 15.50 percent BSA | Standard Deviation 16.522 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 28.57 percent BSA | Standard Deviation 21.645 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 5.88 percent BSA | Standard Deviation 8.351 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 2 (n=88,86,44,44) | 36.84 percent BSA | Standard Deviation 18.808 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 36.75 percent BSA | Standard Deviation 19.817 |
| Placebo | Actual BSA Over Time Through Week 52 | Baseline (n=90,88,44,44) | 35.29 percent BSA | Standard Deviation 18.294 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 6.95 percent BSA | Standard Deviation 10.262 |
| Placebo | Actual BSA Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 33.15 percent BSA | Standard Deviation 20.483 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 7.87 percent BSA | Standard Deviation 9.584 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 34.99 percent BSA | Standard Deviation 16.182 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Baseline (n=90,88,44,44) | 36.25 percent BSA | Standard Deviation 16.018 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 2 (n=88,86,44,44) | 36.38 percent BSA | Standard Deviation 16.592 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 36.30 percent BSA | Standard Deviation 16.916 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 34.06 percent BSA | Standard Deviation 17.142 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 34.54 percent BSA | Standard Deviation 18.293 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 24.83 percent BSA | Standard Deviation 19.044 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 9.03 percent BSA | Standard Deviation 11.781 |
| Placebo to Tofacitinib 5 mg | Actual BSA Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 6.35 percent BSA | Standard Deviation 9.462 |
Secondary
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 3.2 units on a scale | Standard Deviation 4.39 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 9.5 units on a scale | Standard Deviation 5.31 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 12 (n=84,88,39,39) | 4.6 units on a scale | Standard Deviation 4.47 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 5.9 units on a scale | Standard Deviation 5.49 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 20 (n=82,84,38,39) | 3.8 units on a scale | Standard Deviation 4.46 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Baseline (n=90,88,44,44) | 14.1 units on a scale | Standard Deviation 7.17 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 4 (n=86,88,42,41) | 7.6 units on a scale | Standard Deviation 5 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 4.6 units on a scale | Standard Deviation 5.83 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 4.3 units on a scale | Standard Deviation 4.7 |
| Tofacitinib 10 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 3.7 units on a scale | Standard Deviation 4.37 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 5.1 units on a scale | Standard Deviation 5.31 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Baseline (n=90,88,44,44) | 13.5 units on a scale | Standard Deviation 7.29 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 5.9 units on a scale | Standard Deviation 5.44 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 6.5 units on a scale | Standard Deviation 6.25 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 4 (n=86,88,42,41) | 8.2 units on a scale | Standard Deviation 5.46 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 7.5 units on a scale | Standard Deviation 5.89 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 12 (n=84,88,39,39) | 6.7 units on a scale | Standard Deviation 6.16 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 6.2 units on a scale | Standard Deviation 5.62 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 10.0 units on a scale | Standard Deviation 6.2 |
| Tofacitinib 5 mg | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 20 (n=82,84,38,39) | 5.4 units on a scale | Standard Deviation 5.5 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 4 (n=86,88,42,41) | 12.4 units on a scale | Standard Deviation 7.99 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 4.7 units on a scale | Standard Deviation 5.85 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 20 (n=82,84,38,39) | 6.2 units on a scale | Standard Deviation 4.8 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 10.7 units on a scale | Standard Deviation 7.2 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 12.6 units on a scale | Standard Deviation 7.34 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 4.6 units on a scale | Standard Deviation 5.07 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 11.2 units on a scale | Standard Deviation 7.25 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Baseline (n=90,88,44,44) | 12.5 units on a scale | Standard Deviation 6.82 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 4.7 units on a scale | Standard Deviation 5.42 |
| Placebo | Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 | Week 12 (n=84,88,39,39) | 11.1 units on a scale | Standard Deviation 7.11 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Actual Itch Severity Item (ISI) Score Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Baseline (n=88,88,44,44) | 5.66 units on a scale | Standard Deviation 2.586 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 2 (n=87,86,44,42) | 2.97 units on a scale | Standard Deviation 2.043 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 4 (n=88,88,43,42) | 2.13 units on a scale | Standard Deviation 2.061 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 1.47 units on a scale | Standard Deviation 1.9 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 1.24 units on a scale | Standard Deviation 1.565 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 1.17 units on a scale | Standard Deviation 1.782 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 20 (n=83,84,38,38) | 1.06 units on a scale | Standard Deviation 1.564 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 32 (n=838238,37 | 0.88 units on a scale | Standard Deviation 1.273 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.96 units on a scale | Standard Deviation 1.145 |
| Tofacitinib 10 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 1.45 units on a scale | Standard Deviation 2.074 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 4 (n=88,88,43,42) | 2.68 units on a scale | Standard Deviation 2.322 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 2.30 units on a scale | Standard Deviation 2.283 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 2.41 units on a scale | Standard Deviation 2.283 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 2.13 units on a scale | Standard Deviation 2.323 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 2.01 units on a scale | Standard Deviation 2.367 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 20 (n=83,84,38,38) | 2.01 units on a scale | Standard Deviation 2.326 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 2.55 units on a scale | Standard Deviation 2.516 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 32 (n=838238,37 | 2.07 units on a scale | Standard Deviation 2.382 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Baseline (n=88,88,44,44) | 5.10 units on a scale | Standard Deviation 2.679 |
| Tofacitinib 5 mg | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 2 (n=87,86,44,42) | 3.49 units on a scale | Standard Deviation 2.669 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 32 (n=838238,37 | 1.24 units on a scale | Standard Deviation 1.747 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 20 (n=83,84,38,38) | 1.95 units on a scale | Standard Deviation 2.253 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 1.89 units on a scale | Standard Deviation 2.482 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Baseline (n=88,88,44,44) | 5.22 units on a scale | Standard Deviation 2.501 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 4.75 units on a scale | Standard Deviation 2.677 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 3.89 units on a scale | Standard Deviation 2.391 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 1.49 units on a scale | Standard Deviation 2.181 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 2 (n=87,86,44,42) | 5.45 units on a scale | Standard Deviation 2.791 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 4.00 units on a scale | Standard Deviation 2.621 |
| Placebo | Actual Itch Severity Item (ISI) Score Over Time Through Week 52 | Week 4 (n=88,88,43,42) | 5.23 units on a scale | Standard Deviation 2.715 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 2.38 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 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) | 25.8 units on a scale | Standard Deviation 20.58 |
| Tofacitinib 10 mg | 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) | 9.6 units on a scale | Standard Deviation 18.65 |
| Tofacitinib 10 mg | 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) | 12.6 units on a scale | Standard Deviation 19.59 |
| Tofacitinib 10 mg | 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) | 23.0 units on a scale | Standard Deviation 19.45 |
| Tofacitinib 10 mg | 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) | 10.0 units on a scale | Standard Deviation 20.22 |
| Tofacitinib 10 mg | 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) | 17.2 units on a scale | Standard Deviation 19.14 |
| Tofacitinib 10 mg | 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) | 13.9 units on a scale | Standard Deviation 18.7 |
| Tofacitinib 5 mg | 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) | 14.9 units on a scale | Standard Deviation 16.01 |
| Tofacitinib 5 mg | 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) | 17.2 units on a scale | Standard Deviation 16.94 |
| Tofacitinib 5 mg | 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) | 19.8 units on a scale | Standard Deviation 18.3 |
| Tofacitinib 5 mg | 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) | 15.5 units on a scale | Standard Deviation 16.69 |
| Tofacitinib 5 mg | 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) | 13.2 units on a scale | Standard Deviation 17.96 |
| Tofacitinib 5 mg | 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) | 23.6 units on a scale | Standard Deviation 17.29 |
| Tofacitinib 5 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) | 26.2 units on a scale | Standard Deviation 16.97 |
| Placebo | 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) | 28.6 units on a scale | Standard Deviation 24.02 |
| Placebo | 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) | 28.7 units on a scale | Standard Deviation 21.9 |
| Placebo | 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) | 28.6 units on a scale | Standard Deviation 23.66 |
| Placebo | 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) | 30.3 units on a scale | Standard Deviation 23.86 |
| Placebo | 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) | 16.2 units on a scale | Standard Deviation 18.48 |
| Placebo | 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) | 15.7 units on a scale | Standard Deviation 15.82 |
| Placebo | 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) | 13.8 units on a scale | Standard Deviation 18.54 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Actual PASI Scores Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 19.03 percentage of participants | Standard Deviation 9.392 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 3.48 percentage of participants | Standard Deviation 6.722 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 20 (84,84,38,39) | 2.75 percentage of participants | Standard Deviation 5.61 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 2.04 percentage of participants | Standard Deviation 3.553 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 2.15 percentage of participants | Standard Deviation 3.81 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 8.18 percentage of participants | Standard Deviation 9.075 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 13.81 percentage of participants | Standard Deviation 9.826 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Baseline (n=90,88,44,44) | 25.34 percentage of participants | Standard Deviation 9.106 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 4.56 percentage of participants | Standard Deviation 6.979 |
| Tofacitinib 10 mg | Actual PASI Scores Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 2.82 percentage of participants | Standard Deviation 4.674 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 17.41 percentage of participants | Standard Deviation 10.565 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 5.74 percentage of participants | Standard Deviation 6.415 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 6.00 percentage of participants | Standard Deviation 7.313 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 21.23 percentage of participants | Standard Deviation 9.979 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Baseline (n=90,88,44,44) | 25.32 percentage of participants | Standard Deviation 10.185 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 20 (84,84,38,39) | 7.13 percentage of participants | Standard Deviation 8.28 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 10.10 percentage of participants | Standard Deviation 9.858 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 8.42 percentage of participants | Standard Deviation 9.8 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 12.56 percentage of participants | Standard Deviation 10.623 |
| Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 6.23 percentage of participants | Standard Deviation 7.817 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 21.38 percentage of participants | Standard Deviation 11.689 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 2.79 percentage of participants | Standard Deviation 4.458 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 3.11 percentage of participants | Standard Deviation 5.027 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 24.81 percentage of participants | Standard Deviation 12.081 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Baseline (n=90,88,44,44) | 25.62 percentage of participants | Standard Deviation 10.429 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 3.09 percentage of participants | Standard Deviation 5.434 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 17.83 percentage of participants | Standard Deviation 10.503 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 15.27 percentage of participants | Standard Deviation 11.441 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 20 (84,84,38,39) | 6.52 percentage of participants | Standard Deviation 6.512 |
| Placebo | Actual PASI Scores Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 25.72 percentage of participants | Standard Deviation 10.582 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 4.69 percentage of participants | Standard Deviation 4.607 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Baseline (n=90,88,44,44) | 26.51 percentage of participants | Standard Deviation 8.525 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 26.34 percentage of participants | Standard Deviation 9.456 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 24.65 percentage of participants | Standard Deviation 9.433 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 22.46 percentage of participants | Standard Deviation 8.966 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 21.35 percentage of participants | Standard Deviation 9.477 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 20.64 percentage of participants | Standard Deviation 9.738 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 20 (84,84,38,39) | 10.43 percentage of participants | Standard Deviation 7.612 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 4.82 percentage of participants | Standard Deviation 5.517 |
| Placebo to Tofacitinib 5 mg | Actual PASI Scores Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 3.74 percentage of participants | Standard Deviation 4.54 |
Secondary
Change From Baseline in DLQI Score Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | -10.05 units on a scale | Standard Error 0.565 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 20 (n=82,84,38,39) | -9.36 units on a scale | Standard Error 0.562 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | -8.63 units on a scale | Standard Error 0.679 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 12 (n=84,88,39,39) | -8.59 units on a scale | Standard Error 0.618 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -7.52 units on a scale | Standard Error 0.594 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 4 (n=86,88,44,42) | -5.96 units on a scale | Standard Error 0.492 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -9.56 units on a scale | Standard Error 0.563 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -9.03 units on a scale | Standard Error 0.618 |
| Tofacitinib 10 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 2 (n=88,86,44,42) | -3.98 units on a scale | Standard Error 0.455 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -7.00 units on a scale | Standard Error 0.611 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | -8.07 units on a scale | Standard Error 0.562 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 20 (n=82,84,38,39) | -7.78 units on a scale | Standard Error 0.555 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 4 (n=86,88,44,42) | -5.11 units on a scale | Standard Error 0.488 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 2 (n=88,86,44,42) | -3.26 units on a scale | Standard Error 0.458 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -5.83 units on a scale | Standard Error 0.587 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | -6.63 units on a scale | Standard Error 0.681 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -7.32 units on a scale | Standard Error 0.559 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 12 (n=84,88,39,39) | -6.64 units on a scale | Standard Error 0.609 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -1.15 units on a scale | Standard Error 0.899 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 2 (n=88,86,44,42) | -0.20 units on a scale | Standard Error 0.644 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 4 (n=86,88,44,42) | 0.17 units on a scale | Standard Error 0.7 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -1.00 units on a scale | Standard Error 0.852 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 12 (n=84,88,39,39) | -0.76 units on a scale | Standard Error 0.891 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 20 (n=82,84,38,39) | -5.84 units on a scale | Standard Error 0.819 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | -7.44 units on a scale | Standard Error 0.828 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -7.61 units on a scale | Standard Error 0.826 |
| Placebo | Change From Baseline in DLQI Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | -7.42 units on a scale | Standard Error 1.012 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 1.01 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Change From Baseline in DLQI Total Score at Week 16
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in DLQI Total Score at Week 16 | -9.10 scores on a scale | Standard Error 0.635 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Total Score at Week 16 | -7.03 scores on a scale | Standard Error 0.627 |
| Placebo | Change From Baseline in DLQI Total Score at Week 16 | -1.57 scores on a scale | Standard Error 0.655 |
Comparison: Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [-9.32, 5.72]Mixed Models Analysis
Comparison: Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [-7.24, -3.67]Mixed Models Analysis
Secondary
Change From Baseline in DLQI Total Score at Week 4
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in DLQI Total Score at Week 4 | -6.03 scores on a scale | Standard Error 0.497 |
| Tofacitinib 5 mg | Change From Baseline in DLQI Total Score at Week 4 | -5.14 scores on a scale | Standard Error 0.493 |
| Placebo | Change From Baseline in DLQI Total Score at Week 4 | -0.94 scores on a scale | Standard Error 0.504 |
Comparison: Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [-6.49, -3.7]Mixed Models Analysis
Comparison: Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [-5.59, -2.81]Mixed Models Analysis
Secondary
Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 0.170 units on a scale | Standard Deviation 0.2092 |
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.168 units on a scale | Standard Deviation 0.2159 |
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 0.172 units on a scale | Standard Deviation 0.2164 |
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 0.156 units on a scale | Standard Deviation 0.2071 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 0.128 units on a scale | Standard Deviation 0.2108 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 0.109 units on a scale | Standard Deviation 0.2347 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.120 units on a scale | Standard Deviation 0.2322 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 0.101 units on a scale | Standard Deviation 0.2477 |
| Placebo | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 0.160 units on a scale | Standard Deviation 0.1904 |
| Placebo | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 0.147 units on a scale | Standard Deviation 0.2136 |
| Placebo | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.159 units on a scale | Standard Deviation 0.1937 |
| Placebo | Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 0.105 units on a scale | Standard Deviation 0.1824 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 16.1 units on a scale | Standard Deviation 26.08 |
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 17.5 units on a scale | Standard Deviation 25.23 |
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 18.4 units on a scale | Standard Deviation 25.92 |
| Tofacitinib 10 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 19.9 units on a scale | Standard Deviation 27.07 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 8.8 units on a scale | Standard Deviation 21.15 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 13.1 units on a scale | Standard Deviation 22.36 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 13.3 units on a scale | Standard Deviation 22.31 |
| Tofacitinib 5 mg | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 9.9 units on a scale | Standard Deviation 24.54 |
| Placebo | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 15.4 units on a scale | Standard Deviation 23.5 |
| Placebo | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 2.6 units on a scale | Standard Deviation 22.17 |
| Placebo | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 14.3 units on a scale | Standard Deviation 23.19 |
| Placebo | Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 15.2 units on a scale | Standard Deviation 22.96 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Change From Baseline in ISI Score Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 32 (n=82,82,38,37) | -4.51 units on a scale | Standard Error 0.22 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 20 (n=82,84,38,38) | -4.32 units on a scale | Standard Error 0.219 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 52 (n=79,78,36,36) | -3.91 units on a scale | Standard Error 0.272 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 12 (n=83,88,40,39) | -4.10 units on a scale | Standard Error 0.237 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 8 (n=84,88,40,39) | -3.93 units on a scale | Standard Error 0.232 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -3.33 units on a scale | Standard Error 0.226 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 40 (n=80,81,37,36) | -4.39 units on a scale | Standard Error 0.224 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 16 (n=83,84,38,39) | -4.21 units on a scale | Standard Error 0.232 |
| Tofacitinib 10 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 2 (n=86,86,44,42) | -2.50 units on a scale | Standard Error 0.219 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 16 (n=83,84,38,39) | -3.28 units on a scale | Standard Error 0.229 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 32 (n=82,82,38,37) | -3.17 units on a scale | Standard Error 0.219 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 20 (n=82,84,38,38) | -3.28 units on a scale | Standard Error 0.216 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -2.60 units on a scale | Standard Error 0.224 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 2 (n=86,86,44,42) | -1.76 units on a scale | Standard Error 0.218 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 8 (n=84,88,40,39) | -2.88 units on a scale | Standard Error 0.228 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 52 (n=79,78,36,36) | -2.71 units on a scale | Standard Error 0.272 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 40 (n=80,81,37,36) | -2.98 units on a scale | Standard Error 0.222 |
| Tofacitinib 5 mg | Change From Baseline in ISI Score Over Time Through Week 52 | Week 12 (n=83,88,40,39) | -3.16 units on a scale | Standard Error 0.233 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 16 (n=83,84,38,39) | -1.30 units on a scale | Standard Error 0.335 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 2 (n=86,86,44,42) | 0.12 units on a scale | Standard Error 0.306 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -0.03 units on a scale | Standard Error 0.319 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 8 (n=84,88,40,39) | -0.50 units on a scale | Standard Error 0.331 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 12 (n=83,88,40,39) | -1.15 units on a scale | Standard Error 0.338 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 20 (n=82,84,38,38) | -3.22 units on a scale | Standard Error 0.318 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 32 (n=82,82,38,37) | -4.01 units on a scale | Standard Error 0.322 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 40 (n=80,81,37,36) | -3.81 units on a scale | Standard Error 0.328 |
| Placebo | Change From Baseline in ISI Score Over Time Through Week 52 | Week 52 (n=79,78,36,36) | -3.47 units on a scale | Standard Error 0.401 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 0.32 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 8 (n=39,38,15,15) | -3.60 units on a scale | Standard Error 1.416 |
| Tofacitinib 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) | -9.38 units on a scale | Standard Error 1.927 |
| Tofacitinib 10 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 20 (n=37,38,14,15) | -12.68 units on a scale | Standard Error 1.886 |
| Tofacitinib 10 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 32 (n=37,37,14,14) | -14.02 units on a scale | Standard Error 2.35 |
| Tofacitinib 10 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 40 (n=36,36,13,13) | -16.31 units on a scale | Standard Error 2.365 |
| Tofacitinib 10 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 52 (n=31,34,12,13) | -17.13 units on a scale | Standard Error 2.689 |
| Tofacitinib 5 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 52 (n=31,34,12,13) | -13.55 units on a scale | Standard Error 2.651 |
| Tofacitinib 5 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 32 (n=37,37,14,14) | -11.31 units on a scale | Standard Error 2.35 |
| Tofacitinib 5 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 8 (n=39,38,15,15) | -2.76 units on a scale | Standard Error 1.434 |
| Tofacitinib 5 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 20 (n=37,38,14,15) | -9.18 units on a scale | Standard Error 1.884 |
| Tofacitinib 5 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) | -6.63 units on a scale | Standard Error 1.936 |
| Tofacitinib 5 mg | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 40 (n=36,36,13,13) | -11.94 units on a scale | Standard Error 2.359 |
| Placebo | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 16 (n=38,38,14,15) | 2.04 units on a scale | Standard Error 3.151 |
| Placebo | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 20 (n=37,38,14,15) | 0.48 units on a scale | Standard Error 3.079 |
| Placebo | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 32 (n=37,37,14,14) | -11.81 units on a scale | Standard Error 3.834 |
| Placebo | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 52 (n=31,34,12,13) | -15.08 units on a scale | Standard Error 4.387 |
| Placebo | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 40 (n=36,36,13,13) | -13.42 units on a scale | Standard Error 3.876 |
| Placebo | Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline | Week 8 (n=39,38,15,15) | 2.17 units on a scale | Standard Error 2.282 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Change From Baseline in PASI Component Scores Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Trunk) n=88,86,44,42 | -0.65 units on a scale | Standard Deviation 0.728 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Upper Limbs) n=80,78,36,36 | -2.20 units on a scale | Standard Deviation 1.107 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Lower Limbs) n=88,86,44,42 | -0.50 units on a scale | Standard Deviation 0.587 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Trunk) n=84,84,38,39 | -2.23 units on a scale | Standard Deviation 1.09 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Upper Limbs) n=81,81,37,36 | -2.25 units on a scale | Standard Deviation 1.067 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Upper Limbs) n=83,83,38,37 | -2.29 units on a scale | Standard Deviation 1.018 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Lower Limbs) n=87,88,43,42 | -1.07 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Trunk) n=84,88,40,39 | -2.06 units on a scale | Standard Deviation 1.045 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Upper Limbs) n=84,84,38,39 | -2.35 units on a scale | Standard Deviation 1.012 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Upper Limbs) n=84,84,38,39 | -2.32 units on a scale | Standard Deviation 0.867 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Lower Limbs) n=85,88,40,39 | -1.71 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Head/Neck) n=81,81,37,36 | -1.78 units on a scale | Standard Deviation 1.084 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Upper Limbs) n=84,88,40,39 | -2.17 units on a scale | Standard Deviation 0.862 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Upper Limbs) n=85,88,40,39 | -1.69 units on a scale | Standard Deviation 1.024 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Lower Limbs) n=84,88,40,39 | -2.24 units on a scale | Standard Deviation 0.965 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Lower Limbs) n=83,83,38,37 | -2.58 units on a scale | Standard Deviation 0.964 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Upper Limbs) n=87,88,43,42 | -1.17 units on a scale | Standard Deviation 1.048 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Upper Limbs) n=88,86,44,42 | -0.68 units on a scale | Standard Deviation 0.766 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Lower Limbs) n=84,84,38,39 | -2.36 units on a scale | Standard Deviation 1.014 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Trunk) n=85,88,40,39 | -1.79 units on a scale | Standard Deviation 1.124 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Head/Neck) n=80,78,36,36 | -1.68 units on a scale | Standard Deviation 1.178 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Head/Neck) n=81,81,37,36 | -1.75 units on a scale | Standard Deviation 1.124 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Lower Limbs) n=84,84,38,39 | -2.49 units on a scale | Standard Deviation 1 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Trunk) n=87,88,43,42 | -1.22 units on a scale | Standard Deviation 1.104 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Head/Neck) n=83,83,38,37 | -1.71 units on a scale | Standard Deviation 1.121 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Head/Neck) n=84,84,38,39 | -1.81 units on a scale | Standard Deviation 1.058 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Lower Limbs) n=83,83,38,37 | -2.54 units on a scale | Standard Deviation 1.028 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Head/Neck) n=80,78,36,36 | -1.73 units on a scale | Standard Deviation 1.079 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Head/Neck) n=84,84,38,39 | -1.70 units on a scale | Standard Deviation 1.106 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Head/Neck) n=84,88,40,39 | -1.58 units on a scale | Standard Deviation 1.032 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Lower Limbs) n=81,81,37,36 | -2.52 units on a scale | Standard Deviation 1.062 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Lower Limbs) n=84,84,38,39 | -2.51 units on a scale | Standard Deviation 0.963 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Head/Neck) n=85,88,40,39 | -1.38 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Head/Neck) n=87,88,43,42 | -1.07 units on a scale | Standard Deviation 0.974 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Lower Limbs) n=80,78,36,36 | -2.33 units on a scale | Standard Deviation 1.077 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Trunk) n=88,86,44,42 | -0.68 units on a scale | Standard Deviation 0.81 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Head/Neck) n=88,86,44,42 | -0.59 units on a scale | Standard Deviation 0.705 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Upper Limbs) n=80,78,36,36 | -2.25 units on a scale | Standard Deviation 1.175 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Upper Limbs) n=88,86,44,42 | -0.64 units on a scale | Standard Deviation 0.698 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Head/Neck) n=85,88,40,39 | -1.36 units on a scale | Standard Deviation 0.962 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Upper Limbs) n=81,81,37,36 | -2.32 units on a scale | Standard Deviation 1.127 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Upper Limbs) n=83,83,38,37 | -2.37 units on a scale | Standard Deviation 1.009 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Upper Limbs) n=87,88,43,42 | -1.09 units on a scale | Standard Deviation 0.858 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Trunk) n=80,78,36,36 | -2.18 units on a scale | Standard Deviation 1.188 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Upper Limbs) n=84,84,38,39 | -2.35 units on a scale | Standard Deviation 1.047 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Upper Limbs) n=84,84,38,39 | -2.33 units on a scale | Standard Deviation 0.998 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Upper Limbs) n=85,88,40,39 | -1.65 units on a scale | Standard Deviation 0.984 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Lower Limbs) n=84,84,38,39 | -2.50 units on a scale | Standard Deviation 0.912 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Upper Limbs) n=84,88,40,39 | -2.18 units on a scale | Standard Deviation 0.894 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Upper Limbs) n=85,88,40,39 | -1.84 units on a scale | Standard Deviation 1.078 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Upper Limbs) n=84,88,40,39 | -2.08 units on a scale | Standard Deviation 0.908 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Lower Limbs) n=84,88,40,39 | -2.30 units on a scale | Standard Deviation 0.915 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Upper Limbs) n=87,88,43,42 | -1.31 units on a scale | Standard Deviation 1.154 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Upper Limbs) n=88,86,44,42 | -0.72 units on a scale | Standard Deviation 0.843 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Upper Limbs) n=84,84,38,39 | -2.17 units on a scale | Standard Deviation 1.004 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Head/Neck) n=84,88,40,39 | -1.61 units on a scale | Standard Deviation 0.957 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Head/Neck) n=80,78,36,36 | -1.81 units on a scale | Standard Deviation 1.192 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Head/Neck) n=81,81,37,36 | -1.88 units on a scale | Standard Deviation 1.198 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Upper Limbs) n=84,84,38,39 | -2.27 units on a scale | Standard Deviation 1.057 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Lower Limbs) n=80,78,36,36 | -2.33 units on a scale | Standard Deviation 1.111 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Head/Neck) n=83,83,38,37 | -1.92 units on a scale | Standard Deviation 1.073 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Head/Neck) n=84,84,38,39 | -1.98 units on a scale | Standard Deviation 1.075 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Upper Limbs) n=83,83,38,37 | -2.29 units on a scale | Standard Deviation 0.957 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Lower Limbs) n=85,88,40,39 | -1.80 units on a scale | Standard Deviation 1.044 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Head/Neck) n=84,84,38,39 | -1.83 units on a scale | Standard Deviation 1.16 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Head/Neck) n=84,88,40,39 | -1.76 units on a scale | Standard Deviation 1.137 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Upper Limbs) n=81,81,37,36 | -2.26 units on a scale | Standard Deviation 1.081 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Lower Limbs) n=87,88,43,42 | -1.22 units on a scale | Standard Deviation 1.016 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Head/Neck) n=85,88,40,39 | -1.60 units on a scale | Standard Deviation 1.157 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Head/Neck) n=87,88,43,42 | -1.16 units on a scale | Standard Deviation 1.077 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Upper Limbs) n=80,78,36,36 | -2.14 units on a scale | Standard Deviation 1.111 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Head/Neck) n=84,84,38,39 | -1.70 units on a scale | Standard Deviation 1.015 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Head/Neck) n=88,86,44,42 | -0.72 units on a scale | Standard Deviation 0.802 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Lower Limbs) n=80,78,36,36 | -2.43 units on a scale | Standard Deviation 1.041 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Trunk) n=88,86,44,42 | -0.57 units on a scale | Standard Deviation 0.724 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Lower Limbs) n=81,81,37,36 | -2.40 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Lower Limbs) n=81,81,37,36 | -2.57 units on a scale | Standard Deviation 0.974 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Lower Limbs) n=83,83,38,37 | -2.64 units on a scale | Standard Deviation 0.957 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Trunk) n=87,88,43,42 | -1.05 units on a scale | Standard Deviation 0.888 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Lower Limbs) n=88,86,44,42 | -0.70 units on a scale | Standard Deviation 0.846 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Lower Limbs) n=84,84,38,39 | -2.61 units on a scale | Standard Deviation 0.865 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Lower Limbs) n=84,84,38,39 | -2.51 units on a scale | Standard Deviation 0.814 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Trunk) n=85,88,40,39 | -1.66 units on a scale | Standard Deviation 1.041 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Trunk) n=81,81,37,36 | -2.22 units on a scale | Standard Deviation 1.173 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Lower Limbs) n=84,88,40,39 | -2.36 units on a scale | Standard Deviation 0.845 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Lower Limbs) n=85,88,40,39 | -1.82 units on a scale | Standard Deviation 1.002 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Trunk) n=84,88,40,39 | -2.04 units on a scale | Standard Deviation 1.092 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Head/Neck) n=84,84,38,39 | -1.79 units on a scale | Standard Deviation 0.945 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Lower Limbs) n=87,88,43,42 | -1.22 units on a scale | Standard Deviation 0.993 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Lower Limbs) n=88,86,44,42 | -0.65 units on a scale | Standard Deviation 0.803 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Trunk) n=84,84,38,39 | -2.21 units on a scale | Standard Deviation 1.054 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Head/Neck) n=87,88,43,42) | -0.94 units on a scale | Standard Deviation 0.854 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Trunk) n=80,78,36,36 | -2.36 units on a scale | Standard Deviation 1.07 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Trunk) n=81,81,37,36 | -2.41 units on a scale | Standard Deviation 1.058 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Trunk) n=84,84,38,39 | -2.23 units on a scale | Standard Deviation 1.134 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Trunk) n=83,83,38,37 | -2.28 units on a scale | Standard Deviation 0.992 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Trunk) n=83,83,38,37 | -2.41 units on a scale | Standard Deviation 0.938 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Trunk) n=84,84,38,39 | -2.42 units on a scale | Standard Deviation 0.984 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Trunk) n=83,83,38,37 | -2.25 units on a scale | Standard Deviation 1.034 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Trunk) n=84,84,38,39 | -2.26 units on a scale | Standard Deviation 1.088 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Trunk) n=84,84,38,39 | -2.36 units on a scale | Standard Deviation 0.965 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Trunk) n=84,88,40,39 | -2.19 units on a scale | Standard Deviation 1.035 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Trunk) n=81,81,37,36 | -2.36 units on a scale | Standard Deviation 1.028 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Head/Neck) n=83,83,38,37 | -1.71 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Trunk) n=85,88,40,39 | -1.78 units on a scale | Standard Deviation 1.084 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Trunk) n=87,88,43,42 | -1.20 units on a scale | Standard Deviation 1.044 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Trunk) n=80,78,36,36 | -2.24 units on a scale | Standard Deviation 1.082 |
| Tofacitinib 10 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Head/Neck) n=88,86,44,42) | -0.56 units on a scale | Standard Deviation 0.676 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Head/Neck) n=80,78,36,36 | -1.45 units on a scale | Standard Deviation 1.202 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Head/Neck) n=88,86,44,42) | -0.41 units on a scale | Standard Deviation 0.757 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Head/Neck) n=87,88,43,42) | -0.74 units on a scale | Standard Deviation 0.89 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Head/Neck) n=85,88,40,39 | -1.05 units on a scale | Standard Deviation 1.038 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Head/Neck) n=84,88,40,39 | -1.24 units on a scale | Standard Deviation 1.135 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Head/Neck) n=84,84,38,39 | -1.43 units on a scale | Standard Deviation 1.175 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Head/Neck) n=84,84,38,39 | -1.43 units on a scale | Standard Deviation 1.185 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Head/Neck) n=83,83,38,37 | -1.51 units on a scale | Standard Deviation 1.203 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Head/Neck) n=81,81,37,36 | -1.51 units on a scale | Standard Deviation 1.195 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Head/Neck) n=80,78,36,36 | -1.53 units on a scale | Standard Deviation 1.181 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Upper Limbs) n=88,86,44,42 | -0.51 units on a scale | Standard Deviation 0.609 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Upper Limbs) n=87,88,43,42 | -0.91 units on a scale | Standard Deviation 0.839 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Upper Limbs) n=85,88,40,39 | -1.32 units on a scale | Standard Deviation 0.977 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Upper Limbs) n=84,88,40,39 | -1.61 units on a scale | Standard Deviation 1.159 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Upper Limbs) n=84,84,38,39 | -1.81 units on a scale | Standard Deviation 1.092 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Upper Limbs) n=84,84,38,39 | -1.87 units on a scale | Standard Deviation 1.117 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Upper Limbs) n=83,83,38,37 | -1.83 units on a scale | Standard Deviation 1.257 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Upper Limbs) n=81,81,37,36 | -1.89 units on a scale | Standard Deviation 1.151 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Upper Limbs) n=80,78,36,36 | -1.85 units on a scale | Standard Deviation 1.185 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Trunk) n=88,86,44,42 | -0.41 units on a scale | Standard Deviation 0.639 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Trunk) n=87,88,43,42 | -0.76 units on a scale | Standard Deviation 0.844 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Trunk) n=85,88,40,39 | -1.16 units on a scale | Standard Deviation 0.969 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Trunk) n=84,88,40,39 | -1.36 units on a scale | Standard Deviation 1.176 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Trunk) n=84,84,38,39 | -1.61 units on a scale | Standard Deviation 1.203 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Trunk) n=84,84,38,39 | -1.70 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Trunk) n=83,83,38,37 | -1.80 units on a scale | Standard Deviation 1.276 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Trunk) n=81,81,37,36 | -1.86 units on a scale | Standard Deviation 1.212 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Trunk) n=80,78,36,36 | -1.82 units on a scale | Standard Deviation 1.256 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Lower Limbs) n=88,86,44,42 | -0.38 units on a scale | Standard Deviation 0.722 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Lower Limbs) n=87,88,43,42 | -0.75 units on a scale | Standard Deviation 0.82 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Lower Limbs) n=85,88,40,39 | -1.19 units on a scale | Standard Deviation 1.123 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Lower Limbs) n=84,88,40,39 | -1.44 units on a scale | Standard Deviation 1.183 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Lower Limbs) n=84,84,38,39 | -1.55 units on a scale | Standard Deviation 1.255 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Lower Limbs) n=84,84,38,39 | -1.73 units on a scale | Standard Deviation 1.274 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Lower Limbs) n=83,83,38,37 | -1.86 units on a scale | Standard Deviation 1.372 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Lower Limbs) n=81,81,37,36 | -1.86 units on a scale | Standard Deviation 1.243 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Lower Limbs) n=80,78,36,36 | -1.74 units on a scale | Standard Deviation 1.4 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Head/Neck) n=88,86,44,42 | -0.27 units on a scale | Standard Deviation 0.602 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Head/Neck) n=87,88,43,42 | -0.59 units on a scale | Standard Deviation 0.892 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Head/Neck) n=85,88,40,39 | -0.86 units on a scale | Standard Deviation 0.937 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Head/Neck) n=84,88,40,39 | -1.08 units on a scale | Standard Deviation 1.031 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Head/Neck) n=84,84,38,39 | -1.24 units on a scale | Standard Deviation 1.06 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Head/Neck) n=84,84,38,39 | -1.30 units on a scale | Standard Deviation 1.084 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Head/Neck) n=83,83,38,37 | -1.41 units on a scale | Standard Deviation 1.094 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Head/Neck) n=81,81,37,36 | -1.37 units on a scale | Standard Deviation 1.066 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Head/Neck) n=80,78,36,36 | -1.36 units on a scale | Standard Deviation 1.139 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Upper Limbs) n=88,86,44,42 | -0.42 units on a scale | Standard Deviation 0.727 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Upper Limbs) n=87,88,43,42 | -0.77 units on a scale | Standard Deviation 0.867 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Upper Limbs) n=85,88,40,39 | -1.19 units on a scale | Standard Deviation 1.092 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Upper Limbs) n=84,88,40,39 | -1.47 units on a scale | Standard Deviation 1.231 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Upper Limbs) n=84,84,38,39 | -1.52 units on a scale | Standard Deviation 1.217 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Upper Limbs) n=84,84,38,39 | -1.67 units on a scale | Standard Deviation 1.186 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Upper Limbs) n=83,83,38,37 | -1.61 units on a scale | Standard Deviation 1.296 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Upper Limbs) n=81,81,37,36 | -1.65 units on a scale | Standard Deviation 1.266 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Upper Limbs) n=80,78,36,36 | -1.69 units on a scale | Standard Deviation 1.282 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Trunk) n=88,86,44,42 | -0.43 units on a scale | Standard Deviation 0.66 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Trunk) n=87,88,43,42 | -0.78 units on a scale | Standard Deviation 0.85 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Trunk) n=85,88,40,39 | -1.23 units on a scale | Standard Deviation 1.003 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Trunk) n=84,88,40,39 | -1.39 units on a scale | Standard Deviation 1.129 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Trunk) n=84,84,38,39 | -1.57 units on a scale | Standard Deviation 1.154 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Trunk) n=84,84,38,39 | -1.71 units on a scale | Standard Deviation 1.071 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Trunk) n=83,83,38,37 | -1.76 units on a scale | Standard Deviation 1.122 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Trunk) n=81,81,37,36 | -1.84 units on a scale | Standard Deviation 1.145 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Trunk) n=80,78,36,36 | -1.90 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Lower Limbs) n=88,86,44,42 | -0.43 units on a scale | Standard Deviation 0.66 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Lower Limbs) n=87,88,43,42 | -0.78 units on a scale | Standard Deviation 0.809 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Lower Limbs) n=85,88,40,39 | -1.26 units on a scale | Standard Deviation 0.977 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Lower Limbs) n=84,88,40,39 | -1.51 units on a scale | Standard Deviation 1.093 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Lower Limbs) n=84,84,38,39 | -1.63 units on a scale | Standard Deviation 1.159 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Lower Limbs) n=84,84,38,39 | -1.80 units on a scale | Standard Deviation 1.039 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Lower Limbs) n=83,83,38,37 | -1.86 units on a scale | Standard Deviation 1.106 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Lower Limbs) n=81,81,37,36 | -1.93 units on a scale | Standard Deviation 1.022 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Lower Limbs) n=80,78,36,36 | -1.85 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Head/Neck) n=88,86,44,42 | -0.28 units on a scale | Standard Deviation 0.587 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Head/Neck) n=87,88,43,42 | -0.60 units on a scale | Standard Deviation 0.766 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Head/Neck) n=85,88,40,39 | -0.99 units on a scale | Standard Deviation 1 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Head/Neck) n=84,88,40,39 | -1.16 units on a scale | Standard Deviation 1.103 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Head/Neck) n=84,84,38,39 | -1.31 units on a scale | Standard Deviation 1.151 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Head/Neck) n=84,84,38,39 | -1.40 units on a scale | Standard Deviation 1.11 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Head/Neck) n=83,83,38,37 | -1.47 units on a scale | Standard Deviation 1.162 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Head/Neck) n=81,81,37,36 | -1.41 units on a scale | Standard Deviation 1.138 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Upper Limbs) n=84,84,38,39 | -1.62 units on a scale | Standard Deviation 1.04 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Upper Limbs) n=88,86,44,42 | -0.41 units on a scale | Standard Deviation 0.602 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Upper Limbs) n=87,88,43,42 | -0.83 units on a scale | Standard Deviation 0.847 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Upper Limbs) n=85,88,40,39 | -1.25 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Upper Limbs) n=84,88,40,39 | -1.47 units on a scale | Standard Deviation 1.114 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Upper Limbs) n=84,84,38,39 | -1.75 units on a scale | Standard Deviation 1.005 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Upper Limbs) n=83,83,38,37 | -1.67 units on a scale | Standard Deviation 1.025 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Upper Limbs) n=81,81,37,36 | -1.65 units on a scale | Standard Deviation 1.153 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Upper Limbs) n=80,78,36,36 | -1.68 units on a scale | Standard Deviation 1.201 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Trunk) n=88,86,44,42 | -0.49 units on a scale | Standard Deviation 0.682 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Trunk) n=87,88,43,42 | -0.81 units on a scale | Standard Deviation 0.842 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Trunk) n=85,88,40,39 | -1.25 units on a scale | Standard Deviation 0.997 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Trunk) n=84,88,40,39 | -1.45 units on a scale | Standard Deviation 1.174 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Trunk) n=84,84,38,39 | -1.71 units on a scale | Standard Deviation 1.136 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Trunk) n=84,84,38,39 | -1.77 units on a scale | Standard Deviation 1.09 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Trunk) n=83,83,38,37 | -1.82 units on a scale | Standard Deviation 1.049 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Trunk) n=81,81,37,36 | -1.83 units on a scale | Standard Deviation 1.16 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Trunk) n=80,78,36,36 | -1.94 units on a scale | Standard Deviation 1.049 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Lower Limbs) n=88,86,44,42 | -0.51 units on a scale | Standard Deviation 0.778 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Lower Limbs) n=87,88,43,42 | -0.84 units on a scale | Standard Deviation 0.933 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Lower Limbs) n=85,88,40,39 | -1.40 units on a scale | Standard Deviation 1.078 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Lower Limbs) n=84,88,40,39 | -1.60 units on a scale | Standard Deviation 1.16 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Lower Limbs) n=84,84,38,39 | -1.74 units on a scale | Standard Deviation 1.173 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Lower Limbs) n=84,84,38,39 | -1.80 units on a scale | Standard Deviation 1.138 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Lower Limbs) n=83,83,38,37 | -1.86 units on a scale | Standard Deviation 1.128 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Lower Limbs) n=81,81,37,36 | -1.89 units on a scale | Standard Deviation 1.118 |
| Tofacitinib 5 mg | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Lower Limbs) n=80,78,36,36 | -1.88 units on a scale | Standard Deviation 1.151 |
| Placebo | 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 1.136 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Trunk) n=80,78,36,36 | -2.22 units on a scale | Standard Deviation 1.174 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Trunk) n=84,84,38,39 | -1.21 units on a scale | Standard Deviation 1.255 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Trunk) n=88,86,44,42 | -0.02 units on a scale | Standard Deviation 0.457 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Trunk) n=87,88,43,42 | -0.23 units on a scale | Standard Deviation 0.812 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Trunk) n=81,81,37,36 | -2.43 units on a scale | Standard Deviation 0.929 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Trunk) n=85,88,40,39 | -0.68 units on a scale | Standard Deviation 1.071 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Trunk) n=84,88,40,39 | -0.90 units on a scale | Standard Deviation 1.194 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Trunk) n=83,83,38,37 | -2.32 units on a scale | Standard Deviation 1.016 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Trunk) n=84,84,38,39 | -1.97 units on a scale | Standard Deviation 1.219 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Trunk) n=84,84,38,39 | -1.13 units on a scale | Standard Deviation 1.398 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Trunk) n=84,84,38,39 | -1.95 units on a scale | Standard Deviation 1.138 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Trunk) n=84,84,38,39 | -1.76 units on a scale | Standard Deviation 1.025 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Head/Neck) n=84,84,38,39 | -1.37 units on a scale | Standard Deviation 1.172 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Trunk) n=83,83,38,37 | -2.42 units on a scale | Standard Deviation 1.222 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Head/Neck) n=87,88,43,42) | -0.26 units on a scale | Standard Deviation 0.727 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Trunk) n=81,81,37,36 | -2.57 units on a scale | Standard Deviation 1.068 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Trunk) n=84,84,38,39 | -0.97 units on a scale | Standard Deviation 1.262 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Trunk) n=83,83,38,37 | -2.39 units on a scale | Standard Deviation 1.054 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Trunk) n=80,78,36,36 | -2.47 units on a scale | Standard Deviation 1.207 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Lower Limbs) n=88,86,44,42 | -0.09 units on a scale | Standard Deviation 0.421 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Trunk) n=84,88,40,39 | -0.65 units on a scale | Standard Deviation 1.167 |
| Placebo | 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 0.773 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Lower Limbs) n=85,88,40,39 | -0.60 units on a scale | Standard Deviation 0.955 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Trunk) n=85,88,40,39 | -0.35 units on a scale | Standard Deviation 0.949 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Trunk) n=81,81,37,36 | -2.43 units on a scale | Standard Deviation 1.042 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Lower Limbs) n=84,88,40,39 | -0.85 units on a scale | Standard Deviation 0.975 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Lower Limbs) n=84,84,38,39 | -1.08 units on a scale | Standard Deviation 1.148 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Trunk) n=87,88,43,42 | -0.14 units on a scale | Standard Deviation 0.774 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Lower Limbs) n=83,83,38,37 | -2.29 units on a scale | Standard Deviation 1.16 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Lower Limbs) n=84,84,38,39 | -1.97 units on a scale | Standard Deviation 1.026 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Trunk) n=80,78,36,36 | -2.31 units on a scale | Standard Deviation 1.215 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Lower Limbs) n=83,83,38,37 | -2.45 units on a scale | Standard Deviation 1.083 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Trunk) n=88,86,44,42 | -0.02 units on a scale | Standard Deviation 0.457 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Lower Limbs) n=81,81,37,36 | -2.35 units on a scale | Standard Deviation 1.033 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Head/Neck) n=84,84,38,39 | -0.66 units on a scale | Standard Deviation 1.361 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Lower Limbs) n=80,78,36,36 | -2.39 units on a scale | Standard Deviation 1.178 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Upper Limbs) n=80,78,36,36 | -1.94 units on a scale | Standard Deviation 1.286 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Head/Neck) n=88,86,44,42 | -0.14 units on a scale | Standard Deviation 0.594 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Lower Limbs) n=88,86,44,42 | -0.18 units on a scale | Standard Deviation 0.657 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Head/Neck) n=87,88,43,42 | -0.40 units on a scale | Standard Deviation 0.955 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Upper Limbs) n=81,81,37,36 | -2.05 units on a scale | Standard Deviation 1.153 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Head/Neck) n=85,88,40,39 | -0.75 units on a scale | Standard Deviation 1.296 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Head/Neck) n=84,88,40,39 | -0.83 units on a scale | Standard Deviation 1.338 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Upper Limbs) n=83,83,38,37 | -2.08 units on a scale | Standard Deviation 1.148 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Head/Neck) n=84,84,38,39 | -0.97 units on a scale | Standard Deviation 1.404 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Lower Limbs) n=87,88,43,42 | -0.35 units on a scale | Standard Deviation 0.997 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Head/Neck) n=84,84,38,39 | -1.61 units on a scale | Standard Deviation 1.366 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Upper Limbs) n=84,84,38,39 | -1.66 units on a scale | Standard Deviation 0.966 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Head/Neck) n=83,83,38,37 | -1.89 units on a scale | Standard Deviation 1.29 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Head/Neck) n=84,88,40,39 | -0.38 units on a scale | Standard Deviation 1.295 |
| Placebo | 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 1.25 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Upper Limbs) n=84,84,38,39 | -0.92 units on a scale | Standard Deviation 0.941 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Lower Limbs) n=80,78,36,36 | -2.08 units on a scale | Standard Deviation 1.36 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Head/Neck) n=80,78,36,36 | -1.78 units on a scale | Standard Deviation 1.456 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Lower Limbs) n=85,88,40,39 | -0.63 units on a scale | Standard Deviation 1.125 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Upper Limbs) n=88,86,44,42 | -0.11 units on a scale | Standard Deviation 0.579 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Upper Limbs) n=84,88,40,39 | -0.50 units on a scale | Standard Deviation 0.877 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Upper Limbs) n=87,88,43,42 | -0.26 units on a scale | Standard Deviation 0.848 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Upper Limbs) n=85,88,40,39 | -0.63 units on a scale | Standard Deviation 1.03 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Upper Limbs) n=85,88,40,39 | -0.28 units on a scale | Standard Deviation 0.784 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Lower Limbs) n=81,81,37,36 | -2.22 units on a scale | Standard Deviation 1.004 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Upper Limbs) n=84,88,40,39 | -0.93 units on a scale | Standard Deviation 1.023 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Upper Limbs) n=84,84,38,39 | -1.00 units on a scale | Standard Deviation 1.115 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Upper Limbs) n=87,88,43,42 | -0.12 units on a scale | Standard Deviation 0.697 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Lower Limbs) n=84,88,40,39 | -0.75 units on a scale | Standard Deviation 1.08 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Upper Limbs) n=84,84,38,39 | -1.68 units on a scale | Standard Deviation 1.093 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Upper Limbs) n=83,83,38,37 | -2.08 units on a scale | Standard Deviation 0.997 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Upper Limbs) n=88,86,44,42 | 0.02 units on a scale | Standard Deviation 0.403 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Head/Neck) n=85,88,40,39 | -0.20 units on a scale | Standard Deviation 1.114 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Upper Limbs) n=81,81,37,36 | -2.08 units on a scale | Standard Deviation 1.064 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Upper Limbs) n=80,78,36,36 | -1.89 units on a scale | Standard Deviation 1.282 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Lower Limbs) n=80,78,36,36 | -2.25 units on a scale | Standard Deviation 1.251 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Head/Neck) n=80,78,36,36 | -1.61 units on a scale | Standard Deviation 1.225 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Head/Neck) n=88,86,44,42 | -0.07 units on a scale | Standard Deviation 0.398 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Lower Limbs) n=84,84,38,39 | -0.95 units on a scale | Standard Deviation 1.293 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Head/Neck) n=87,88,43,42 | -0.30 units on a scale | Standard Deviation 0.708 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Lower Limbs) n=81,81,37,36 | -2.32 units on a scale | Standard Deviation 1.082 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Trunk) n=88,86,44,42 | -0.11 units on a scale | Standard Deviation 0.655 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Head/Neck) n=85,88,40,39 | -0.50 units on a scale | Standard Deviation 1.086 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Head/Neck) n=84,88,40,39 | -0.65 units on a scale | Standard Deviation 1.075 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Lower Limbs) n=83,83,38,37 | -2.37 units on a scale | Standard Deviation 1.025 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Head/Neck) n=84,84,38,39 | -0.76 units on a scale | Standard Deviation 1.24 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Head/Neck) n=84,84,38,39 | -1.47 units on a scale | Standard Deviation 1.133 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Lower Limbs) n=84,84,38,39 | -1.87 units on a scale | Standard Deviation 0.991 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Trunk) n=87,88,43,42 | -0.28 units on a scale | Standard Deviation 0.934 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Head/Neck) n=83,83,38,37 | -1.74 units on a scale | Standard Deviation 1.155 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Head/Neck) n=81,81,37,36 | -1.68 units on a scale | Standard Deviation 1.056 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Lower Limbs) n=84,84,38,39 | -0.89 units on a scale | Standard Deviation 1.085 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Head/Neck) n=81,81,37,36 | -1.68 units on a scale | Standard Deviation 1.132 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Head/Neck) n=80,78,36,36 | -1.58 units on a scale | Standard Deviation 1.228 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Upper Limbs) n=88,86,44,42 | -0.05 units on a scale | Standard Deviation 0.526 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Lower Limbs) n=84,88,40,39 | -0.58 units on a scale | Standard Deviation 0.958 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Trunk) n=85,88,40,39 | -0.70 units on a scale | Standard Deviation 1.018 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Upper Limbs) n=87,88,43,42 | -0.21 units on a scale | Standard Deviation 0.833 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Upper Limbs) n=85,88,40,39 | -0.55 units on a scale | Standard Deviation 1.011 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Lower Limbs) n=85,88,40,39 | -0.33 units on a scale | Standard Deviation 0.764 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Upper Limbs) n=84,88,40,39 | -0.80 units on a scale | Standard Deviation 1.091 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Head/Neck) n=88,86,44,42) | -0.14 units on a scale | Standard Deviation 0.594 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Upper Limbs) n=84,84,38,39 | -1.05 units on a scale | Standard Deviation 1.293 |
| Placebo | 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 0.625 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Trunk) n=84,88,40,39 | -1.05 units on a scale | Standard Deviation 1.154 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Upper Limbs) n=84,84,38,39 | -1.71 units on a scale | Standard Deviation 1.25 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Upper Limbs) n=83,83,38,37 | -2.03 units on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Lower Limbs) n=88,86,44,42 | 0.00 units on a scale | Standard Deviation 0.374 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Head/Neck) n=83,83,38,37 | -1.68 units on a scale | Standard Deviation 1.254 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Upper Limbs) n=81,81,37,36 | -2.11 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Upper Limbs) n=80,78,36,36 | -2.03 units on a scale | Standard Deviation 1.183 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.97 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.94 |
| Placebo to Tofacitinib 5 mg | 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 0.79 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 1.36 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 1.25 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 1.16 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.56 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.55 |
| Placebo to Tofacitinib 5 mg | 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 1.41 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.37 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.67 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.49 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Change From Baseline in PASI Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -23.45 units on a scale | Standard Deviation 9.369 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -22.79 units on a scale | Standard Deviation 9.675 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -22.71 units on a scale | Standard Deviation 10.655 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -20.98 units on a scale | Standard Deviation 9.612 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -17.25 units on a scale | Standard Deviation 10.244 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -11.74 units on a scale | Standard Deviation 8.528 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -23.47 units on a scale | Standard Deviation 9.702 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -22.07 units on a scale | Standard Deviation 10.127 |
| Tofacitinib 10 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 2 (n=88,86,44,42) | -6.40 units on a scale | Standard Deviation 6.724 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -17.12 units on a scale | Standard Deviation 11.711 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -19.45 units on a scale | Standard Deviation 10.312 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -18.42 units on a scale | Standard Deviation 10.955 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -7.91 units on a scale | Standard Deviation 7.053 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 2 (n=88,86,44,42) | -4.26 units on a scale | Standard Deviation 5.231 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -12.76 units on a scale | Standard Deviation 10.033 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -20.04 units on a scale | Standard Deviation 10.819 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -20.11 units on a scale | Standard Deviation 10.292 |
| Tofacitinib 5 mg | Change From Baseline in PASI Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -15.22 units on a scale | Standard Deviation 11.214 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -10.03 units on a scale | Standard Deviation 12.976 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 0.10 units on a scale | Standard Deviation 4.715 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -0.76 units on a scale | Standard Deviation 7.423 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -4.25 units on a scale | Standard Deviation 8.996 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -7.71 units on a scale | Standard Deviation 10.717 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -18.79 units on a scale | Standard Deviation 12.428 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -22.22 units on a scale | Standard Deviation 11.55 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -22.80 units on a scale | Standard Deviation 11.268 |
| Placebo | Change From Baseline in PASI Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -22.54 units on a scale | Standard Deviation 12.368 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 6.13 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Baseline (n=90,88,44,44) | 0.784 units on a scale | Standard Deviation 0.2088 |
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.950 units on a scale | Standard Deviation 0.094 |
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 0.957 units on a scale | Standard Deviation 0.0778 |
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 0.955 units on a scale | Standard Deviation 0.0796 |
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 0.938 units on a scale | Standard Deviation 0.1303 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 0.893 units on a scale | Standard Deviation 0.1719 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 0.904 units on a scale | Standard Deviation 0.1368 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.918 units on a scale | Standard Deviation 0.1177 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 0.930 units on a scale | Standard Deviation 0.1226 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Baseline (n=90,88,44,44) | 0.797 units on a scale | Standard Deviation 0.1991 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 0.960 units on a scale | Standard Deviation 0.0739 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 0.941 units on a scale | Standard Deviation 0.1118 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Baseline (n=90,88,44,44) | 0.779 units on a scale | Standard Deviation 0.1803 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.954 units on a scale | Standard Deviation 0.0776 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 0.905 units on a scale | Standard Deviation 0.1191 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
Secondary
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 85.5 units on a scale | Standard Deviation 14.45 |
| Tofacitinib 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) | 65.8 units on a scale | Standard Deviation 24.9 |
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 82.5 units on a scale | Standard Deviation 17.13 |
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 84.5 units on a scale | Standard Deviation 16.17 |
| Tofacitinib 10 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 83.7 units on a scale | Standard Deviation 15.3 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 80.0 units on a scale | Standard Deviation 18.4 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Baseline (n=90,88,44,44) | 69.5 units on a scale | Standard Deviation 19.84 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 78.9 units on a scale | Standard Deviation 15.41 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 82.4 units on a scale | Standard Deviation 16 |
| Tofacitinib 5 mg | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 83.0 units on a scale | Standard Deviation 14.35 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 32 (n=83,82,38,37) | 85.2 units on a scale | Standard Deviation 14.36 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 16 (n=84,83,38,39) | 72.3 units on a scale | Standard Deviation 22.04 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Baseline (n=90,88,44,44) | 66.4 units on a scale | Standard Deviation 23.09 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 83.5 units on a scale | Standard Deviation 16.86 |
| Placebo | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 | Week 52 (n=80,78,35,36) | 85.0 units on a scale | Standard Deviation 13.58 |
| Placebo to Tofacitinib 5 mg | 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 19.2 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 20.2 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 32 (n=37,37,14,14) | 3.8 nails | Standard Deviation 3.92 |
| Tofacitinib 10 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Baseline (n=40,38,18,18) | 7.6 nails | Standard Deviation 3.06 |
| Tofacitinib 10 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 40 (n=36,36,13,13) | 3.0 nails | Standard Deviation 3.6 |
| Tofacitinib 10 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 20 (n=37,38,14,15) | 5.1 nails | Standard Deviation 3.84 |
| Tofacitinib 10 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 8 (n=39,38,15,15) | 7.2 nails | Standard Deviation 3.07 |
| Tofacitinib 10 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 16 (n=38,38,14,15) | 6.1 nails | Standard Deviation 3.53 |
| Tofacitinib 10 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 52 (n=31,34,12,13) | 3.0 nails | Standard Deviation 3.67 |
| Tofacitinib 5 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 16 (n=38,38,14,15) | 6.6 nails | Standard Deviation 3.57 |
| Tofacitinib 5 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 20 (n=37,38,14,15) | 6.0 nails | Standard Deviation 3.84 |
| Tofacitinib 5 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 32 (n=37,37,14,14) | 5.5 nails | Standard Deviation 3.85 |
| Tofacitinib 5 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 40 (n=36,36,13,13) | 5.4 nails | Standard Deviation 4.08 |
| Tofacitinib 5 mg | 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 4.23 |
| Tofacitinib 5 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 8 (n=39,38,15,15) | 7.2 nails | Standard Deviation 3.61 |
| Tofacitinib 5 mg | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Baseline (n=40,38,18,18) | 7.3 nails | Standard Deviation 3.21 |
| Placebo | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Baseline (n=40,38,18,18) | 8.1 nails | Standard Deviation 2.97 |
| Placebo | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 20 (n=37,38,14,15) | 7.4 nails | Standard Deviation 3.93 |
| Placebo | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 52 (n=31,34,12,13) | 4.6 nails | Standard Deviation 4.12 |
| Placebo | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 8 (n=39,38,15,15) | 7.3 nails | Standard Deviation 3.58 |
| Placebo | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 32 (n=37,37,14,14) | 6.1 nails | Standard Deviation 3.95 |
| Placebo | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 16 (n=38,38,14,15) | 7.9 nails | Standard Deviation 3.82 |
| Placebo | Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 | Week 40 (n=36,36,13,13) | 6.3 nails | Standard Deviation 4.39 |
| Placebo to Tofacitinib 5 mg | 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 3.2 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
PASI Component Scores Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Lower Limbs) n=88,86,44,42 | 2.24 units on a scale | Standard Deviation 1.017 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Head/Neck) n=87,88,43,42 | 1.24 units on a scale | Standard Deviation 1.131 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Head/Neck) n=85,88,40,39 | 0.80 units on a scale | Standard Deviation 0.986 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Head/Neck) n=84,88,40,39 | 0.64 units on a scale | Standard Deviation 0.887 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Head/Neck) n=84,84,38,39 | 0.57 units on a scale | Standard Deviation 0.811 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Head/Neck) n=84,84,38,39 | 0.43 units on a scale | Standard Deviation 0.664 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Head/Neck) n=83,83,38,37 | 0.48 units on a scale | Standard Deviation 0.739 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Head/Neck) n=81,81,37,36 | 0.51 units on a scale | Standard Deviation 0.839 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Head/Neck) n=80,78,36,36 | 0.58 units on a scale | Standard Deviation 0.897 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Upper Limbs) n=90,88,44,44 | 2.72 units on a scale | Standard Deviation 0.779 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Upper Limbs) n=88,86,44,42 | 2.00 units on a scale | Standard Deviation 0.922 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Upper Limbs) n=87,88,43,42 | 1.41 units on a scale | Standard Deviation 1.106 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Upper Limbs) n=85,88,40,39 | 0.89 units on a scale | Standard Deviation 0.939 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Upper Limbs) n=84,88,40,39 | 0.56 units on a scale | Standard Deviation 0.841 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Upper Limbs) n=84,84,38,39 | 0.40 units on a scale | Standard Deviation 0.793 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Upper Limbs) n=84,84,38,39 | 0.39 units on a scale | Standard Deviation 0.807 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Upper Limbs) n=83,83,38,37 | 0.36 units on a scale | Standard Deviation 0.708 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Upper Limbs) n=81,81,37,36 | 0.40 units on a scale | Standard Deviation 0.801 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Upper Limbs) n=80,78,36,36 | 0.48 units on a scale | Standard Deviation 0.763 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Trunk) n=90,88,44,44 | 2.72 units on a scale | Standard Deviation 0.765 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Trunk) n=88,86,44,42 | 2.03 units on a scale | Standard Deviation 0.928 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Trunk) n=87,88,43,42 | 1.52 units on a scale | Standard Deviation 1.109 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Trunk) n=85,88,40,39 | 0.95 units on a scale | Standard Deviation 1.057 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Trunk) n=84,88,40,39 | 0.69 units on a scale | Standard Deviation 1.006 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Trunk) n=84,84,38,39 | 0.52 units on a scale | Standard Deviation 0.938 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Trunk) n=84,84,38,37 | 0.49 units on a scale | Standard Deviation 0.871 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Trunk) n=83,83,38,37 | 0.46 units on a scale | Standard Deviation 0.754 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Trunk) n=81,81,37,36 | 0.49 units on a scale | Standard Deviation 0.882 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Trunk) n=80,78,36,36 | 0.55 units on a scale | Standard Deviation 0.855 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Lower Limbs) n=90,88,44,44 | 2.94 units on a scale | Standard Deviation 0.709 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Head/Neck) n=88,86,44,42 | 1.67 units on a scale | Standard Deviation 1.003 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Lower Limbs) n=87,88,43,42 | 1.72 units on a scale | Standard Deviation 1.117 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Lower Limbs) n=85,88,40,39 | 1.15 units on a scale | Standard Deviation 1.129 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Lower Limbs) n=84,88,40,39 | 0.67 units on a scale | Standard Deviation 0.896 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Lower Limbs) n=84,84,38,39 | 0.46 units on a scale | Standard Deviation 0.783 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Lower Limbs) n=84,84,38,39 | 0.45 units on a scale | Standard Deviation 0.87 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Lower Limbs) n=83,83,38,37 | 0.37 units on a scale | Standard Deviation 0.76 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Lower Limbs) n=81,81,37,36 | 0.53 units on a scale | Standard Deviation 0.976 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Lower Limbs) n=80,78,36,36 | 0.61 units on a scale | Standard Deviation 0.921 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Head/Neck) n=90,88,44,44 | 2.31 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Head/Neck) n=88,86,44,42 | 1.74 units on a scale | Standard Deviation 0.903 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Head/Neck) n=87,88,43,42 | 1.37 units on a scale | Standard Deviation 0.978 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Head/Neck) n=85,88,40,39 | 0.93 units on a scale | Standard Deviation 0.997 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Head/Neck) n=84,88,40,39 | 0.68 units on a scale | Standard Deviation 0.867 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Head/Neck) n=84,84,38,39 | 0.58 units on a scale | Standard Deviation 0.839 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Head/Neck) n=84,84,38,39 | 0.50 units on a scale | Standard Deviation 0.784 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Head/Neck) n=83,83,38,37 | 0.58 units on a scale | Standard Deviation 0.885 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Head/Neck) n=81,81,37,36 | 0.51 units on a scale | Standard Deviation 0.882 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Head/Neck) n=80,78,36,36 | 0.58 units on a scale | Standard Deviation 0.925 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Upper Limbs) n=90,88,44,44 | 2.70 units on a scale | Standard Deviation 0.694 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Upper Limbs) n=88,86,44,42 | 2.06 units on a scale | Standard Deviation 0.793 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Upper Limbs) n=87,88,43,42 | 1.61 units on a scale | Standard Deviation 0.826 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Upper Limbs) n=85,88,40,39 | 1.05 units on a scale | Standard Deviation 0.937 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Upper Limbs) n=84,88,40,39 | 0.60 units on a scale | Standard Deviation 0.778 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Upper Limbs) n=84,84,38,39 | 0.51 units on a scale | Standard Deviation 0.784 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Upper Limbs) n=81,81,37,36 | 0.44 units on a scale | Standard Deviation 0.791 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Upper Limbs) n=84,84,38,39 | 0.40 units on a scale | Standard Deviation 0.793 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Upper Limbs) n=83,83,38,37 | 0.40 units on a scale | Standard Deviation 0.697 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Upper Limbs) n=80,78,36,36 | 0.56 units on a scale | Standard Deviation 0.939 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Trunk) n=90,88,44,44 | 2.86 units on a scale | Standard Deviation 0.696 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Trunk) n=88,86,44,42 | 2.28 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Trunk) n=87,88,43,42 | 1.82 units on a scale | Standard Deviation 0.922 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Trunk) n=85,88,40,39 | 1.20 units on a scale | Standard Deviation 1.056 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Trunk) n=84,88,40,39 | 0.81 units on a scale | Standard Deviation 1.024 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Trunk) n=84,84,38,39 | 0.63 units on a scale | Standard Deviation 0.929 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Trunk) n=84,84,38,39 | 0.62 units on a scale | Standard Deviation 1.005 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Trunk) n=83,83,38,37 | 0.58 units on a scale | Standard Deviation 0.952 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Trunk) n=81,81,37,36 | 0.48 units on a scale | Standard Deviation 0.823 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Trunk) n=80,78,36,36 | 0.59 units on a scale | Standard Deviation 0.924 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Lower Limbs) n=90,88,44,44 | 3.03 units on a scale | Standard Deviation 0.678 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Lower Limbs) n=88,86,44,42 | 2.53 units on a scale | Standard Deviation 0.87 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Lower Limbs) n=87,88,43,42 | 1.97 units on a scale | Standard Deviation 0.946 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Lower Limbs) n=85,88,40,39 | 1.33 units on a scale | Standard Deviation 1.051 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Lower Limbs) n=84,88,40,39 | 0.79 units on a scale | Standard Deviation 0.865 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Lower Limbs) n=84,84,38,39 | 0.67 units on a scale | Standard Deviation 0.883 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Lower Limbs) n=84,84,38,39 | 0.54 units on a scale | Standard Deviation 0.87 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Lower Limbs) n=83,83,38,37 | 0.47 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Lower Limbs) n=81,81,37,36 | 0.52 units on a scale | Standard Deviation 0.963 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Head/Neck) n=90,88,44,44 | 2.23 units on a scale | Standard Deviation 0.937 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Lower Limbs) n=80,78,36,36 | 0.70 units on a scale | Standard Deviation 1.024 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Head/Neck) n=88,86,44,42 | 1.63 units on a scale | Standard Deviation 0.998 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Head/Neck) n=87,88,43,42 | 1.16 units on a scale | Standard Deviation 1.022 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Head/Neck) n=85,88,40,39 | 0.84 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Head/Neck) n=84,88,40,39 | 0.63 units on a scale | Standard Deviation 0.847 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Head/Neck) n=84,84,38,39 | 0.51 units on a scale | Standard Deviation 0.736 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Head/Neck) n=84,84,38,39 | 0.40 units on a scale | Standard Deviation 0.642 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Head/Neck) n=83,83,38,37 | 0.49 units on a scale | Standard Deviation 0.755 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Head/Neck) n=81,81,37,36 | 0.44 units on a scale | Standard Deviation 0.742 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Head/Neck) n=80,78,36,36 | 0.53 units on a scale | Standard Deviation 0.871 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Upper Limbs) n=90,88,44,44 | 2.71 units on a scale | Standard Deviation 0.738 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Upper Limbs) n=88,86,44,42 | 2.02 units on a scale | Standard Deviation 0.884 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Upper Limbs) n=87,88,43,42 | 1.54 units on a scale | Standard Deviation 1.054 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Upper Limbs) n=85,88,40,39 | 1.01 units on a scale | Standard Deviation 1.029 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Upper Limbs) n=84,88,40,39 | 0.55 units on a scale | Standard Deviation 0.813 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Upper Limbs) n=84,84,38,39 | 0.39 units on a scale | Standard Deviation 0.761 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Upper Limbs) n=84,84,38,39 | 0.37 units on a scale | Standard Deviation 0.818 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Upper Limbs) n=83,83,38,37 | 0.42 units on a scale | Standard Deviation 0.798 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Upper Limbs) n=81,81,37,36 | 0.47 units on a scale | Standard Deviation 0.867 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Upper Limbs) n=80,78,36,36 | 0.53 units on a scale | Standard Deviation 0.886 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Trunk) n=90,88,44,44 | 2.90 units on a scale | Standard Deviation 0.619 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Trunk) n=88,86,44,42 | 2.25 units on a scale | Standard Deviation 0.913 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Trunk) n=87,88,43,42 | 1.71 units on a scale | Standard Deviation 1.109 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Trunk) n=85,88,40,39 | 1.13 units on a scale | Standard Deviation 1.142 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Trunk) n=84,88,40,39 | 0.73 units on a scale | Standard Deviation 1.034 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Trunk) n=84,84,38,39 | 0.56 units on a scale | Standard Deviation 0.961 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Trunk) n=84,84,38,39 | 0.50 units on a scale | Standard Deviation 0.976 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Trunk) n=83,83,38,37 | 0.49 units on a scale | Standard Deviation 0.846 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Trunk) n=81,81,37,36 | 0.49 units on a scale | Standard Deviation 0.91 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Trunk) n=80,78,36,36 | 0.55 units on a scale | Standard Deviation 0.899 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Lower Limbs) n=90,88,44,44 | 3.03 units on a scale | Standard Deviation 0.678 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Lower Limbs) n=88,86,44,42 | 2.39 units on a scale | Standard Deviation 0.915 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Lower Limbs) n=87,88,43,42 | 1.83 units on a scale | Standard Deviation 1.102 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Lower Limbs) n=85,88,40,39 | 1.22 units on a scale | Standard Deviation 1.138 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Lower Limbs) n=84,88,40,39 | 0.69 units on a scale | Standard Deviation 0.878 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Lower Limbs) n=84,84,38,39 | 0.54 units on a scale | Standard Deviation 0.798 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Lower Limbs) n=84,84,38,39 | 0.44 units on a scale | Standard Deviation 0.827 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Lower Limbs) n=83,83,38,37 | 0.40 units on a scale | Standard Deviation 0.826 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Lower Limbs) n=81,81,37,36 | 0.46 units on a scale | Standard Deviation 0.791 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Lower Limbs) n=80,78,36,36 | 0.61 units on a scale | Standard Deviation 0.907 |
| Tofacitinib 10 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Head/Neck) n=90,88,44,44 | 2.40 units on a scale | Standard Deviation 0.946 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Lower Limbs) n=85,88,40,39 | 1.61 units on a scale | Standard Deviation 1.044 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Trunk) n=88,86,44,42 | 2.44 units on a scale | Standard Deviation 0.776 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Upper Limbs) n=81,81,37,36 | 0.94 units on a scale | Standard Deviation 1.041 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Head/Neck) n=80,78,36,36 | 0.60 units on a scale | Standard Deviation 0.888 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Trunk) n=84,84,38,39 | 1.01 units on a scale | Standard Deviation 1.07 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Trunk) n=87,88,43,42 | 2.05 units on a scale | Standard Deviation 0.883 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Trunk) n=88,86,44,42 | 2.27 units on a scale | Standard Deviation 0.938 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Head/Neck) n=81,81,37,36 | 0.60 units on a scale | Standard Deviation 0.801 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Trunk) n=90,88,44,44 | 2.73 units on a scale | Standard Deviation 0.784 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Trunk) n=85,88,40,39 | 1.65 units on a scale | Standard Deviation 1.006 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Upper Limbs) n=80,78,36,36 | 0.95 units on a scale | Standard Deviation 0.979 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Head/Neck) n=83,83,38,37 | 0.57 units on a scale | Standard Deviation 0.814 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Head/Neck) n=84,84,38,39 | 0.67 units on a scale | Standard Deviation 0.91 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Trunk) n=84,88,40,39 | 1.44 units on a scale | Standard Deviation 1.133 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Trunk) n=88,86,44,42 | 2.33 units on a scale | Standard Deviation 0.804 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Lower Limbs) n=87,88,43,42 | 2.09 units on a scale | Standard Deviation 0.978 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Lower Limbs) n=83,83,38,37 | 1.01 units on a scale | Standard Deviation 1.088 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Trunk) n=84,84,38,39 | 1.21 units on a scale | Standard Deviation 1.173 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Head/Neck) n=87,88,43,42 | 1.44 units on a scale | Standard Deviation 1.015 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Head/Neck) n=84,84,38,39 | 0.73 units on a scale | Standard Deviation 0.974 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Trunk) n=83,83,38,37 | 0.96 units on a scale | Standard Deviation 1.087 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Trunk) n=84,84,38,39 | 1.12 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Trunk) n=83,83,38,37 | 0.92 units on a scale | Standard Deviation 0.953 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Head/Neck) n=84,88,40,39 | 0.86 units on a scale | Standard Deviation 1.008 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Upper Limbs) n=81,81,37,36 | 0.96 units on a scale | Standard Deviation 1.006 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Trunk) n=83,83,38,37 | 1.02 units on a scale | Standard Deviation 1.137 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Lower Limbs) n=87,88,43,42 | 2.08 units on a scale | Standard Deviation 0.997 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Head/Neck) n=85,88,40,39 | 1.08 units on a scale | Standard Deviation 1.074 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Head/Neck) n=87,88,43,42 | 1.35 units on a scale | Standard Deviation 1.073 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Trunk) n=81,81,37,36 | 0.96 units on a scale | Standard Deviation 1.078 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Head/Neck) n=85,88,40,39 | 1.14 units on a scale | Standard Deviation 1.052 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Lower Limbs) n=88,86,44,42 | 2.43 units on a scale | Standard Deviation 0.888 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Lower Limbs) n=84,84,38,39 | 1.20 units on a scale | Standard Deviation 1.106 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Trunk) n=80,78,36,36 | 0.99 units on a scale | Standard Deviation 1.099 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Upper Limbs) n=84,84,38,39 | 1.05 units on a scale | Standard Deviation 1.108 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Head/Neck) n=88,86,44,42 | 1.67 units on a scale | Standard Deviation 1.011 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Trunk) n=81,81,37,36 | 0.89 units on a scale | Standard Deviation 1.037 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Lower Limbs) n=90,88,44,44 | 2.98 units on a scale | Standard Deviation 0.66 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Upper Limbs) n=83,83,38,37 | 0.93 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Lower Limbs) n=81,81,37,36 | 0.95 units on a scale | Standard Deviation 1.011 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Lower Limbs) n=88,86,44,42 | 2.40 units on a scale | Standard Deviation 0.911 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Lower Limbs) n=88,86,44,42 | 2.60 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Head/Neck) n=84,88,40,39 | 0.94 units on a scale | Standard Deviation 1.065 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Head/Neck) n=90,88,44,44 | 1.94 units on a scale | Standard Deviation 0.998 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Lower Limbs) n=80,78,36,36 | 1.24 units on a scale | Standard Deviation 1.281 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Lower Limbs) n=87,88,43,42 | 2.23 units on a scale | Standard Deviation 0.854 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Trunk) n=84,84,38,37 | 0.96 units on a scale | Standard Deviation 0.987 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Lower Limbs) n=81,81,37,36 | 1.14 units on a scale | Standard Deviation 1.159 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Lower Limbs) n=90,88,44,44 | 2.88 units on a scale | Standard Deviation 0.708 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Lower Limbs) n=85,88,40,39 | 1.78 units on a scale | Standard Deviation 1.077 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Upper Limbs) n=84,84,38,39 | 0.86 units on a scale | Standard Deviation 0.907 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Lower Limbs) n=83,83,38,37 | 1.13 units on a scale | Standard Deviation 1.197 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Trunk) n=80,78,36,36 | 0.83 units on a scale | Standard Deviation 1.012 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Lower Limbs) n=84,88,40,39 | 1.53 units on a scale | Standard Deviation 1.082 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Upper Limbs) n=84,84,38,39 | 0.99 units on a scale | Standard Deviation 1.07 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Head/Neck) n=90,88,44,44 | 2.01 units on a scale | Standard Deviation 1.011 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Head/Neck) n=84,84,38,39 | 0.82 units on a scale | Standard Deviation 1.032 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Lower Limbs) n=84,84,38,39 | 1.44 units on a scale | Standard Deviation 1.155 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Trunk) n=80,78,36,36 | 0.82 units on a scale | Standard Deviation 0.818 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Lower Limbs) n=84,84,38,39 | 1.26 units on a scale | Standard Deviation 1.043 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Upper Limbs) n=84,88,40,39 | 1.14 units on a scale | Standard Deviation 1.106 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Trunk) n=87,88,43,42 | 1.95 units on a scale | Standard Deviation 0.97 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Head/Neck) n=84,84,38,39 | 0.82 units on a scale | Standard Deviation 0.971 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Upper Limbs) n=83,83,38,37 | 0.96 units on a scale | Standard Deviation 1.064 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Upper Limbs) n=84,88,40,39 | 1.13 units on a scale | Standard Deviation 1.081 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Lower Limbs) n=84,84,38,39 | 1.14 units on a scale | Standard Deviation 1.02 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Head/Neck) n=83,83,38,37 | 0.73 units on a scale | Standard Deviation 0.989 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Upper Limbs) n=85,88,40,39 | 1.35 units on a scale | Standard Deviation 1.018 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Lower Limbs) n=84,88,40,39 | 1.36 units on a scale | Standard Deviation 1.063 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Head/Neck) n=81,81,37,36 | 0.74 units on a scale | Standard Deviation 0.946 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Trunk) n=84,84,38,39 | 1.02 units on a scale | Standard Deviation 1.097 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Upper Limbs) n=87,88,43,42 | 1.77 units on a scale | Standard Deviation 1.047 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Upper Limbs) n=88,86,44,42 | 2.19 units on a scale | Standard Deviation 0.952 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Lower Limbs) n=84,84,38,39 | 1.07 units on a scale | Standard Deviation 1.027 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Head/Neck) n=80,78,36,36 | 0.72 units on a scale | Standard Deviation 0.966 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Lower Limbs) n=84,84,38,39 | 1.24 units on a scale | Standard Deviation 1.115 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Upper Limbs) n=90,88,44,44 | 2.60 units on a scale | Standard Deviation 0.796 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Trunk) n=85,88,40,39 | 1.51 units on a scale | Standard Deviation 1.061 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Upper Limbs) n=90,88,44,44 | 2.78 units on a scale | Standard Deviation 0.686 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Lower Limbs) n=83,83,38,37 | 1.08 units on a scale | Standard Deviation 1.118 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Lower Limbs) n=85,88,40,39 | 1.52 units on a scale | Standard Deviation 1.093 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Upper Limbs) n=88,86,44,42 | 2.28 units on a scale | Standard Deviation 0.792 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Trunk) n=84,88,40,39 | 1.27 units on a scale | Standard Deviation 1.132 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Upper Limbs) n=85,88,40,39 | 1.40 units on a scale | Standard Deviation 1.078 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Head/Neck) n=80,78,36,36 | 0.63 units on a scale | Standard Deviation 0.884 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Upper Limbs) n=87,88,43,42 | 1.88 units on a scale | Standard Deviation 0.92 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Trunk) n=90,88,44,44 | 2.74 units on a scale | Standard Deviation 0.703 |
| Tofacitinib 5 mg | 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 1.069 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Lower Limbs) n=81,81,37,36 | 1.06 units on a scale | Standard Deviation 1.041 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Upper Limbs) n=85,88,40,39 | 1.47 units on a scale | Standard Deviation 0.982 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Lower Limbs) n=90,88,44,44 | 2.92 units on a scale | Standard Deviation 0.776 |
| Tofacitinib 5 mg | 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 0.894 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Trunk) n=84,88,40,39 | 1.35 units on a scale | Standard Deviation 1.115 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Upper Limbs) n=84,88,40,39 | 1.17 units on a scale | Standard Deviation 1.074 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Trunk) n=85,88,40,39 | 1.48 units on a scale | Standard Deviation 1.039 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Head/Neck) n=83,83,38,37 | 0.61 units on a scale | Standard Deviation 0.809 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Trunk) n=81,81,37,36 | 0.91 units on a scale | Standard Deviation 0.938 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Head/Neck) n=84,84,38,39 | 0.67 units on a scale | Standard Deviation 0.841 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Upper Limbs) n=84,84,38,39 | 0.99 units on a scale | Standard Deviation 1.024 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Lower Limbs) n=80,78,36,36 | 1.08 units on a scale | Standard Deviation 1.042 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Upper Limbs) n=87,88,43,42 | 1.82 units on a scale | Standard Deviation 1.012 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Head/Neck) n=84,84,38,39 | 0.76 units on a scale | Standard Deviation 1.025 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Upper Limbs) n=84,84,38,39 | 0.93 units on a scale | Standard Deviation 0.967 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Upper Limbs) n=80,78,36,36 | 0.90 units on a scale | Standard Deviation 0.988 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Head/Neck) n=84,88,40,39 | 0.85 units on a scale | Standard Deviation 1.012 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Trunk) n=84,84,38,39 | 1.15 units on a scale | Standard Deviation 1.156 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Upper Limbs) n=83,83,38,37 | 0.96 units on a scale | Standard Deviation 1.087 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Trunk) n=87,88,43,42 | 1.92 units on a scale | Standard Deviation 0.997 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Head/Neck) n=85,88,40,39 | 1.02 units on a scale | Standard Deviation 1.039 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Upper Limbs) n=81,81,37,36 | 0.93 units on a scale | Standard Deviation 1.034 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Head/Neck) n=88,86,44,42 | 1.77 units on a scale | Standard Deviation 1.037 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Head/Neck) n=87,88,43,42 | 1.41 units on a scale | Standard Deviation 1.068 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Lower Limbs) n=84,88,40,39 | 1.32 units on a scale | Standard Deviation 1.12 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Upper Limbs) n=80,78,36,36 | 0.95 units on a scale | Standard Deviation 1.031 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Upper Limbs) n=84,84,38,39 | 0.90 units on a scale | Standard Deviation 1.013 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Upper Limbs) n=88,86,44,42 | 2.16 units on a scale | Standard Deviation 0.919 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Head/Neck) n=88,86,44,42 | 1.71 units on a scale | Standard Deviation 1.004 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Trunk) n=90,88,44,44 | 2.81 units on a scale | Standard Deviation 0.658 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Head/Neck) n=90,88,44,44 | 2.18 units on a scale | Standard Deviation 0.977 |
| Tofacitinib 5 mg | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Upper Limbs) n=90,88,44,44 | 2.59 units on a scale | Standard Deviation 0.783 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Upper Limbs) n=85,88,40,39 | 2.35 units on a scale | Standard Deviation 1.075 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Lower Limbs) n=88,86,44,42 | 2.66 units on a scale | Standard Deviation 0.888 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Lower Limbs) n=87,88,43,42 | 2.49 units on a scale | Standard Deviation 0.96 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Lower Limbs) n=85,88,40,39 | 2.20 units on a scale | Standard Deviation 1.018 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Lower Limbs) n=84,88,40,39 | 2.03 units on a scale | Standard Deviation 0.92 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Upper Limbs) n=80,78,36,36 | 0.58 units on a scale | Standard Deviation 0.874 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Lower Limbs) n=84,84,38,39 | 1.82 units on a scale | Standard Deviation 1.062 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Lower Limbs) n=84,84,38,39 | 0.95 units on a scale | Standard Deviation 0.868 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Lower Limbs) n=84,84,38,39 | 1.95 units on a scale | Standard Deviation 1.138 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Lower Limbs) n=83,83,38,37 | 0.47 units on a scale | Standard Deviation 0.797 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Lower Limbs) n=81,81,37,36 | 0.51 units on a scale | Standard Deviation 0.731 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Trunk) n=90,88,44,44 | 2.91 units on a scale | Standard Deviation 0.772 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Lower Limbs) n=80,78,36,36 | 0.67 units on a scale | Standard Deviation 1.069 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Head/Neck) n=88,86,44,42 | 2.05 units on a scale | Standard Deviation 1.033 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Head/Neck) n=90,88,44,44 | 2.18 units on a scale | Standard Deviation 1.018 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Head/Neck) n=87,88,43,42 | 1.91 units on a scale | Standard Deviation 1.065 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Trunk) n=88,86,44,42 | 2.89 units on a scale | Standard Deviation 0.689 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Head/Neck) n=85,88,40,39 | 1.93 units on a scale | Standard Deviation 1.141 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Head/Neck) n=83,83,38,37 | 0.45 units on a scale | Standard Deviation 0.86 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Head/Neck) n=84,88,40,39 | 1.75 units on a scale | Standard Deviation 1.171 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Head/Neck) n=84,84,38,39 | 1.47 units on a scale | Standard Deviation 1.156 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Head/Neck) n=84,84,38,39 | 0.76 units on a scale | Standard Deviation 0.883 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Trunk) n=87,88,43,42 | 2.67 units on a scale | Standard Deviation 0.919 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Head/Neck) n=81,81,37,36 | 0.43 units on a scale | Standard Deviation 0.728 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Head/Neck) n=80,78,36,36 | 0.47 units on a scale | Standard Deviation 0.774 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Upper Limbs) n=90,88,44,44 | 2.66 units on a scale | Standard Deviation 0.805 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Trunk) n=85,88,40,39 | 2.25 units on a scale | Standard Deviation 1.08 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Upper Limbs) n=88,86,44,42 | 2.68 units on a scale | Standard Deviation 0.829 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Upper Limbs) n=87,88,43,42 | 2.53 units on a scale | Standard Deviation 0.96 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Lower Limbs) n=84,84,38,39 | 1.05 units on a scale | Standard Deviation 1.012 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Upper Limbs) n=81,81,37,36 | 0.49 units on a scale | Standard Deviation 0.768 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Upper Limbs) n=84,88,40,39 | 2.13 units on a scale | Standard Deviation 1.067 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Trunk) n=84,88,40,39 | 2.00 units on a scale | Standard Deviation 1.109 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Upper Limbs) n=84,84,38,39 | 1.71 units on a scale | Standard Deviation 1.137 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Upper Limbs) n=84,84,38,39 | 0.97 units on a scale | Standard Deviation 0.788 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Upper Limbs) n=83,83,38,37 | 0.55 units on a scale | Standard Deviation 0.76 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Upper Limbs) n=81,81,37,36 | 0.59 units on a scale | Standard Deviation 0.927 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Trunk) n=84,84,38,39 | 1.79 units on a scale | Standard Deviation 1.298 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Upper Limbs) n=80,78,36,36 | 0.69 units on a scale | Standard Deviation 0.98 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Trunk) n=90,88,44,44 | 2.86 units on a scale | Standard Deviation 0.51 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Trunk) n=88,86,44,42 | 2.84 units on a scale | Standard Deviation 0.568 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Trunk) n=87,88,43,42 | 2.72 units on a scale | Standard Deviation 0.734 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Trunk) n=84,84,38,39 | 0.97 units on a scale | Standard Deviation 0.972 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Trunk) n=85,88,40,39 | 2.50 units on a scale | Standard Deviation 0.987 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Trunk) n=84,88,40,39 | 2.20 units on a scale | Standard Deviation 1.137 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Trunk) n=84,84,38,39 | 1.87 units on a scale | Standard Deviation 1.234 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Trunk) n=84,84,38,39 | 1.08 units on a scale | Standard Deviation 0.997 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Trunk) n=83,83,38,37 | 0.50 units on a scale | Standard Deviation 0.98 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Trunk) n=83,83,38,37 | 0.53 units on a scale | Standard Deviation 0.893 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Trunk) n=81,81,37,36 | 0.43 units on a scale | Standard Deviation 0.835 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Lower Limbs) n=83,83,38,37 | 0.58 units on a scale | Standard Deviation 0.976 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Trunk) n=80,78,36,36 | 0.64 units on a scale | Standard Deviation 1.073 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Erythema (Lower Limbs) n=90,88,44,44 | 3.05 units on a scale | Standard Deviation 0.746 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Trunk) n=81,81,37,36 | 0.38 units on a scale | Standard Deviation 0.861 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Erythema (Lower Limbs) n=88,86,44,42 | 3.05 units on a scale | Standard Deviation 0.776 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Erythema (Lower Limbs) n=87,88,43,42 | 2.93 units on a scale | Standard Deviation 0.856 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Erythema (Lower Limbs) n=85,88,40,39 | 2.70 units on a scale | Standard Deviation 0.939 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Erythema (Lower Limbs) n=84,88,40,39 | 2.48 units on a scale | Standard Deviation 1.012 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Trunk) n=80,78,36,36 | 0.50 units on a scale | Standard Deviation 0.941 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Erythema (Lower Limbs) n=84,84,38,39 | 2.13 units on a scale | Standard Deviation 1.166 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Erythema (Lower Limbs) n=84,84,38,39 | 1.16 units on a scale | Standard Deviation 0.945 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Erythema (Lower Limbs) n=83,83,38,37 | 0.66 units on a scale | Standard Deviation 0.909 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Lower Limbs) n=90,88,44,44 | 3.02 units on a scale | Standard Deviation 0.821 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Erythema (Lower Limbs) n=81,81,37,36 | 0.70 units on a scale | Standard Deviation 0.968 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Erythema (Lower Limbs) n=80,78,36,36 | 0.78 units on a scale | Standard Deviation 1.198 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Head/Neck) n=90,88,44,44 | 2.07 units on a scale | Standard Deviation 1.065 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Head/Neck) n=88,86,44,42 | 2.00 units on a scale | Standard Deviation 1.1 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Head/Neck) n=87,88,43,42 | 1.74 units on a scale | Standard Deviation 1.071 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Lower Limbs) n=88,86,44,42 | 2.93 units on a scale | Standard Deviation 0.846 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Head/Neck) n=85,88,40,39 | 1.55 units on a scale | Standard Deviation 0.959 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Head/Neck) n=84,88,40,39 | 1.40 units on a scale | Standard Deviation 0.9 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Head/Neck) n=84,84,38,39 | 1.29 units on a scale | Standard Deviation 0.984 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Head/Neck) n=84,84,38,39 | 0.58 units on a scale | Standard Deviation 0.683 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Lower Limbs) n=87,88,43,42 | 2.81 units on a scale | Standard Deviation 0.932 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Head/Neck) n=83,83,38,37 | 0.32 units on a scale | Standard Deviation 0.702 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Head/Neck) n=81,81,37,36 | 0.35 units on a scale | Standard Deviation 0.633 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Head/Neck) n=90,88,44,44 | 2.25 units on a scale | Standard Deviation 1.184 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Head/Neck) n=80,78,36,36 | 0.44 units on a scale | Standard Deviation 0.735 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Induration (Upper Limbs) n=90,88,44,44 | 2.57 units on a scale | Standard Deviation 0.925 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Lower Limbs) n=85,88,40,39 | 2.43 units on a scale | Standard Deviation 1.035 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Head/Neck) n=88,86,44,42 | 2.11 units on a scale | Standard Deviation 1.185 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Head/Neck) n=87,88,43,42 | 1.84 units on a scale | Standard Deviation 1.214 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Induration (Upper Limbs) n=88,86,44,42 | 2.52 units on a scale | Standard Deviation 0.876 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Head/Neck) n=85,88,40,39 | 1.48 units on a scale | Standard Deviation 1.109 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Head/Neck) n=84,88,40,39 | 1.38 units on a scale | Standard Deviation 1.03 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Head/Neck) n=84,84,38,39 | 1.21 units on a scale | Standard Deviation 1.018 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Head/Neck) n=84,84,38,39 | 0.58 units on a scale | Standard Deviation 0.758 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Induration (Upper Limbs) n=87,88,43,42 | 2.35 units on a scale | Standard Deviation 1.021 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Head/Neck) n=83,83,38,37 | 0.29 units on a scale | Standard Deviation 0.654 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Head/Neck) n=81,81,37,36 | 0.35 units on a scale | Standard Deviation 0.716 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Head/Neck) n=80,78,36,36 | 0.36 units on a scale | Standard Deviation 0.723 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Upper Limbs) n=90,88,44,44 | 2.55 units on a scale | Standard Deviation 0.848 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Induration (Upper Limbs) n=85,88,40,39 | 2.03 units on a scale | Standard Deviation 1.05 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Upper Limbs) n=88,86,44,42 | 2.43 units on a scale | Standard Deviation 0.9 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Upper Limbs) n=87,88,43,42 | 2.28 units on a scale | Standard Deviation 1.031 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Upper Limbs) n=85,88,40,39 | 1.93 units on a scale | Standard Deviation 1.118 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Upper Limbs) n=84,88,40,39 | 1.60 units on a scale | Standard Deviation 1.033 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Upper Limbs) n=84,88,40,39 | 1.78 units on a scale | Standard Deviation 1 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Upper Limbs) n=84,84,38,39 | 1.50 units on a scale | Standard Deviation 1.033 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Upper Limbs) n=84,84,38,39 | 0.82 units on a scale | Standard Deviation 0.834 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Induration (Lower Limbs) n=81,81,37,36 | 0.68 units on a scale | Standard Deviation 1.029 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Upper Limbs) n=83,83,38,37 | 0.42 units on a scale | Standard Deviation 0.642 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Upper Limbs) n=81,81,37,36 | 0.41 units on a scale | Standard Deviation 0.686 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Induration (Upper Limbs) n=84,84,38,39 | 1.55 units on a scale | Standard Deviation 1.083 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Upper Limbs) n=80,78,36,36 | 0.61 units on a scale | Standard Deviation 0.871 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Trunk) n=90,88,44,44 | 2.77 units on a scale | Standard Deviation 0.677 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Induration (Lower Limbs) n=84,88,40,39 | 2.15 units on a scale | Standard Deviation 0.975 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 2: Scaling (Trunk) n=88,86,44,42 | 2.66 units on a scale | Standard Deviation 0.745 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 4: Scaling (Trunk) n=87,88,43,42 | 2.49 units on a scale | Standard Deviation 0.883 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Induration (Upper Limbs) n=84,84,38,39 | 0.89 units on a scale | Standard Deviation 0.924 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 8: Scaling (Trunk) n=85,88,40,39 | 2.10 units on a scale | Standard Deviation 1.008 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 12: Scaling (Trunk) n=84,88,40,39 | 1.73 units on a scale | Standard Deviation 1.037 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 16: Scaling (Trunk) n=84,84,38,39 | 1.58 units on a scale | Standard Deviation 1.106 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 20: Scaling (Trunk) n=84,84,38,37 | 0.82 units on a scale | Standard Deviation 0.955 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Induration (Upper Limbs) n=83,83,38,37 | 0.58 units on a scale | Standard Deviation 0.919 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 32: Scaling (Trunk) n=83,83,38,37 | 0.39 units on a scale | Standard Deviation 0.823 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 40: Scaling (Trunk) n=81,81,37,36 | 0.38 units on a scale | Standard Deviation 0.861 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Induration (Lower Limbs) n=80,78,36,36 | 0.67 units on a scale | Standard Deviation 1.069 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Week 52: Scaling (Trunk) n=80,78,36,36 | 0.53 units on a scale | Standard Deviation 0.971 |
| Placebo | PASI Component Scores Over Time Through Week 52 | Baseline: Scaling (Lower Limbs) n=90,88,44,44 | 2.84 units on a scale | Standard Deviation 0.834 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 1.12 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.77 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.97 |
| Placebo to Tofacitinib 5 mg | 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 0.81 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.81 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 1.1 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.68 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.93 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 1.01 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.8 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.91 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.79 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.66 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 0.81 |
| Placebo to Tofacitinib 5 mg | 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 0.87 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16 | 60.00 percentage of participants | 5.903 |
| Tofacitinib 5 mg | Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16 | 35.23 percentage of participants | 5.838 |
| Placebo | Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16 | 3.41 percentage of participants | 6.061 |
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [13.38, 267.15]Cochran-Mantel-Haenszel
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [4.31, 79.62]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving PASI75 Response at Week 4
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response at Week 4 | 24.44 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response at Week 4 | 4.55 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response at Week 4 | 0.00 percentage of participants |
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: 0.0386Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 52 | 76.67 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 4 | 24.44 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 32 | 81.11 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 12 | 72.22 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 8 | 51.11 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 20 | 83.33 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 40 | 80.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 16 | 81.11 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 2 | 1.11 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 16 | 54.55 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 32 | 59.09 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 20 | 54.55 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 8 | 31.82 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 40 | 56.82 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 12 | 47.73 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 4 | 4.55 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 52 | 59.09 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 4 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 8 | 2.27 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 12 | 11.36 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 16 | 20.45 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 20 | 52.27 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 32 | 75.00 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 40 | 68.18 percentage of participants |
| Placebo | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 52 | 63.64 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 32 | 65.91 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 12 | 2.27 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 8 | 2.27 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 52 | 59.09 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 40 | 65.91 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 4 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 20 | 27.27 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 16 | 4.55 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
Secondary
Percentage of Participants in Each PGA Category Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Clear (n=84,84,38,39) | 50.0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Mild (n=90,88,44,44) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Clear (n=84,84,38,39) | 42.9 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Mild (n=87,88,43,42) | 29.9 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Almost Clear (n=80,78,36,36) | 31.3 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Moderate (n=84,84,38,39) | 7.1 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Almost Clear (n=84,84,38,39) | 31.0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Moderate (n=87,88,43,42) | 27.6 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Almost Clear (n=88,86,44,42) | 3.4 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Mild (n=88,86,44,42) | 47.7 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Moderate (n=81,81,37,36) | 6.2 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Severe (n=87,88,43,42) | 3.4 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Almost Clear (n=84,84,38,39) | 38.1 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Moderate (n=80,78,36,36) | 7.5 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Mild (n=84,84,38,39) | 11.9 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Clear (n=85,88,40,39) | 23.5 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Moderate (n=84,84,38,39) | 9.5 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Moderate (n=90,88,44,44) | 85.6 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Mild (n=81,81,37,36) | 13.6 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Almost Clear (n=85,88,40,39) | 37.6 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Almost Clear (n=90,88,44,44) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Severe (n=84,88,40,39) | 2.4 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Moderate (n=88,86,44,42) | 40.9 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Mild (n=85,88,40,39) | 20.0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Almost Clear (n=83,83,38,37) | 27.7 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Clear (n=90,88,44,44) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Almost Clear (n=81,81,37,36) | 27.2 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Moderate (n=85,88,40,39) | 17.6 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Severe (n=84,84,38,39) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Clear (n=80,78,36,36) | 45.0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Severe (n=83,83,38,37) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Severe (n=85,88,40,39) | 1.2 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Severe (n=88,86,44,42) | 8.0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Severe (n=90,88,44,44) | 14.4 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Severe (n=84,84,38,39) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Clear (n=84,88,40,39) | 34.5 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Clear (n=81,81,37,36) | 53.1 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Clear (n=83,83,38,37) | 51.8 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Moderate (n=83,83,38,37) | 7.2 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Almost Clear (n=84,88,40,39) | 45.2 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Clear (n=87,88,43,42) | 2.3 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Severe (n=80,78,36,36) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Mild (n=84,84,38,39) | 9.5 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Mild (n=84,88,40,39) | 11.9 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Severe (n=81,81,37,36) | 0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Mild (n=80,78,36,36) | 16.3 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Mild (n=83,83,38,37) | 13.3 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Moderate (n=84,88,40,39) | 6.0 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Almost Clear (n=87,88,43,42) | 36.8 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Clear (n=88,86,44,42) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Severe (n=87,88,43,42) | 4.5 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Severe (n=84,88,40,39) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Clear (n=88,86,44,42) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Clear (n=84,84,38,39) | 16.7 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Severe (n=80,78,36,36) | 1.3 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Clear (n=83,83,38,37) | 31.3 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Almost Clear (n=84,84,38,39) | 38.1 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Almost Clear (n=80,78,36,36) | 35.9 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Mild (n=84,84,38,39) | 21.4 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Severe (n=84,84,38,39) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Moderate (n=84,84,38,39) | 23.8 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Almost Clear (n=88,86,44,42) | 2.3 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Severe (n=84,84,38,39) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Moderate (n=84,84,38,39) | 13.1 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Clear (n=84,84,38,39) | 25.0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Almost Clear (n=84,84,38,39) | 32.1 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Mild (n=84,84,38,39) | 29.8 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Mild (n=88,86,44,42) | 36.0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Clear (n=80,78,36,36) | 25.6 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Moderate (n=88,86,44,42) | 55.8 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Almost Clear (n=90,88,44,44) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Severe (n=88,86,44,42) | 5.8 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Severe (n=81,81,37,36) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Clear (n=87,88,43,42) | 1.1 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Moderate (n=80,78,36,36) | 17.9 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Almost Clear (n=87,88,43,42) | 18.2 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Severe (n=83,83,38,37) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Mild (n=87,88,43,42) | 39.8 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Mild (n=90,88,44,44) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Moderate (n=81,81,37,36) | 13.6 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Moderate (n=87,88,43,42) | 36.4 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Clear (n=81,81,37,36) | 29.6 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Almost Clear (n=83,83,38,37) | 25.3 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Mild (n=81,81,37,36) | 25.9 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Clear (n=85,88,40,39) | 3.4 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Almost Clear (n=85,88,40,39) | 35.2 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Moderate (n=90,88,44,44) | 87.5 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Almost Clear (n=81,81,37,36) | 30.9 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Mild (n=85,88,40,39) | 28.4 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Moderate (n=85,88,40,39) | 30.7 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Mild (n=80,78,36,36) | 19.2 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Severe (n=85,88,40,39) | 2.3 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Moderate (n=83,83,38,37) | 16.9 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Clear (n=84,88,40,39) | 12.5 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Severe (n=90,88,44,44) | 12.5 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Almost Clear (n=84,88,40,39) | 37.5 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Clear (n=90,88,44,44) | 0 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Mild (n=83,83,38,37) | 26.5 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Mild (n=84,88,40,39) | 27.3 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Moderate (n=84,88,40,39) | 22.7 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Moderate (n=81,81,37,36) | 8.1 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Severe (n=83,83,38,37) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Clear (n=90,88,44,44) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Almost Clear (n=90,88,44,44) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Mild (n=90,88,44,44) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Moderate (n=90,88,44,44) | 81.8 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Severe (n=90,88,44,44) | 18.2 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Clear (n=88,86,44,42) | 0 percentage of participants |
| Placebo | 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 |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Mild (n=88,86,44,42) | 11.4 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Moderate (n=88,86,44,42) | 75.0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Severe (n=88,86,44,42) | 13.6 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Clear (n=87,88,43,42) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Almost Clear (n=87,88,43,42) | 2.3 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Mild (n=87,88,43,42) | 23.3 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Moderate (n=87,88,43,42) | 53.5 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Severe (n=87,88,43,42) | 20.9 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Clear (n=85,88,40,39) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Almost Clear (n=85,88,40,39) | 12.5 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Mild (n=85,88,40,39) | 30.0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Moderate (n=85,88,40,39) | 42.5 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Severe (n=85,88,40,39) | 15.0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Clear (n=84,88,40,39) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Almost Clear (n=84,88,40,39) | 27.5 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Mild (n=84,88,40,39) | 30.0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Moderate (n=84,88,40,39) | 37.5 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Severe (n=84,88,40,39) | 5.0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Clear (n=84,84,38,39) | 5.3 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Almost Clear (n=84,84,38,39) | 28.9 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Mild (n=84,84,38,39) | 26.3 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Moderate (n=84,84,38,39) | 34.2 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Severe (n=84,84,38,39) | 5.3 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Clear (n=84,84,38,39) | 15.8 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Almost Clear (n=84,84,38,39) | 52.6 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Mild (n=84,84,38,39) | 18.4 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Moderate (n=84,84,38,39) | 13.2 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Severe (n=84,84,38,39) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Clear (n=83,83,38,37) | 44.7 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Almost Clear (n=83,83,38,37) | 34.2 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Mild (n=83,83,38,37) | 18.4 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Moderate (n=83,83,38,37) | 2.6 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Clear (n=81,81,37,36) | 48.6 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Almost Clear (n=81,81,37,36) | 29.7 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Mild (n=81,81,37,36) | 13.5 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Severe (n=81,81,37,36) | 0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Clear (n=80,78,36,36) | 50.0 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Almost Clear (n=80,78,36,36) | 22.2 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Mild (n=80,78,36,36) | 16.7 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Moderate (n=80,78,36,36) | 11.1 percentage of participants |
| Placebo | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Severe (n=80,78,36,36) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Severe (n=90,88,44,44) | 29.5 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Moderate (n=90,88,44,44) | 70.5 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 12: Clear (n=84,88,40,39) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 32: Severe (n=83,83,38,37) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Mild (n=90,88,44,44) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 8: Clear (n=85,88,40,39) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Almost Clear (n=90,88,44,44) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 4: Clear (n=87,88,43,42) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 52: Severe (n=80,78,36,36) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 40: Severe (n=81,81,37,36) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 2: Clear (n=88,86,44,42) | 0 percentage of participants |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Baseline: Clear (n=90,88,44,44) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 20: Severe (n=84,84,38,39) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percentage of Participants in Each PGA Category Over Time Through Week 52 | Week 16: Clear (n=84,84,38,39) | 0 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Tofacitinib 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 |
| Tofacitinib 5 mg | Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16 | 76.82 percentage of participants | 95% Confidence Interval 0.493 |
Secondary
Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Tofacitinib 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 |
| Tofacitinib 5 mg | Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16 | 70.45 percentage of participants | 95% Confidence Interval 0.493 |
Secondary
Percentage of Participants Maintaining PGA Score of Clear or Almost Clear at Week 52 Among Participants Achieving PGA Response at Week 16
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Tofacitinib 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 |
| Tofacitinib 5 mg | Percentage of Participants Maintaining PGA Score of Clear or Almost Clear at Week 52 Among Participants Achieving PGA Response at Week 16 | 73.63 percentage of participants | 95% Confidence Interval 0.493 |
Secondary
Percentage of Participants With NAPSI100 Response Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 16 | 5.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 20 | 17.50 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 32 | 27.50 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 40 | 30.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 52 | 30.00 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 52 | 31.58 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 32 | 13.16 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 8 | 5.26 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 20 | 10.53 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 16 | 5.26 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 40 | 15.79 percentage of participants |
| Placebo | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 16 | 11.11 percentage of participants |
| Placebo | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 20 | 11.11 percentage of participants |
| Placebo | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 32 | 11.11 percentage of participants |
| Placebo | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 52 | 16.67 percentage of participants |
| Placebo | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 40 | 11.11 percentage of participants |
| Placebo | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 40 | 16.67 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 52 | 16.67 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 16 | 5.56 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 32 | 5.56 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI100 Response Over Time Through Week 52 | Week 20 | 0.00 percentage of participants |
Secondary
Percentage of Participants With NAPSI75 Response Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 16 | 20.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 20 | 30.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 32 | 52.50 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 40 | 65.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 52 | 52.50 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 52 | 47.37 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 32 | 28.95 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 8 | 10.53 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 20 | 13.16 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 16 | 15.79 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 40 | 34.21 percentage of participants |
| Placebo | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 16 | 11.11 percentage of participants |
| Placebo | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 20 | 11.11 percentage of participants |
| Placebo | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 32 | 27.78 percentage of participants |
| Placebo | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 52 | 38.89 percentage of participants |
| Placebo | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 8 | 5.56 percentage of participants |
| Placebo | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 40 | 33.33 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 52 | 38.89 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 40 | 33.33 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 16 | 5.56 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 32 | 16.67 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With NAPSI75 Response Over Time Through Week 52 | Week 20 | 0.00 percentage of participants |
Secondary
Percentage of Participants With PASI125 Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 2.35 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 1.25 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 1.19 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 1.19 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 0.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 2.30 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 2.27 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 1.19 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.00 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 2.38 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 1.16 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 1.14 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 1.14 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 1.14 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 0.00 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 0.00 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.00 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 17.50 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 10.53 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 13.95 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 4.55 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 7.50 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 40 (n=81,81,37,36) | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 32 (n=83,83,38,37) | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 16 (n=84,84,38,39) | 7.69 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 2.38 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 5.13 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 2.56 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 20 (n=84,84,38,39) | 2.56 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 4.76 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI125 Over Time Through Week 52 | Week 52 (n=80,78,36,36) | 0.00 percentage of participants |
Secondary
Percentage of Participants With PASI50 Response Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 32 | 88.89 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 20 | 85.56 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 52 | 83.33 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 12 | 81.11 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 8 | 74.44 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 4 | 48.89 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 40 | 87.78 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 16 | 86.67 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 2 | 21.11 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 16 | 71.59 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 32 | 78.41 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 20 | 72.73 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 4 | 27.27 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 2 | 5.68 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 8 | 55.68 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 52 | 73.86 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 40 | 80.68 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 12 | 64.77 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 16 | 40.91 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 4 | 4.55 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 8 | 13.64 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 12 | 27.27 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 20 | 68.18 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 32 | 79.55 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 40 | 79.55 percentage of participants |
| Placebo | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 52 | 77.27 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 32 | 75.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 12 | 9.09 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 8 | 4.55 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 52 | 75.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 40 | 72.73 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 4 | 4.55 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 20 | 63.64 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 16 | 18.18 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI50 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
Secondary
Percentage of Participants With PASI90 Response Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 8 | 27.78 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 40 | 66.67 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 16 | 60.00 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 52 | 56.67 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 12 | 51.11 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 4 | 7.78 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 32 | 65.56 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 20 | 71.11 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 32 | 42.05 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 40 | 35.23 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 4 | 2.27 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 52 | 38.64 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 8 | 13.64 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 12 | 29.55 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 16 | 35.23 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 20 | 35.23 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 52 | 56.82 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 16 | 6.82 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 32 | 56.82 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 4 | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 40 | 56.82 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 20 | 25.00 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 12 | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 52 | 36.36 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 4 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 12 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 16 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 32 | 40.91 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 40 | 45.45 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PASI90 Response Over Time Through Week 52 | Week 20 | 9.09 percentage of participants |
Secondary
Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 32 | 56.67 percentage of participants |
| Tofacitinib 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 |
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 8 | 32.22 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 20 | 52.22 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 12 | 45.56 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 40 | 52.22 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 52 | 51.11 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 4 | 7.78 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 16 | 55.56 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 20 | 31.82 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 40 | 34.09 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 52 | 26.14 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 16 | 34.09 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 32 | 34.09 percentage of participants |
| Tofacitinib 5 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 |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 4 | 5.68 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 12 | 27.27 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 8 | 19.32 percentage of participants |
| Placebo | 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 |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 52 | 47.73 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 12 | 2.27 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 4 | 2.27 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 8 | 2.27 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 20 | 18.18 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 32 | 45.45 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 16 | 9.09 percentage of participants |
| Placebo | Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52 | Week 40 | 50.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
Secondary
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 32 | 73.33 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 20 | 75.56 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 52 | 67.78 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 12 | 74.44 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 8 | 57.78 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 4 | 37.78 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 40 | 72.22 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 16 | 75.56 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 2 | 3.33 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 16 | 52.27 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 32 | 53.41 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 20 | 54.55 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 4 | 19.32 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 2 | 2.27 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 8 | 38.64 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 52 | 54.55 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 40 | 55.68 percentage of participants |
| Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 12 | 50.00 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 16 | 29.55 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 4 | 2.27 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 8 | 11.36 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 12 | 25.00 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 20 | 59.09 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 32 | 68.18 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 40 | 65.91 percentage of participants |
| Placebo | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 52 | 59.09 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 32 | 52.27 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 12 | 6.82 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 8 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 52 | 50.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 40 | 54.55 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 4 | 0.00 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 20 | 47.73 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 16 | 9.09 percentage of participants |
| Placebo to Tofacitinib 5 mg | Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 | Week 2 | 0.00 percentage of participants |
Secondary
Percentage of Participants With PGA Score of Clear or Almost Clear at Week 4
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants With PGA Score of Clear or Almost Clear at Week 4 | 37.78 percentage of participants | 0.497 |
| Tofacitinib 5 mg | Percentage of Participants With PGA Score of Clear or Almost Clear at Week 4 | 19.32 percentage of participants | 0.493 |
| Placebo | Percentage of Participants With PGA Score of Clear or Almost Clear at Week 4 | 1.14 percentage of participants | 0.504 |
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant,only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [8.95, 2657.62]Cochran-Mantel-Haenszel
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [3.47, 1084.02]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in BSA Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -87.55 percent change | Standard Error 3.531 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -82.65 percent change | Standard Error 4.459 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -84.16 percent change | Standard Error 3.867 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -65.97 percent change | Standard Error 5.536 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -46.98 percent change | Standard Error 4.909 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -21.90 percent change | Standard Error 3.202 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -90.00 percent change | Standard Error 3.213 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -73.80 percent change | Standard Error 5.903 |
| Tofacitinib 10 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 2 (n=88,86,44,44) | -5.58 percent change | Standard Error 2.083 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -54.41 percent change | Standard Error 5.839 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -70.55 percent change | Standard Error 3.521 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -62.35 percent change | Standard Error 4.419 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -10.98 percent change | Standard Error 3.193 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 2 (n=88,86,44,44) | -2.53 percent change | Standard Error 2.093 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -33.22 percent change | Standard Error 4.87 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -72.28 percent change | Standard Error 3.868 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -73.00 percent change | Standard Error 3.207 |
| Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -44.44 percent change | Standard Error 5.471 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -8.85 percent change | Standard Error 8.511 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 2 (n=88,86,44,44) | 4.79 percent change | Standard Error 2.947 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 4 (n=87,88,43,42) | 10.29 percent change | Standard Error 4.541 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 8 (n=85,88,40,39) | 8.73 percent change | Standard Error 7.017 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 12 (n=84,88,40,39) | 0.41 percent change | Standard Error 7.928 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -49.35 percent change | Standard Error 6.495 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -74.83 percent change | Standard Error 5.186 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -79.48 percent change | Standard Error 4.743 |
| Placebo | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -81.70 percent change | Standard Error 5.681 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | Percent Change From Baseline in BSA Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -28.86 percent change | Standard Error 6.53 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline
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.
Time frame: 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..
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 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 |
| Tofacitinib 5 mg | Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline | -14.98 percent change | Standard Error 10.566 |
| Placebo | Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline | 7.91 percent change | Standard Error 12.025 |
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: 0.011395% CI: [-72.91, -9.54]Mixed Models Analysis
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: 0.155895% CI: [-54.64, 8.86]Mixed Models Analysis
Secondary
Percent Change From Baseline in NAPSI Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 8 (n=39,38,15,15) | -9.59 percent change | Standard Error 8.473 |
| Tofacitinib 10 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 16 (n=38,38,14,15) | -33.31 percent change | Standard Error 10.552 |
| Tofacitinib 10 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 20 (n=37,38,14,15) | -51.97 percent change | Standard Error 8.748 |
| Tofacitinib 10 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 32 (n=37,37,14,14) | -58.44 percent change | Standard Error 10.256 |
| Tofacitinib 10 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 40 (n=36,36,13,13) | -68.68 percent change | Standard Error 9.243 |
| Tofacitinib 10 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 52 (n=31,34,12,13) | -71.40 percent change | Standard Error 10.891 |
| Tofacitinib 5 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 52 (n=31,34,12,13) | -51.71 percent change | Standard Error 10.636 |
| Tofacitinib 5 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 32 (n=37,37,14,14) | -25.27 percent change | Standard Error 10.247 |
| Tofacitinib 5 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 20 (n=37,38,14,15) | -25.10 percent change | Standard Error 8.715 |
| Tofacitinib 5 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 40 (n=36,36,13,13) | -37.40 percent change | Standard Error 9.208 |
| Tofacitinib 5 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 16 (n=38,38,14,15) | -14.91 percent change | Standard Error 10.6 |
| Tofacitinib 5 mg | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 8 (n=39,38,15,15) | -8.81 percent change | Standard Error 8.585 |
| Placebo | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 16 (n=38,38,14,15) | -3.26 percent change | Standard Error 17.257 |
| Placebo | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 20 (n=37,38,14,15) | -8.87 percent change | Standard Error 14.276 |
| Placebo | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 52 (n=31,34,12,13) | -56.08 percent change | Standard Error 17.621 |
| Placebo | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 32 (n=37,37,14,14) | -50.20 percent change | Standard Error 16.734 |
| Placebo | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 40 (n=36,36,13,13) | -47.17 percent change | Standard Error 15.143 |
| Placebo | Percent Change From Baseline in NAPSI Over Time Through Week 52 | Week 8 (n=39,38,15,15) | 5.28 percent change | Standard Error 13.661 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Percent Change From Baseline in PASI Scores Over Time Through Week 52
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -90.47 percent change | Standard Error 2.444 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -87.89 percent change | Standard Error 3.024 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -86.05 percent change | Standard Error 2.763 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -80.64 percent change | Standard Error 3.631 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -66.96 percent change | Standard Error 3.769 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -46.24 percent change | Standard Error 3.135 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -90.18 percent change | Standard Error 2.264 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -84.35 percent change | Standard Error 3.912 |
| Tofacitinib 10 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 2 (n=88,86,44,42) | -24.93 percent change | Standard Error 2.399 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -66.69 percent change | Standard Error 3.874 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -76.06 percent change | Standard Error 2.437 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -71.93 percent change | Standard Error 3.002 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -32.47 percent change | Standard Error 3.127 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 2 (n=88,86,44,42) | -16.28 percent change | Standard Error 2.409 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -51.24 percent change | Standard Error 3.739 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -75.55 percent change | Standard Error 2.764 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -77.29 percent change | Standard Error 2.258 |
| Tofacitinib 5 mg | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -59.73 percent change | Standard Error 3.585 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 16 (n=84,84,38,39) | -32.79 percent change | Standard Error 5.651 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 2 (n=88,86,44,42) | 1.37 percent change | Standard Error 3.392 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 4 (n=87,88,43,42) | -1.98 percent change | Standard Error 4.444 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 8 (n=85,88,40,39) | -13.17 percent change | Standard Error 5.384 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 12 (n=84,88,40,39) | -25.13 percent change | Standard Error 5.205 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 20 (n=84,84,38,39) | -69.85 percent change | Standard Error 4.399 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 32 (n=83,83,38,37) | -86.63 percent change | Standard Error 3.584 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 40 (n=81,81,37,36) | -87.73 percent change | Standard Error 3.332 |
| Placebo | Percent Change From Baseline in PASI Scores Over Time Through Week 52 | Week 52 (n=80,78,36,36) | -84.65 percent change | Standard Error 4.066 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Secondary
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 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 |
| Tofacitinib 5 mg | Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 | -54.39 percent change | Standard Error 5.838 |
| Placebo | Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 | -2.27 percent change | Standard Error 6.061 |
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [-88.2, -54.87]Mixed Models Analysis
Comparison: This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.p-value: <0.000195% CI: [-68.7, -35.55]Mixed Models Analysis
Secondary
Time to PASI50 Response up to Week 16
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%.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib 10 mg | Time to PASI50 Response up to Week 16 | 4.0 weeks |
| Tofacitinib 5 mg | Time to PASI50 Response up to Week 16 | 8.0 weeks |
| Placebo | Time to PASI50 Response up to Week 16 | NA weeks |
Secondary
Time to PASI75 Response up to Week 16
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib 10 mg | Time to PASI75 Response up to Week 16 | 8.0 weeks |
| Tofacitinib 5 mg | Time to PASI75 Response up to Week 16 | 16.0 weeks |
| Placebo | Time to PASI75 Response up to Week 16 | NA weeks |
Secondary
Time to PGA Response up to Week 16
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib 10 mg | Time to PGA Response up to Week 16 | 8.0 weeks |
| Tofacitinib 5 mg | Time to PGA Response up to Week 16 | 14.0 weeks |
| Placebo | Time to PGA Response up to Week 16 | NA weeks |
Other Pre-specified
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16
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.
Time frame: Baseline to Week 16
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | New Ischemic Heart Disease | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Coronary Revascularization Procedure | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Non-CV Death | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | MACE | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Heart Failure | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Myocardial Infarction | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Peripheral Vascular Disease | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Cerebrovascular Accident | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Cerebrovascular Accident | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Myocardial Infarction | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | New Ischemic Heart Disease | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Coronary Revascularization Procedure | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Heart Failure | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | MACE | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Peripheral Vascular Disease | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Non-CV Death | 1 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Peripheral Vascular Disease | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | MACE | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | New Ischemic Heart Disease | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Myocardial Infarction | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Cerebrovascular Accident | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Heart Failure | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Non-CV Death | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16 | Coronary Revascularization Procedure | 0 participants |
Other Pre-specified
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52
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.
Time frame: Baseline up to Week 52
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Myocardial Infarction | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Cerebrovascular Accident | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | New Ischemic Heart Disease | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | MACE | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Coronary Revascularization Procedure | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Peripheral Vascular Disease | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Heart Failure | 0 participants |
| Tofacitinib 10 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Non-CV Death | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | New Ischemic Heart Disease | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Cerebrovascular Accident | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Coronary Revascularization Procedure | 1 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Heart Failure | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Myocardial Infarction | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Non-CV Death | 1 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | MACE | 0 participants |
| Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Peripheral Vascular Disease | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Heart Failure | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | New Ischemic Heart Disease | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Non-CV Death | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | MACE | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Coronary Revascularization Procedure | 1 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Peripheral Vascular Disease | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Cerebrovascular Accident | 0 participants |
| Placebo | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Myocardial Infarction | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Heart Failure | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | MACE | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Coronary Revascularization Procedure | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Peripheral Vascular Disease | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Cerebrovascular Accident | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Non-CV Death | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | New Ischemic Heart Disease | 0 participants |
| Placebo to Tofacitinib 5 mg | Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52 | Myocardial Infarction | 0 participants |
Other Pre-specified
Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16
As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.
Time frame: Baseline to Week 16
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16 | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16 | 1 participants |
| Placebo | Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16 | 0 participants |
Other Pre-specified
Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52
As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.
Time frame: Baseline to Week 52
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52 | 1 participants |
| Tofacitinib 5 mg | Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52 | 1 participants |
| Placebo | Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52 | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52 | 0 participants |
Other Pre-specified
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16
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.
Time frame: Baseline to Week 16
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential AST or ALT reason #2 | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential platelet count | 2 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential serum creatinine | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential absolute neutrophil count | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 sequential creatine kinase | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential AST or ALT reason #1 | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential hemoglobin | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential absolute lymphocyte count | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential absolute neutrophil count | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential platelet count | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential AST or ALT reason #1 | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential AST or ALT reason #2 | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential absolute lymphocyte count | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential hemoglobin | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential serum creatinine | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 sequential creatine kinase | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential absolute lymphocyte count | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential hemoglobin | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential absolute neutrophil count | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential platelet count | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 sequential creatine kinase | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential serum creatinine | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential AST or ALT reason #1 | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16 | 2 Sequential AST or ALT reason #2 | 0 participants |
Other Pre-specified
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52
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.
Time frame: Baseline up to Week 52
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential hemoglobin | 1 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute neutrophil count | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #2 | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 sequential creatine kinase | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #1 | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute lymphocyte count | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential serum creatinine | 0 participants |
| Tofacitinib 10 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential platelet count | 2 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential serum creatinine | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 sequential creatine kinase | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute neutrophil count | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #1 | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential hemoglobin | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #2 | 1 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential platelet count | 0 participants |
| Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute lymphocyte count | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute lymphocyte count | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential platelet count | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #1 | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential serum creatinine | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #2 | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential hemoglobin | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 sequential creatine kinase | 0 participants |
| Placebo | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute neutrophil count | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 sequential creatine kinase | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute neutrophil count | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential hemoglobin | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #1 | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential AST or ALT reason #2 | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential serum creatinine | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential absolute lymphocyte count | 0 participants |
| Placebo to Tofacitinib 5 mg | Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52 | 2 Sequential platelet count | 1 participants |
Other Pre-specified
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | 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 |
| Tofacitinib 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 |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 5 mg | 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) | 5 participants |
| Tofacitinib 5 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) | 0 participants |
| Tofacitinib 5 mg | 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 |
| Tofacitinib 5 mg | 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 |
| Tofacitinib 5 mg | 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 |
| Tofacitinib 5 mg | 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) | 1 participants |
| Tofacitinib 5 mg | 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) | 0 participants |
| Tofacitinib 5 mg | 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) | 2 participants |
| Placebo | 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) | 1 participants |
| Placebo | 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 |
| Placebo | 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) | 0 participants |
| Placebo | 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) | 0 participants |
| Placebo | 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 |
| Placebo | 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) | 1 participants |
| Placebo | 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) | 2 participants |
| Placebo | 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) | 1 participants |
Other Pre-specified
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 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) | 1 participants |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 10 mg | 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 |
| Tofacitinib 10 mg | 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) | 5 participants |
| Tofacitinib 10 mg | 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) | 5 participants |
| Tofacitinib 10 mg | 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) | 4 participants |
| Tofacitinib 10 mg | 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) | 3 participants |
| Tofacitinib 10 mg | 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) | 0 participants |
| Tofacitinib 5 mg | 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) | 0 participants |
| Tofacitinib 5 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 |
| Tofacitinib 5 mg | 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 |
| Tofacitinib 5 mg | 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) | 4 participants |
| Tofacitinib 5 mg | 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 |
| Tofacitinib 5 mg | 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) | 8 participants |
| Tofacitinib 5 mg | 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) | 1 participants |
| Tofacitinib 5 mg | 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) | 3 participants |
| Placebo | 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) | 2 participants |
| Placebo | 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) | 2 participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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) | 0 participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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) | 1 participants |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 mg | 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 |
| Placebo to Tofacitinib 5 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 |
| Placebo to Tofacitinib 5 mg | 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 |
Other Pre-specified
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16
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.
Time frame: Baseline to Week 16
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants with AEs(All Causalities) | 61 participants |
| Tofacitinib 10 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants with SAEs(All Causalities) | 0 participants |
| Tofacitinib 10 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants Discontinued due to AEs | 1 participants |
| Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants with SAEs(All Causalities) | 2 participants |
| Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants Discontinued due to AEs | 3 participants |
| Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants with AEs(All Causalities) | 57 participants |
| Placebo | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants with SAEs(All Causalities) | 0 participants |
| Placebo | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants Discontinued due to AEs | 3 participants |
| Placebo | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16 | Number of Participants with AEs(All Causalities) | 43 participants |
Other Pre-specified
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52
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.
Time frame: Baseline to Week 52
Population: The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with AEs (All Causalities) | 76 participants |
| Tofacitinib 10 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants Discontinued due to AEs | 1 participants |
| Tofacitinib 10 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with SAEs(All Causalities) | 2 participants |
| Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with AEs (All Causalities) | 74 participants |
| Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants Discontinued due to AEs | 3 participants |
| Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with SAEs(All Causalities) | 4 participants |
| Placebo | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with SAEs(All Causalities) | 1 participants |
| Placebo | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with AEs (All Causalities) | 35 participants |
| Placebo | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants Discontinued due to AEs | 3 participants |
| Placebo to Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with SAEs(All Causalities) | 0 participants |
| Placebo to Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants with AEs (All Causalities) | 33 participants |
| Placebo to Tofacitinib 5 mg | Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52 | Number of Participants Discontinued due to AEs | 1 participants |