Psoriasis
Conditions
Keywords
CP-690,550, Etanercept, Moderate, Severe, Chronic, Plaque, Psoriasis, Efficacy, Safety, Tofacitinib, Xeljanz, OPT Compare, OPT, head-to-head, non-inferiority, Psoriasis vulgaris, short-term, Itch, Pruritus, Plaque psoriasis, DLQI
Brief summary
To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.
Interventions
DRUGCP 690,550 5 mg
CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
DRUGCP 690,550 10 mg
CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
BIOLOGICALEtanercept 50 mg
Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
OTHERPlacebo
Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris); * Have plaque-type psoriasis covering at least 10% of total body surface area * Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis
Exclusion criteria
* Non-plaque or drug induced forms of psoriasis * Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis * Cannot discontinue phototherapy * Any uncontrolled significant medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12 | Week 12 | 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 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). |
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 | Week 12 | 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 percent (%) reduction in PASI relative to baseline/Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Weeks 2, 4, and 8 | 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 to 4). The severity scores are summed and averaged after which the total average is 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 is defined as 0 (clear) or 1 (almost clear). |
| Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline and Weeks 2, 4, 8, and 12 | 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 to 4). The severity scores are summed and averaged after which the total average is 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 a PASI75 Response During the 12-Week Double-Blind Treatment | Weeks 2, 4, and 8 | 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. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1. |
| Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | 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. |
| Mean PASI Score During the 12-Week Double-Blind Treatment | Baseline and Weeks 2, 4, 8, and 12 | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. |
| Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. |
| Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Baseline and Weeks 2, 4, 8, and 12 | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. |
| Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Weeks 2, 4, 8, and 12 | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. |
| Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Baseline and Weeks 2, 4, 8, and 12 | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area 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. 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. |
| Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area 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. 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. |
| Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis. |
| Median Time to PASI50 Response During the 12-Week Double-Blind Treatment | Baseline up to Week 12 | — |
| Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis. |
| Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment | Baseline up to Week 12 | — |
| Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | — |
| Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Baseline, Weeks 2, 4, 8, and 12 | 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. |
| Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | 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. |
| Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Baseline and Weeks 4 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 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. |
| Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Weeks 4 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. |
| Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Baseline and Weeks 4 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). |
| Mean Change From Baseline in EQ-5D VAS at Week 12 | Week 12 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Weeks 4 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. |
| Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Weeks 4 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. |
| Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Weeks 4 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 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. |
| Median Time to DLQI Response | Weeks 4 and 12 | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 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. DLQI Response was defined as a 5-point reduction in the total DLQI score. |
| Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline and Week 12 | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score\*10) plus 50. Higher scores indicate a better health related quality of life. |
| Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline and Week 12 | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. |
| Mean Change From Baseline in SF-36 MCS and PCS Scores | Week 12 | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score\*10) plus 50. Higher scores indicate a better health related quality of life. |
| Mean Change From Baseline in SF-36 Domain Scores | Week 12 | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. |
| Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Baseline and Weeks 2, 4, and 8 | 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; 1=almost clear; 2=mild; 3=moderate; 4=severe). |
| Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Weeks 2, 4, 8, and 12 | 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; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1. |
| Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Week 12 | The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study medication. |
| Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12 | Week 12 | The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study medication. |
| Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Baseline and Week 12 | 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. |
| Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment | Week 12 | 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. |
| Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Baseline and Week 12 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Baseline and Week 12 | 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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). |
| Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Week 12 | 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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). |
| Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline (BL) and Week 12 | The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners \[GPs\], primary care physicians \[PCPs\], or family medicine physicians \[FMP\], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. |
| Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment | Week 12 | — |
| Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline and Week 12 | Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis. |
| Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment | Week 12 | Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. |
| Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Baseline and Week 12 | The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life. |
| Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment | Week 12 | The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life. |
Countries
Argentina, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Chile, Colombia, Croatia, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Netherlands, Poland, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks. | 329 |
| CP-690,550 10 mg BID + Placebo BIW Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks. | 330 |
| Placebo BID + Etanercept 50 mg BIW Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks. | 335 |
| Placebo BID + Placebo BIW Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks. | 107 |
| Total | 1,101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 11 | 12 | 4 |
| Overall Study | Lack of Efficacy | 5 | 2 | 2 | 3 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 | 2 |
| Overall Study | Other | 0 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 5 | 2 | 3 | 0 |
| Overall Study | Screen Failure | 3 | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 4 | 2 | 2 |
Baseline characteristics
| Characteristic | Total | CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | CP-690,550 10 mg BID + Placebo BIW | Placebo BID + Etanercept 50 mg BIW | Placebo BID + Placebo BIW |
|---|---|---|---|---|---|
| Age, Continuous | 44.0 years STANDARD_DEVIATION 12.4 | 44.4 years STANDARD_DEVIATION 12.1 | 43.6 years STANDARD_DEVIATION 12.6 | 43.3 years STANDARD_DEVIATION 12.2 | 46.1 years STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 323 Participants | 93 Participants | 92 Participants | 102 Participants | 36 Participants |
| Sex: Female, Male Male | 778 Participants | 236 Participants | 238 Participants | 233 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 103 / 329 | 121 / 330 | 109 / 335 | 34 / 107 |
| serious Total, serious adverse events | 7 / 329 | 5 / 330 | 7 / 335 | 2 / 107 |
Outcome results
Primary
Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12
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 to 4). The severity scores are summed and averaged after which the total average is 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 12
Population: Full Analysis Set (FAS): all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550, etanercept, or placebo); Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12 | 47.11 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12 | 68.18 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12 | 66.27 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12 | 14.95 percentage of participants |
Comparison: Difference from Etanercept (Active-Etanercept)95% CI: [-26.55, -11.76]
Comparison: Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the lower bounds of the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.95% CI: [23.51, 40.81]
Comparison: Difference from Etanercept (Active-Etanercept)95% CI: [-5.22, 9.05]
Comparison: Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.95% CI: [44.81, 61.65]
Primary
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
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 percent (%) reduction in PASI relative to baseline/Day 1.
Time frame: Week 12
Population: FAS; NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 | 39.51 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 | 63.64 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 | 58.81 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 | 5.61 percentage of participants |
Comparison: Difference from Etanercept (Active-Etanercept)95% CI: [-26.75, -11.83]
Comparison: Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.95% CI: [27.06, 40.76]
Comparison: Difference from Etanercept (Active-Etanercept)95% CI: [-2.57, 12.23]
Comparison: Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.95% CI: [51.25, 64.81]
Secondary
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment
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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed).
Time frame: Baseline and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Baseline (n=327,327,330,104) | 1.2 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Baseline (n=327,328,330,104) | 1.8 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Week 12 (n=307,304,307,95) | 1.5 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Week 12 (n=306,304,307,95) | 1.2 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Week 12 (n=306,304,307,95) | 1.1 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Week 12 (n=305,304,307,95) | 1.4 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Baseline (n=327,327,330,104) | 1.4 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Baseline (n=326,327,330,104) | 1.6 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Week 12 (n=307,304,307,95) | 1.2 Units on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Baseline (n=326,327,330,104) | 1.3 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Week 12 (n=307,304,307,95) | 1.3 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Week 12 (n=306,304,307,95) | 1.1 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Baseline (n=326,327,330,104) | 1.7 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Week 12 (n=305,304,307,95) | 1.3 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Baseline (n=327,327,330,104) | 1.1 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Baseline (n=326,327,330,104) | 1.3 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Week 12 (n=306,304,307,95) | 1.0 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Baseline (n=327,327,330,104) | 1.4 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Week 12 (n=307,304,307,95) | 1.1 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Baseline (n=327,328,330,104) | 1.8 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Baseline (n=327,327,330,104) | 1.4 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Baseline (n=327,327,330,104) | 1.1 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Week 12 (n=305,304,307,95) | 1.3 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Baseline (n=327,328,330,104) | 1.9 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Week 12 (n=307,304,307,95) | 1.2 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Week 12 (n=306,304,307,95) | 1.2 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Baseline (n=326,327,330,104) | 1.6 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Baseline (n=326,327,330,104) | 1.3 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Week 12 (n=306,304,307,95) | 1.1 Units on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Week 12 (n=307,304,307,95) | 1.4 Units on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Week 12 (n=305,304,307,95) | 1.5 Units on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Baseline (n=326,327,330,104) | 1.3 Units on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Mobility, Week 12 (n=306,304,307,95) | 1.3 Units on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Baseline (n=327,327,330,104) | 1.2 Units on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Self Care, Week 12 (n=306,304,307,95) | 1.2 Units on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Baseline (n=327,327,330,104) | 1.5 Units on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Usual Activities, Week 12 (n=307,304,307,95) | 1.3 Units on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Week 12 (n=307,304,307,95) | 1.7 Units on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Anxiety/Depression, Baseline (n=326,327,330,104) | 1.7 Units on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment | Pain/Discomfort, Baseline (n=327,328,330,104) | 1.8 Units on a scale | Standard Error 0.1 |
Secondary
Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment
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: Week 12
Population: FAS; OC
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment | 0.14 scores on a scale | Standard Error 0.011 |
| CP-690,550 10 mg BID + Placebo BIW | Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment | 0.21 scores on a scale | Standard Error 0.011 |
| Placebo BID + Etanercept 50 mg BIW | Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment | 0.19 scores on a scale | Standard Error 0.011 |
| Placebo BID + Placebo BIW | Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment | 0.03 scores on a scale | Standard Error 0.021 |
Secondary
Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Time frame: Weeks 4 and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 4 (n=317,319,322,99) | -5.28 score on a scale | Standard Error 0.35 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 12 (n=305,301,305,93) | -7.33 score on a scale | Standard Error 0.43 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 12 (n=305,301,305,93) | -9.72 score on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 4 (n=317,319,322,99) | -7.43 score on a scale | Standard Error 0.36 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 4 (n=317,319,322,99) | -5.80 score on a scale | Standard Error 0.33 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 12 (n=305,301,305,93) | -8.97 score on a scale | Standard Error 0.4 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 4 (n=317,319,322,99) | -1.64 score on a scale | Standard Error 0.55 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment | Week 12 (n=305,301,305,93) | -1.85 score on a scale | Standard Error 0.66 |
Secondary
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Time frame: Weeks 4 and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=305,301,305,93) | -1.10 scores on a scale | Standard Error 0.11 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=305,302,305,93) | -0.75 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=305,301,304,92) | -0.69 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=317,320,321,99) | -1.34 scores on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=317,319,322,99) | -0.76 scores on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=316,319,321,99) | -1.13 scores on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=304,302,304,93) | -1.58 scores on a scale | Standard Error 0.1 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=305,301,305,93) | -1.81 scores on a scale | Standard Error 0.1 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=317,320,322,99) | -0.47 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=316,318,320,99) | -1.03 scores on a scale | Standard Error 0.1 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=303,301,303,93) | -1.41 scores on a scale | Standard Error 0.11 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=317,320,321,99) | -0.56 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=305,301,305,93) | -2.41 scores on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=317,320,321,99) | -0.63 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=304,302,304,93) | -2.14 scores on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=317,319,322,99) | -1.09 scores on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=305,301,305,93) | -1.46 scores on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=305,301,304,92) | -0.86 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=317,320,321,99) | -1.87 scores on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=303,301,303,93) | -1.95 scores on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=316,318,320,99) | -1.54 scores on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=316,319,321,99) | -1.57 scores on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=305,302,305,93) | -0.91 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=317,320,322,99) | -0.72 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=305,301,304,92) | -0.77 scores on a scale | Standard Error 0.07 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=317,320,321,99) | -1.53 scores on a scale | Standard Error 0.08 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=305,301,305,93) | -2.30 scores on a scale | Standard Error 0.1 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=316,319,321,99) | -1.21 scores on a scale | Standard Error 0.09 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=304,302,304,93) | -1.96 scores on a scale | Standard Error 0.1 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=316,318,320,99) | -1.24 scores on a scale | Standard Error 0.1 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=303,301,303,93) | -1.90 scores on a scale | Standard Error 0.11 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=317,320,321,99) | -0.52 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=317,319,322,99) | -0.73 scores on a scale | Standard Error 0.08 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=305,301,305,93) | -1.17 scores on a scale | Standard Error 0.09 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=317,320,322,99) | -0.58 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=305,302,305,93) | -0.91 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=303,301,303,93) | -0.31 scores on a scale | Standard Error 0.18 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=316,318,320,99) | -0.39 scores on a scale | Standard Error 0.15 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=317,320,321,99) | -0.53 scores on a scale | Standard Error 0.15 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=305,301,305,93) | -0.20 scores on a scale | Standard Error 0.15 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=304,302,304,93) | -0.34 scores on a scale | Standard Error 0.19 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=316,319,321,99) | -0.28 scores on a scale | Standard Error 0.15 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=305,302,305,93) | -0.24 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=317,320,322,99) | -0.12 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=305,301,304,92) | -0.12 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=317,320,321,99) | -0.13 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=305,301,305,93) | -0.62 scores on a scale | Standard Error 0.18 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=317,319,322,99) | -0.18 scores on a scale | Standard Error 0.14 |
Secondary
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12
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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed).
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Self-Care | -0.1 scores on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Mobility | -0.1 scores on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Usual Activities | -0.3 scores on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Anxiety/Depression | -0.2 scores on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Pain/Discomfort | -0.4 scores on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Anxiety/Depression | -0.4 scores on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Mobility | -0.1 scores on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Self-Care | -0.1 scores on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Usual Activities | -0.3 scores on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Pain/Discomfort | -0.5 scores on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Self-Care | -0.1 scores on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Usual Activities | -0.2 scores on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Pain/Discomfort | -0.5 scores on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Mobility | -0.1 scores on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Anxiety/Depression | -0.3 scores on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Self-Care | -0.1 scores on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Pain/Discomfort | -0.1 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Usual Activities | -0.1 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Mobility | -0.0 scores on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 | Anxiety/Depression | -0.1 scores on a scale | Standard Error 0.1 |
Secondary
Mean Change From Baseline in EQ-5D VAS at Week 12
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in EQ-5D VAS at Week 12 | 11.6 mm | Standard Error 1.4 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in EQ-5D VAS at Week 12 | 16.6 mm | Standard Error 1.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in EQ-5D VAS at Week 12 | 15.7 mm | Standard Error 1.4 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in EQ-5D VAS at Week 12 | 3.0 mm | Standard Error 2.4 |
Secondary
Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment
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: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 12 | -3.18 score on a scale | Standard Error 0.18 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 4 | -2.24 score on a scale | Standard Error 0.18 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 8 | -3.01 score on a scale | Standard Error 0.18 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 2 | -1.73 score on a scale | Standard Error 0.15 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 4 | -3.43 score on a scale | Standard Error 0.17 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 12 | -3.96 score on a scale | Standard Error 0.18 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 8 | -4.02 score on a scale | Standard Error 0.17 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 2 | -2.39 score on a scale | Standard Error 0.14 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 8 | -3.13 score on a scale | Standard Error 0.17 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 4 | -2.20 score on a scale | Standard Error 0.15 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 2 | -1.22 score on a scale | Standard Error 0.15 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 12 | -3.46 score on a scale | Standard Error 0.19 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 12 | -0.43 score on a scale | Standard Error 0.28 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 4 | -0.44 score on a scale | Standard Error 0.24 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 8 | -0.46 score on a scale | Standard Error 0.26 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment | Week 2 | -0.26 score on a scale | Standard Error 0.22 |
Secondary
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time frame: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | -1.26 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | -1.28 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | -0.91 scores on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | -0.53 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | -0.94 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | -0.52 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | -1.23 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | -1.53 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | -1.42 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | -1.08 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | -0.46 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | -0.80 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | -1.19 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | -1.25 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | -0.47 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | -0.83 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | -0.44 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | -0.91 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | -0.94 scores on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | -1.55 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | -1.34 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | -1.16 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | -0.55 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | -0.95 scores on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | -0.52 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | -1.31 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | -1.31 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | -1.38 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | -1.19 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | -0.52 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | -1.56 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | -0.92 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | -0.52 scores on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | -0.94 scores on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | -1.43 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | -1.26 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | -1.31 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | -1.09 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | -0.93 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | -0.49 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | -1.39 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | -1.37 scores on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | -1.41 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | -0.54 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | -0.56 scores on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | -0.92 scores on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | -1.36 scores on a scale | Standard Error 0.07 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | -0.96 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | -1.61 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | -0.72 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | -1.19 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | -1.59 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | -0.65 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | -1.15 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | -0.76 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | -1.30 scores on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | -1.70 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | -1.78 scores on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | -0.68 scores on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | -1.60 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | -1.77 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | -0.72 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | -1.13 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | -1.66 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | -1.73 scores on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | -1.50 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | -1.23 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | -1.62 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | -1.13 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | -1.79 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | -0.73 scores on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | -1.23 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | -1.65 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | -1.73 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | -0.67 scores on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | -1.90 scores on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | -0.69 scores on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | -1.20 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | -1.74 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | -1.91 scores on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | -0.74 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | -1.27 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | -1.71 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | -1.92 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | -0.69 scores on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | -1.15 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | -1.63 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | -1.92 scores on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | -0.71 scores on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | -1.25 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | -1.80 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | -2.01 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | -0.69 scores on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | -1.26 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | -1.74 scores on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | -1.99 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | -0.67 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | -1.66 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | -1.62 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | -1.92 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | -0.63 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | -1.54 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | -1.92 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | -0.49 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | -2.03 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | -0.56 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | -0.61 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | -1.62 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | -1.91 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | -1.17 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | -1.68 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | -1.11 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | -1.99 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | -0.64 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | -0.61 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | -0.67 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | -1.15 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | -1.67 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | -1.81 scores on a scale | Standard Error 0.07 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | -1.63 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | -1.94 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | -1.92 scores on a scale | Standard Error 0.07 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | -0.53 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | -1.62 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | -1.18 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | -1.00 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | -1.51 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | -1.13 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | -1.10 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | -1.80 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | -1.83 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | -0.56 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | -1.41 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | -1.57 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | -0.69 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | -1.19 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | -1.67 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | -1.67 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | -1.08 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | -1.95 scores on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | -0.59 scores on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | -1.16 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | -0.95 scores on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | -1.13 scores on a scale | Standard Error 0.05 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | -0.58 scores on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | -0.39 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | -0.64 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | -0.28 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | -0.20 scores on a scale | Standard Error 0.05 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | -0.59 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | -0.65 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | -0.68 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | -0.66 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | -0.35 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | -0.24 scores on a scale | Standard Error 0.05 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | -0.32 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | -0.48 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | -0.43 scores on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | -0.67 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | -0.67 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | -0.35 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | -0.55 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | -0.27 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | -0.71 scores on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | -0.75 scores on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | -0.49 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | -0.37 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | -0.26 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | -0.67 scores on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | -0.61 scores on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | -0.62 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | -0.20 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | -0.54 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | -0.76 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | -0.64 scores on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | -0.18 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | -0.23 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | -0.64 scores on a scale | Standard Error 0.12 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | -0.25 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | -0.17 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | -0.25 scores on a scale | Standard Error 0.05 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | -0.39 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | -0.47 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | -0.80 scores on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | -0.27 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | -0.38 scores on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | -0.75 scores on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | -0.58 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | -0.32 scores on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | -0.15 scores on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | -0.71 scores on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | -0.69 scores on a scale | Standard Error 0.1 |
Secondary
Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time frame: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | -5.03 scores on a scale | Standard Error 0.31 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | -8.83 scores on a scale | Standard Error 0.42 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -12.62 scores on a scale | Standard Error 0.52 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -14.55 scores on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | -11.30 scores on a scale | Standard Error 0.43 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -17.54 scores on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | -6.47 scores on a scale | Standard Error 0.31 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -15.81 scores on a scale | Standard Error 0.51 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -15.20 scores on a scale | Standard Error 0.51 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -17.55 scores on a scale | Standard Error 0.57 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | -5.48 scores on a scale | Standard Error 0.29 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | -10.14 scores on a scale | Standard Error 0.39 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -5.33 scores on a scale | Standard Error 0.97 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | -1.58 scores on a scale | Standard Error 0.46 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | -2.58 scores on a scale | Standard Error 0.62 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -4.82 scores on a scale | Standard Error 0.81 |
Secondary
Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment
The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment | -35.2 scores on a scale | Standard Error 1.9 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment | -47.9 scores on a scale | Standard Error 1.8 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment | -44.3 scores on a scale | Standard Error 1.8 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment | -9.6 scores on a scale | Standard Error 2.6 |
Secondary
Mean Change From Baseline in SF-36 Domain Scores
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Vitality | 4.2 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Bodily Pain | 7.0 score on a scale | Standard Error 0.7 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Role Physical | 5.1 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | General Health | 2.5 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Physical Functioning | 3.5 score on a scale | Standard Error 0.4 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Health Transition | -0.5 score on a scale | Standard Error 0.1 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Mental Health | 4.5 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Social Functioning | 6.0 score on a scale | Standard Error 0.7 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 Domain Scores | Role - Emotional | 5.4 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Role - Emotional | 7.2 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Mental Health | 7.0 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Health Transition | -0.6 score on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Role Physical | 6.3 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Bodily Pain | 8.5 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | General Health | 5.5 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Vitality | 5.4 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Physical Functioning | 3.7 score on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Social Functioning | 9.2 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Physical Functioning | 3.7 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Vitality | 4.6 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Mental Health | 5.9 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Health Transition | -0.6 score on a scale | Standard Error 0.1 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Role - Emotional | 5.8 score on a scale | Standard Error 0.7 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Bodily Pain | 8.6 score on a scale | Standard Error 0.7 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Social Functioning | 7.3 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | General Health | 4.4 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 Domain Scores | Role Physical | 6.1 score on a scale | Standard Error 0.5 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Health Transition | -0.2 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | General Health | 0.2 score on a scale | Standard Error 0.8 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Physical Functioning | 1.1 score on a scale | Standard Error 0.8 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Bodily Pain | 1.6 score on a scale | Standard Error 1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Vitality | 1.3 score on a scale | Standard Error 0.9 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Social Functioning | 0.7 score on a scale | Standard Error 1.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Role - Emotional | 2.3 score on a scale | Standard Error 1.2 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Mental Health | 1.4 score on a scale | Standard Error 1.1 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 Domain Scores | Role Physical | 1.3 score on a scale | Standard Error 0.9 |
Secondary
Mean Change From Baseline in SF-36 MCS and PCS Scores
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score\*10) plus 50. Higher scores indicate a better health related quality of life.
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 MCS and PCS Scores | Physical Health Score | 4.1 score on a scale | Standard Error 0.4 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Change From Baseline in SF-36 MCS and PCS Scores | Mental Health Score | 5.0 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 MCS and PCS Scores | Mental Health Score | 7.6 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Change From Baseline in SF-36 MCS and PCS Scores | Physical Health Score | 5.0 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 MCS and PCS Scores | Physical Health Score | 5.2 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Change From Baseline in SF-36 MCS and PCS Scores | Mental Health Score | 5.8 score on a scale | Standard Error 0.6 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 MCS and PCS Scores | Physical Health Score | 0.8 score on a scale | Standard Error 0.7 |
| Placebo BID + Placebo BIW | Mean Change From Baseline in SF-36 MCS and PCS Scores | Mental Health Score | 1.5 score on a scale | Standard Error 1.1 |
Secondary
Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 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 4 and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Baseline (n=328,326,332,106) | 12.98 score on a scale | Standard Error 0.39 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=306,305,307,93) | 5.61 score on a scale | Standard Error 0.36 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,325,100) | 7.82 score on a scale | Standard Error 0.36 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Baseline (n=328,326,332,106) | 13.32 score on a scale | Standard Error 0.38 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=306,305,307,93) | 3.47 score on a scale | Standard Error 0.27 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,325,100) | 5.95 score on a scale | Standard Error 0.32 |
| Placebo BID + Etanercept 50 mg BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,325,100) | 6.90 score on a scale | Standard Error 0.35 |
| Placebo BID + Etanercept 50 mg BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Baseline (n=328,326,332,106) | 12.73 score on a scale | Standard Error 0.38 |
| Placebo BID + Etanercept 50 mg BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=306,305,307,93) | 3.84 score on a scale | Standard Error 0.3 |
| Placebo BID + Placebo BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Baseline (n=328,326,332,106) | 12.27 score on a scale | Standard Error 0.69 |
| Placebo BID + Placebo BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=306,305,307,93) | 10.33 score on a scale | Standard Error 0.81 |
| Placebo BID + Placebo BIW | Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,325,100) | 10.51 score on a scale | Standard Error 0.77 |
Secondary
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).
Time frame: Baseline and Weeks 4 and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School,Baseline (n=328,327,331,106) | 1.12 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=306,305,307,93) | 1.09 score on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=306,305,306,93) | 1.19 score on a scale | Standard Error 0.08 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=306,305,307,93) | 0.45 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=318,322,325,100) | 1.50 score on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Baseline (n=326,326,330,106) | 2.52 score on a scale | Standard Error 0.11 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Baseline(n=328,327,332,106) | 1.22 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=306,305,307,93) | 0.85 score on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=306,304,307,93) | 1.60 score on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings,Baseline (n=328,327,332,106) | 3.44 score on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=318,323,325,100) | 1.21 score on a scale | Standard Error 0.09 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships,Baseline(n=328,326,332,106) | 1.95 score on a scale | Standard Error 0.11 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities,Baseline (n=327,327,332,106) | 2.76 score on a scale | Standard Error 0.1 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=318,323,325,100) | 0.76 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=306,304,307,92) | 0.41 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=318,323,325,100) | 0.56 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=318,322,324,100) | 1.68 score on a scale | Standard Error 0.08 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=318,323,324,100) | 2.11 score on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=306,304,307,93) | 1.04 score on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings,Baseline (n=328,327,332,106) | 3.49 score on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=318,323,324,100) | 1.63 score on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities,Baseline (n=327,327,332,106) | 2.85 score on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=318,322,324,100) | 1.30 score on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=306,305,306,93) | 0.70 score on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Baseline (n=326,326,330,106) | 2.67 score on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=318,322,325,100) | 1.14 score on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=306,305,307,93) | 0.70 score on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School,Baseline (n=328,327,331,106) | 1.08 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=318,323,325,100) | 0.46 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=306,304,307,92) | 0.24 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships,Baseline(n=328,326,332,106) | 1.98 score on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=318,323,325,100) | 0.90 score on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=306,305,307,93) | 0.48 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Baseline(n=328,327,332,106) | 1.24 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=318,323,325,100) | 0.52 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=306,305,307,93) | 0.31 score on a scale | Standard Error 0.03 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=318,322,324,100) | 1.53 score on a scale | Standard Error 0.08 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School,Baseline (n=328,327,331,106) | 1.06 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=318,323,325,100) | 0.54 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities,Baseline (n=327,327,332,106) | 2.76 score on a scale | Standard Error 0.09 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=306,305,307,93) | 0.33 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=306,304,307,92) | 0.32 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=318,323,325,100) | 0.65 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships,Baseline(n=328,326,332,106) | 1.67 score on a scale | Standard Error 0.1 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=306,304,307,93) | 1.16 score on a scale | Standard Error 0.07 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=318,323,325,100) | 0.93 score on a scale | Standard Error 0.08 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings,Baseline (n=328,327,332,106) | 3.47 score on a scale | Standard Error 0.08 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=306,305,307,93) | 0.52 score on a scale | Standard Error 0.07 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=318,323,324,100) | 1.94 score on a scale | Standard Error 0.07 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Baseline (n=326,326,330,106) | 2.57 score on a scale | Standard Error 0.11 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=306,305,306,93) | 0.79 score on a scale | Standard Error 0.07 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=318,322,325,100) | 1.33 score on a scale | Standard Error 0.09 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Baseline(n=328,327,332,106) | 1.23 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=306,305,307,93) | 0.71 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Baseline (n=326,326,330,106) | 2.25 score on a scale | Standard Error 0.17 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Baseline(n=328,327,332,106) | 1.18 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 4 (n=318,323,325,100) | 1.64 score on a scale | Standard Error 0.2 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School,Baseline (n=328,327,331,106) | 0.97 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities,Baseline (n=327,327,332,106) | 2.52 score on a scale | Standard Error 0.16 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings,Baseline (n=328,327,332,106) | 3.46 score on a scale | Standard Error 0.16 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 4 (n=318,323,324,100) | 2.92 score on a scale | Standard Error 0.15 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 4 (n=318,323,325,100) | 0.81 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 4 (n=318,322,324,100) | 2.28 score on a scale | Standard Error 0.18 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 12 (n=306,305,307,93) | 0.95 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships, Week 12 (n=306,305,307,93) | 1.65 score on a scale | Standard Error 0.2 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Work and School, Week 12 (n=306,304,307,92) | 0.83 score on a scale | Standard Error 0.12 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Symptoms and Feelings, Week 12 (n=306,304,307,93) | 2.85 score on a scale | Standard Error 0.17 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Daily Activities, Week 12 (n=306,305,306,93) | 2.17 score on a scale | Standard Error 0.19 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 12 (n=306,305,307,93) | 1.90 score on a scale | Standard Error 0.19 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Personal Relationships,Baseline(n=328,326,332,106) | 1.89 score on a scale | Standard Error 0.18 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Leisure, Week 4 (n=318,322,325,100) | 1.84 score on a scale | Standard Error 0.18 |
| Placebo BID + Placebo BIW | Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment | Treatment, Week 4 (n=318,323,325,100) | 1.02 score on a scale | Standard Error 0.11 |
Secondary
Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Week 12 (n=298,294,297,91) | 75.3 mm | Standard Error 1.1 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Baseline (n=315,318,312,100) | 63.3 mm | Standard Error 1.3 |
| CP-690,550 10 mg BID + Placebo BIW | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Baseline (n=315,318,312,100) | 63.3 mm | Standard Error 1.3 |
| CP-690,550 10 mg BID + Placebo BIW | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Week 12 (n=298,294,297,91) | 81.1 mm | Standard Error 1 |
| Placebo BID + Etanercept 50 mg BIW | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Week 12 (n=298,294,297,91) | 80.0 mm | Standard Error 1 |
| Placebo BID + Etanercept 50 mg BIW | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Baseline (n=315,318,312,100) | 64.2 mm | Standard Error 1.3 |
| Placebo BID + Placebo BIW | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Week 12 (n=298,294,297,91) | 65.1 mm | Standard Error 2.6 |
| Placebo BID + Placebo BIW | Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment | Baseline (n=315,318,312,100) | 60.5 mm | Standard Error 2.7 |
Secondary
Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment
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 and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Baseline | 0.7 score on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Week 12 | 0.8 score on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Week 12 | 0.9 score on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Baseline | 0.7 score on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Baseline | 0.7 score on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Week 12 | 0.9 score on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Baseline | 0.6 score on a scale | Standard Error 0 |
| Placebo BID + Placebo BIW | Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment | Week 12 | 0.7 score on a scale | Standard Error 0 |
Secondary
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment
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, Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 8 (n=313,315,320,100) | 2.11 score on a scale | Standard Error 0.14 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 2 (n=325,322,330,105) | 3.47 score on a scale | Standard Error 0.15 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=312,309,311,95) | 1.98 score on a scale | Standard Error 0.14 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,328,101) | 2.92 score on a scale | Standard Error 0.15 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Baseline (n=305,308,305,107) | 5.19 score on a scale | Standard Error 0.16 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,328,101) | 1.86 score on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 8 (n=313,315,320,100) | 1.22 score on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=312,309,311,95) | 1.25 score on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 2 (n=325,322,330,105) | 2.87 score on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Baseline (n=305,308,305,107) | 5.26 score on a scale | Standard Error 0.16 |
| Placebo BID + Etanercept 50 mg BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,328,101) | 2.97 score on a scale | Standard Error 0.13 |
| Placebo BID + Etanercept 50 mg BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Baseline (n=305,308,305,107) | 5.23 score on a scale | Standard Error 0.15 |
| Placebo BID + Etanercept 50 mg BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 2 (n=325,322,330,105) | 3.90 score on a scale | Standard Error 0.15 |
| Placebo BID + Etanercept 50 mg BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 8 (n=313,315,320,100) | 2.06 score on a scale | Standard Error 0.13 |
| Placebo BID + Etanercept 50 mg BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=312,309,311,95) | 1.72 score on a scale | Standard Error 0.13 |
| Placebo BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 8 (n=313,315,320,100) | 4.74 score on a scale | Standard Error 0.32 |
| Placebo BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 2 (n=325,322,330,105) | 4.90 score on a scale | Standard Error 0.3 |
| Placebo BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Baseline (n=305,308,305,107) | 5.15 score on a scale | Standard Error 0.27 |
| Placebo BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 4 (n=318,323,328,101) | 4.65 score on a scale | Standard Error 0.31 |
| Placebo BID + Placebo BIW | Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment | Week 12 (n=312,309,311,95) | 4.75 score on a scale | Standard Error 0.32 |
Secondary
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time frame: Baseline and Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | 1.19 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | 1.04 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Baseline (n=329,329,335,107) | 2.64 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | 2.12 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | 1.73 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | 1.28 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Baseline (n=329,329,335,107) | 3.12 score on a scale | Standard Error 0.03 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | 2.60 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | 1.77 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | 1.56 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | 2.03 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | 1.58 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | 1.40 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Baseline (n=329,329,335,107) | 2.91 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Baseline (n=329,329,335,107) | 2.28 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | 1.82 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | 1.48 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Baseline (n=329,329,335,107) | 2.04 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | 1.60 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | 1.21 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | 0.96 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | 0.87 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Baseline (n=329,329,335,107) | 2.29 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | 1.75 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | 1.38 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | 1.12 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | 0.98 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Baseline (n=329,329,335,107) | 2.87 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | 2.35 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | 1.92 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | 1.55 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | 1.45 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration Baseline(n=329,329,335,107) | 2.69 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | 2.17 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | 1.76 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | 1.43 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | 1.31 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Baseline (n=329,329,335,107) | 2.66 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | 2.11 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | 1.71 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | 1.39 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | 1.30 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Baseline (n=329,329,335,107) | 2.95 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | 2.40 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | 2.03 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | 1.71 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | 1.53 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Baseline (n=329,329,335,107) | 2.75 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | 2.26 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | 1.83 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | 1.50 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | 1.33 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | 1.47 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | 1.39 score on a scale | Standard Error 0.06 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | 2.17 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration Baseline(n=329,329,335,107) | 2.94 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | 2.47 score on a scale | Standard Error 0.04 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | 2.36 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | 1.98 score on a scale | Standard Error 0.05 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | 1.60 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | 1.21 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | 0.78 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Baseline (n=329,329,335,107) | 2.08 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | 0.80 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | 1.44 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | 1.92 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | 0.94 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | 0.59 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | 0.49 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Baseline (n=329,329,335,107) | 2.38 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | 1.63 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | 1.07 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | 0.94 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | 0.70 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | 0.60 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Baseline (n=329,329,335,107) | 2.87 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | 2.25 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | 2.18 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | 1.73 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | 1.27 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | 1.07 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration Baseline(n=329,329,335,107) | 2.76 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | 2.03 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | 1.98 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | 1.54 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | 1.21 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | 1.13 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | 1.01 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Baseline (n=329,329,335,107) | 2.72 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | 2.00 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration Baseline(n=329,329,335,107) | 2.97 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | 1.50 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | 1.11 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | 1.69 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | 1.00 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | 2.26 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Baseline (n=329,329,335,107) | 2.88 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | 2.20 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | 1.75 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | 1.23 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | 0.96 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | 0.65 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | 0.97 score on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | 1.18 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Baseline (n=329,329,335,107) | 2.66 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Baseline (n=329,329,335,107) | 2.70 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | 1.39 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | 0.74 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | 2.01 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Baseline (n=329,329,335,107) | 3.13 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | 2.44 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | 1.50 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | 1.50 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | 1.72 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | 0.97 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Baseline (n=329,329,335,107) | 2.95 score on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | 0.97 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Baseline (n=329,329,335,107) | 2.36 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | 1.65 score on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | 1.18 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | 2.61 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | 0.94 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration Baseline(n=329,329,335,107) | 2.72 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | 2.13 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | 1.38 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | 1.59 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | 0.62 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | 1.18 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | 1.35 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | 0.81 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Baseline (n=329,329,335,107) | 2.98 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Baseline (n=329,329,335,107) | 2.73 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | 2.31 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | 2.03 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | 2.05 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | 1.76 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | 1.54 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration Baseline(n=329,329,335,107) | 3.00 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | 2.15 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | 1.07 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | 0.82 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | 1.62 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Baseline (n=329,329,335,107) | 2.91 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | 2.45 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | 2.27 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | 1.76 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | 1.92 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | 1.24 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | 0.89 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | 0.48 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Baseline (n=329,329,335,107) | 2.32 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Baseline (n=329,329,335,107) | 1.96 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | 1.08 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | 1.46 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | 1.23 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | 1.01 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | 1.93 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | 0.69 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | 0.54 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | 0.37 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | 1.44 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Baseline (n=329,329,335,107) | 2.28 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | 0.65 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | 1.60 score on a scale | Standard Error 0.06 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | 1.81 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | 1.16 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | 1.50 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Baseline (n=329,329,335,107) | 2.66 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | 0.90 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | 0.66 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | 0.46 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | 1.32 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Baseline (n=329,329,335,107) | 2.88 score on a scale | Standard Error 0.04 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | 0.98 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | 2.27 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Baseline (n=329,329,335,107) | 3.14 score on a scale | Standard Error 0.03 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Baseline (n=329,329,335,107) | 2.57 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | 1.77 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | 1.25 score on a scale | Standard Error 0.05 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | 1.10 score on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Baseline (n=329,329,335,107) | 2.33 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 8 (n=315,319,323,99) | 2.11 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 12 (n=313,311,309,95) | 2.32 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 2 (n=326,326,331,106) | 2.92 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Baseline (n=329,329,335,107) | 2.66 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 8 (n=315,319,323,99) | 1.89 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration Baseline(n=329,329,335,107) | 2.79 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 2 (n=326,326,331,106) | 2.62 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 12 (n=313,311,309,95) | 2.21 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 4 (n=320,323,328,102) | 2.12 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 2 (n=326,326,331,106) | 2.54 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 8 (n=315,319,323,99) | 1.86 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 12 (n=313,311,309,95) | 1.74 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Baseline (n=329,329,335,107) | 2.89 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 4 (n=320,323,328,102) | 2.36 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 4 (n=320,323,328,102) | 2.03 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 4 (n=320,323,328,102) | 2.61 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 12 (n=313,311,309,95) | 1.51 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 8 (n=315,319,323,99) | 2.12 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Baseline (n=329,329,335,107) | 2.12 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 12 (n=313,311,309,95) | 1.91 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 2 (n=326,326,331,106) | 2.15 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Induration, Week 12 (n=313,311,309,95) | 2.08 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 12 (n=313,311,309,95) | 2.45 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 12 (n=313,311,309,95) | 2.09 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Baseline (n=329,329,335,107) | 3.10 score on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Baseline (n=329,329,335,107) | 2.63 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Scaling, Week 4 (n=320,323,328,102) | 2.44 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 2 (n=326,326,331,106) | 1.97 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Week 2 (n=326,326,331,106) | 2.27 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 2 (n=326,326,331,106) | 2.35 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 2 (n=326,326,331,106) | 2.75 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 12 (n=313,311,309,95) | 2.03 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 4 (n=320,323,328,102) | 1.69 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 4 (n=320,323,328,102) | 2.22 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 4 (n=320,323,328,102) | 1.80 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Baseline (n=329,329,335,107) | 2.61 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Baseline (n=329,329,335,107) | 2.92 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 8 (n=315,319,323,99) | 1.98 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 4 (n=320,323,328,102) | 2.75 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 2 (n=326,326,331,106) | 2.40 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 8 (n=315,319,323,99) | 1.57 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Scaling, Week 12 (n=313,311,309,95) | 1.95 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 8 (n=315,319,323,99) | 2.06 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Scaling, Week 2 (n=326,326,331,106) | 2.36 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 12 (n=313,311,309,95) | 2.33 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Baseline (n=329,329,335,107) | 2.97 score on a scale | Standard Error 0.06 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Scaling, Week 8 (n=315,319,323,99) | 1.66 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Erythema, Week 8 (n=315,319,323,99) | 2.55 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Induration, Week 12 (n=313,311,309,95) | 1.41 score on a scale | Standard Error 0.11 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 2 (n=326,326,331,106) | 2.75 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 2 (n=326,326,331,106) | 2.69 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 8 (n=315,319,323,99) | 2.25 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Induration, Week 4 (n=320,323,328,102) | 2.26 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 4 (n=320,323,328,102) | 2.59 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Head/Neck Erythema, Baseline (n=329,329,335,107) | 2.40 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration Baseline(n=329,329,335,107) | 2.92 score on a scale | Standard Error 0.07 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Upper Limbs Erythema, Week 8 (n=315,319,323,99) | 2.42 score on a scale | Standard Error 0.08 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Trunk Erythema, Week 8 (n=315,319,323,99) | 2.41 score on a scale | Standard Error 0.09 |
| Placebo BID + Placebo BIW | Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment | Lower Limbs Induration, Week 4 (n=320,323,328,102) | 2.54 score on a scale | Standard Error 0.07 |
Secondary
Mean PASI Score During the 12-Week Double-Blind Treatment
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time frame: Baseline and Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 14.46 score on a scale | Standard Error 0.46 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,328,102) | 18.16 score on a scale | Standard Error 0.47 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Score During the 12-Week Double-Blind Treatment | Baseline (n=329,330,335,107) | 23.13 score on a scale | Standard Error 0.48 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 8.80 score on a scale | Standard Error 0.43 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 10.63 score on a scale | Standard Error 0.44 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 12.13 score on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Baseline (n=329,330,335,107) | 23.29 score on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,328,102) | 16.81 score on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 7.59 score on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 5.77 score on a scale | Standard Error 0.45 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 7.70 score on a scale | Standard Error 0.38 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 12.73 score on a scale | Standard Error 0.44 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Baseline (n=329,330,335,107) | 22.73 score on a scale | Standard Error 0.53 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,328,102) | 17.29 score on a scale | Standard Error 0.49 |
| Placebo BID + Etanercept 50 mg BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 5.42 score on a scale | Standard Error 0.36 |
| Placebo BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,328,102) | 21.26 score on a scale | Standard Error 0.95 |
| Placebo BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 20.06 score on a scale | Standard Error 0.94 |
| Placebo BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 17.91 score on a scale | Standard Error 0.99 |
| Placebo BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 17.39 score on a scale | Standard Error 1.06 |
| Placebo BID + Placebo BIW | Mean PASI Score During the 12-Week Double-Blind Treatment | Baseline (n=329,330,335,107) | 22.78 score on a scale | Standard Error 0.88 |
Secondary
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area 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. 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.
Time frame: Baseline and Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 19.74 percent psoriatic BSA | Standard Error 0.98 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | 29.53 percent psoriatic BSA | Standard Error 0.96 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 16.04 percent psoriatic BSA | Standard Error 0.94 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 25.98 percent psoriatic BSA | Standard Error 0.96 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Baseline (n=329,329,335,107) | 32.15 percent psoriatic BSA | Standard Error 0.98 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 22.88 percent psoriatic BSA | Standard Error 0.93 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 14.76 percent psoriatic BSA | Standard Error 0.89 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 10.55 percent psoriatic BSA | Standard Error 0.77 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | 28.12 percent psoriatic BSA | Standard Error 0.94 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Baseline (n=329,329,335,107) | 31.74 percent psoriatic BSA | Standard Error 0.95 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 24.82 percent psoriatic BSA | Standard Error 0.95 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Baseline (n=329,329,335,107) | 30.63 percent psoriatic BSA | Standard Error 1 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | 28.29 percent psoriatic BSA | Standard Error 0.97 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 15.42 percent psoriatic BSA | Standard Error 0.81 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 10.60 percent psoriatic BSA | Standard Error 0.76 |
| Placebo BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 31.00 percent psoriatic BSA | Standard Error 1.98 |
| Placebo BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | 32.03 percent psoriatic BSA | Standard Error 1.76 |
| Placebo BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Baseline (n=329,329,335,107) | 31.88 percent psoriatic BSA | Standard Error 1.62 |
| Placebo BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 32.47 percent psoriatic BSA | Standard Error 1.89 |
| Placebo BID + Placebo BIW | Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 29.77 percent psoriatic BSA | Standard Error 2.12 |
Secondary
Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area 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. 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.
Time frame: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | -7.54 percent change from baseline | Standard Error 1.23 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | -19.90 percent change from baseline | Standard Error 1.66 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -37.81 percent change from baseline | Standard Error 2.81 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -47.66 percent change from baseline | Standard Error 3.35 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | -29.17 percent change from baseline | Standard Error 1.69 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -55.02 percent change from baseline | Standard Error 1.93 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -67.51 percent change from baseline | Standard Error 1.86 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | -11.71 percent change from baseline | Standard Error 1.12 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -48.65 percent change from baseline | Standard Error 1.91 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | -19.60 percent change from baseline | Standard Error 1.46 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -64.91 percent change from baseline | Standard Error 1.91 |
| Placebo BID + Etanercept 50 mg BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | -7.54 percent change from baseline | Standard Error 0.96 |
| Placebo BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | -6.68 percent change from baseline | Standard Error 4.06 |
| Placebo BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 1.58 percent change from baseline | Standard Error 2.84 |
| Placebo BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 2 (n=326,326,331,106) | 0.23 percent change from baseline | Standard Error 1.89 |
| Placebo BID + Placebo BIW | Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | -1.33 percent change from baseline | Standard Error 3.57 |
Secondary
Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment
The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.
Time frame: Baseline and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Baseline (n=323,326,331,105) | 75.4 score on a scale | Standard Error 1.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Week 12 (n=303,303,306,92) | 40.0 score on a scale | Standard Error 1.8 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Week 12 (n=303,303,306,92) | 29.2 score on a scale | Standard Error 1.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Baseline (n=323,326,331,105) | 77.0 score on a scale | Standard Error 1.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Baseline (n=323,326,331,105) | 75.7 score on a scale | Standard Error 1.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Week 12 (n=303,303,306,92) | 31.0 score on a scale | Standard Error 1.7 |
| Placebo BID + Placebo BIW | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Baseline (n=323,326,331,105) | 74.9 score on a scale | Standard Error 2.9 |
| Placebo BID + Placebo BIW | Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment | Week 12 (n=303,303,306,92) | 65.5 score on a scale | Standard Error 3.5 |
Secondary
Mean SF-36 Domain Scores at Baseline and Week 12
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Time frame: Baseline and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Vitality (n=306,305,307,95) | 52.4 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Vitality (n=328,329,331,107) | 47.9 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Bodily Pain (n=306,305,307,95) | 51.7 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Health Transition (n=306,305,307,95) | 2.6 score on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 General Health (n=305,304,308,95) | 46.2 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline General Health (n=328,328,330,106) | 43.4 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Mental Health (n=306,305,307,95) | 46.6 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Mental Health (n=328,329,331,107) | 42.0 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role Physical (n=328,328,330,106) | 45.4 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Physical Functioning (n=328,328,330,106) | 48.3 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role-Emotional (n=306,305,307,95) | 48.6 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role-Emotional (n=328,329,331,107) | 43.2 score on a scale | Standard Error 0.7 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role Physical (n=307,305,308,95) | 50.5 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Health Transition (n=328,329,331,107) | 3.2 score on a scale | Standard Error 0 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Social Functioning (n=306,305,307,95) | 47.8 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Social Functioning (n=328,329,331,107) | 41.6 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Bodily Pain (n=328,329,331,107) | 44.5 score on a scale | Standard Error 0.7 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Physical Functioning (n=306,305,308,95) | 51.9 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role Physical (n=328,328,330,106) | 45.9 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Physical Functioning (n=328,328,330,106) | 49.0 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Physical Functioning (n=306,305,308,95) | 53.1 score on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role Physical (n=307,305,308,95) | 52.5 score on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Bodily Pain (n=328,329,331,107) | 45.6 score on a scale | Standard Error 0.7 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Bodily Pain (n=306,305,307,95) | 54.6 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline General Health (n=328,328,330,106) | 42.8 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 General Health (n=305,304,308,95) | 48.5 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Vitality (n=328,329,331,107) | 48.5 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Vitality (n=306,305,307,95) | 54.4 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Social Functioning (n=328,329,331,107) | 41.1 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Social Functioning (n=306,305,307,95) | 50.6 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role-Emotional (n=328,329,331,107) | 42.4 score on a scale | Standard Error 0.7 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role-Emotional (n=306,305,307,95) | 50.2 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Mental Health (n=328,329,331,107) | 41.5 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Mental Health (n=306,305,307,95) | 48.9 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Health Transition (n=328,329,331,107) | 3.2 score on a scale | Standard Error 0 |
| CP-690,550 10 mg BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Health Transition (n=306,305,307,95) | 2.6 score on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Bodily Pain (n=328,329,331,107) | 44.0 score on a scale | Standard Error 0.7 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Vitality (n=306,305,307,95) | 52.9 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Social Functioning (n=328,329,331,107) | 42.3 score on a scale | Standard Error 0.7 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role Physical (n=307,305,308,95) | 51.2 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Health Transition (n=306,305,307,95) | 2.5 score on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Social Functioning (n=306,305,307,95) | 49.3 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Health Transition (n=328,329,331,107) | 3.1 score on a scale | Standard Error 0 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role-Emotional (n=328,329,331,107) | 43.1 score on a scale | Standard Error 0.7 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role Physical (n=328,328,330,106) | 45.5 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role-Emotional (n=306,305,307,95) | 48.6 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Physical Functioning (n=328,328,330,106) | 48.6 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Mental Health (n=328,329,331,107) | 41.7 score on a scale | Standard Error 0.7 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Physical Functioning (n=306,305,308,95) | 52.2 score on a scale | Standard Error 0.4 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline General Health (n=328,328,330,106) | 43.5 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Bodily Pain (n=306,305,307,95) | 52.4 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 General Health (n=305,304,308,95) | 47.9 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Mental Health (n=306,305,307,95) | 47.5 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Vitality (n=328,329,331,107) | 48.3 score on a scale | Standard Error 0.5 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline General Health (n=328,328,330,106) | 42.4 score on a scale | Standard Error 1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Mental Health (n=306,305,307,95) | 41.4 score on a scale | Standard Error 1.2 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role-Emotional (n=306,305,307,95) | 43.3 score on a scale | Standard Error 1.4 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Vitality (n=306,305,307,95) | 47.9 score on a scale | Standard Error 1.1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Role Physical (n=307,305,308,95) | 46.1 score on a scale | Standard Error 1.1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Physical Functioning (n=328,328,330,106) | 46.7 score on a scale | Standard Error 1.1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Physical Functioning (n=306,305,308,95) | 48.1 score on a scale | Standard Error 1.1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Social Functioning (n=328,329,331,107) | 40.7 score on a scale | Standard Error 1.2 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Bodily Pain (n=328,329,331,107) | 43.6 score on a scale | Standard Error 1.2 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Health Transition (n=306,305,307,95) | 3.0 score on a scale | Standard Error 0.1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Mental Health (n=328,329,331,107) | 39.5 score on a scale | Standard Error 1.2 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Social Functioning (n=306,305,307,95) | 42.0 score on a scale | Standard Error 1.2 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role Physical (n=328,328,330,106) | 44.4 score on a scale | Standard Error 1.1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 Bodily Pain (n=306,305,307,95) | 45.7 score on a scale | Standard Error 1.3 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Vitality (n=328,329,331,107) | 46.5 score on a scale | Standard Error 1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Role-Emotional (n=328,329,331,107) | 40.4 score on a scale | Standard Error 1.3 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Week 12 General Health (n=305,304,308,95) | 42.6 score on a scale | Standard Error 1 |
| Placebo BID + Placebo BIW | Mean SF-36 Domain Scores at Baseline and Week 12 | Baseline Health Transition (n=328,329,331,107) | 3.2 score on a scale | Standard Error 0.1 |
Secondary
Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score\*10) plus 50. Higher scores indicate a better health related quality of life.
Time frame: Baseline and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Physical Health Score (n=327,327,327,105) | 47.4 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Physical Health Score (n=303,304,307,95) | 51.7 score on a scale | Standard Error 0.5 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Mental Health Score (n=327,327,327,105) | 42.0 score on a scale | Standard Error 0.6 |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Mental Health Score (n=303,304,307,95) | 47.0 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Physical Health Score (n=303,304,307,95) | 53.6 score on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Mental Health Score (n=327,327,327,105) | 41.2 score on a scale | Standard Error 0.6 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Mental Health Score (n=303,304,307,95) | 49.3 score on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Physical Health Score (n=327,327,327,105) | 48.3 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Mental Health Score (n=327,327,327,105) | 42.0 score on a scale | Standard Error 0.7 |
| Placebo BID + Etanercept 50 mg BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Physical Health Score (n=303,304,307,95) | 52.5 score on a scale | Standard Error 0.5 |
| Placebo BID + Etanercept 50 mg BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Mental Health Score (n=303,304,307,95) | 47.8 score on a scale | Standard Error 0.6 |
| Placebo BID + Etanercept 50 mg BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Physical Health Score (n=327,327,327,105) | 47.5 score on a scale | Standard Error 0.5 |
| Placebo BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Mental Health Score (n=303,304,307,95) | 41.7 score on a scale | Standard Error 1.3 |
| Placebo BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Week 12 Physical Health Score (n=303,304,307,95) | 47.8 score on a scale | Standard Error 1 |
| Placebo BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Physical Health Score (n=327,327,327,105) | 46.8 score on a scale | Standard Error 1 |
| Placebo BID + Placebo BIW | Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 | Baseline Mental Health Score (n=327,327,327,105) | 39.8 score on a scale | Standard Error 1.2 |
Secondary
Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment
Time frame: Baseline up to Week 12
Population: FAS; OC
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment | 12.6 weeks |
| CP-690,550 10 mg BID + Placebo BIW | Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment | 8.6 weeks |
| Placebo BID + Etanercept 50 mg BIW | Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment | 12.1 weeks |
| Placebo BID + Placebo BIW | Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment | NA weeks |
Secondary
Median Time to DLQI Response
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 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. DLQI Response was defined as a 5-point reduction in the total DLQI score.
Time frame: Weeks 4 and 12
Population: Data were not analyzed as the endpoint of proportion of participants achieving a 5-point reduction from baseline in DLQI provided similar information.
Secondary
Median Time to PASI50 Response During the 12-Week Double-Blind Treatment
Time frame: Baseline up to Week 12
Population: FAS; OC
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Median Time to PASI50 Response During the 12-Week Double-Blind Treatment | 8.1 weeks |
| CP-690,550 10 mg BID + Placebo BIW | Median Time to PASI50 Response During the 12-Week Double-Blind Treatment | 5.0 weeks |
| Placebo BID + Etanercept 50 mg BIW | Median Time to PASI50 Response During the 12-Week Double-Blind Treatment | 7.9 weeks |
| Placebo BID + Placebo BIW | Median Time to PASI50 Response During the 12-Week Double-Blind Treatment | NA weeks |
Secondary
Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment
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: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 2 | 10.42 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 4 | 15.66 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 8 | 29.45 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 12 | 31.64 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 4 | 34.28 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 8 | 47.83 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 12 | 51.85 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 2 | 13.88 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 8 | 28.67 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 4 | 14.09 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 12 | 40.07 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 2 | 10.54 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 12 | 6.74 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 4 | 2.13 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 2 | 1.02 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment | Week 8 | 6.38 percentage of participants |
Secondary
Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 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: Weeks 4 and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 4 | 13.07 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 12 | 33.22 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 12 | 51.36 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 4 | 21.79 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 4 | 15.51 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 12 | 47.18 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 4 | 7.37 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment | Week 12 | 8.89 percentage of participants |
Secondary
Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 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: Weeks 4 and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 4 | 60.93 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 12 | 71.54 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 12 | 85.28 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 4 | 71.38 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 4 | 61.35 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 12 | 81.34 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 4 | 36.59 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment | Week 12 | 35.90 percentage of participants |
Secondary
Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12
The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study medication.
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12 | 71.01 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12 | 85.90 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12 | 85.95 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12 | 31.58 percentage of participants |
Secondary
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work
Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.
Time frame: Baseline and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, employed | 67.8 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, not employed | 32.2 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, absent/sick leave due to psoriasis | 18.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, unemployed due to psoriasis | 4.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, absent/sick leave due to psoriasis | 13.2 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, unemployed due to psoriasis | 9.6 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, employed | 69.2 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, not employed | 30.8 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, not employed | 26.2 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, employed | 73.8 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, absent/sick leave due to psoriasis | 14.7 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, absent/sick leave due to psoriasis | 21.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, not employed | 28.8 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, unemployed due to psoriasis | 4.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, unemployed due to psoriasis | 7.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, employed | 71.2 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, absent/sick leave due to psoriasis | 15.7 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, not employed | 30.9 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, unemployed due to psoriasis | 4.7 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, absent/sick leave due to psoriasis | 22.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, not employed | 27.7 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, employed | 72.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, unemployed due to psoriasis | 6.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, employed | 69.1 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, unemployed due to psoriasis | 4.3 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, employed | 71.4 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, absent/sick leave due to psoriasis | 23.4 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, not employed | 28.6 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Baseline, unemployed due to psoriasis | 2.6 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, employed | 68.1 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, absent/sick leave due to psoriasis | 17.4 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work | Week 12, not employed | 31.9 percentage of participants |
Secondary
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment
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; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Time frame: Baseline and Weeks 2, 4, and 8
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 8 (n=313,317,315,97) | 2.9 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 4 (n=319,323,324,100) | 6.9 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Baseline (n=328,328,330,107) | 32.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 4 (n=319,323,324,100) | 24.5 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 4 (n=319,323,324,100) | 21.6 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Baseline (n=328,328,330,107) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 4 (n=319,323,324,100) | 46.7 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 8 (n=313,317,315,97) | 31.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Baseline (n=328,328,330,107) | 64.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 2 (n=324,322,331,106) | 0.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 8 (n=313,317,315,97) | 33.5 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 2 (n=324,322,331,106) | 1.2 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 8 (n=313,317,315,97) | 15.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 2 (n=324,322,331,106) | 13.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Baseline (n=328,328,330,107) | 3.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 8 (n=313,317,315,97) | 16.9 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 2 (n=324,322,331,106) | 49.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 2 (n=324,322,331,106) | 35.8 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Baseline (n=328,328,330,107) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 4 (n=319,323,324,100) | 0.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 2 (n=324,322,331,106) | 14.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 4 (n=319,323,324,100) | 0.6 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 8 (n=313,317,315,97) | 22.1 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 4 (n=319,323,324,100) | 14.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 2 (n=324,322,331,106) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 4 (n=319,323,324,100) | 17.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Baseline (n=328,328,330,107) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Baseline (n=328,328,330,107) | 1.5 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 8 (n=313,317,315,97) | 4.7 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 4 (n=319,323,324,100) | 30.7 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 2 (n=324,322,331,106) | 4.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 4 (n=319,323,324,100) | 36.8 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 2 (n=324,322,331,106) | 26.4 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Baseline (n=328,328,330,107) | 30.2 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 8 (n=313,317,315,97) | 7.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 8 (n=313,317,315,97) | 38.2 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 2 (n=324,322,331,106) | 54.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Baseline (n=328,328,330,107) | 68.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Baseline (n=328,328,330,107) | 0.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 8 (n=313,317,315,97) | 27.1 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 4 (n=319,323,324,100) | 26.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Baseline (n=328,328,330,107) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Baseline (n=328,328,330,107) | 0.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Baseline (n=328,328,330,107) | 4.2 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Baseline (n=328,328,330,107) | 28.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Baseline (n=328,328,330,107) | 67.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 2 (n=324,322,331,106) | 0.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 2 (n=324,322,331,106) | 1.2 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 2 (n=324,322,331,106) | 11.8 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 2 (n=324,322,331,106) | 52.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 2 (n=324,322,331,106) | 34.7 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 4 (n=319,323,324,100) | 0.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 4 (n=319,323,324,100) | 9.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 4 (n=319,323,324,100) | 43.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 4 (n=319,323,324,100) | 20.4 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 8 (n=313,317,315,97) | 3.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 8 (n=313,317,315,97) | 29.8 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 8 (n=313,317,315,97) | 33.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 8 (n=313,317,315,97) | 24.8 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 8 (n=313,317,315,97) | 8.9 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 2 (n=324,322,331,106) | 57.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 2 (n=324,322,331,106) | 38.7 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 8 (n=313,317,315,97) | 38.1 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 8 (n=313,317,315,97) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 2 (n=324,322,331,106) | 2.8 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 2 (n=324,322,331,106) | 0.9 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Baseline (n=328,328,330,107) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 8 (n=313,317,315,97) | 4.1 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 2 (n=324,322,331,106) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Baseline (n=328,328,330,107) | 72.9 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Baseline (n=328,328,330,107) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 8 (n=313,317,315,97) | 7.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Baseline (n=328,328,330,107) | 23.4 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Week 4 (n=319,323,324,100) | 5.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Mild, Baseline (n=328,328,330,107) | 3.7 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Moderate, Week 4 (n=319,323,324,100) | 35.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Almost Clear, Week 4 (n=319,323,324,100) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Clear, Week 4 (n=319,323,324,100) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 8 (n=313,317,315,97) | 50.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment | Severe, Week 4 (n=319,323,324,100) | 60.0 percentage of participants |
Secondary
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment
The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study medication.
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very satisfied | 44.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat dissatisfied | 4.6 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly dissatisfied | 2.6 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat satisfied | 27.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very dissatisfied | 5.5 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly satisfied | 11.7 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Neither satisfied nor dissatisfied | 4.6 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat dissatisfied | 3.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Neither satisfied nor dissatisfied | 2.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly satisfied | 5.2 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly dissatisfied | 1.6 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very dissatisfied | 2.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat satisfied | 17.4 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very satisfied | 68.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Neither satisfied nor dissatisfied | 2.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very satisfied | 62.4 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat satisfied | 23.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly satisfied | 7.2 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly dissatisfied | 2.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat dissatisfied | 2.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very dissatisfied | 1.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly satisfied | 11.6 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very dissatisfied | 28.4 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat dissatisfied | 12.6 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Somewhat satisfied | 15.8 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Very satisfied | 15.8 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Slightly dissatisfied | 4.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment | Neither satisfied nor dissatisfied | 11.6 percentage of participants |
Secondary
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment
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 to 4). The severity scores are summed and averaged after which the total average is 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).
Time frame: Baseline and Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Clear (n=325,326,331,107) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Clear (n=329,330,335,107) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Almost Clear (n=329,330,335,107) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Mild (n=329,330,335,107) | 1.8 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Moderate (n=329,330,335,107) | 80.2 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Severe (n=329,330,335,107) | 17.9 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Almost Clear (n=325,326,331,107) | 6.8 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Mild (n=325,326,331,107) | 38.5 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Moderate (n=325,326,331,107) | 48.9 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Severe (n=325,326,331,107) | 5.8 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Clear (n=320,323,328,102) | 1.9 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Almost Clear (n=320,323,328,102) | 19.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Mild (n=320,323,328,102) | 46.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Moderate (n=320,323,328,102) | 30.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Severe (n=320,323,328,102) | 2.5 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Clear (n=314,316,322,100) | 5.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Almost Clear (n=314,316,322,100) | 35.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Mild (n=314,316,322,100) | 41.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Moderate (n=314,316,322,100) | 15.9 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Severe (n=314,316,322,100) | 2.2 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Clear (n=314,316,322,100) | 11.8 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Almost Clear (n=313,311,309,95) | 37.7 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Mild (n=313,311,309,95) | 33.5 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Moderate (n=313,311,309,95) | 15.7 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Severe (n=313,311,309,95) | 1.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Almost Clear (n=325,326,331,107) | 10.7 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Mild (n=320,323,328,102) | 44.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Mild (n=329,330,335,107) | 1.2 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Severe (n=313,311,309,95) | 1.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Mild (n=314,316,322,100) | 25.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Moderate (n=320,323,328,102) | 17.6 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Severe (n=329,330,335,107) | 15.5 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Almost Clear (n=314,316,322,100) | 49.4 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Moderate (n=325,326,331,107) | 38.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Severe (n=320,323,328,102) | 2.2 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Moderate (n=329,330,335,107) | 83.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Clear (n=314,316,322,100) | 14.2 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Mild (n=313,311,309,95) | 19.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Severe (n=314,316,322,100) | 0.6 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Almost Clear (n=329,330,335,107) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Severe (n=325,326,331,107) | 3.1 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Moderate (n=313,311,309,95) | 7.4 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Clear (n=325,326,331,107) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Clear (n=320,323,328,102) | 2.5 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Clear (n=314,316,322,100) | 27.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Clear (n=329,330,335,107) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Almost Clear (n=313,311,309,95) | 45.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Almost Clear (n=320,323,328,102) | 33.4 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Mild (n=325,326,331,107) | 47.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Moderate (n=314,316,322,100) | 10.8 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Clear (n=329,330,335,107) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Moderate (n=313,311,309,95) | 5.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Almost Clear (n=325,326,331,107) | 7.9 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Mild (n=325,326,331,107) | 42.6 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Clear (n=314,316,322,100) | 21.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Moderate (n=325,326,331,107) | 45.6 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Clear (n=320,323,328,102) | 0.6 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Almost Clear (n=320,323,328,102) | 27.7 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Almost Clear (n=313,311,309,95) | 50.8 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Mild (n=320,323,328,102) | 51.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Moderate (n=320,323,328,102) | 19.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Severe (n=313,311,309,95) | 1.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Severe (n=320,323,328,102) | 0.6 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Clear (n=314,316,322,100) | 9.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Mild (n=313,311,309,95) | 21.4 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Almost Clear (n=314,316,322,100) | 51.9 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Mild (n=314,316,322,100) | 30.1 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Moderate (n=314,316,322,100) | 8.1 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Severe (n=325,326,331,107) | 3.9 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Almost Clear (n=329,330,335,107) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Mild (n=329,330,335,107) | 1.2 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Severe (n=314,316,322,100) | 0.9 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Moderate (n=329,330,335,107) | 80.9 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Severe (n=329,330,335,107) | 17.9 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Clear (n=325,326,331,107) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Almost Clear (n=325,326,331,107) | 1.9 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Severe (n=329,330,335,107) | 15.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Clear (n=314,316,322,100) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Severe (n=313,311,309,95) | 4.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Moderate (n=314,316,322,100) | 49.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Clear (n=320,323,328,102) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Moderate (n=313,311,309,95) | 42.1 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Clear (n=329,330,335,107) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Severe (n=325,326,331,107) | 8.4 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Clear (n=314,316,322,100) | 2.1 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Moderate (n=329,330,335,107) | 82.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Almost Clear (n=329,330,335,107) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Moderate (n=325,326,331,107) | 64.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Severe (n=320,323,328,102) | 5.9 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Mild (n=325,326,331,107) | 25.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Severe (n=314,316,322,100) | 3.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Moderate (n=320,323,328,102) | 55.9 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Baseline, Mild (n=329,330,335,107) | 2.8 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Almost Clear (n=314,316,322,100) | 13.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Mild (n=313,311,309,95) | 36.8 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 12, Almost Clear (n=313,311,309,95) | 14.7 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 2, Clear (n=325,326,331,107) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 8, Mild (n=314,316,322,100) | 35.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Mild (n=320,323,328,102) | 34.3 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment | Week 4, Almost Clear (n=320,323,328,102) | 3.9 percentage of participants |
Secondary
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners \[GPs\], primary care physicians \[PCPs\], or family medicine physicians \[FMP\], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.
Time frame: Baseline (BL) and Week 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, GP/PCP/FMP (n=255,251,261,79) | 10.1 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Other (n=230,220,224,77) | 2.1 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Psychiatrist (n=230,220,224,77) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Other (n=255,251,261,79) | 8.6 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Nurse (n=230,220,224,77) | 1.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Surgeon (n=230,220,224,77) | 0.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Surgeon (n=255,251,261,79) | 0.3 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Psychiatrist (n=255,251,261,79) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Rheumatologist (n=230,220,224,77) | 0.0 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, GP/PCP/FMP (n=230,220,224,77) | 0.8 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Gastroenterologist (n=255,251,261,79) | 1.1 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Cardiologist (n=255,251,261,79) | 1.5 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Cardiologist (n=230,220,224,77) | 0.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Nurse (n=255,251,261,79) | 1.1 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Rheumatologist (n=255,251,261,79) | 0.7 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Dermatologist (n=255,251,261,79) | 8.2 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Gastroenterologist (n=230,220,224,77) | 0.4 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Dermatologist (n=230,220,224,77) | 6.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Rheumatologist (n=230,220,224,77) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, GP/PCP/FMP (n=230,220,224,77) | 0.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Dermatologist (n=230,220,224,77) | 4.5 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Cardiologist (n=230,220,224,77) | 0.4 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Gastroenterologist (n=230,220,224,77) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Psychiatrist (n=230,220,224,77) | 0.4 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Surgeon (n=230,220,224,77) | 0.0 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Nurse (n=230,220,224,77) | 1.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Other (n=230,220,224,77) | 0.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, GP/PCP/FMP (n=255,251,261,79) | 6.7 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Dermatologist (n=255,251,261,79) | 4.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Rheumatologist (n=255,251,261,79) | 1.1 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Cardiologist (n=255,251,261,79) | 1.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Gastroenterologist (n=255,251,261,79) | 1.5 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Psychiatrist (n=255,251,261,79) | 0.7 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Surgeon (n=255,251,261,79) | 0.3 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Nurse (n=255,251,261,79) | 1.9 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Other (n=255,251,261,79) | 5.1 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Gastroenterologist (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, GP/PCP/FMP (n=255,251,261,79) | 8.4 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Dermatologist (n=255,251,261,79) | 5.7 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Cardiologist (n=230,220,224,77) | 0.4 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Other (n=255,251,261,79) | 6.8 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Rheumatologist (n=255,251,261,79) | 0.7 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Nurse (n=255,251,261,79) | 2.6 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Cardiologist (n=255,251,261,79) | 2.6 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Rheumatologist (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Gastroenterologist (n=255,251,261,79) | 1.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, GP/PCP/FMP (n=230,220,224,77) | 1.3 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Psychiatrist (n=255,251,261,79) | 1.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Dermatologist (n=230,220,224,77) | 7.5 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Surgeon (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Psychiatrist (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Nurse (n=230,220,224,77) | 0.8 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Surgeon (n=255,251,261,79) | 0.0 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Other (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Surgeon (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Surgeon (n=255,251,261,79) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Gastroenterologist (n=255,251,261,79) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, GP/PCP/FMP (n=255,251,261,79) | 8.8 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Cardiologist (n=230,220,224,77) | 2.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, GP/PCP/FMP (n=230,220,224,77) | 2.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Dermatologist (n=230,220,224,77) | 10.3 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Dermatologist (n=255,251,261,79) | 7.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Gastroenterologist (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Other (n=255,251,261,79) | 2.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Psychiatrist (n=255,251,261,79) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Rheumatologist (n=255,251,261,79) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Rheumatologist (n=230,220,224,77) | 0.0 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Psychiatrist (n=230,220,224,77) | 1.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Other (n=230,220,224,77) | 1.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Cardiologist (n=255,251,261,79) | 1.2 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Baseline, Nurse (n=230,220,224,77) | 2.5 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment | Week 12, Nurse (n=255,251,261,79) | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment | 10.43 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment | 9.78 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment | 10.08 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment | 8.45 percentage of participants |
Secondary
Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment
Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.
Time frame: Week 12
Population: FAS; OC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment | 37.97 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment | 30.49 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment | 34.15 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment | 56.25 percentage of participants |
Secondary
Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.
Time frame: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 10.74 percentage of participatns |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 33.23 percentage of participatns |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319, 323,99) | 59.05 percentage of participatns |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 69.01 percentage of participatns |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 50.46 percentage of participatns |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319, 323,99) | 78.06 percentage of participatns |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 85.53 percentage of participatns |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 18.35 percentage of participatns |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319, 323,99) | 77.09 percentage of participatns |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 48.78 percentage of participatns |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 87.06 percentage of participatns |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 11.18 percentage of participatns |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 23.16 percentage of participatns |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 6.86 percentage of participatns |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.94 percentage of participatns |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319, 323,99) | 20.20 percentage of participatns |
Secondary
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.
Time frame: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.00 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 1.57 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 12.06 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 22.04 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 4.64 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 26.02 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 38.26 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.61 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 15.79 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 1.83 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 34.95 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.30 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 1.05 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 0.00 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.00 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 0.00 percentage of participants |
Secondary
Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment
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. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.
Time frame: Weeks 2, 4, and 8
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 1.53 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 28.57 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 10.34 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 2.75 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 52.35 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 19.81 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 8.23 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.91 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 42.72 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.00 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 3.03 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 0.00 percentage of participants |
Secondary
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment
Time frame: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 2.88 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 2.19 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Overall (n=327,329,334,107) | 4.59 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 2.54 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.92 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 0.31 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 0.32 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Overall (n=327,329,334,107) | 1.82 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 0.93 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.61 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 0.31 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 0.30 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 0.91 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 0.97 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Overall (n=327,329,334,107) | 1.80 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 12 (n=313,311,309,95) | 7.37 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,328,102) | 8.82 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 2 (n=326,327,331,106) | 4.72 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Week 8 (n=315,319,323,99) | 7.07 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment | Overall (n=327,329,334,107) | 15.89 percentage of participants |
Secondary
Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment
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 to 4). The severity scores are summed and averaged after which the total average is 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 is defined as 0 (clear) or 1 (almost clear).
Time frame: Weeks 2, 4, and 8
Population: FAS; Observed Case (OC): no imputation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 2 (n=325,326,331,107) | 6.77 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 8 (n=314,316,322,100) | 40.45 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 21.25 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 2 (n=325,326,331,107) | 10.74 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 8 (n=314,316,322,100) | 63.61 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 35.91 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 28.35 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 2 (n=325,326,331,107) | 7.85 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 8 (n=314,316,322,100) | 60.87 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 2 (n=325,326,331,107) | 1.87 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 8 (n=314,316,322,100) | 13.00 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment | Week 4 (n=320,323,328,102) | 3.92 percentage of participants |
Secondary
Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment
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; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.
Time frame: Weeks 2, 4, 8, and 12
Population: FAS; OC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 2 (n=324,322,331,106) | 1.54 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,324,100) | 7.21 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 8 (n=313,317,315,97) | 19.81 percentage of participants |
| CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 12 (n=306,304,309,95) | 32.68 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,324,100) | 17.65 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 8 (n=313,317,315,97) | 42.90 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 12 (n=306,304,309,95) | 56.25 percentage of participants |
| CP-690,550 10 mg BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 2 (n=324,322,331,106) | 4.35 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 8 (n=313,317,315,97) | 33.33 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,324,100) | 9.57 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 12 (n=306,304,309,95) | 53.07 percentage of participants |
| Placebo BID + Etanercept 50 mg BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 2 (n=324,322,331,106) | 1.51 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 12 (n=306,304,309,95) | 1.05 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 4 (n=319,323,324,100) | 0.00 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 2 (n=324,322,331,106) | 0.94 percentage of participants |
| Placebo BID + Placebo BIW | Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment | Week 8 (n=313,317,315,97) | 4.12 percentage of participants |