Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01815424
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: placebo
Drug: CP-690,550
Enrollment 266
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52. Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52. 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). Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52. Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Period Title: Week 0 to 16
Started 90 88 88 0 0
Completed 83 84 77 0 0
Not Completed 7 4 11 0 0
Reason Not Completed
Adverse Event             1             3             3             0             0
Does Not Meet Entrance Criteria             2             0             0             0             0
Lost to Follow-up             0             1             0             0             0
Withdrawal by Subject             0             0             1             0             0
Other             1             0             3             0             0
Protocol Violation             1             0             0             0             0
Insufficient Clinical Response             2             0             4             0             0
Period Title: Week 16 to 52
Started 83 84 0 38 39
Completed 81 79 0 35 36
Not Completed 2 5 0 3 3
Reason Not Completed
Other             0             1             0             0             0
Adverse Event             0             0             0             0             1
Insufficient Clinical Response             1             0             0             1             1
Lost to Follow-up             0             2             0             2             1
Withdrawal by Subject             1             2             0             0             0
Arm/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo Total
Hide Arm/Group Description Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52. Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52. Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg). Total of all reporting groups
Overall Number of Baseline Participants 90 88 88 266
Hide Baseline Analysis Population Description
The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 88 participants 88 participants 266 participants
41.0  (12.0) 40.7  (11.3) 41.7  (13.7) 41.1  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 88 participants 88 participants 266 participants
Female
23
  25.6%
23
  26.1%
26
  29.5%
72
  27.1%
Male
67
  74.4%
65
  73.9%
62
  70.5%
194
  72.9%
1.Primary Outcome
Title Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 90 88 88
Measure Type: Number
Unit of Measure: percentage of participants
75.56 52.27 19.32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 14.52
Confidence Interval (2-Sided) 95%
6.03 to 32.77
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.27
Confidence Interval (2-Sided) 95%
2.46 to 11.86
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 90 88 88
Measure Type: Number
Unit of Measure: percentage of participants
81.11 54.55 12.50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 41.71
Confidence Interval (2-Sided) 95%
14.84 to 151.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.97
Confidence Interval (2-Sided) 95%
4.06 to 25.17
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 84 84 77
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-73.81  (5.903) -54.39  (5.838) -2.27  (6.061)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -71.54
Confidence Interval (2-Sided) 95%
-88.20 to -54.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.461
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -52.12
Confidence Interval (2-Sided) 95%
-68.70 to -35.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.416
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 90 88 88
Measure Type: Number
Unit of Measure: percentage of participants
60.00 35.23 3.41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 70.31
Confidence Interval (2-Sided) 95%
13.38 to 267.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 16.44
Confidence Interval (2-Sided) 95%
4.31 to 79.62
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in DLQI Total Score at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 84 84 77
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-9.10  (0.635) -7.03  (0.627) -1.57  (0.655)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -7.52
Confidence Interval (2-Sided) 95%
-9.32 to 5.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.913
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -5.45
Confidence Interval (2-Sided) 95%
-7.24 to -3.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.907
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 90 88 88
Measure Type: Number
Unit of Measure: percentage of participants
37.78 19.32 1.14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 114.40
Confidence Interval (2-Sided) 95%
8.95 to 2657.62
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 35.37
Confidence Interval (2-Sided) 95%
3.47 to 1084.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving PASI75 Response at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 90 88 88
Measure Type: Number
Unit of Measure: percentage of participants
24.44 4.55 0.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).
Method Cochran-Mantel-Haenszel
Comments OR and 95% CI not available due to 0% frequency in placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0386
Comments Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).
Method Cochran-Mantel-Haenszel
Comments OR and 95% CI not available due to 0% frequency in placebo group.
8.Secondary Outcome
Title Change From Baseline in DLQI Total Score at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 86 88 83
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-6.03  (0.497) -5.14  (0.493) -0.94  (0.504)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -5.09
Confidence Interval (2-Sided) 95%
-6.49 to -3.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.709
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -4.20
Confidence Interval (2-Sided) 95%
-5.59 to -2.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.706
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 38 38 29
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-33.32  (10.518) -14.98  (10.566) 7.91  (12.025)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0113
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean of difference
Estimated Value -41.23
Confidence Interval (2-Sided) 95%
-72.91 to -9.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.977
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1558
Comments Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean of difference
Estimated Value -22.89
Confidence Interval (2-Sided) 95%
-54.64 to 8.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.010
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Overall Number of Participants Analyzed 68 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.00
(62.91 to 83.65)
73.63
(58.24 to 84.08)
11.Secondary Outcome
Title Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Overall Number of Participants Analyzed 73 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.93
(74.44 to 91.36)
76.82
(62.04 to 86.44)
12.Secondary Outcome
Title Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Overall Number of Participants Analyzed 54 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.07
(60.19 to 83.75)
70.45
(50.85 to 83.41)
13.Secondary Outcome
Title Time to PGA Response up to Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 88 88 86
Median (95% Confidence Interval)
Unit of Measure: weeks
8.0
(4.0 to 8.0)
14.0 [1] 
(12.0 to NA)
NA [2] 
(NA to NA)
[1]
The CI estimate depends on the survival probability by time curve. In the study data, a time meeting the criteria for the upper limit is not reached as of the last observed time point, therefore, the upper limit is not estimable.
[2]
Not estimable
14.Secondary Outcome
Title Time to PASI75 Response up to Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 88 88 86
Median (95% Confidence Interval)
Unit of Measure: weeks
8.0
(8.0 to 12.0)
16.0 [1] 
(12.0 to NA)
NA [2] 
(NA to NA)
[1]
The CI estimate depends on the survival probability by time curve. In the study data, a time meeting the criteria for the upper limit is not reached as of the last observed time point, therefore, the upper limit is not estimable.
[2]
Not estimable
15.Secondary Outcome
Title Time to PASI50 Response up to Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
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).
Overall Number of Participants Analyzed 88 88 86
Median (95% Confidence Interval)
Unit of Measure: weeks
4.0
(4.0 to 8.0)
8.0
(8.0 to 12.0)
NA [1] 
(NA to NA)
[1]
Not estimable
16.Secondary Outcome
Title Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
3.33
(0.00 to 7.04)
2.27
(0.00 to 5.39)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 4
37.78
(27.76 to 47.79)
19.32
(11.07 to 27.57)
2.27
(0.00 to 6.68)
0.00 [1] 
(NA to NA)
Week 8
57.78
(47.57 to 67.98)
38.64
(28.46 to 48.81)
11.36
(1.99 to 20.74)
0.00 [1] 
(NA to NA)
Week 12
74.44
(65.43 to 83.46)
50.00
(39.55 to 60.45)
25.00
(12.21 to 37.79)
6.82
(0.00 to 14.27)
Week 16
75.56
(66.68 to 84.43)
52.27
(41.84 to 62.71)
29.55
(16.06 to 43.03)
9.09
(0.60 to 17.59)
Week 20
75.56
(66.68 to 84.43)
54.55
(44.14 to 64.95)
59.09
(44.56 to 73.62)
47.73
(32.97 to 62.49)
Week 32
73.33
(64.20 to 82.47)
53.41
(42.99 to 63.83)
68.18
(54.42 to 81.94)
52.27
(37.51 to 67.03)
Week 40
72.22
(62.97 to 81.48)
55.68
(45.30 to 66.06)
65.91
(51.90 to 79.92)
54.55
(39.83 to 69.26)
Week 52
67.78
(58.12 to 77.43)
54.55
(44.14 to 64.95)
59.09
(44.56 to 73.62)
50.00
(35.23 to 64.77)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
17.Secondary Outcome
Title Percentage of Participants in Each PGA Category Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: Clear (n=90,88,44,44) 0 0 0 0
Baseline: Almost Clear (n=90,88,44,44) 0 0 0 0
Baseline: Mild (n=90,88,44,44) 0 0 0 0
Baseline: Moderate (n=90,88,44,44) 85.6 87.5 81.8 70.5
Baseline: Severe (n=90,88,44,44) 14.4 12.5 18.2 29.5
Week 2: Clear (n=88,86,44,42) 0 0 0 0
Week 2: Almost Clear (n=88,86,44,42) 3.4 2.3 0 0
Week 2: Mild (n=88,86,44,42) 47.7 36.0 11.4 4.8
Week 2: Moderate (n=88,86,44,42) 40.9 55.8 75.0 71.4
Week 2: Severe (n=88,86,44,42) 8.0 5.8 13.6 23.8
Week 4: Clear (n=87,88,43,42) 2.3 1.1 0 0
Week 4: Almost Clear (n=87,88,43,42) 36.8 18.2 2.3 0
Week 4: Mild (n=87,88,43,42) 29.9 39.8 23.3 14.3
Week 4: Moderate (n=87,88,43,42) 27.6 36.4 53.5 69.0
Week 4: Severe (n=87,88,43,42) 3.4 4.5 20.9 16.7
Week 8: Clear (n=85,88,40,39) 23.5 3.4 0 0
Week 8: Almost Clear (n=85,88,40,39) 37.6 35.2 12.5 0
Week 8: Mild (n=85,88,40,39) 20.0 28.4 30.0 25.6
Week 8: Moderate (n=85,88,40,39) 17.6 30.7 42.5 61.5
Week 8: Severe (n=85,88,40,39) 1.2 2.3 15.0 12.8
Week 12: Clear (n=84,88,40,39) 34.5 12.5 0 0
Week 12: Almost Clear (n=84,88,40,39) 45.2 37.5 27.5 7.7
Week 12: Mild (n=84,88,40,39) 11.9 27.3 30.0 30.8
Week 12: Moderate (n=84,88,40,39) 6.0 22.7 37.5 51.3
Week 12: Severe (n=84,88,40,39) 2.4 0 5.0 10.3
Week 16: Clear (n=84,84,38,39) 42.9 16.7 5.3 0
Week 16: Almost Clear (n=84,84,38,39) 38.1 38.1 28.9 10.3
Week 16: Mild (n=84,84,38,39) 9.5 21.4 26.3 30.8
Week 16: Moderate (n=84,84,38,39) 9.5 23.8 34.2 51.3
Week 16: Severe (n=84,84,38,39) 0 0 5.3 7.7
Week 20: Clear (n=84,84,38,39) 50.0 25.0 15.8 2.6
Week 20: Almost Clear (n=84,84,38,39) 31.0 32.1 52.6 51.3
Week 20: Mild (n=84,84,38,39) 11.9 29.8 18.4 38.5
Week 20: Moderate (n=84,84,38,39) 7.1 13.1 13.2 7.7
Week 20: Severe (n=84,84,38,39) 0 0 0 0
Week 32: Clear (n=83,83,38,37) 51.8 31.3 44.7 29.7
Week 32: Almost Clear (n=83,83,38,37) 27.7 25.3 34.2 32.4
Week 32: Mild (n=83,83,38,37) 13.3 26.5 18.4 32.4
Week 32: Moderate (n=83,83,38,37) 7.2 16.9 2.6 5.4
Week 32: Severe (n=83,83,38,37) 0 0 0 0
Week 40: Clear (n=81,81,37,36) 53.1 29.6 48.6 36.1
Week 40: Almost Clear (n=81,81,37,36) 27.2 30.9 29.7 30.6
Week 40: Mild (n=81,81,37,36) 13.6 25.9 13.5 19.4
Week 40: Moderate (n=81,81,37,36) 6.2 13.6 8.1 13.9
Week 40: Severe (n=81,81,37,36) 0 0 0 0
Week 52: Clear (n=80,78,36,36) 45.0 25.6 50.0 30.6
Week 52: Almost Clear (n=80,78,36,36) 31.3 35.9 22.2 30.6
Week 52: Mild (n=80,78,36,36) 16.3 19.2 16.7 30.6
Week 52: Moderate (n=80,78,36,36) 7.5 17.9 11.1 8.3
Week 52: Severe (n=80,78,36,36) 0 1.3 0 0
18.Secondary Outcome
Title Percentage of Participants Achieving PASI75 Response Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
1.11
(0.00 to 3.28)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 4
24.44
(15.57 to 33.32)
4.55
(0.19 to 8.90)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 8
51.11
(40.78 to 61.44)
31.82
(22.09 to 41.55)
2.27
(0.00 to 6.68)
2.27
(0.00 to 6.68)
Week 12
72.22
(62.97 to 81.48)
47.73
(37.29 to 58.16)
11.36
(1.99 to 20.74)
2.27
(0.00 to 6.68)
Week 16
81.11
(73.02 to 89.20)
54.55
(44.14 to 64.95)
20.45
(8.54 to 32.37)
4.55
(0.00 to 10.70)
Week 20
83.33
(75.63 to 91.03)
54.55
(44.14 to 64.95)
52.27
(37.51 to 67.03)
27.27
(14.11 to 40.43)
Week 32
81.11
(73.02 to 89.20)
59.09
(48.82 to 69.36)
75.00
(62.21 to 87.79)
65.91
(51.90 to 79.92)
Week 40
80.00
(71.74 to 88.26)
56.82
(46.47 to 67.17)
68.18
(54.42 to 81.94)
65.91
(51.90 to 79.92)
Week 52
76.67
(67.93 to 85.40)
59.09
(48.82 to 69.36)
63.64
(49.42 to 77.85)
59.09
(44.56 to 73.62)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
19.Secondary Outcome
Title Actual PASI Scores Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Mean (Standard Deviation)
Unit of Measure: percentage of participants
Baseline (n=90,88,44,44) 25.34  (9.106) 25.32  (10.185) 25.62  (10.429) 26.51  (8.525)
Week 2 (n=88,86,44,42) 19.03  (9.392) 21.23  (9.979) 25.72  (10.582) 26.34  (9.456)
Week 4 (n=87,88,43,42) 13.81  (9.826) 17.41  (10.565) 24.81  (12.081) 24.65  (9.433)
Week 8 (n=85,88,40,39) 8.18  (9.075) 12.56  (10.623) 21.38  (11.689) 22.46  (8.966)
Week 12 (n=84,88,40,39) 4.56  (6.979) 10.10  (9.858) 17.83  (10.503) 21.35  (9.477)
Week 16 (n=84,84,38,39) 3.48  (6.722) 8.42  (9.800) 15.27  (11.441) 20.64  (9.738)
Week 20 (84,84,38,39) 2.75  (5.610) 7.13  (8.280) 6.52  (6.512) 10.43  (7.612)
Week 32 (n=83,83,38,37) 2.15  (3.810) 6.23  (7.817) 3.09  (5.434) 4.82  (5.517)
Week 40 (n=81,81,37,36) 2.04  (3.553) 5.74  (6.415) 2.79  (4.458) 3.74  (4.540)
Week 52 (n=80,78,36,36) 2.82  (4.674) 6.00  (7.313) 3.11  (5.027) 4.69  (4.607)
20.Secondary Outcome
Title Change From Baseline in PASI Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (n=88,86,44,42) -6.40  (6.724) -4.26  (5.231) 0.10  (4.715) -0.04  (3.676)
Week 4 (n=87,88,43,42) -11.74  (8.528) -7.91  (7.053) -0.76  (7.423) -1.72  (3.799)
Week 8 (n=85,88,40,39) -17.25  (10.244) -12.76  (10.033) -4.25  (8.996) -4.51  (6.130)
Week 12 (n=84,88,40,39) -20.98  (9.612) -15.22  (11.214) -7.71  (10.717) -5.62  (7.169)
Week 16 (n=84,84,38,39) -22.07  (10.127) -17.12  (11.711) -10.03  (12.976) -6.33  (8.973)
Week 20 (n=84,84,38,39) -22.79  (9.675) -18.42  (10.955) -18.79  (12.428) -16.54  (8.732)
Week 32 (n=83,83,38,37) -23.45  (9.369) -19.45  (10.312) -22.22  (11.550) -21.86  (9.283)
Week 40 (n=81,81,37,36) -23.47  (9.702) -20.11  (10.292) -22.80  (11.268) -22.94  (9.512)
Week 52 (n=80,78,36,36) -22.71  (10.655) -20.04  (10.819) -22.54  (12.368) -22.00  (9.429)
21.Secondary Outcome
Title PASI Component Scores Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Erythema (Head/Neck) n=90,88,44,44 2.31  (0.830) 2.18  (0.977) 2.18  (1.018) 2.39  (0.868)
Week 2: Erythema (Head/Neck) n=88,86,44,42 1.74  (0.903) 1.77  (1.037) 2.05  (1.033) 2.50  (0.834)
Week 4: Erythema (Head/Neck) n=87,88,43,42 1.37  (0.978) 1.44  (1.015) 1.91  (1.065) 2.24  (0.726)
Week 8: Erythema (Head/Neck) n=85,88,40,39 0.93  (0.997) 1.14  (1.052) 1.93  (1.141) 2.05  (1.075)
Week 12: Erythema (Head/Neck) n=84,88,40,39 0.68  (0.867) 0.94  (1.065) 1.75  (1.171) 1.97  (1.038)
Week 16: Erythema (Head/Neck) n=84,84,38,39 0.58  (0.839) 0.82  (1.032) 1.47  (1.156) 1.82  (1.073)
Week 20: Erythema (Head/Neck) n=84,84,38,39 0.50  (0.784) 0.82  (0.971) 0.76  (0.883) 1.08  (0.839)
Week 32: Erythema (Head/Neck) n=83,83,38,37 0.58  (0.885) 0.73  (0.989) 0.45  (0.860) 0.84  (1.041)
Week 40: Erythema (Head/Neck) n=81,81,37,36 0.51  (0.882) 0.74  (0.946) 0.43  (0.728) 0.64  (0.899)
Week 52: Erythema (Head/Neck) n=80,78,36,36 0.58  (0.925) 0.72  (0.966) 0.47  (0.774) 0.78  (0.929)
Baseline: Erythema (Upper Limbs) n=90,88,44,44 2.70  (0.694) 2.78  (0.686) 2.66  (0.805) 2.73  (0.624)
Week 2: Erythema (Upper Limbs) n=88,86,44,42 2.06  (0.793) 2.28  (0.792) 2.68  (0.829) 2.90  (0.692)
Week 4: Erythema (Upper Limbs) n=87,88,43,42 1.61  (0.826) 1.88  (0.920) 2.53  (0.960) 2.71  (0.673)
Week 8: Erythema (Upper Limbs) n=85,88,40,39 1.05  (0.937) 1.47  (0.982) 2.35  (1.075) 2.51  (0.823)
Week 12: Erythema (Upper Limbs) n=84,88,40,39 0.60  (0.778) 1.17  (1.074) 2.13  (1.067) 2.36  (0.873)
Week 16: Erythema (Upper Limbs) n=84,84,38,39 0.51  (0.784) 0.99  (1.024) 1.71  (1.137) 2.33  (0.927)
Week 20: Erythema (Upper Limbs) n=84,84,38,39 0.40  (0.793) 0.93  (0.967) 0.97  (0.788) 1.38  (0.877)
Week 32: Erythema (Upper Limbs) n=83,83,38,37 0.40  (0.697) 0.96  (1.087) 0.55  (0.760) 0.86  (1.004)
Week 40: Erythema (Upper Limbs) n=81,81,37,36 0.44  (0.791) 0.93  (1.034) 0.59  (0.927) 0.78  (0.866)
Week 52: Erythema (Upper Limbs) n=80,78,36,36 0.56  (0.939) 0.95  (1.031) 0.69  (0.980) 0.89  (1.063)
Baseline: Erythema (Trunk) n=90,88,44,44 2.86  (0.696) 2.81  (0.658) 2.86  (0.510) 2.93  (0.625)
Week 2: Erythema (Trunk) n=88,86,44,42 2.28  (0.830) 2.44  (0.776) 2.84  (0.568) 3.05  (0.697)
Week 4: Erythema (Trunk) n=87,88,43,42 1.82  (0.922) 2.05  (0.883) 2.72  (0.734) 2.83  (0.660)
Week 8: Erythema (Trunk) n=85,88,40,39 1.20  (1.056) 1.65  (1.006) 2.50  (0.987) 2.64  (0.778)
Week 12: Erythema (Trunk) n=84,88,40,39 0.81  (1.024) 1.44  (1.133) 2.20  (1.137) 2.54  (0.790)
Week 16: Erythema (Trunk) n=84,84,38,39 0.63  (0.929) 1.21  (1.173) 1.87  (1.234) 2.64  (0.811)
Week 20: Erythema (Trunk) n=84,84,38,39 0.62  (1.005) 1.12  (1.080) 1.08  (0.997) 1.31  (0.800)
Week 32: Erythema (Trunk) n=83,83,38,37 0.58  (0.952) 1.02  (1.137) 0.53  (0.893) 0.70  (0.968)
Week 40: Erythema (Trunk) n=81,81,37,36 0.48  (0.823) 0.96  (1.078) 0.43  (0.835) 0.67  (0.862)
Week 52: Erythema (Trunk) n=80,78,36,36 0.59  (0.924) 0.99  (1.099) 0.64  (1.073) 0.92  (0.937)
Baseline: Erythema (Lower Limbs) n=90,88,44,44 3.03  (0.678) 2.98  (0.660) 3.05  (0.746) 3.16  (0.608)
Week 2: Erythema (Lower Limbs) n=88,86,44,42 2.53  (0.870) 2.60  (0.830) 3.05  (0.776) 3.24  (0.576)
Week 4: Erythema (Lower Limbs) n=87,88,43,42 1.97  (0.946) 2.23  (0.854) 2.93  (0.856) 3.07  (0.677)
Week 8: Erythema (Lower Limbs) n=85,88,40,39 1.33  (1.051) 1.78  (1.077) 2.70  (0.939) 2.92  (0.739)
Week 12: Erythema (Lower Limbs) n=84,88,40,39 0.79  (0.865) 1.53  (1.082) 2.48  (1.012) 2.82  (0.756)
Week 16: Erythema (Lower Limbs) n=84,84,38,39 0.67  (0.883) 1.44  (1.155) 2.13  (1.166) 2.77  (0.810)
Week 20: Erythema (Lower Limbs) n=84,84,38,39 0.54  (0.870) 1.26  (1.043) 1.16  (0.945) 1.77  (0.842)
Week 32: Erythema (Lower Limbs) n=83,83,38,37 0.47  (0.860) 1.13  (1.197) 0.66  (0.909) 1.11  (1.100)
Week 40: Erythema (Lower Limbs) n=81,81,37,36 0.52  (0.963) 1.14  (1.159) 0.70  (0.968) 0.81  (0.889)
Week 52: Erythema (Lower Limbs) n=80,78,36,36 0.70  (1.024) 1.24  (1.281) 0.78  (1.198) 0.94  (1.068)
Baseline: Induration (Head/Neck) n=90,88,44,44 2.23  (0.937) 1.94  (0.998) 2.07  (1.065) 2.20  (0.930)
Week 2: Induration (Head/Neck) n=88,86,44,42 1.63  (0.998) 1.67  (1.011) 2.00  (1.100) 2.19  (0.943)
Week 4: Induration (Head/Neck) n=87,88,43,42 1.16  (1.022) 1.35  (1.073) 1.74  (1.071) 2.10  (0.932)
Week 8: Induration (Head/Neck) n=85,88,40,39 0.84  (1.010) 1.08  (1.074) 1.55  (0.959) 1.92  (1.010)
Week 12: Induration (Head/Neck) n=84,88,40,39 0.63  (0.847) 0.86  (1.008) 1.40  (0.900) 1.72  (0.972)
Week 16: Induration (Head/Neck) n=84,84,38,39 0.51  (0.736) 0.73  (0.974) 1.29  (0.984) 1.56  (0.995)
Week 20: Induration (Head/Neck) n=84,84,38,39 0.40  (0.642) 0.67  (0.910) 0.58  (0.683) 0.90  (0.718)
Week 32: Induration (Head/Neck) n=83,83,38,37 0.49  (0.755) 0.57  (0.814) 0.32  (0.702) 0.62  (0.794)
Week 40: Induration (Head/Neck) n=81,81,37,36 0.44  (0.742) 0.60  (0.801) 0.35  (0.633) 0.53  (0.810)
Week 52: Induration (Head/Neck) n=80,78,36,36 0.53  (0.871) 0.60  (0.888) 0.44  (0.735) 0.61  (0.871)
Baseline: Induration (Upper Limbs) n=90,88,44,44 2.71  (0.738) 2.59  (0.783) 2.57  (0.925) 2.77  (0.677)
Week 2: Induration (Upper Limbs) n=88,86,44,42 2.02  (0.884) 2.16  (0.919) 2.52  (0.876) 2.74  (0.798)
Week 4: Induration (Upper Limbs) n=87,88,43,42 1.54  (1.054) 1.82  (1.012) 2.35  (1.021) 2.62  (0.795)
Week 8: Induration (Upper Limbs) n=85,88,40,39 1.01  (1.029) 1.40  (1.078) 2.03  (1.050) 2.36  (0.903)
Week 12: Induration (Upper Limbs) n=84,88,40,39 0.55  (0.813) 1.13  (1.081) 1.78  (1.000) 2.23  (0.842)
Week 16: Induration (Upper Limbs) n=84,84,38,39 0.39  (0.761) 1.05  (1.108) 1.55  (1.083) 2.08  (0.870)
Week 20: Induration (Upper Limbs) n=84,84,38,39 0.37  (0.818) 0.90  (1.013) 0.89  (0.924) 1.18  (0.823)
Week 32: Induration (Upper Limbs) n=83,83,38,37 0.42  (0.798) 0.96  (1.064) 0.58  (0.919) 0.78  (0.917)
Week 40: Induration (Upper Limbs) n=81,81,37,36 0.47  (0.867) 0.94  (1.041) 0.49  (0.768) 0.75  (0.841)
Week 52: Induration (Upper Limbs) n=80,78,36,36 0.53  (0.886) 0.90  (0.988) 0.58  (0.874) 0.81  (0.951)
Baseline: Induration (Trunk) n=90,88,44,44 2.90  (0.619) 2.74  (0.703) 2.91  (0.772) 2.93  (0.695)
Week 2: Induration (Trunk) n=88,86,44,42 2.25  (0.913) 2.33  (0.804) 2.89  (0.689) 2.90  (0.759)
Week 4: Induration (Trunk) n=87,88,43,42 1.71  (1.109) 1.95  (0.970) 2.67  (0.919) 2.71  (0.742)
Week 8: Induration (Trunk) n=85,88,40,39 1.13  (1.142) 1.51  (1.061) 2.25  (1.080) 2.54  (0.969)
Week 12: Induration (Trunk) n=84,88,40,39 0.73  (1.034) 1.35  (1.115) 2.00  (1.109) 2.33  (0.898)
Week 16: Induration (Trunk) n=84,84,38,39 0.56  (0.961) 1.15  (1.156) 1.79  (1.298) 2.18  (0.942)
Week 20: Induration (Trunk) n=84,84,38,39 0.50  (0.976) 1.01  (1.070) 0.97  (0.972) 1.13  (0.833)
Week 32: Induration (Trunk) n=83,83,38,37 0.49  (0.846) 0.96  (1.087) 0.50  (0.980) 0.70  (0.939)
Week 40: Induration (Trunk) n=81,81,37,36 0.49  (0.910) 0.89  (1.037) 0.38  (0.861) 0.81  (1.091)
Week 52: Induration (Trunk) n=80,78,36,36 0.55  (0.899) 0.83  (1.012) 0.50  (0.941) 0.97  (1.028)
Baseline: Induration (Lower Limbs) n=90,88,44,44 3.03  (0.678) 2.88  (0.708) 3.02  (0.821) 3.16  (0.680)
Week 2: Induration (Lower Limbs) n=88,86,44,42 2.39  (0.915) 2.43  (0.888) 2.93  (0.846) 3.00  (0.826)
Week 4: Induration (Lower Limbs) n=87,88,43,42 1.83  (1.102) 2.09  (0.978) 2.81  (0.932) 2.93  (0.808)
Week 8: Induration (Lower Limbs) n=85,88,40,39 1.22  (1.138) 1.61  (1.044) 2.43  (1.035) 2.67  (0.927)
Week 12: Induration (Lower Limbs) n=84,88,40,39 0.69  (0.878) 1.36  (1.063) 2.15  (0.975) 2.49  (0.970)
Week 16: Induration (Lower Limbs) n=84,84,38,39 0.54  (0.798) 1.24  (1.115) 1.95  (1.138) 2.46  (0.969)
Week 20: Induration (Lower Limbs) n=84,84,38,39 0.44  (0.827) 1.07  (1.027) 1.05  (1.012) 1.41  (0.785)
Week 32: Induration (Lower Limbs) n=83,83,38,37 0.40  (0.826) 1.01  (1.088) 0.58  (0.976) 0.97  (1.013)
Week 40: Induration (Lower Limbs) n=81,81,37,36 0.46  (0.791) 0.95  (1.011) 0.68  (1.029) 0.78  (0.898)
Week 52: Induration (Lower Limbs) n=80,78,36,36 0.61  (0.907) 1.03  (1.069) 0.67  (1.069) 1.03  (1.134)
Baseline: Scaling (Head/Neck) n=90,88,44,44 2.40  (0.946) 2.01  (1.011) 2.25  (1.184) 2.34  (0.987)
Week 2: Scaling (Head/Neck) n=88,86,44,42 1.67  (1.003) 1.71  (1.004) 2.11  (1.185) 2.40  (0.939)
Week 4: Scaling (Head/Neck) n=87,88,43,42 1.24  (1.131) 1.41  (1.068) 1.84  (1.214) 2.24  (0.906)
Week 8: Scaling (Head/Neck) n=85,88,40,39 0.80  (0.986) 1.02  (1.039) 1.48  (1.109) 2.03  (1.013)
Week 12: Scaling (Head/Neck) n=84,88,40,39 0.64  (0.887) 0.85  (1.012) 1.38  (1.030) 1.82  (0.914)
Week 16: Scaling (Head/Neck) n=84,84,38,39 0.57  (0.811) 0.76  (1.025) 1.21  (1.018) 1.72  (0.999)
Week 20: Scaling (Head/Neck) n=84,84,38,39 0.43  (0.664) 0.67  (0.841) 0.58  (0.758) 0.85  (0.812)
Week 32: Scaling (Head/Neck) n=83,83,38,37 0.48  (0.739) 0.61  (0.809) 0.29  (0.654) 0.70  (0.878)
Week 40: Scaling (Head/Neck) n=81,81,37,36 0.51  (0.839) 0.67  (0.894) 0.35  (0.716) 0.67  (0.956)
Week 52: Scaling (Head/Neck) n=80,78,36,36 0.58  (0.897) 0.63  (0.884) 0.36  (0.723) 0.72  (0.914)
Baseline: Scaling (Upper Limbs) n=90,88,44,44 2.72  (0.779) 2.60  (0.796) 2.55  (0.848) 2.82  (0.724)
Week 2: Scaling (Upper Limbs) n=88,86,44,42 2.00  (0.922) 2.19  (0.952) 2.43  (0.900) 2.62  (0.764)
Week 4: Scaling (Upper Limbs) n=87,88,43,42 1.41  (1.106) 1.77  (1.047) 2.28  (1.031) 2.52  (0.804)
Week 8: Scaling (Upper Limbs) n=85,88,40,39 0.89  (0.939) 1.35  (1.018) 1.93  (1.118) 2.28  (0.887)
Week 12: Scaling (Upper Limbs) n=84,88,40,39 0.56  (0.841) 1.14  (1.106) 1.60  (1.033) 2.23  (0.810)
Week 16: Scaling (Upper Limbs) n=84,84,38,39 0.40  (0.793) 0.99  (1.070) 1.50  (1.033) 1.97  (0.903)
Week 20: Scaling (Upper Limbs) n=84,84,38,39 0.39  (0.807) 0.86  (0.907) 0.82  (0.834) 1.21  (0.833)
Week 32: Scaling (Upper Limbs) n=83,83,38,37 0.36  (0.708) 0.93  (1.010) 0.42  (0.642) 0.81  (0.967)
Week 40: Scaling (Upper Limbs) n=81,81,37,36 0.40  (0.801) 0.96  (1.006) 0.41  (0.686) 0.83  (0.910)
Week 52: Scaling (Upper Limbs) n=80,78,36,36 0.48  (0.763) 0.95  (0.979) 0.61  (0.871) 0.92  (1.052)
Baseline: Scaling (Trunk) n=90,88,44,44 2.72  (0.765) 2.73  (0.784) 2.77  (0.677) 2.93  (0.789)
Week 2: Scaling (Trunk) n=88,86,44,42 2.03  (0.928) 2.27  (0.938) 2.66  (0.745) 2.76  (0.759)
Week 4: Scaling (Trunk) n=87,88,43,42 1.52  (1.109) 1.92  (0.997) 2.49  (0.883) 2.57  (0.770)
Week 8: Scaling (Trunk) n=85,88,40,39 0.95  (1.057) 1.48  (1.039) 2.10  (1.008) 2.38  (0.815)
Week 12: Scaling (Trunk) n=84,88,40,39 0.69  (1.006) 1.27  (1.132) 1.73  (1.037) 2.28  (0.857)
Week 16: Scaling (Trunk) n=84,84,38,39 0.52  (0.938) 1.02  (1.097) 1.58  (1.106) 2.10  (0.882)
Week 20: Scaling (Trunk) n=84,84,38,37 0.49  (0.871) 0.96  (0.987) 0.82  (0.955) 1.13  (0.894)
Week 32: Scaling (Trunk) n=83,83,38,37 0.46  (0.754) 0.92  (0.953) 0.39  (0.823) 0.68  (0.852)
Week 40: Scaling (Trunk) n=81,81,37,36 0.49  (0.882) 0.91  (0.938) 0.38  (0.861) 0.78  (0.989)
Week 52: Scaling (Trunk) n=80,78,36,36 0.55  (0.855) 0.82  (0.818) 0.53  (0.971) 0.89  (0.887)
Baseline: Scaling (Lower Limbs) n=90,88,44,44 2.94  (0.709) 2.92  (0.776) 2.84  (0.834) 3.20  (0.765)
Week 2: Scaling (Lower Limbs) n=88,86,44,42 2.24  (1.017) 2.40  (0.911) 2.66  (0.888) 2.98  (0.841)
Week 4: Scaling (Lower Limbs) n=87,88,43,42 1.72  (1.117) 2.08  (0.997) 2.49  (0.960) 2.76  (0.906)
Week 8: Scaling (Lower Limbs) n=85,88,40,39 1.15  (1.129) 1.52  (1.093) 2.20  (1.018) 2.54  (0.884)
Week 12: Scaling (Lower Limbs) n=84,88,40,39 0.67  (0.896) 1.32  (1.120) 2.03  (0.920) 2.51  (0.885)
Week 16: Scaling (Lower Limbs) n=84,84,38,39 0.46  (0.783) 1.20  (1.106) 1.82  (1.062) 2.38  (0.815)
Week 20: Scaling (Lower Limbs) n=84,84,38,39 0.45  (0.870) 1.14  (1.020) 0.95  (0.868) 1.41  (0.751)
Week 32: Scaling (Lower Limbs) n=83,83,38,37 0.37  (0.760) 1.08  (1.118) 0.47  (0.797) 1.03  (1.013)
Week 40: Scaling (Lower Limbs) n=81,81,37,36 0.53  (0.976) 1.06  (1.041) 0.51  (0.731) 0.83  (1.056)
Week 52: Scaling (Lower Limbs) n=80,78,36,36 0.61  (0.921) 1.08  (1.042) 0.67  (1.069) 1.06  (1.120)
22.Secondary Outcome
Title Change From Baseline in PASI Component Scores Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2: Erythema (Head/Neck) n=88,86,44,42) -0.56  (0.676) -0.41  (0.757) -0.14  (0.594) 0.10  (0.532)
Week 4: Erythema (Head/Neck) n=87,88,43,42) -0.94  (0.854) -0.74  (0.890) -0.26  (0.727) -0.17  (0.621)
Week 8: Erythema (Head/Neck) n=85,88,40,39 -1.36  (0.962) -1.05  (1.038) -0.20  (1.114) -0.38  (0.935)
Week 12: Erythema (Head/Neck) n=84,88,40,39 -1.61  (0.957) -1.24  (1.135) -0.38  (1.295) -0.46  (0.942)
Week 16: Erythema (Head/Neck) n=84,84,38,39 -1.70  (1.015) -1.43  (1.175) -0.66  (1.361) -0.62  (0.907)
Week 20: Erythema (Head/Neck) n=84,84,38,39 -1.79  (0.945) -1.43  (1.185) -1.37  (1.172) -1.36  (1.158)
Week 32: Erythema (Head/Neck) n=83,83,38,37 -1.71  (1.030) -1.51  (1.203) -1.68  (1.254) -1.59  (1.257)
Week 40: Erythema (Head/Neck) n=81,81,37,36 -1.78  (1.084) -1.51  (1.195) -1.68  (1.132) -1.81  (1.191)
Week 52: Erythema (Head/Neck) n=80,78,36,36 -1.73  (1.079) -1.53  (1.181) -1.61  (1.225) -1.67  (1.265)
Week 2: Erythema (Upper Limbs) n=88,86,44,42 -0.64  (0.698) -0.51  (0.609) 0.02  (0.403) 0.14  (0.417)
Week 4: Erythema (Upper Limbs) n=87,88,43,42 -1.09  (0.858) -0.91  (0.839) -0.12  (0.697) -0.05  (0.582)
Week 8: Erythema (Upper Limbs) n=85,88,40,39 -1.65  (0.984) -1.32  (0.977) -0.28  (0.784) -0.26  (0.677)
Week 12: Erythema (Upper Limbs) n=84,88,40,39 -2.08  (0.908) -1.61  (1.159) -0.50  (0.877) -0.41  (0.818)
Week 16: Erythema (Upper Limbs) n=84,84,38,39 -2.17  (1.004) -1.81  (1.092) -0.92  (0.941) -0.44  (0.852)
Week 20: Erythema (Upper Limbs) n=84,84,38,39 -2.27  (1.057) -1.87  (1.117) -1.66  (0.966) -1.38  (1.042)
Week 32: Erythema (Upper Limbs) n=83,83,38,37 -2.29  (0.957) -1.83  (1.257) -2.08  (1.148) -1.89  (0.994)
Week 40: Erythema (Upper Limbs) n=81,81,37,36 -2.26  (1.081) -1.89  (1.151) -2.05  (1.153) -1.94  (1.094)
Week 52: Erythema (Upper Limbs) n=80,78,36,36 -2.14  (1.111) -1.85  (1.185) -1.94  (1.286) -1.83  (1.183)
Week 2: Erythema (Trunk) n=88,86,44,42 -0.57  (0.724) -0.41  (0.639) -0.02  (0.457) 0.10  (0.370)
Week 4: Erythema (Trunk) n=87,88,43,42 -1.05  (0.888) -0.76  (0.844) -0.14  (0.774) -0.12  (0.550)
Week 8: Erythema (Trunk) n=85,88,40,39 -1.66  (1.041) -1.16  (0.969) -0.35  (0.949) -0.28  (0.560)
Week 12: Erythema (Trunk) n=84,88,40,39 -2.04  (1.092) -1.36  (1.176) -0.65  (1.167) -0.38  (0.711)
Week 16: Erythema (Trunk) n=84,84,38,39 -2.21  (1.054) -1.61  (1.203) -0.97  (1.262) -0.28  (0.793)
Week 20: Erythema (Trunk) n=84,84,38,39 -2.23  (1.134) -1.70  (1.200) -1.76  (1.025) -1.62  (1.091)
Week 32: Erythema (Trunk) n=83,83,38,37 -2.25  (1.034) -1.80  (1.276) -2.32  (1.016) -2.22  (1.004)
Week 40: Erythema (Trunk) n=81,81,37,36 -2.36  (1.028) -1.86  (1.212) -2.43  (0.929) -2.22  (1.072)
Week 52: Erythema (Trunk) n=80,78,36,36 -2.24  (1.082) -1.82  (1.256) -2.22  (1.174) -1.97  (1.158)
Week 2: Erythema (Lower Limbs) n=88,86,44,42 -0.50  (0.587) -0.38  (0.722) 0.00  (0.374) 0.05  (0.379)
Week 4: Erythema (Lower Limbs) n=87,88,43,42 -1.07  (0.860) -0.75  (0.820) -0.12  (0.625) -0.12  (0.593)
Week 8: Erythema (Lower Limbs) n=85,88,40,39 -1.71  (1.010) -1.19  (1.123) -0.33  (0.764) -0.26  (0.637)
Week 12: Erythema (Lower Limbs) n=84,88,40,39 -2.24  (0.965) -1.44  (1.183) -0.58  (0.958) -0.36  (0.778)
Week 16: Erythema (Lower Limbs) n=84,84,38,39 -2.36  (1.014) -1.55  (1.255) -0.89  (1.085) -0.41  (0.818)
Week 20: Erythema (Lower Limbs) n=84,84,38,39 -2.49  (1.000) -1.73  (1.274) -1.87  (0.991) -1.41  (0.993)
Week 32: Erythema (Lower Limbs) n=83,83,38,37 -2.54  (1.028) -1.86  (1.372) -2.37  (1.025) -2.05  (1.129)
Week 40: Erythema (Lower Limbs) n=81,81,37,36 -2.52  (1.062) -1.86  (1.243) -2.32  (1.082) -2.33  (1.121)
Week 52: Erythema (Lower Limbs) n=80,78,36,36 -2.33  (1.077) -1.74  (1.400) -2.25  (1.251) -2.19  (1.215)
Week 2: Induration (Head/Neck) n=88,86,44,42 -0.59  (0.705) -0.27  (0.602) -0.07  (0.398) -0.02  (0.468)
Week 4: Induration (Head/Neck) n=87,88,43,42 -1.07  (0.974) -0.59  (0.892) -0.30  (0.708) -0.12  (0.670)
Week 8: Induration (Head/Neck) n=85,88,40,39 -1.38  (1.080) -0.86  (0.937) -0.50  (1.086) -0.33  (0.927)
Week 12: Induration (Head/Neck) n=84,88,40,39 -1.58  (1.032) -1.08  (1.031) -0.65  (1.075) -0.54  (0.913)
Week 16: Induration (Head/Neck) n=84,84,38,39 -1.70  (1.106) -1.24  (1.060) -0.76  (1.240) -0.69  (0.863)
Week 20: Induration (Head/Neck) n=84,84,38,39 -1.81  (1.058) -1.30  (1.084) -1.47  (1.133) -1.36  (0.903)
Week 32: Induration (Head/Neck) n=83,83,38,37 -1.71  (1.121) -1.41  (1.094) -1.74  (1.155) -1.65  (1.160)
Week 40: Induration (Head/Neck) n=81,81,37,36 -1.75  (1.124) -1.37  (1.066) -1.68  (1.056) -1.78  (1.198)
Week 52: Induration (Head/Neck) n=80,78,36,36 -1.68  (1.178) -1.36  (1.139) -1.58  (1.228) -1.69  (1.215)
Week 2: Induration (Upper Limbs) n=88,86,44,42 -0.68  (0.766) -0.42  (0.727) -0.05  (0.526) -0.07  (0.407)
Week 4: Induration (Upper Limbs) n=87,88,43,42 -1.17  (1.048) -0.77  (0.867) -0.21  (0.833) -0.19  (0.707)
Week 8: Induration (Upper Limbs) n=85,88,40,39 -1.69  (1.024) -1.19  (1.092) -0.55  (1.011) -0.41  (0.751)
Week 12: Induration (Upper Limbs) n=84,88,40,39 -2.17  (0.862) -1.47  (1.231) -0.80  (1.091) -0.54  (0.822)
Week 16: Induration (Upper Limbs) n=84,84,38,39 -2.32  (0.867) -1.52  (1.217) -1.05  (1.293) -0.69  (0.977)
Week 20: Induration (Upper Limbs) n=84,84,38,39 -2.35  (1.012) -1.67  (1.186) -1.71  (1.250) -1.59  (1.093)
Week 32: Induration (Upper Limbs) n=83,83,38,37 -2.29  (1.018) -1.61  (1.296) -2.03  (1.150) -1.97  (1.093)
Week 40: Induration (Upper Limbs) n=81,81,37,36 -2.25  (1.067) -1.65  (1.266) -2.11  (1.100) -1.97  (1.108)
Week 52: Induration (Upper Limbs) n=80,78,36,36 -2.20  (1.107) -1.69  (1.282) -2.03  (1.183) -1.92  (1.204)
Week 2: Induration (Trunk) n=88,86,44,42 -0.65  (0.728) -0.43  (0.660) -0.02  (0.457) -0.05  (0.439)
Week 4: Induration (Trunk) n=87,88,43,42 -1.20  (1.044) -0.78  (0.850) -0.23  (0.812) -0.24  (0.576)
Week 8: Induration (Trunk) n=85,88,40,39 -1.78  (1.084) -1.23  (1.003) -0.68  (1.071) -0.38  (0.673)
Week 12: Induration (Trunk) n=84,88,40,39 -2.19  (1.035) -1.39  (1.129) -0.90  (1.194) -0.59  (0.637)
Week 16: Induration (Trunk) n=84,84,38,39 -2.36  (0.965) -1.57  (1.154) -1.13  (1.398) -0.74  (0.785)
Week 20: Induration (Trunk) n=84,84,38,39 -2.42  (0.984) -1.71  (1.071) -1.95  (1.138) -1.79  (1.031)
Week 32: Induration (Trunk) n=83,83,38,37 -2.41  (0.938) -1.76  (1.122) -2.42  (1.222) -2.22  (1.158)
Week 40: Induration (Trunk) n=81,81,37,36 -2.41  (1.058) -1.84  (1.145) -2.57  (1.068) -2.08  (1.360)
Week 52: Induration (Trunk) n=80,78,36,36 -2.36  (1.070) -1.90  (1.180) -2.47  (1.207) -1.92  (1.339)
Week 2: Induration (Lower Limbs) n=88,86,44,42 -0.65  (0.803) -0.43  (0.660) -0.09  (0.421) -0.14  (0.417)
Week 4: Induration (Lower Limbs) n=87,88,43,42 -1.22  (0.993) -0.78  (0.809) -0.21  (0.773) -0.21  (0.415)
Week 8: Induration (Lower Limbs) n=85,88,40,39 -1.82  (1.002) -1.26  (0.977) -0.60  (0.955) -0.49  (0.683)
Week 12: Induration (Lower Limbs) n=84,88,40,39 -2.36  (0.845) -1.51  (1.093) -0.85  (0.975) -0.67  (0.772)
Week 16: Induration (Lower Limbs) n=84,84,38,39 -2.51  (0.814) -1.63  (1.159) -1.08  (1.148) -0.69  (0.766)
Week 20: Induration (Lower Limbs) n=84,84,38,39 -2.61  (0.865) -1.80  (1.039) -1.97  (1.026) -1.74  (0.818)
Week 32: Induration (Lower Limbs) n=83,83,38,37 -2.64  (0.957) -1.86  (1.106) -2.45  (1.083) -2.14  (1.058)
Week 40: Induration (Lower Limbs) n=81,81,37,36 -2.57  (0.974) -1.93  (1.022) -2.35  (1.033) -2.31  (1.064)
Week 52: Induration (Lower Limbs) n=80,78,36,36 -2.43  (1.041) -1.85  (1.140) -2.39  (1.178) -2.06  (1.194)
Week 2: Scaling (Head/Neck) n=88,86,44,42 -0.72  (0.802) -0.28  (0.587) -0.14  (0.594) 0.05  (0.379)
Week 4: Scaling (Head/Neck) n=87,88,43,42 -1.16  (1.077) -0.60  (0.766) -0.40  (0.955) -0.12  (0.633)
Week 8: Scaling (Head/Neck) n=85,88,40,39 -1.60  (1.157) -0.99  (1.000) -0.75  (1.296) -0.38  (0.963)
Week 12: Scaling (Head/Neck) n=84,88,40,39 -1.76  (1.137) -1.16  (1.103) -0.83  (1.338) -0.59  (0.993)
Week 16: Scaling (Head/Neck) n=84,84,38,39 -1.83  (1.160) -1.31  (1.151) -0.97  (1.404) -0.69  (0.977)
Week 20: Scaling (Head/Neck) n=84,84,38,39 -1.98  (1.075) -1.40  (1.110) -1.61  (1.366) -1.56  (1.021)
Week 32: Scaling (Head/Neck) n=83,83,38,37 -1.92  (1.073) -1.47  (1.162) -1.89  (1.290) -1.70  (1.266)
Week 40: Scaling (Head/Neck) n=81,81,37,36 -1.88  (1.198) -1.41  (1.138) -1.78  (1.250) -1.78  (1.267)
Week 52: Scaling (Head/Neck) n=80,78,36,36 -1.81  (1.192) -1.45  (1.202) -1.78  (1.456) -1.72  (1.233)
Week 2: Scaling (Upper Limbs) n=88,86,44,42 -0.72  (0.843) -0.41  (0.602) -0.11  (0.579) -0.19  (0.634)
Week 4: Scaling (Upper Limbs) n=87,88,43,42 -1.31  (1.154) -0.83  (0.847) -0.26  (0.848) -0.29  (0.742)
Week 8: Scaling (Upper Limbs) n=85,88,40,39 -1.84  (1.078) -1.25  (0.950) -0.63  (1.030) -0.56  (0.940)
Week 12: Scaling (Upper Limbs) n=84,88,40,39 -2.18  (0.894) -1.47  (1.114) -0.93  (1.023) -0.62  (1.016)
Week 16: Scaling (Upper Limbs) n=84,84,38,39 -2.33  (0.998) -1.62  (1.040) -1.00  (1.115) -0.87  (1.105)
Week 20: Scaling (Upper Limbs) n=84,84,38,39 -2.35  (1.047) -1.75  (1.005) -1.68  (1.093) -1.64  (1.112)
Week 32: Scaling (Upper Limbs) n=83,83,38,37 -2.37  (1.009) -1.67  (1.025) -2.08  (0.997) -2.03  (1.258)
Week 40: Scaling (Upper Limbs) n=81,81,37,36 -2.32  (1.127) -1.65  (1.153) -2.08  (1.064) -2.00  (1.195)
Week 52: Scaling (Upper Limbs) n=80,78,36,36 -2.25  (1.175) -1.68  (1.201) -1.89  (1.282) -1.92  (1.381)
Week 2: Scaling (Trunk) n=88,86,44,42 -0.68  (0.810) -0.49  (0.682) -0.11  (0.655) -0.17  (0.490)
Week 4: Scaling (Trunk) n=87,88,43,42 -1.22  (1.104) -0.81  (0.842) -0.28  (0.934) -0.36  (0.692)
Week 8: Scaling (Trunk) n=85,88,40,39 -1.79  (1.124) -1.25  (0.997) -0.70  (1.018) -0.54  (0.790)
Week 12: Scaling (Trunk) n=84,88,40,39 -2.06  (1.045) -1.45  (1.174) -1.05  (1.154) -0.64  (0.932)
Week 16: Scaling (Trunk) n=84,84,38,39 -2.23  (1.090) -1.71  (1.136) -1.21  (1.255) -0.82  (0.970)
Week 20: Scaling (Trunk) n=84,84,38,39 -2.26  (1.088) -1.77  (1.090) -1.97  (1.219) -1.79  (1.174)
Week 32: Scaling (Trunk) n=83,83,38,37 -2.28  (0.992) -1.82  (1.049) -2.39  (1.054) -2.22  (1.250)
Week 40: Scaling (Trunk) n=81,81,37,36 -2.22  (1.173) -1.83  (1.160) -2.43  (1.042) -2.11  (1.410)
Week 52: Scaling (Trunk) n=80,78,36,36 -2.18  (1.188) -1.94  (1.049) -2.31  (1.215) -2.00  (1.352)
Week 2: Scaling (Lower Limbs) n=88,86,44,42 -0.70  (0.846) -0.51  (0.778) -0.18  (0.657) -0.21  (0.565)
Week 4: Scaling (Lower Limbs) n=87,88,43,42 -1.22  (1.016) -0.84  (0.933) -0.35  (0.997) -0.43  (0.668)
Week 8: Scaling (Lower Limbs) n=85,88,40,39 -1.80  (1.044) -1.40  (1.078) -0.63  (1.125) -0.69  (0.863)
Week 12: Scaling (Lower Limbs) n=84,88,40,39 -2.30  (0.915) -1.60  (1.160) -0.75  (1.080) -0.72  (0.916)
Week 16: Scaling (Lower Limbs) n=84,84,38,39 -2.50  (0.912) -1.74  (1.173) -0.95  (1.293) -0.85  (1.014)
Week 20: Scaling (Lower Limbs) n=84,84,38,39 -2.51  (0.963) -1.80  (1.138) -1.82  (1.136) -1.82  (1.023)
Week 32: Scaling (Lower Limbs) n=83,83,38,37 -2.58  (0.964) -1.86  (1.128) -2.29  (1.160) -2.16  (1.236)
Week 40: Scaling (Lower Limbs) n=81,81,37,36 -2.40  (1.190) -1.89  (1.118) -2.22  (1.004) -2.33  (1.331)
Week 52: Scaling (Lower Limbs) n=80,78,36,36 -2.33  (1.111) -1.88  (1.151) -2.08  (1.360) -2.11  (1.326)
23.Secondary Outcome
Title Percent Change From Baseline in PASI Scores Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Week 2 (n=88,86,44,42) -24.93  (2.399) -16.28  (2.409) 1.37  (3.392) -0.35  (3.473)
Week 4 (n=87,88,43,42) -46.24  (3.135) -32.47  (3.127) -1.98  (4.444) -7.31  (4.527)
Week 8 (n=85,88,40,39) -66.96  (3.769) -51.24  (3.739) -13.17  (5.384) -16.18  (5.488)
Week 12 (n=84,88,40,39) -80.64  (3.631) -59.73  (3.585) -25.13  (5.205) -20.40  (5.304)
Week 16 (n=84,84,38,39) -84.35  (3.912) -66.69  (3.874) -32.79  (5.651) -21.63  (5.721)
Week 20 (n=84,84,38,39) -87.89  (3.024) -71.93  (3.002) -69.85  (4.399) -60.85  (4.423)
Week 32 (n=83,83,38,37) -90.47  (2.444) -76.06  (2.437) -86.63  (3.584) -81.43  (3.622)
Week 40 (n=81,81,37,36) -90.18  (2.264) -77.29  (2.258) -87.73  (3.332) -83.64  (3.368)
Week 52 (n=80,78,36,36) -86.05  (2.763) -75.55  (2.764) -84.65  (4.066) -79.27  (4.101)
24.Secondary Outcome
Title Actual BSA Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Mean (Standard Deviation)
Unit of Measure: percent BSA
Baseline (n=90,88,44,44) 36.36  (18.035) 37.41  (19.614) 35.29  (18.294) 36.25  (16.018)
Week 2 (n=88,86,44,44) 33.95  (17.537) 36.56  (19.363) 36.84  (18.808) 36.38  (16.592)
Week 4 (n=87,88,43,42) 27.82  (18.599) 32.75  (18.314) 38.32  (19.355) 36.30  (16.916)
Week 8 (n=85,88,40,39) 17.62  (18.411) 24.38  (19.583) 36.75  (19.817) 34.99  (16.182)
Week 12 (n=84,88,40,39) 10.59  (15.486) 20.45  (20.462) 33.15  (20.483) 34.06  (17.142)
Week 16 (n=84,84,38,39) 7.57  (13.395) 16.52  (18.899) 28.57  (21.645) 34.54  (18.293)
Week 20 (n=84,84,38,39) 5.05  (10.041) 13.69  (16.976) 15.50  (16.522) 24.83  (19.044)
Week 32 (n=83,83,38,37) 3.22  (5.894) 11.47  (16.304) 6.95  (10.262) 9.03  (11.781)
Week 40 (n=81,81,37,36) 2.56  (5.412) 10.32  (13.077) 5.88  (8.351) 6.35  (9.462)
Week 52 (n=80,78,36,36) 3.83  (7.908) 10.94  (15.255) 5.00  (7.686) 7.87  (9.584)
25.Secondary Outcome
Title Percent Change From Baseline in BSA Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Week 2 (n=88,86,44,44) -5.58  (2.083) -2.53  (2.093) 4.79  (2.947) 2.14  (3.016)
Week 4 (n=87,88,43,42) -21.90  (3.202) -10.98  (3.193) 10.29  (4.541) 2.28  (4.622)
Week 8 (n=85,88,40,39) -46.98  (4.909) -33.22  (4.870) 8.73  (7.017) -0.42  (7.155)
Week 12 (n=84,88,40,39) -65.97  (5.536) -44.44  (5.471) 0.41  (7.928) 0.48  (8.086)
Week 16 (n=84,84,38,39) -73.80  (5.903) -54.41  (5.839) -8.85  (8.511) 4.13  (8.632)
Week 20 (n=84,84,38,39) -82.65  (4.459) -62.35  (4.419) -49.35  (6.495) -28.86  (6.530)
Week 32 (n=83,83,38,37) -87.55  (3.531) -70.55  (3.521) -74.83  (5.186) -73.95  (5.235)
Week 40 (n=81,81,37,36) -90.00  (3.213) -73.00  (3.207) -79.48  (4.743) -79.91  (4.786)
Week 52 (n=80,78,36,36) -84.16  (3.867) -72.28  (3.868) -81.70  (5.681) -74.02  (5.737)
26.Secondary Outcome
Title Percentage of Participants With PASI50 Response Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
21.11
(12.68 to 29.54)
5.68
(0.85 to 10.52)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 4
48.89
(38.56 to 59.22)
27.27
(17.97 to 36.58)
4.55
(0.00 to 10.70)
4.55
(0.00 to 10.70)
Week 8
74.44
(65.43 to 83.46)
55.68
(45.30 to 66.06)
13.64
(3.50 to 23.78)
4.55
(0.00 to 10.70)
Week 12
81.11
(73.02 to 89.20)
64.77
(54.79 to 74.75)
27.27
(14.11 to 40.43)
9.09
(0.60 to 17.59)
Week 16
86.67
(79.64 to 93.69)
71.59
(62.17 to 81.01)
40.91
(26.38 to 55.44)
18.18
(6.79 to 29.58)
Week 20
85.56
(78.29 to 92.82)
72.73
(63.42 to 82.03)
68.18
(54.42 to 81.94)
63.64
(49.42 to 77.85)
Week 32
88.89
(82.40 to 95.38)
78.41
(69.81 to 87.01)
79.55
(67.63 to 91.46)
75.00
(62.21 to 87.79)
Week 40
87.78
(81.01 to 94.54)
80.68
(72.43 to 88.93)
79.55
(67.63 to 91.46)
72.73
(59.57 to 85.89)
Week 52
83.33
(75.63 to 91.03)
73.86
(64.68 to 83.04)
77.27
(64.89 to 89.66)
75.00
(62.21 to 87.79)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
27.Secondary Outcome
Title Percentage of Participants With PASI90 Response Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 4
7.78
(2.24 to 13.31)
2.27
(0.00 to 5.39)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 8
27.78
(18.52 to 37.03)
13.64
(6.47 to 20.81)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 12
51.11
(40.78 to 61.44)
29.55
(20.01 to 39.08)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 16
60.00
(49.88 to 70.12)
35.23
(25.25 to 45.21)
6.82
(0.00 to 14.27)
0.00 [1] 
(NA to NA)
Week 20
71.11
(61.75 to 80.48)
35.23
(25.25 to 45.21)
25.00
(12.21 to 37.79)
9.09
(0.60 to 17.59)
Week 32
65.56
(55.74 to 75.37)
42.05
(31.73 to 52.36)
56.82
(42.18 to 71.45)
40.91
(26.38 to 55.44)
Week 40
66.67
(56.93 to 76.41)
35.23
(25.25 to 45.21)
56.82
(42.18 to 71.45)
45.45
(30.74 to 60.17)
Week 52
56.67
(46.43 to 66.90)
38.64
(28.46 to 48.81)
56.82
(42.18 to 71.45)
36.36
(22.15 to 50.58)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
28.Secondary Outcome
Title Percentage of Participants With PASI125 Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 (n=88,86,44,42)
2.27
(0.00 to 5.39)
1.16
(0.00 to 3.43)
4.55
(0.00 to 10.70)
4.76
(0.00 to 11.20)
Week 4 (n=87,88,43,42)
2.30
(0.00 to 5.45)
1.14
(0.00 to 3.35)
13.95
(3.60 to 24.31)
2.38
(0.00 to 6.99)
Week 8 (n=85,88,40,39)
2.35
(0.00 to 5.58)
1.14
(0.00 to 3.35)
17.50
(5.72 to 29.28)
2.56
(0.00 to 7.52)
Week 12 (n=84,88,40,39)
1.19
(0.00 to 3.51)
1.14
(0.00 to 3.35)
7.50
(0.00 to 15.66)
5.13
(0.00 to 12.05)
Week 16 (n=84,84,38,39)
1.19
(0.00 to 3.51)
2.38
(0.00 to 5.64)
10.53
(0.77 to 20.28)
7.69
(0.00 to 16.06)
Week 20 (n=84,84,38,39)
1.19
(0.00 to 3.51)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
2.56
(0.00 to 7.52)
Week 32 (n=83,83,38,37)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 40 (n=81,81,37,36)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 52 (n=80,78,36,36)
1.25
(0.00 to 3.68)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
29.Secondary Outcome
Title Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 40 38 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=40,38,18,18) 25.8  (20.58) 26.2  (16.97) 28.7  (21.90) 25.2  (16.37)
Week 8 (n=39,38,15,15) 23.0  (19.45) 23.6  (17.29) 28.6  (23.66) 30.7  (18.48)
Week 16 (n=38,38,14,15) 17.2  (19.14) 19.8  (18.30) 30.3  (23.86) 28.9  (20.54)
Week 20 (n=37,38,14,15) 13.9  (18.70) 17.2  (16.94) 28.6  (24.02) 30.1  (19.08)
Week 32 (n=37,37,14,14) 12.6  (19.59) 15.5  (16.69) 16.2  (18.48) 17.1  (12.69)
Week 40 (n=36,36,13,13) 9.6  (18.65) 14.9  (16.01) 15.7  (15.82) 14.5  (13.93)
Week 52 (n=31,34,12,13) 10.0  (20.22) 13.2  (17.96) 13.8  (18.54) 10.5  (12.67)
30.Secondary Outcome
Title Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 40 38 18 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 8 (n=39,38,15,15) -3.60  (1.416) -2.76  (1.434) 2.17  (2.282) 2.64  (2.283)
Week 16 (n=38,38,14,15) -9.38  (1.927) -6.63  (1.936) 2.04  (3.151) 0.84  (3.082)
Week 20 (n=37,38,14,15) -12.68  (1.886) -9.18  (1.884) 0.48  (3.079) 2.04  (2.999)
Week 32 (n=37,37,14,14) -14.02  (2.350) -11.31  (2.350) -11.81  (3.834) -12.61  (3.788)
Week 40 (n=36,36,13,13) -16.31  (2.365) -11.94  (2.359) -13.42  (3.876) -14.19  (3.842)
Week 52 (n=31,34,12,13) -17.13  (2.689) -13.55  (2.651) -15.08  (4.387) -17.89  (4.315)
31.Secondary Outcome
Title Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 40 38 18 18
Mean (Standard Deviation)
Unit of Measure: nails
Baseline (n=40,38,18,18) 7.6  (3.06) 7.3  (3.21) 8.1  (2.97) 7.4  (3.45)
Week 8 (n=39,38,15,15) 7.2  (3.07) 7.2  (3.61) 7.3  (3.58) 7.9  (3.20)
Week 16 (n=38,38,14,15) 6.1  (3.53) 6.6  (3.57) 7.9  (3.82) 7.6  (3.56)
Week 20 (n=37,38,14,15) 5.1  (3.84) 6.0  (3.84) 7.4  (3.93) 7.9  (3.08)
Week 32 (n=37,37,14,14) 3.8  (3.92) 5.5  (3.85) 6.1  (3.95) 7.6  (3.72)
Week 40 (n=36,36,13,13) 3.0  (3.60) 5.4  (4.08) 6.3  (4.39) 5.8  (4.28)
Week 52 (n=31,34,12,13) 3.0  (3.67) 4.4  (4.23) 4.6  (4.12) 4.4  (3.75)
32.Secondary Outcome
Title Percent Change From Baseline in NAPSI Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 0hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 40 38 18 18
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Week 8 (n=39,38,15,15) -9.59  (8.473) -8.81  (8.585) 5.28  (13.661) 25.40  (13.662)
Week 16 (n=38,38,14,15) -33.31  (10.552) -14.91  (10.600) -3.26  (17.257) 18.43  (16.869)
Week 20 (n=37,38,14,15) -51.97  (8.748) -25.10  (8.715) -8.87  (14.276) 13.72  (13.869)
Week 32 (n=37,37,14,14) -58.44  (10.256) -25.27  (10.247) -50.20  (16.734) -45.83  (16.481)
Week 40 (n=36,36,13,13) -68.68  (9.243) -37.40  (9.208) -47.17  (15.143) -58.60  (14.988)
Week 52 (n=31,34,12,13) -71.40  (10.891) -51.71  (10.636) -56.08  (17.621) -45.67  (17.192)
33.Secondary Outcome
Title Percentage of Participants With NAPSI75 Response Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 40 38 18 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 8
0.00 [1] 
(NA to NA)
10.53
(0.77 to 20.28)
5.56
(0.00 to 16.14)
0.00 [1] 
(NA to NA)
Week 16
20.00
(7.60 to 32.40)
15.79
(4.20 to 27.38)
11.11
(0.00 to 25.63)
5.56
(0.00 to 16.14)
Week 20
30.00
(15.80 to 44.20)
13.16
(2.41 to 23.91)
11.11
(0.00 to 25.63)
0.00 [1] 
(NA to NA)
Week 32
52.50
(37.02 to 67.98)
28.95
(14.53 to 43.37)
27.78
(7.09 to 48.47)
16.67
(0.00 to 33.88)
Week 40
65.00
(50.22 to 79.78)
34.21
(19.13 to 49.29)
33.33
(11.56 to 55.11)
33.33
(11.56 to 55.11)
Week 52
52.50
(37.02 to 67.98)
47.37
(31.49 to 63.24)
38.89
(16.37 to 61.41)
38.89
(16.37 to 61.41)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
34.Secondary Outcome
Title Percentage of Participants With NAPSI100 Response Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 40 38 18 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 8
0.00 [1] 
(NA to NA)
5.26
(0.00 to 12.36)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 16
5.00
(0.00 to 11.75)
5.26
(0.00 to 12.36)
11.11
(0.00 to 25.63)
5.56
(0.00 to 16.14)
Week 20
17.50
(5.72 to 29.28)
10.53
(0.77 to 20.28)
11.11
(0.00 to 25.63)
0.00 [1] 
(NA to NA)
Week 32
27.50
(13.66 to 41.34)
13.16
(2.41 to 23.91)
11.11
(0.00 to 25.63)
5.56
(0.00 to 16.14)
Week 40
30.00
(15.80 to 44.20)
15.79
(4.20 to 27.38)
11.11
(0.00 to 25.63)
16.67
(0.00 to 33.88)
Week 52
30.00
(15.80 to 44.20)
31.58
(16.80 to 46.36)
16.67
(0.00 to 33.88)
16.67
(0.00 to 33.88)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
35.Secondary Outcome
Title Actual Itch Severity Item (ISI) Score Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=88,88,44,44) 5.66  (2.586) 5.10  (2.679) 5.22  (2.501) 5.75  (2.679)
Week 2 (n=87,86,44,42) 2.97  (2.043) 3.49  (2.669) 5.45  (2.791) 4.95  (2.731)
Week 4 (n=88,88,43,42) 2.13  (2.061) 2.68  (2.322) 5.23  (2.715) 5.12  (2.491)
Week 8 (n=85,88,40,39) 1.47  (1.900) 2.41  (2.283) 4.75  (2.677) 4.97  (2.978)
Week 12 (n=84,88,40,39) 1.24  (1.565) 2.13  (2.323) 4.00  (2.621) 5.00  (2.938)
Week 16 (n=84,84,38,39) 1.17  (1.782) 2.01  (2.367) 3.89  (2.391) 5.13  (2.811)
Week 20 (n=83,84,38,38) 1.06  (1.564) 2.01  (2.326) 1.95  (2.253) 2.11  (2.227)
Week 32 (n=838238,37 0.88  (1.273) 2.07  (2.382) 1.24  (1.747) 1.51  (2.388)
Week 40 (n=81,81,37,36) 0.96  (1.145) 2.30  (2.283) 1.49  (2.181) 1.53  (2.158)
Week 52 (n=80,78,36,36) 1.45  (2.074) 2.55  (2.516) 1.89  (2.482) 2.36  (2.380)
36.Secondary Outcome
Title Change From Baseline in ISI Score Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 2 (n=86,86,44,42) -2.50  (0.219) -1.76  (0.218) 0.12  (0.306) -0.64  (0.314)
Week 4 (n=87,88,43,42) -3.33  (0.226) -2.60  (0.224) -0.03  (0.319) -0.47  (0.325)
Week 8 (n=84,88,40,39) -3.93  (0.232) -2.88  (0.228) -0.50  (0.331) -0.46  (0.337)
Week 12 (n=83,88,40,39) -4.10  (0.237) -3.16  (0.233) -1.15  (0.338) -0.44  (0.344)
Week 16 (n=83,84,38,39) -4.21  (0.232) -3.28  (0.229) -1.30  (0.335) -0.33  (0.337)
Week 20 (n=82,84,38,38) -4.32  (0.219) -3.28  (0.216) -3.22  (0.318) -3.36  (0.320)
Week 32 (n=82,82,38,37) -4.51  (0.220) -3.17  (0.219) -4.01  (0.322) -4.04  (0.325)
Week 40 (n=80,81,37,36) -4.39  (0.224) -2.98  (0.222) -3.81  (0.328) -3.89  (0.331)
Week 52 (n=79,78,36,36) -3.91  (0.272) -2.71  (0.272) -3.47  (0.401) -3.11  (0.403)
37.Secondary Outcome
Title Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=90,88,44,44) 14.1  (7.17) 13.5  (7.29) 12.5  (6.82) 12.1  (6.92)
Week 2 (n=88,86,44,42) 9.5  (5.31) 10.0  (6.20) 12.6  (7.34) 10.4  (5.97)
Week 4 (n=86,88,42,41) 7.6  (5.00) 8.2  (5.46) 12.4  (7.99) 10.3  (5.39)
Week 8 (n=85,88,40,39) 5.9  (5.49) 7.5  (5.89) 11.2  (7.25) 9.9  (6.66)
Week 12 (n=84,88,39,39) 4.6  (4.47) 6.7  (6.16) 11.1  (7.11) 10.2  (6.86)
Week 16 (n=84,84,38,39) 4.3  (4.70) 6.2  (5.62) 10.7  (7.20) 10.5  (6.77)
Week 20 (n=82,84,38,39) 3.8  (4.46) 5.4  (5.50) 6.2  (4.80) 6.4  (5.17)
Week 32 (n=83,82,38,37) 3.2  (4.39) 5.1  (5.31) 4.7  (5.42) 5.0  (6.03)
Week 40 (n=81,81,37,36) 3.7  (4.37) 5.9  (5.44) 4.6  (5.07) 4.1  (4.03)
Week 52 (n=80,78,35,36) 4.6  (5.83) 6.5  (6.25) 4.7  (5.85) 6.0  (5.68)
38.Secondary Outcome
Title Change From Baseline in DLQI Score Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 2 (n=88,86,44,42) -3.98  (0.455) -3.26  (0.458) -0.20  (0.644) -2.27  (0.659)
Week 4 (n=86,88,44,42) -5.96  (0.492) -5.11  (0.488) 0.17  (0.700) -2.26  (0.712)
Week 8 (n=85,88,40,39) -7.52  (0.594) -5.83  (0.587) -1.00  (0.852) -2.70  (0.868)
Week 12 (n=84,88,39,39) -8.59  (0.618) -6.64  (0.609) -0.76  (0.891) -2.44  (0.904)
Week 16 (n=84,84,38,39) -9.03  (0.618) -7.00  (0.611) -1.15  (0.899) -2.22  (0.905)
Week 20 (n=82,84,38,39) -9.36  (0.562) -7.78  (0.555) -5.84  (0.819) -6.30  (0.821)
Week 32 (n=83,82,38,37) -10.05  (0.565) -8.07  (0.562) -7.44  (0.828) -7.94  (0.837)
Week 40 (n=81,81,37,36) -9.56  (0.563) -7.32  (0.559) -7.61  (0.826) -8.28  (0.836)
Week 52 (n=80,78,35,36) -8.63  (0.679) -6.63  (0.681) -7.42  (1.012) -6.37  (1.010)
39.Secondary Outcome
Title Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tofacitinib 10 mg Tofacitinib 5 mg Placebo to Tofacitinib 10 mg Placebo to Tofacitinib 5 mg
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
Overall Number of Participants Analyzed 90 88 44 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 4
7.78
(2.24 to 13.31)
5.68
(0.85 to 10.52)
2.27
(0.00 to 6.68)
0.00 [1] 
(NA to NA)
Week 8
32.22
(22.57 to 41.88)
19.32
(11.07 to 27.57)
2.27
(0.00 to 6.68)
0.00 [1] 
(NA to NA)
Week 12
45.56
(35.27 to 55.84)
27.27
(17.97 to 36.58)
2.27
(0.00 to 6.68)
0.00 [1] 
(NA to NA)
Week 16
55.56
(45.29 to 65.82)
34.09
(24.19 to 43.99)
9.09
(0.60 to 17.59)
4.55
(0.00 to 10.70)
Week 20
52.22
(41.90 to 62.54)
31.82
(22.09 to 41.55)
18.18
(6.79 to 29.58)
13.64
(3.50 to 23.78)
Week 32
56.67
(46.43 to 66.90)
34.09
(24.19 to 43.99)
45.45
(30.74 to 60.17)
31.82
(18.06 to 45.58)
Week 40
52.22
(41.90 to 62.54)
34.09
(24.19 to 43.99)
50.00
(35.23 to 64.77)
40.91
(26.38 to 55.44)
Week 52
51.11
(40.78 to 61.44)
26.14
(16.96 to 35.32)
47.73
(32.97 to 62.49)
29.55
(16.06 to 43.03)
[1]
It is because the calculation method is based on normal approximation which assumes a big sample size, but n=0 at these weeks. Hence, it's not appropriate to use normal approximation to estimate the CI's.
40.Secondary Outcome
Title Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52
Hide Description 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 better health state.
Time Frame Baseline, Weeks 16, 32, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.