Psoriasis
Conditions
Keywords
chronic, severe, moderate, treatment, safety, efficacy, CP-690, 550, Plaque psoriasis, Psoriasis Vulgaris, Psoriatic Arthritis, tofacitinib, Xeljanz
Brief summary
The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.
Interventions
DRUGCP-690,550
10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
DRUGCP-690, 550
5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are 20 years or older and considered to be candidates for systemic or phototherapy. \[Moderate to Severe Plaque Psoriasis\] * Diagnosed for at least 12 months. * Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA). \[Psoriatic Arthritis\] * Diagnosed for at least 6 months. * Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening; * Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.
Exclusion criteria
* Non-plaque or drug induced forms of psoriasis * Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB) * any uncontrolled significant medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed 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 at Week 16 relative to Baseline. |
| Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 | Week 16 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). |
| Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 | Week 16 | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
| Number of Participants With Adjudicated Cardiovacular Events | Baseline to Follow-up | Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication. |
| Number of Participants With Malignancy Events _Week 0 Through Follow-up | Baseline to Follow-up | For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed 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. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%. |
| Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%. |
| Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions. |
| Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 2, 4, 8, 12, 20, 28, 40, 52 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). |
| Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). |
| Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 20, 28, 40, 52 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. 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. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported. |
| Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 20, 28, 40, 52 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. |
| Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 8, 16, 20, 28, 40, 52 | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. |
| Number of Affected Nails | Baseline, Week 8, 16, 20, 28, 40, 52 | Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported. |
| Itch Severity Item (ISI) Score | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment. |
| Dermatology Life Quality Index (DLQI) Score | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. |
| Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | Week (W) 16, 28, 52 | 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning). |
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 2, 4, 8, 12, 20, 28, 40, 52 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed 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 at the each visit relative to Baseline. |
| Work Limitation Questionnaire (WLQ) | Baseline (BL), Week (W) 4, 16, 28, 52 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 \[no loss\] to 100 \[complete loss of work\]). |
| Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear \[no psoriasis\]; 1=almost clear; 2=mild; 3=moderate; 4=severe). |
| Joint Pain Assessment (JPA) | Baseline, Week 4, 16, 28, 52 | The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain. |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 2, 4, 8, 12, 20, 28, 40, 52 | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | ACR70 response: greater than or equal to (\>=) 70 percent (%) improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
| Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints). |
| Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints). |
| Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain. |
| Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | Subjects answered the following question, Considering the possible effects of the arthritis, how are you feeling today? The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly. |
| Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor. |
| Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory. |
| Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty. |
| Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 16, 28, 52 | 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning). |
| Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed 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. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline. |
| Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline. |
| Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 16 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%. |
| Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg BID CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52. | 47 |
| CP-690,550 10 mg BID CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52. | 47 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Not received study drug | 0 | 1 |
| Overall Study | Other | 2 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 11.8 | 46.4 years STANDARD_DEVIATION 10.8 | 48.7 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 39 Participants | 39 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 37 / 47 | 40 / 47 | 77 / 94 |
| serious Total, serious adverse events | 3 / 47 | 3 / 47 | 6 / 94 |
Outcome results
Primary
Number of Participants With Adjudicated Cardiovacular Events
Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.
Time frame: Baseline to Follow-up
Population: Participants treated with at least 1 dose of study drugs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg BID | Number of Participants With Adjudicated Cardiovacular Events | 0 Participants |
| CP-690,550 10 mg BID | Number of Participants With Adjudicated Cardiovacular Events | 0 Participants |
| Total | Number of Participants With Adjudicated Cardiovacular Events | 0 Participants |
Primary
Number of Participants With Malignancy Events _Week 0 Through Follow-up
For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.
Time frame: Baseline to Follow-up
Population: Participants treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Non-melanoma skin cancer | 0 Participants |
| CP-690,550 5 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Number of participants with any malignancy events | 0 Participants |
| CP-690,550 5 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Lymphoma/Lymphoproliferative disorders (LPD) | 0 Participants |
| CP-690,550 5 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Malignancy excluding non-melanoma skin cancer | 0 Participants |
| CP-690,550 5 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Melanoma | 0 Participants |
| CP-690,550 10 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Malignancy excluding non-melanoma skin cancer | 0 Participants |
| CP-690,550 10 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Non-melanoma skin cancer | 0 Participants |
| CP-690,550 10 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Melanoma | 0 Participants |
| CP-690,550 10 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Number of participants with any malignancy events | 0 Participants |
| CP-690,550 10 mg BID | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Lymphoma/Lymphoproliferative disorders (LPD) | 0 Participants |
| Total | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Non-melanoma skin cancer | 0 Participants |
| Total | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Number of participants with any malignancy events | 0 Participants |
| Total | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Malignancy excluding non-melanoma skin cancer | 0 Participants |
| Total | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Melanoma | 0 Participants |
| Total | Number of Participants With Malignancy Events _Week 0 Through Follow-up | Lymphoma/Lymphoproliferative disorders (LPD) | 0 Participants |
Primary
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time frame: Week 16
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 | 67.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 | 68.2 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 | 67.8 Percentage of participants |
Primary
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed 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 at Week 16 relative to Baseline.
Time frame: Week 16
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | 62.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | 72.7 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | 67.8 Percentage of participants |
Primary
Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 16
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg BID | Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 | 100 Percentage of participants |
| CP-690,550 10 mg BID | Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 | 100 Percentage of participants |
| Total | Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 | 100 Percentage of participants |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Time frame: Week 16, 28, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 28: Mental Health Score (n=43, 39, 82) | 7.085 Units on a scale | Standard Deviation 11.366 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 16: Mental Health Score (n=43, 40, 83) | 6.767 Units on a scale | Standard Deviation 11.0945 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 16: Physical Health Score (n=43, 40, 83) | 4.719 Units on a scale | Standard Deviation 6.6806 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 52: Mental Health Score (n=39, 32, 71) | 7.878 Units on a scale | Standard Deviation 10.1983 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 52: Physical Health Score (n=39, 32, 71) | 4.676 Units on a scale | Standard Deviation 5.7405 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 28: Physical Health Score (n=43, 39, 82) | 3.770 Units on a scale | Standard Deviation 7.7829 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 16: Physical Health Score (n=43, 40, 83) | 6.146 Units on a scale | Standard Deviation 8.5192 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 52: Physical Health Score (n=39, 32, 71) | 5.250 Units on a scale | Standard Deviation 5.7614 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 52: Mental Health Score (n=39, 32, 71) | 6.826 Units on a scale | Standard Deviation 10.5988 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 28: Mental Health Score (n=43, 39, 82) | 5.364 Units on a scale | Standard Deviation 10.9089 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 16: Mental Health Score (n=43, 40, 83) | 5.029 Units on a scale | Standard Deviation 11.4967 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 28: Physical Health Score (n=43, 39, 82) | 4.799 Units on a scale | Standard Deviation 8.8893 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 28: Physical Health Score (n=43, 39, 82) | 4.259 Units on a scale | Standard Deviation 8.2914 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 16: Mental Health Score (n=43, 40, 83) | 5.929 Units on a scale | Standard Deviation 11.2548 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 52: Physical Health Score (n=39, 32, 71) | 4.935 Units on a scale | Standard Deviation 5.7159 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 28: Mental Health Score (n=43, 39, 82) | 6.266 Units on a scale | Standard Deviation 11.1159 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 16: Physical Health Score (n=43, 40, 83) | 5.407 Units on a scale | Standard Deviation 7.6087 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score | Week 52: Mental Health Score (n=39, 32, 71) | 7.404 Units on a scale | Standard Deviation 10.3192 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Time frame: Week (W) 16, 28, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Social Function Domain (n=43, 40, 83) | 7.629 Units on a scale | Standard Deviation 9.9734 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Physical Functioning Domain (n=39,32,71) | 2.151 Units on a scale | Standard Deviation 5.6134 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Role-Physical Domain (n=39, 32, 71) | 6.669 Units on a scale | Standard Deviation 10.052 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Role-Emotional Domain (n=43, 40, 83) | 7.219 Units on a scale | Standard Deviation 11.5898 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: General Health Domain (n=39, 32, 71) | 2.758 Units on a scale | Standard Deviation 6.0866 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Vitality Domain (n=39, 32, 71) | 4.068 Units on a scale | Standard Deviation 10.5612 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Bodily Pain Domain (n=43, 40, 83) | 11.808 Units on a scale | Standard Deviation 13.8431 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Social Function Domain (n=39, 32, 71) | 8.411 Units on a scale | Standard Deviation 9.4598 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Mental Health Domain (n=43, 40, 83) | 5.928 Units on a scale | Standard Deviation 12.8757 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Role-Emotional Domain (n=39, 32, 71) | 8.445 Units on a scale | Standard Deviation 11.0018 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Mental Health Domain (n=39, 32, 71) | 7.317 Units on a scale | Standard Deviation 11.6243 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Bodily Pain Domain (n=39, 32, 71) | 12.335 Units on a scale | Standard Deviation 12.1413 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Physical Functioning Domain (n=43, 39, 82) | 1.571 Units on a scale | Standard Deviation 6.3446 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Physical Functioning Domain (n=43, 40, 83) | 1.951 Units on a scale | Standard Deviation 5.188 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Role-Physical Domain (n=43, 39, 82) | 5.882 Units on a scale | Standard Deviation 10.6375 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: General Health Domain (n=43, 40, 83) | 2.392 Units on a scale | Standard Deviation 7.0933 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Bodily Pain Domain (n=43, 39, 82) | 10.113 Units on a scale | Standard Deviation 15.9485 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: General Health Domain (n=43, 39, 82) | 2.644 Units on a scale | Standard Deviation 5.923 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Role-Physical Domain (n=43, 40, 83) | 6.160 Units on a scale | Standard Deviation 9.3615 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Vitality Domain (n=43, 39, 82) | 4.038 Units on a scale | Standard Deviation 10.0116 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Vitality Domain (n=43, 40, 83) | 4.664 Units on a scale | Standard Deviation 9.5406 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Social Function Domain (n=43, 39, 82) | 6.628 Units on a scale | Standard Deviation 11.3068 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Role-Emotional Domain (n=43, 39, 82) | 7.395 Units on a scale | Standard Deviation 11.8846 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Mental Health Domain (n=43, 39, 82) | 6.701 Units on a scale | Standard Deviation 12.4375 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Bodily Pain Domain (n=43, 40, 83) | 10.663 Units on a scale | Standard Deviation 12.2936 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Vitality Domain (n=43, 40, 83) | 3.517 Units on a scale | Standard Deviation 11.4421 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Physical Functioning Domain (n=39,32,71) | 3.773 Units on a scale | Standard Deviation 7.3533 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Social Function Domain (n=43, 40, 83) | 7.932 Units on a scale | Standard Deviation 8.8645 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Physical Functioning Domain (n=43, 39, 82) | 4.303 Units on a scale | Standard Deviation 10.3695 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Role-Physical Domain (n=39, 32, 71) | 4.623 Units on a scale | Standard Deviation 9.734 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Physical Functioning Domain (n=43, 40, 83) | 4.809 Units on a scale | Standard Deviation 9.1822 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Bodily Pain Domain (n=39, 32, 71) | 10.673 Units on a scale | Standard Deviation 9.7128 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Mental Health Domain (n=43, 39, 82) | 5.328 Units on a scale | Standard Deviation 12.8129 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Vitality Domain (n=43, 39, 82) | 3.608 Units on a scale | Standard Deviation 10.0742 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: General Health Domain (n=39, 32, 71) | 4.888 Units on a scale | Standard Deviation 6.8235 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Role-Emotional Domain (n=43, 40, 83) | 5.584 Units on a scale | Standard Deviation 11.5654 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Role-Physical Domain (n=43, 39, 82) | 5.017 Units on a scale | Standard Deviation 11.4671 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Vitality Domain (n=39, 32, 71) | 5.052 Units on a scale | Standard Deviation 8.516 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Role-Emotional Domain (n=43, 39, 82) | 6.310 Units on a scale | Standard Deviation 12.9504 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Role-Physical Domain (n=43, 40, 83) | 5.130 Units on a scale | Standard Deviation 11.16 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Social Function Domain (n=39, 32, 71) | 8.402 Units on a scale | Standard Deviation 9.2577 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Bodily Pain Domain (n=43, 39, 82) | 8.394 Units on a scale | Standard Deviation 12.5405 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: General Health Domain (n=43, 40, 83) | 4.333 Units on a scale | Standard Deviation 7.0145 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Role-Emotional Domain (n=39, 32, 71) | 5.915 Units on a scale | Standard Deviation 10.3091 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Mental Health Domain (n=43, 40, 83) | 5.125 Units on a scale | Standard Deviation 13.3613 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Social Function Domain (n=43, 39, 82) | 6.205 Units on a scale | Standard Deviation 10.4347 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Mental Health Domain (n=39, 32, 71) | 6.926 Units on a scale | Standard Deviation 12.6861 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: General Health Domain (n=43, 39, 82) | 3.517 Units on a scale | Standard Deviation 7.1375 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Mental Health Domain (n=39, 32, 71) | 7.141 Units on a scale | Standard Deviation 12.0276 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Physical Functioning Domain (n=43, 40, 83) | 3.329 Units on a scale | Standard Deviation 7.48 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Role-Physical Domain (n=43, 40, 83) | 5.664 Units on a scale | Standard Deviation 10.2172 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Bodily Pain Domain (n=43, 40, 83) | 11.256 Units on a scale | Standard Deviation 13.0524 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: General Health Domain (n=43, 40, 83) | 3.328 Units on a scale | Standard Deviation 7.0799 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Vitality Domain (n=43, 40, 83) | 4.112 Units on a scale | Standard Deviation 10.4509 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Social Function Domain (n=43, 40, 83) | 7.775 Units on a scale | Standard Deviation 9.3992 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Role-Emotional Domain (n=43, 40, 83) | 6.431 Units on a scale | Standard Deviation 11.5365 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W16: Mental Health Domain (n=43, 40, 83) | 5.541 Units on a scale | Standard Deviation 13.0378 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Physical Functioning Domain (n=43, 39, 82) | 2.870 Units on a scale | Standard Deviation 8.5558 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Role-Physical Domain (n=43, 39, 82) | 5.471 Units on a scale | Standard Deviation 10.9795 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Bodily Pain Domain (n=43, 39, 82) | 9.295 Units on a scale | Standard Deviation 14.367 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: General Health Domain (n=43, 39, 82) | 3.059 Units on a scale | Standard Deviation 6.5025 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Vitality Domain (n=43, 39, 82) | 3.833 Units on a scale | Standard Deviation 9.9815 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Social Function Domain (n=43, 39, 82) | 6.427 Units on a scale | Standard Deviation 10.8358 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Role-Emotional Domain (n=43, 39, 82) | 6.879 Units on a scale | Standard Deviation 12.3375 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W28: Mental Health Domain (n=43, 39, 82) | 6.048 Units on a scale | Standard Deviation 12.558 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Physical Functioning Domain (n=39,32,71) | 2.882 Units on a scale | Standard Deviation 6.4585 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Role-Physical Domain (n=39, 32, 71) | 5.747 Units on a scale | Standard Deviation 9.8926 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Bodily Pain Domain (n=39, 32, 71) | 11.586 Units on a scale | Standard Deviation 11.0678 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: General Health Domain (n=39, 32, 71) | 3.718 Units on a scale | Standard Deviation 6.4707 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Vitality Domain (n=39, 32, 71) | 4.511 Units on a scale | Standard Deviation 9.639 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Social Function Domain (n=39, 32, 71) | 8.407 Units on a scale | Standard Deviation 9.3024 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score | W52: Role-Emotional Domain (n=39, 32, 71) | 7.305 Units on a scale | Standard Deviation 10.6949 |
Secondary
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 28 | -1.30 mg/dL | Standard Deviation 2.337 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 2 | -1.20 mg/dL | Standard Deviation 2.137 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 4 | -1.20 mg/dL | Standard Deviation 2.267 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 8 | -1.28 mg/dL | Standard Deviation 2.354 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 12 | -1.28 mg/dL | Standard Deviation 2.351 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 16 | -1.30 mg/dL | Standard Deviation 2.337 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 20 | -1.33 mg/dL | Standard Deviation 2.387 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 40 (n=4, 7, 11) | -1.15 mg/dL | Standard Deviation 2.037 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 52 (n=3, 8, 11) | -0.03 mg/dL | Standard Deviation 0.058 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 16 | -1.69 mg/dL | Standard Deviation 2.189 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 28 | -1.15 mg/dL | Standard Deviation 2.77 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 2 | -1.68 mg/dL | Standard Deviation 2.231 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 40 (n=4, 7, 11) | -1.84 mg/dL | Standard Deviation 2.461 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 12 | -1.68 mg/dL | Standard Deviation 2.235 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 4 | -1.69 mg/dL | Standard Deviation 2.272 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 20 | -1.59 mg/dL | Standard Deviation 2.336 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 52 (n=3, 8, 11) | -1.65 mg/dL | Standard Deviation 2.295 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 8 | -1.70 mg/dL | Standard Deviation 2.222 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 20 | -1.50 mg/dL | Standard Deviation 2.246 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 12 | -1.54 mg/dL | Standard Deviation 2.174 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 40 (n=4, 7, 11) | -1.59 mg/dL | Standard Deviation 2.236 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 16 | -1.56 mg/dL | Standard Deviation 2.139 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 52 (n=3, 8, 11) | -1.21 mg/dL | Standard Deviation 2.064 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 8 | -1.56 mg/dL | Standard Deviation 2.167 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 2 | -1.52 mg/dL | Standard Deviation 2.114 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 28 | -1.20 mg/dL | Standard Deviation 2.526 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) | Week 4 | -1.53 mg/dL | Standard Deviation 2.178 |
Secondary
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 12 | -0.28 Units on a scale | Standard Deviation 0.359 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 52 (n=3, 8, 11) | -0.13 Units on a scale | Standard Deviation 0.573 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 20 | -0.28 Units on a scale | Standard Deviation 0.359 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 16 | -0.31 Units on a scale | Standard Deviation 0.375 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 2 | -0.19 Units on a scale | Standard Deviation 0.239 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 40 | -0.09 Units on a scale | Standard Deviation 0.64 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 8 | -0.28 Units on a scale | Standard Deviation 0.359 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 4 | -0.28 Units on a scale | Standard Deviation 0.329 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 28 | -0.34 Units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 16 | -0.42 Units on a scale | Standard Deviation 0.433 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 2 | -0.28 Units on a scale | Standard Deviation 0.376 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 4 | -0.36 Units on a scale | Standard Deviation 0.381 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 8 | -0.42 Units on a scale | Standard Deviation 0.433 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 12 | -0.42 Units on a scale | Standard Deviation 0.433 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 20 | -0.42 Units on a scale | Standard Deviation 0.433 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 28 | -0.42 Units on a scale | Standard Deviation 0.433 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 40 | -0.42 Units on a scale | Standard Deviation 0.433 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 52 (n=3, 8, 11) | -0.42 Units on a scale | Standard Deviation 0.433 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 8 | -0.38 Units on a scale | Standard Deviation 0.399 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 2 | -0.25 Units on a scale | Standard Deviation 0.329 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 28 | -0.40 Units on a scale | Standard Deviation 0.405 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 4 | -0.33 Units on a scale | Standard Deviation 0.351 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 52 (n=3, 8, 11) | -0.34 Units on a scale | Standard Deviation 0.465 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 16 | -0.39 Units on a scale | Standard Deviation 0.4 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 12 | -0.38 Units on a scale | Standard Deviation 0.399 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 40 | -0.31 Units on a scale | Standard Deviation 0.507 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 20 | -0.38 Units on a scale | Standard Deviation 0.399 |
Secondary
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 12 | -34.5 Units on a scale | Standard Deviation 19.71 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 52 (n=3, 8, 11) | -33.0 Units on a scale | Standard Deviation 31.19 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 20 | -44.0 Units on a scale | Standard Deviation 22.82 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 16 | -27.3 Units on a scale | Standard Deviation 15.22 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 2 | -13.3 Units on a scale | Standard Deviation 8.3 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 40 | -20.0 Units on a scale | Standard Deviation 54.86 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 8 | -16.0 Units on a scale | Standard Deviation 19.78 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 4 | -13.0 Units on a scale | Standard Deviation 23.41 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 28 | -45.8 Units on a scale | Standard Deviation 23.26 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 16 | -46.0 Units on a scale | Standard Deviation 22.44 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 2 | -29.5 Units on a scale | Standard Deviation 23.4 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 4 | -41.4 Units on a scale | Standard Deviation 25.29 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 8 | -43.6 Units on a scale | Standard Deviation 22.68 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 12 | -46.0 Units on a scale | Standard Deviation 23.42 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 20 | -45.3 Units on a scale | Standard Deviation 21.53 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 28 | -45.8 Units on a scale | Standard Deviation 20.46 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 40 | -46.9 Units on a scale | Standard Deviation 22.66 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 52 (n=3, 8, 11) | -48.4 Units on a scale | Standard Deviation 22.14 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 8 | -34.4 Units on a scale | Standard Deviation 24.88 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 2 | -24.1 Units on a scale | Standard Deviation 20.77 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 28 | -45.8 Units on a scale | Standard Deviation 20.34 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 4 | -31.9 Units on a scale | Standard Deviation 27.42 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 52 (n=3, 8, 11) | -44.2 Units on a scale | Standard Deviation 24.28 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 16 | -39.8 Units on a scale | Standard Deviation 21.65 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 12 | -42.2 Units on a scale | Standard Deviation 22.07 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 40 | -37.9 Units on a scale | Standard Deviation 36.37 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain | Week 20 | -44.8 Units on a scale | Standard Deviation 20.91 |
Secondary
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Subjects answered the following question, Considering the possible effects of the arthritis, how are you feeling today? The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 2 | -8.0 Units on a scale | Standard Deviation 8.87 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 40 | -20.8 Units on a scale | Standard Deviation 30.24 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 12 | -45.0 Units on a scale | Standard Deviation 8.83 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 28 | -52.3 Units on a scale | Standard Deviation 11.18 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 8 | -23.3 Units on a scale | Standard Deviation 19.69 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 16 | -40.0 Units on a scale | Standard Deviation 13.64 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 52 (n=3, 8, 11) | -40.7 Units on a scale | Standard Deviation 16.8 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 4 | -20.5 Units on a scale | Standard Deviation 11.27 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 20 | -49.5 Units on a scale | Standard Deviation 20.09 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 8 | -51.3 Units on a scale | Standard Deviation 20.53 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 4 | -43.4 Units on a scale | Standard Deviation 27.47 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 28 | -46.3 Units on a scale | Standard Deviation 26.67 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 40 | -50.8 Units on a scale | Standard Deviation 20.78 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 20 | -49.6 Units on a scale | Standard Deviation 20.26 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 2 | -32.6 Units on a scale | Standard Deviation 27.55 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 12 | -52.1 Units on a scale | Standard Deviation 21.35 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 52 (n=3, 8, 11) | -55.3 Units on a scale | Standard Deviation 20.51 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 16 | -53.0 Units on a scale | Standard Deviation 20.96 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 52 (n=3, 8, 11) | -51.3 Units on a scale | Standard Deviation 19.94 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 2 | -24.4 Units on a scale | Standard Deviation 25.53 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 4 | -35.8 Units on a scale | Standard Deviation 25.33 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 8 | -41.9 Units on a scale | Standard Deviation 23.75 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 12 | -49.8 Units on a scale | Standard Deviation 17.99 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 16 | -48.7 Units on a scale | Standard Deviation 19.27 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 20 | -49.6 Units on a scale | Standard Deviation 19.27 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 28 | -48.3 Units on a scale | Standard Deviation 22.26 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis | Week 40 | -40.8 Units on a scale | Standard Deviation 27.24 |
Secondary
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 12 | -39.8 Units on a scale | Standard Deviation 21 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 52 (n=3, 8, 11) | -29.0 Units on a scale | Standard Deviation 20.3 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 20 | -50.8 Units on a scale | Standard Deviation 25.29 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 16 | -49.8 Units on a scale | Standard Deviation 23.34 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 2 | -15.3 Units on a scale | Standard Deviation 18.01 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 40 | -38.5 Units on a scale | Standard Deviation 39.03 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 8 | -29.5 Units on a scale | Standard Deviation 30.01 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 4 | -32.5 Units on a scale | Standard Deviation 22.28 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 28 | -49.5 Units on a scale | Standard Deviation 25.96 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 16 | -47.9 Units on a scale | Standard Deviation 20.09 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 2 | -28.5 Units on a scale | Standard Deviation 18.6 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 4 | -34.6 Units on a scale | Standard Deviation 19.39 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 8 | -41.8 Units on a scale | Standard Deviation 21.87 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 12 | -45.8 Units on a scale | Standard Deviation 22.76 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 20 | -45.3 Units on a scale | Standard Deviation 26.81 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 28 | -42.8 Units on a scale | Standard Deviation 22.79 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 40 | -49.5 Units on a scale | Standard Deviation 18.54 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 52 (n=3, 8, 11) | -46.8 Units on a scale | Standard Deviation 25.08 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 8 | -37.7 Units on a scale | Standard Deviation 24.21 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 2 | -24.1 Units on a scale | Standard Deviation 18.74 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 28 | -45.0 Units on a scale | Standard Deviation 22.92 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 4 | -33.9 Units on a scale | Standard Deviation 19.38 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 52 (n=3, 8, 11) | -41.9 Units on a scale | Standard Deviation 24.32 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 16 | -48.5 Units on a scale | Standard Deviation 20.16 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 12 | -43.8 Units on a scale | Standard Deviation 21.42 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 40 | -45.8 Units on a scale | Standard Deviation 25.76 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis | Week 20 | -47.1 Units on a scale | Standard Deviation 25.28 |
Secondary
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 12 | -6.5 Swollen joints | Standard Deviation 6.35 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 4 | -5.0 Swollen joints | Standard Deviation 4.69 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 20 | -7.0 Swollen joints | Standard Deviation 8 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 16 | -7.3 Swollen joints | Standard Deviation 7.85 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 52 (n=3, 8, 11) | -3.0 Swollen joints | Standard Deviation 0 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 40 | -7.3 Swollen joints | Standard Deviation 7.85 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 8 | -6.0 Swollen joints | Standard Deviation 7.35 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 2 | -1.8 Swollen joints | Standard Deviation 2.22 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 28 | -7.3 Swollen joints | Standard Deviation 7.85 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 2 | -3.8 Swollen joints | Standard Deviation 5.55 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 4 | -5.3 Swollen joints | Standard Deviation 5.8 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 8 | -6.4 Swollen joints | Standard Deviation 4.37 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 12 | -7.0 Swollen joints | Standard Deviation 4.44 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 16 | -7.8 Swollen joints | Standard Deviation 3.85 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 20 | -8.9 Swollen joints | Standard Deviation 4.42 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 28 | -7.6 Swollen joints | Standard Deviation 4.03 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 40 | -8.8 Swollen joints | Standard Deviation 4.2 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 52 (n=3, 8, 11) | -8.8 Swollen joints | Standard Deviation 4.13 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 8 | -6.3 Swollen joints | Standard Deviation 5.19 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 2 | -3.1 Swollen joints | Standard Deviation 4.68 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 28 | -7.5 Swollen joints | Standard Deviation 5.21 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 4 | -5.2 Swollen joints | Standard Deviation 5.24 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 52 (n=3, 8, 11) | -7.2 Swollen joints | Standard Deviation 4.38 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 16 | -7.6 Swollen joints | Standard Deviation 5.12 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 12 | -6.8 Swollen joints | Standard Deviation 4.86 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 40 | -8.3 Swollen joints | Standard Deviation 5.34 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count | Week 20 | -8.3 Swollen joints | Standard Deviation 5.55 |
Secondary
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 28 | -14.0 Tender/painful joints | Standard Deviation 9.38 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 40 | -14.3 Tender/painful joints | Standard Deviation 10.14 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 2 | -1.8 Tender/painful joints | Standard Deviation 1.5 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 52 (n=3, 8, 11) | -11.3 Tender/painful joints | Standard Deviation 9.24 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 8 | -11.5 Tender/painful joints | Standard Deviation 10.08 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 12 | -13.8 Tender/painful joints | Standard Deviation 10.78 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 20 | -14.3 Tender/painful joints | Standard Deviation 9.11 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 16 | -13.0 Tender/painful joints | Standard Deviation 9.59 |
| CP-690,550 5 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 4 | -6.3 Tender/painful joints | Standard Deviation 6.7 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 8 | -11.6 Tender/painful joints | Standard Deviation 10.24 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 28 | -12.4 Tender/painful joints | Standard Deviation 12.52 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 4 | -9.3 Tender/painful joints | Standard Deviation 11.37 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 2 | -3.5 Tender/painful joints | Standard Deviation 2.78 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 40 | -13.4 Tender/painful joints | Standard Deviation 12.09 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 20 | -12.4 Tender/painful joints | Standard Deviation 12.87 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 12 | -12.5 Tender/painful joints | Standard Deviation 11.95 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 52 (n=3, 8, 11) | -13.5 Tender/painful joints | Standard Deviation 12.08 |
| CP-690,550 10 mg BID | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 16 | -13.0 Tender/painful joints | Standard Deviation 12.17 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 52 (n=3, 8, 11) | -12.9 Tender/painful joints | Standard Deviation 10.97 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 2 | -2.9 Tender/painful joints | Standard Deviation 2.5 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 4 | -8.3 Tender/painful joints | Standard Deviation 9.84 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 8 | -11.6 Tender/painful joints | Standard Deviation 9.72 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 12 | -12.9 Tender/painful joints | Standard Deviation 11.09 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 20 | -13.0 Tender/painful joints | Standard Deviation 11.35 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 28 | -12.9 Tender/painful joints | Standard Deviation 11.16 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 40 | -13.7 Tender/painful joints | Standard Deviation 11.02 |
| Total | Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count | Week 16 | -13.0 Tender/painful joints | Standard Deviation 10.92 |
Secondary
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Time frame: Week 8, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 8 (n=32, 28, 60) | -3.3 Units on a scale | Standard Deviation 9.63 |
| CP-690,550 5 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 16 (n=32, 28, 60) | -11.2 Units on a scale | Standard Deviation 15.27 |
| CP-690,550 5 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 20 (n=32, 27, 59) | -15.0 Units on a scale | Standard Deviation 15.29 |
| CP-690,550 5 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 28 (n=32, 27, 59) | -21.1 Units on a scale | Standard Deviation 15.83 |
| CP-690,550 5 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 40 (n=31, 26, 57) | -22.2 Units on a scale | Standard Deviation 16.18 |
| CP-690,550 5 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 52 (n=30, 22, 52) | -20.6 Units on a scale | Standard Deviation 15.16 |
| CP-690,550 10 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 52 (n=30, 22, 52) | -16.2 Units on a scale | Standard Deviation 15.62 |
| CP-690,550 10 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 8 (n=32, 28, 60) | -1.8 Units on a scale | Standard Deviation 7.72 |
| CP-690,550 10 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 28 (n=32, 27, 59) | -16.4 Units on a scale | Standard Deviation 15.27 |
| CP-690,550 10 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 40 (n=31, 26, 57) | -16.2 Units on a scale | Standard Deviation 14.13 |
| CP-690,550 10 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 16 (n=32, 28, 60) | -9.4 Units on a scale | Standard Deviation 12.66 |
| CP-690,550 10 mg BID | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 20 (n=32, 27, 59) | -14.1 Units on a scale | Standard Deviation 13.03 |
| Total | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 16 (n=32, 28, 60) | -10.4 Units on a scale | Standard Deviation 14.02 |
| Total | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 20 (n=32, 27, 59) | -14.6 Units on a scale | Standard Deviation 14.18 |
| Total | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 52 (n=30, 22, 52) | -18.7 Units on a scale | Standard Deviation 15.36 |
| Total | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 28 (n=32, 27, 59) | -18.9 Units on a scale | Standard Deviation 15.62 |
| Total | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 8 (n=32, 28, 60) | -2.6 Units on a scale | Standard Deviation 8.75 |
| Total | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Week 40 (n=31, 26, 57) | -19.5 Units on a scale | Standard Deviation 15.45 |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Lower Limbs) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Upper Limbs) | -1.1 Units on a scale | Standard Deviation 0.86 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Trunk) (n=41, 38, 79) | -2.1 Units on a scale | Standard Deviation 1.04 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Lower Limbs) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Lower Limbs) (n=41, 38, 79) | -2.4 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Lower Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Head/Neck) | -0.7 Units on a scale | Standard Deviation 0.89 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Head/Neck) (n=41, 38, 79) | -1.7 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Head/Neck) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Lower Limbs) | -1.1 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Upper Limbs) (n=41, 38, 79) | -2.0 Units on a scale | Standard Deviation 1.18 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Trunk) (n=43, 40, 83) | -2.1 Units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Trunk) | -1.0 Units on a scale | Standard Deviation 0.64 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Trunk) (n=41, 38, 79) | -1.9 Units on a scale | Standard Deviation 1.26 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Trunk) (n=43, 41, 84) | -2.0 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Upper Limbs) | -1.1 Units on a scale | Standard Deviation 0.81 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Lower Limbs) (n=41, 38, 79) | -2.2 Units on a scale | Standard Deviation 1.14 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Upper Limbs) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 0.97 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Head/Neck) | -0.8 Units on a scale | Standard Deviation 1.02 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Head/Neck) (n=41, 38, 79) | -1.8 Units on a scale | Standard Deviation 0.97 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Lower Limbs) | -0.4 Units on a scale | Standard Deviation 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Trunk) | -0.3 Units on a scale | Standard Deviation 0.57 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Upper Limbs) | -0.4 Units on a scale | Standard Deviation 0.59 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Trunk) (n=41, 38, 79) | -1.7 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Upper Limbs) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Head/Neck) | -0.4 Units on a scale | Standard Deviation 0.66 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Lower Limbs) (n=41, 38, 79) | -1.9 Units on a scale | Standard Deviation 1.11 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Lower Limbs) | -0.5 Units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Head/Neck) (n=39, 32, 71) | -1.9 Units on a scale | Standard Deviation 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Trunk) (n=43, 39, 82) | -2.2 Units on a scale | Standard Deviation 1.04 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Trunk) | -0.5 Units on a scale | Standard Deviation 0.63 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Upper Limbs) (n=39, 32, 71) | -2.0 Units on a scale | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Trunk) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Upper Limbs) | -0.5 Units on a scale | Standard Deviation 0.63 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Trunk) (n=39, 32, 71) | -2.2 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Lower Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 0.92 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Head/Neck) | -0.4 Units on a scale | Standard Deviation 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Lower Limbs) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.04 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Lower Limbs) | -0.7 Units on a scale | Standard Deviation 0.69 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Head/Neck) (n=39, 32, 71) | -1.7 Units on a scale | Standard Deviation 1.06 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Upper Limbs) (n=43, 39, 82) | -1.5 Units on a scale | Standard Deviation 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Trunk) | -0.6 Units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Upper Limbs) (n=39, 32, 71) | -1.9 Units on a scale | Standard Deviation 1.21 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Head/Neck) | -0.5 Units on a scale | Standard Deviation 0.83 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Trunk) (n=39, 32, 71) | -1.8 Units on a scale | Standard Deviation 1.39 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Trunk) (n=43, 41, 84) | -2.1 Units on a scale | Standard Deviation 1.08 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Lower Limbs) (n=39, 32, 71) | -1.7 Units on a scale | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Lower Limbs) (n=39, 32, 71) | -2.0 Units on a scale | Standard Deviation 1.29 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 1 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Trunk) (n=39, 32, 71) | -1.6 Units on a scale | Standard Deviation 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Head/Neck) (n=39, 32, 71) | -1.8 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Upper Limbs) (n=43, 40, 83) | -1.9 Units on a scale | Standard Deviation 1.13 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Upper Limbs) (n=39, 32, 71) | -1.6 Units on a scale | Standard Deviation 1.02 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Upper Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Upper Limbs) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 0.97 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Upper Limbs) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.09 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Head/Neck) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Trunk) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Lower Limbs) (n=43, 40, 83) | -2.1 Units on a scale | Standard Deviation 0.95 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Lower Limbs) (n=43, 41, 84) | -1.3 Units on a scale | Standard Deviation 0.82 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Lower Limbs) (n=43, 39, 82) | -2.2 Units on a scale | Standard Deviation 0.95 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Head/Neck) (n=43, 40, 83) | -1.7 Units on a scale | Standard Deviation 1.14 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Trunk) (n=43, 41, 84) | -1.4 Units on a scale | Standard Deviation 0.82 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Head/Neck) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Trunk) (n=43, 40, 83) | -2.1 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Upper Limbs) (n=43, 41, 84) | -1.3 Units on a scale | Standard Deviation 0.8 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Upper Limbs) (n=43, 40, 83) | -1.8 Units on a scale | Standard Deviation 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Head/Neck) (n=43, 41, 84) | -1.3 Units on a scale | Standard Deviation 0.9 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Trunk) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Lower Limbs) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 0.85 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Trunk) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Lower Limbs) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 0.92 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Upper Limbs) | -0.5 Units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Head/Neck) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.11 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Upper Limbs) (n=41, 38, 79) | -1.7 Units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Upper Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Head/Neck) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 0.95 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Head/Neck) (n=43, 41, 84) | -1.3 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Trunk) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.13 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Lower Limbs) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Lower Limbs) (n=43, 39, 82) | -2.3 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Lower Limbs) (n=39, 32, 71) | -2.1 Units on a scale | Standard Deviation 1.11 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Head/Neck) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 0.97 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Lower Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Trunk) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Upper Limbs) (n=43, 39, 82) | -2.0 Units on a scale | Standard Deviation 1.12 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Trunk) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Upper Limbs) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Trunk) (n=43, 39, 82) | -2.0 Units on a scale | Standard Deviation 1.12 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Upper Limbs) (n=43, 40, 83) | -1.5 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Head/Neck) (n=43, 41, 84) | -1.4 Units on a scale | Standard Deviation 1.13 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Lower Limbs) (n=43, 39, 82) | -2.2 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Head/Neck) (n=43, 40, 83) | -1.5 Units on a scale | Standard Deviation 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Lower Limbs) | -0.8 Units on a scale | Standard Deviation 0.72 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Head/Neck) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Upper Limbs) (n=43, 41, 84) | -1.4 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Trunk) | -0.9 Units on a scale | Standard Deviation 0.71 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Upper Limbs) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Upper Limbs) | -0.9 Units on a scale | Standard Deviation 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Trunk) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Head/Neck) | -0.8 Units on a scale | Standard Deviation 0.86 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Lower Limbs) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.09 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Head/Neck) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Lower Limbs) | -1.0 Units on a scale | Standard Deviation 0.9 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Head/Neck) (n=41, 38, 79) | -1.9 Units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Head/Neck) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.92 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Trunk) | -0.9 Units on a scale | Standard Deviation 0.8 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Upper Limbs) (n=41, 38, 79) | -2.1 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Head/Neck) | -1.3 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Upper Limbs) | -0.8 Units on a scale | Standard Deviation 0.72 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Lower Limbs) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Upper Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.89 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Head/Neck) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 1.08 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Trunk) (n=43, 39, 82) | -2.0 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Upper Limbs) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 1.02 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Trunk) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.11 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Head/Neck) (n=41, 38, 79) | -1.4 Units on a scale | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Lower Limbs) (n=41, 38, 79) | -1.8 Units on a scale | Standard Deviation 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Upper Limbs) (n=39, 32, 71) | -2.0 Units on a scale | Standard Deviation 0.97 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Upper Limbs) (n=43, 40, 83) | -1.7 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Trunk) (n=43, 40, 83) | -1.8 Units on a scale | Standard Deviation 1.09 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Lower Limbs) (n=43, 40, 83) | -1.8 Units on a scale | Standard Deviation 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 0.96 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Upper Limbs) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 1.26 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Trunk) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.04 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Lower Limbs) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.09 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Head/Neck) (n=43, 39, 82) | -1.5 Units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Upper Limbs) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Trunk) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Lower Limbs) (n=43, 39, 82) | -2.0 Units on a scale | Standard Deviation 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Head/Neck) (n=43, 39, 82) | -1.5 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Upper Limbs) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Trunk) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Lower Limbs) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.16 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 0.81 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Upper Limbs) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Lower Limbs) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Upper Limbs) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.1 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Trunk) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.16 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Lower Limbs) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Head/Neck) (n=43, 39, 82) | -1.4 Units on a scale | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Lower Limbs) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.02 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Head/Neck) (n=41, 38, 79) | -1.7 Units on a scale | Standard Deviation 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Upper Limbs) (n=41, 38, 79) | -1.9 Units on a scale | Standard Deviation 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Trunk) (n=41, 38, 79) | -2.2 Units on a scale | Standard Deviation 0.87 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Lower Limbs) (n=41, 38, 79) | -2.0 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Head/Neck) (n=41, 38, 79) | -1.5 Units on a scale | Standard Deviation 1.08 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Upper Limbs) (n=41, 38, 79) | -1.8 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Trunk) (n=41, 38, 79) | -2.1 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Lower Limbs) (n=41, 38, 79) | -1.9 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Upper Limbs) (n=41, 38, 79) | -1.8 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Trunk) (n=41, 38, 79) | -1.9 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Head/Neck) (n=39, 32, 71) | -1.6 Units on a scale | Standard Deviation 1.24 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Upper Limbs) (n=39, 32, 71) | -2.0 Units on a scale | Standard Deviation 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Trunk) (n=39, 32, 71) | -2.2 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Lower Limbs) (n=39, 32, 71) | -2.2 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Head/Neck) (n=39, 32, 71) | -1.5 Units on a scale | Standard Deviation 1.22 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Trunk) (n=39, 32, 71) | -2.1 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Lower Limbs) (n=39, 32, 71) | -2.2 Units on a scale | Standard Deviation 0.97 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Head/Neck) (n=39, 32, 71) | -1.6 Units on a scale | Standard Deviation 1.08 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Upper Limbs) (n=39, 32, 71) | -1.9 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Trunk) (n=39, 32, 71) | -1.9 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Lower Limbs) (n=39, 32, 71) | -2.0 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Head/Neck) | -0.9 Units on a scale | Standard Deviation 0.82 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Trunk) | -0.8 Units on a scale | Standard Deviation 0.69 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Lower Limbs) | -0.8 Units on a scale | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Head/Neck) | -0.8 Units on a scale | Standard Deviation 0.89 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Upper Limbs) | -0.6 Units on a scale | Standard Deviation 0.75 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Trunk) | -0.7 Units on a scale | Standard Deviation 0.59 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Lower Limbs) | -0.7 Units on a scale | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Head/Neck) | -0.9 Units on a scale | Standard Deviation 0.91 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Upper Limbs) | -0.8 Units on a scale | Standard Deviation 0.74 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Trunk) | -0.8 Units on a scale | Standard Deviation 0.76 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Lower Limbs) | -0.7 Units on a scale | Standard Deviation 0.73 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Upper Limbs) | -1.2 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Trunk) | -1.3 Units on a scale | Standard Deviation 0.79 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Lower Limbs) | -1.2 Units on a scale | Standard Deviation 0.79 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Head/Neck) | -1.2 Units on a scale | Standard Deviation 1.09 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Upper Limbs) | -1.0 Units on a scale | Standard Deviation 0.85 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Trunk) | -1.3 Units on a scale | Standard Deviation 0.82 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Lower Limbs) | -1.2 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Head/Neck) | -1.2 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Upper Limbs) | -1.2 Units on a scale | Standard Deviation 0.86 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Trunk) | -1.3 Units on a scale | Standard Deviation 0.95 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Lower Limbs) | -1.3 Units on a scale | Standard Deviation 0.96 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Head/Neck) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Upper Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Trunk) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 0.93 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Head/Neck) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 1.1 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Trunk) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Lower Limbs) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Head/Neck) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Upper Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.86 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Trunk) (n=43, 41, 84) | -1.8 Units on a scale | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Lower Limbs) (n=43, 41, 84) | -1.8 Units on a scale | Standard Deviation 0.88 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Head/Neck) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Upper Limbs) (n=43, 41, 84) | -1.8 Units on a scale | Standard Deviation 1.13 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Trunk) (n=43, 41, 84) | -2.0 Units on a scale | Standard Deviation 0.95 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Lower Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Head/Neck) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Upper Limbs) (n=43, 41, 84) | -1.8 Units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Trunk) (n=43, 41, 84) | -2.0 Units on a scale | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Lower Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Head/Neck) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 1.02 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Upper Limbs) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.95 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Trunk) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Lower Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Head/Neck) (n=43, 40, 83) | -1.7 Units on a scale | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Upper Limbs) (n=43, 40, 83) | -1.9 Units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Trunk) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Lower Limbs) (n=43, 40, 83) | -1.9 Units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Head/Neck) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 1.17 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Upper Limbs) (n=43, 40, 83) | -1.8 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Trunk) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 1.01 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Lower Limbs) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 1.08 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Lower Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 0.92 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Upper Limbs) | -1.0 Units on a scale | Standard Deviation 0.85 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Head/Neck) (n=41, 38, 79) | -1.8 Units on a scale | Standard Deviation 1.01 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Lower Limbs) (n=43, 41, 84) | -1.9 Units on a scale | Standard Deviation 0.98 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Trunk) | -1.1 Units on a scale | Standard Deviation 0.83 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Lower Limbs) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.05 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Trunk) (n=43, 40, 83) | -1.7 Units on a scale | Standard Deviation 1.02 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Lower Limbs) | -1.1 Units on a scale | Standard Deviation 0.94 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Trunk) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.05 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Head/Neck) | -1.0 Units on a scale | Standard Deviation 1.02 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Head/Neck) | -1.0 Units on a scale | Standard Deviation 0.95 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Upper Limbs) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.03 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Head/Neck) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.96 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Upper Limbs) | -1.0 Units on a scale | Standard Deviation 0.79 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Scaling (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 1.04 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Upper Limbs) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 0.99 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Trunk) | -1.1 Units on a scale | Standard Deviation 0.87 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Lower Limbs) (n=43, 39, 82) | -2.0 Units on a scale | Standard Deviation 1.09 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Head/Neck) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 1.06 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Trunk) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 1.14 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Head/Neck) (n=43, 40, 83) | -1.6 Units on a scale | Standard Deviation 1.01 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Upper Limbs) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 1.12 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Head/Neck) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 1.08 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Upper Limbs) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 0.95 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Induration (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 0.98 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Trunk) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 1.03 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Trunk) (n=43, 41, 84) | -1.8 Units on a scale | Standard Deviation 0.92 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Trunk) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.06 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Erythema (Lower Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.91 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Upper Limbs) (n=43, 39, 82) | -2.0 Units on a scale | Standard Deviation 1.08 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Trunk) (n=41, 38, 79) | -2.2 Units on a scale | Standard Deviation 0.95 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Head/Neck) (n=43, 41, 84) | -1.4 Units on a scale | Standard Deviation 1.01 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Head/Neck) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 0.98 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Upper Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.91 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Trunk) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 0.99 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Upper Limbs) | -0.6 Units on a scale | Standard Deviation 0.7 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Trunk) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Lower Limbs) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.95 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Induration (Lower Limbs) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.94 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Upper Limbs) (n=43, 39, 82) | -1.5 Units on a scale | Standard Deviation 1.04 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 28: Erythema (Lower Limbs) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.03 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Head/Neck) (n=43, 41, 84) | -1.4 Units on a scale | Standard Deviation 0.96 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 0.99 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Upper Limbs) (n=43, 40, 83) | -1.8 Units on a scale | Standard Deviation 0.98 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Upper Limbs) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 0.84 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Lower Limbs) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Head/Neck) (n=43, 40, 83) | -1.7 Units on a scale | Standard Deviation 1.1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Trunk) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.93 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Trunk) (n=43, 39, 82) | -2.0 Units on a scale | Standard Deviation 1.04 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Scaling (Lower Limbs) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.04 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 8: Scaling (Lower Limbs) (n=43, 41, 84) | -1.5 Units on a scale | Standard Deviation 0.88 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Upper Limbs) (n=43, 39, 82) | -1.8 Units on a scale | Standard Deviation 1.05 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Scaling (Lower Limbs) | -1.1 Units on a scale | Standard Deviation 0.89 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Head/Neck) (n=39, 32, 71) | -1.7 Units on a scale | Standard Deviation 1.02 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Head/Neck) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 1.04 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Upper Limbs) (n=39, 32, 71) | -1.7 Units on a scale | Standard Deviation 1.01 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Lower Limbs) (n=39, 32, 71) | -2.1 Units on a scale | Standard Deviation 1.15 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Induration (Head/Neck) (n=43, 39, 82) | -1.6 Units on a scale | Standard Deviation 1.06 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Trunk) (n=39, 32, 71) | -1.7 Units on a scale | Standard Deviation 0.98 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Trunk) (n=39, 32, 71) | -2.0 Units on a scale | Standard Deviation 1.24 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Upper Limbs) (n=43, 40, 83) | -1.9 Units on a scale | Standard Deviation 1.12 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Scaling (Lower Limbs) (n=39, 32, 71) | -1.8 Units on a scale | Standard Deviation 1.1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Upper Limbs) (n=39, 32, 71) | -1.9 Units on a scale | Standard Deviation 1.1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Upper Limbs) (n=43, 41, 84) | -1.8 Units on a scale | Standard Deviation 1.05 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Induration (Head/Neck) (n=39, 32, 71) | -1.6 Units on a scale | Standard Deviation 1.13 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Lower Limbs) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.05 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Trunk) | -0.7 Units on a scale | Standard Deviation 0.69 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Lower Limbs) (n=39, 32, 71) | -2.1 Units on a scale | Standard Deviation 1.03 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Lower Limbs) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 0.99 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Lower Limbs) | -0.7 Units on a scale | Standard Deviation 0.7 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Trunk) (n=39, 32, 71) | -2.2 Units on a scale | Standard Deviation 0.97 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Erythema (Trunk) (n=43, 41, 84) | -2.0 Units on a scale | Standard Deviation 1.01 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Head/Neck) | -0.6 Units on a scale | Standard Deviation 0.82 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Upper Limbs) (n=39, 32, 71) | -2.0 Units on a scale | Standard Deviation 1.04 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Trunk) (n=43, 39, 82) | -2.1 Units on a scale | Standard Deviation 1.04 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Upper Limbs) | -0.6 Units on a scale | Standard Deviation 0.69 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 52: Erythema (Head/Neck) (n=39, 32, 71) | -1.8 Units on a scale | Standard Deviation 1.2 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Lower Limbs) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 1.01 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Trunk) | -0.6 Units on a scale | Standard Deviation 0.62 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Lower Limbs) (n=41, 38, 79) | -1.8 Units on a scale | Standard Deviation 1.08 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Erythema (Trunk) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 1.08 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Induration (Lower Limbs) | -0.6 Units on a scale | Standard Deviation 0.69 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Trunk) (n=41, 38, 79) | -1.8 Units on a scale | Standard Deviation 0.98 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Head/Neck) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 1.02 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Head/Neck) | -0.7 Units on a scale | Standard Deviation 0.83 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Upper Limbs) (n=41, 38, 79) | -1.7 Units on a scale | Standard Deviation 1.02 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Upper Limbs) (n=43, 39, 82) | -1.9 Units on a scale | Standard Deviation 1.11 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Upper Limbs) | -0.6 Units on a scale | Standard Deviation 0.69 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Scaling (Upper Limbs) (n=43, 41, 84) | -1.6 Units on a scale | Standard Deviation 0.94 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Trunk) | -0.6 Units on a scale | Standard Deviation 0.71 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Scaling (Head/Neck) (n=41, 38, 79) | -1.6 Units on a scale | Standard Deviation 0.99 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Upper Limbs) (n=43, 41, 84) | -1.7 Units on a scale | Standard Deviation 0.96 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Scaling (Lower Limbs) | -0.6 Units on a scale | Standard Deviation 0.73 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Lower Limbs) (n=41, 38, 79) | -2.1 Units on a scale | Standard Deviation 1.1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 2: Erythema (Head/Neck) | -0.7 Units on a scale | Standard Deviation 0.84 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Trunk) (n=41, 38, 79) | -2.1 Units on a scale | Standard Deviation 1.11 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 20: Erythema (Head/Neck) (n=43, 39, 82) | -1.7 Units on a scale | Standard Deviation 1.07 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Upper Limbs) | -1.1 Units on a scale | Standard Deviation 0.87 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Upper Limbs) (n=41, 38, 79) | -1.9 Units on a scale | Standard Deviation 1.09 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Induration (Trunk) (n=43, 40, 83) | -2.0 Units on a scale | Standard Deviation 1.01 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Trunk) | -1.1 Units on a scale | Standard Deviation 0.72 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Induration (Head/Neck) (n=41, 38, 79) | -1.6 Units on a scale | Standard Deviation 1.07 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 12: Induration (Trunk) (n=43, 41, 84) | -2.0 Units on a scale | Standard Deviation 1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Erythema (Lower Limbs) | -1.2 Units on a scale | Standard Deviation 0.85 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Lower Limbs) (n=41, 38, 79) | -2.2 Units on a scale | Standard Deviation 1.05 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 16: Scaling (Lower Limbs) (n=43, 40, 83) | -1.7 Units on a scale | Standard Deviation 1 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 4: Induration (Head/Neck) | -1.0 Units on a scale | Standard Deviation 1.02 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score | Week 40: Erythema (Upper Limbs) (n=41, 38, 79) | -2.0 Units on a scale | Standard Deviation 1.06 |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
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.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 2 | -5.18 Units on a scale | Standard Deviation 5.898 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=43, 41, 84) | -18.91 Units on a scale | Standard Deviation 8.918 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=43, 41, 84) | -15.95 Units on a scale | Standard Deviation 8.392 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 4 | -10.40 Units on a scale | Standard Deviation 7.518 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=43, 40, 83) | -19.53 Units on a scale | Standard Deviation 9.094 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 52 (n=39, 32, 71) | -21.96 Units on a scale | Standard Deviation 9.621 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=41, 38, 79) | -22.20 Units on a scale | Standard Deviation 10.181 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=43, 39, 82) | -20.95 Units on a scale | Standard Deviation 9.239 |
| CP-690,550 5 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=43, 39, 82) | -21.77 Units on a scale | Standard Deviation 10.196 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=43, 39, 82) | -22.18 Units on a scale | Standard Deviation 12.045 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=43, 39, 82) | -21.46 Units on a scale | Standard Deviation 10.503 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=41, 38, 79) | -21.18 Units on a scale | Standard Deviation 10.229 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 52 (n=39, 32, 71) | -22.11 Units on a scale | Standard Deviation 10.598 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=43, 41, 84) | -19.90 Units on a scale | Standard Deviation 10.741 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=43, 41, 84) | -21.68 Units on a scale | Standard Deviation 11.598 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=43, 40, 83) | -22.06 Units on a scale | Standard Deviation 12.606 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 4 | -13.16 Units on a scale | Standard Deviation 8.739 |
| CP-690,550 10 mg BID | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 2 | -7.36 Units on a scale | Standard Deviation 6.428 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 52 (n=39, 32, 71) | -22.03 Units on a scale | Standard Deviation 10 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 2 | -6.28 Units on a scale | Standard Deviation 6.232 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 4 | -11.79 Units on a scale | Standard Deviation 8.229 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=43, 41, 84) | -17.88 Units on a scale | Standard Deviation 9.756 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=43, 41, 84) | -20.26 Units on a scale | Standard Deviation 10.344 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=43, 40, 83) | -20.75 Units on a scale | Standard Deviation 10.935 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=43, 39, 82) | -21.53 Units on a scale | Standard Deviation 10.617 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=41, 38, 79) | -21.71 Units on a scale | Standard Deviation 10.151 |
| Total | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=43, 39, 82) | -21.62 Units on a scale | Standard Deviation 10.28 |
Secondary
Dermatology Life Quality Index (DLQI) Score
The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Baseline | 11.3 Units on a scale | Standard Deviation 6.25 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 2 | 7.8 Units on a scale | Standard Deviation 5.2 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 4 (n=43, 43, 86) | 5.9 Units on a scale | Standard Deviation 5.07 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 8 (n=43, 41, 84) | 4.0 Units on a scale | Standard Deviation 3.95 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 12 (n=43, 41, 84) | 2.6 Units on a scale | Standard Deviation 2.86 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 16 (n=43, 40, 83) | 2.2 Units on a scale | Standard Deviation 3.04 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 20 (n=43, 39, 82) | 1.9 Units on a scale | Standard Deviation 3.13 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 28 (n=43, 39, 82) | 1.7 Units on a scale | Standard Deviation 2.66 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 40 (n=41, 38, 79) | 1.8 Units on a scale | Standard Deviation 2.81 |
| CP-690,550 5 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 52 (n=39, 32, 71) | 1.6 Units on a scale | Standard Deviation 2.42 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 40 (n=41, 38, 79) | 2.3 Units on a scale | Standard Deviation 4.11 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Baseline | 8.6 Units on a scale | Standard Deviation 5.91 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 16 (n=43, 40, 83) | 1.9 Units on a scale | Standard Deviation 2.73 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 4 (n=43, 43, 86) | 4.2 Units on a scale | Standard Deviation 4.63 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 12 (n=43, 41, 84) | 1.8 Units on a scale | Standard Deviation 2.68 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 2 | 5.8 Units on a scale | Standard Deviation 5.32 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 52 (n=39, 32, 71) | 2.2 Units on a scale | Standard Deviation 4 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 28 (n=43, 39, 82) | 2.9 Units on a scale | Standard Deviation 3.68 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 20 (n=43, 39, 82) | 1.8 Units on a scale | Standard Deviation 2.54 |
| CP-690,550 10 mg BID | Dermatology Life Quality Index (DLQI) Score | Week 8 (n=43, 41, 84) | 2.8 Units on a scale | Standard Deviation 3.3 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 28 (n=43, 39, 82) | 2.3 Units on a scale | Standard Deviation 3.23 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 8 (n=43, 41, 84) | 3.4 Units on a scale | Standard Deviation 3.67 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 12 (n=43, 41, 84) | 2.2 Units on a scale | Standard Deviation 2.79 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 16 (n=43, 40, 83) | 2.1 Units on a scale | Standard Deviation 2.88 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 40 (n=41, 38, 79) | 2.0 Units on a scale | Standard Deviation 3.48 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 20 (n=43, 39, 82) | 1.9 Units on a scale | Standard Deviation 2.84 |
| Total | Dermatology Life Quality Index (DLQI) Score | Baseline | 9.9 Units on a scale | Standard Deviation 6.19 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 52 (n=39, 32, 71) | 1.9 Units on a scale | Standard Deviation 3.22 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 2 | 6.8 Units on a scale | Standard Deviation 5.32 |
| Total | Dermatology Life Quality Index (DLQI) Score | Week 4 (n=43, 43, 86) | 5.1 Units on a scale | Standard Deviation 4.9 |
Secondary
Itch Severity Item (ISI) Score
ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 2 | 5.19 Units on a scale | Standard Deviation 2.797 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 20 (n=43, 39, 82) | 0.95 Units on a scale | Standard Deviation 1.618 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 12 (n=43, 41, 84) | 1.77 Units on a scale | Standard Deviation 2.379 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Baseline | 6.16 Units on a scale | Standard Deviation 2.669 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 16 (n=43, 40, 83) | 1.67 Units on a scale | Standard Deviation 2.378 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 40 (n=41, 38, 79) | 0.90 Units on a scale | Standard Deviation 1.814 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 4 | 3.65 Units on a scale | Standard Deviation 2.379 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 52 (n=39, 32, 71) | 1.15 Units on a scale | Standard Deviation 2.084 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 28 (n=43, 39, 82) | 1.12 Units on a scale | Standard Deviation 1.651 |
| CP-690,550 5 mg BID | Itch Severity Item (ISI) Score | Week 8 (n=43, 41, 84) | 2.26 Units on a scale | Standard Deviation 2.381 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Baseline | 5.32 Units on a scale | Standard Deviation 2.967 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 2 | 3.30 Units on a scale | Standard Deviation 2.53 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 4 | 2.27 Units on a scale | Standard Deviation 2.472 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 8 (n=43, 41, 84) | 1.22 Units on a scale | Standard Deviation 1.739 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 12 (n=43, 41, 84) | 1.20 Units on a scale | Standard Deviation 1.833 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 16 (n=43, 40, 83) | 0.90 Units on a scale | Standard Deviation 1.257 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 20 (n=43, 39, 82) | 1.28 Units on a scale | Standard Deviation 1.589 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 28 (n=43, 39, 82) | 1.62 Units on a scale | Standard Deviation 2.196 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 40 (n=41, 38, 79) | 1.13 Units on a scale | Standard Deviation 1.848 |
| CP-690,550 10 mg BID | Itch Severity Item (ISI) Score | Week 52 (n=39, 32, 71) | 0.91 Units on a scale | Standard Deviation 1.329 |
| Total | Itch Severity Item (ISI) Score | Week 20 (n=43, 39, 82) | 1.11 Units on a scale | Standard Deviation 1.603 |
| Total | Itch Severity Item (ISI) Score | Week 4 | 2.95 Units on a scale | Standard Deviation 2.51 |
| Total | Itch Severity Item (ISI) Score | Baseline | 5.74 Units on a scale | Standard Deviation 2.839 |
| Total | Itch Severity Item (ISI) Score | Week 28 (n=43, 39, 82) | 1.35 Units on a scale | Standard Deviation 1.933 |
| Total | Itch Severity Item (ISI) Score | Week 2 | 4.23 Units on a scale | Standard Deviation 2.815 |
| Total | Itch Severity Item (ISI) Score | Week 12 (n=43, 41, 84) | 1.49 Units on a scale | Standard Deviation 2.137 |
| Total | Itch Severity Item (ISI) Score | Week 52 (n=39, 32, 71) | 1.04 Units on a scale | Standard Deviation 1.776 |
| Total | Itch Severity Item (ISI) Score | Week 16 (n=43, 40, 83) | 1.30 Units on a scale | Standard Deviation 1.949 |
| Total | Itch Severity Item (ISI) Score | Week 8 (n=43, 41, 84) | 1.75 Units on a scale | Standard Deviation 2.145 |
| Total | Itch Severity Item (ISI) Score | Week 40 (n=41, 38, 79) | 1.01 Units on a scale | Standard Deviation 1.822 |
Secondary
Joint Pain Assessment (JPA)
The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain.
Time frame: Baseline, Week 4, 16, 28, 52
Population: The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Joint Pain Assessment (JPA) | Baseline | 5.25 Units on a scale | Standard Deviation 3.327 |
| CP-690,550 5 mg BID | Joint Pain Assessment (JPA) | Week 28 (n=8, 14, 22) | 1.75 Units on a scale | Standard Deviation 1.753 |
| CP-690,550 5 mg BID | Joint Pain Assessment (JPA) | Week 16 (n=8, 15, 23) | 1.88 Units on a scale | Standard Deviation 2.295 |
| CP-690,550 5 mg BID | Joint Pain Assessment (JPA) | Week 52 (n=4, 13, 17) | 0.50 Units on a scale | Standard Deviation 0.577 |
| CP-690,550 5 mg BID | Joint Pain Assessment (JPA) | Week 4 (n=8, 14, 22) | 4.00 Units on a scale | Standard Deviation 2.726 |
| CP-690,550 10 mg BID | Joint Pain Assessment (JPA) | Week 28 (n=8, 14, 22) | 0.86 Units on a scale | Standard Deviation 0.949 |
| CP-690,550 10 mg BID | Joint Pain Assessment (JPA) | Baseline | 4.60 Units on a scale | Standard Deviation 2.558 |
| CP-690,550 10 mg BID | Joint Pain Assessment (JPA) | Week 4 (n=8, 14, 22) | 1.36 Units on a scale | Standard Deviation 1.008 |
| CP-690,550 10 mg BID | Joint Pain Assessment (JPA) | Week 16 (n=8, 15, 23) | 0.60 Units on a scale | Standard Deviation 0.737 |
| CP-690,550 10 mg BID | Joint Pain Assessment (JPA) | Week 52 (n=4, 13, 17) | 0.54 Units on a scale | Standard Deviation 0.66 |
| Total | Joint Pain Assessment (JPA) | Week 4 (n=8, 14, 22) | 2.32 Units on a scale | Standard Deviation 2.191 |
| Total | Joint Pain Assessment (JPA) | Week 28 (n=8, 14, 22) | 1.18 Units on a scale | Standard Deviation 1.332 |
| Total | Joint Pain Assessment (JPA) | Baseline | 4.83 Units on a scale | Standard Deviation 2.79 |
| Total | Joint Pain Assessment (JPA) | Week 52 (n=4, 13, 17) | 0.53 Units on a scale | Standard Deviation 0.624 |
| Total | Joint Pain Assessment (JPA) | Week 16 (n=8, 15, 23) | 1.04 Units on a scale | Standard Deviation 1.551 |
Secondary
Number of Affected Nails
Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.
Time frame: Baseline, Week 8, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Number of Affected Nails | Week 8 (n=32, 28, 60) | 7.66 nails | Standard Deviation 3.17 |
| CP-690,550 5 mg BID | Number of Affected Nails | Week 28 (n=32, 27, 59) | 4.53 nails | Standard Deviation 3.87 |
| CP-690,550 5 mg BID | Number of Affected Nails | Week 20 (n=32, 27, 59) | 6.16 nails | Standard Deviation 3.6 |
| CP-690,550 5 mg BID | Number of Affected Nails | Baseline | 7.94 nails | Standard Deviation 2.82 |
| CP-690,550 5 mg BID | Number of Affected Nails | Week 52 (n=30, 22, 52) | 3.73 nails | Standard Deviation 4.25 |
| CP-690,550 5 mg BID | Number of Affected Nails | Week 40 (n=31, 26, 57) | 3.32 nails | Standard Deviation 3.94 |
| CP-690,550 5 mg BID | Number of Affected Nails | Week 16 (n=32, 28, 60) | 6.91 nails | Standard Deviation 3.43 |
| CP-690,550 10 mg BID | Number of Affected Nails | Week 20 (n=32, 27, 59) | 4.59 nails | Standard Deviation 4.02 |
| CP-690,550 10 mg BID | Number of Affected Nails | Baseline | 7.13 nails | Standard Deviation 3.07 |
| CP-690,550 10 mg BID | Number of Affected Nails | Week 8 (n=32, 28, 60) | 7.11 nails | Standard Deviation 3.02 |
| CP-690,550 10 mg BID | Number of Affected Nails | Week 16 (n=32, 28, 60) | 5.75 nails | Standard Deviation 3.56 |
| CP-690,550 10 mg BID | Number of Affected Nails | Week 28 (n=32, 27, 59) | 3.59 nails | Standard Deviation 3.96 |
| CP-690,550 10 mg BID | Number of Affected Nails | Week 40 (n=31, 26, 57) | 3.77 nails | Standard Deviation 3.81 |
| CP-690,550 10 mg BID | Number of Affected Nails | Week 52 (n=30, 22, 52) | 2.50 nails | Standard Deviation 3.07 |
| Total | Number of Affected Nails | Week 28 (n=32, 27, 59) | 4.10 nails | Standard Deviation 3.91 |
| Total | Number of Affected Nails | Week 8 (n=32, 28, 60) | 7.40 nails | Standard Deviation 3.09 |
| Total | Number of Affected Nails | Week 52 (n=30, 22, 52) | 3.21 nails | Standard Deviation 3.81 |
| Total | Number of Affected Nails | Week 40 (n=31, 26, 57) | 3.53 nails | Standard Deviation 3.85 |
| Total | Number of Affected Nails | Week 20 (n=32, 27, 59) | 5.44 nails | Standard Deviation 3.85 |
| Total | Number of Affected Nails | Week 16 (n=32, 28, 60) | 6.37 nails | Standard Deviation 3.51 |
| Total | Number of Affected Nails | Baseline | 7.55 nails | Standard Deviation 2.95 |
Secondary
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Mild (n=43, 39, 82) | 18.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Clear | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Moderate (n=43, 39, 82) | 9.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Mild | 44.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Severe(n=43, 39, 82) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Almost Clear (n=43, 39, 82) | 30.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Mild (n=43, 39, 82) | 27.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Moderate | 18.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Severe (n=43, 39, 82) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Clear (n=41, 38, 79) | 43.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Clear (n=43, 39, 82) | 37.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Almost Clear (n=41, 38, 79) | 26.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Severe | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Mild (n=41, 38, 79) | 24.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Severe (n=41, 38, 79) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Almost Clear | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Clear (n=39, 32, 71) | 41.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Clear (n=43, 41, 84) | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Almost Clear (n=39, 32, 71) | 23.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Mild (n=39, 32, 71) | 30.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Moderate (n=39, 32, 71) | 5.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Moderate (n=43, 41, 84) | 14.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Almost Clear (n=43, 41, 84) | 51.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Moderate (n=43, 39, 82) | 4.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Mild (n=43, 41, 84) | 27.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Mild | 39.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Severe (n=43, 41, 84) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Clear (n=43, 41, 84) | 14.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Moderate | 46.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Almost Clear (n=43, 41, 84) | 58.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Mild (n=43, 41, 84) | 20.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Moderate (n=43, 41, 84) | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Moderate (n=41, 38, 79) | 4.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Severe (n=43, 41, 84) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Severe | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Clear (n=43, 40, 83) | 27.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Almost Clear (n=43, 40, 83) | 39.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Mild (n=43, 40, 83) | 25.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Clear | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Moderate (n=43, 40, 83) | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Severe (n=43, 40, 83) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Severe (n=39, 32, 71) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Clear (n=43, 39, 82) | 27.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Almost Clear | 30.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Almost Clear (n=43, 39, 82) | 44.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Severe (n=43, 41, 84) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Mild (n=43, 39, 82) | 25.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Almost Clear (n=43, 41, 84) | 39.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Moderate (n=43, 40, 83) | 5.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Moderate (n=43, 39, 82) | 7.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Clear | 11.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Mild (n=43, 41, 84) | 24.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Severe(n=43, 39, 82) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Mild | 40.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Clear (n=43, 40, 83) | 40.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Almost Clear (n=43, 39, 82) | 28.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Clear | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Mild | 43.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Mild (n=43, 39, 82) | 30.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Moderate (n=43, 39, 82) | 7.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Severe | 6.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Severe (n=43, 41, 84) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Severe (n=43, 39, 82) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Moderate | 20.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Clear (n=43, 39, 82) | 33.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Clear (n=41, 38, 79) | 34.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Clear (n=43, 39, 82) | 38.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Clear (n=43, 41, 84) | 36.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Almost Clear (n=41, 38, 79) | 28.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Almost Clear (n=43, 40, 83) | 35.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Moderate (n=43, 41, 84) | 9.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Mild (n=41, 38, 79) | 28.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Moderate (n=41, 38, 79) | 7.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Severe | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Almost Clear (n=43, 41, 84) | 43.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Severe (n=41, 38, 79) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Severe (n=43, 40, 83) | 2.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Mild (n=43, 41, 84) | 9.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Clear (n=39, 32, 71) | 43.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Moderate | 34.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Mild (n=43, 40, 83) | 17.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Almost Clear (n=39, 32, 71) | 34.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Clear (n=43, 41, 84) | 26.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Moderate (n=43, 41, 84) | 9.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Mild (n=39, 32, 71) | 18.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Almost Clear | 15.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Almost Clear (n=43, 39, 82) | 28.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Moderate (n=39, 32, 71) | 3.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Severe (n=39, 32, 71) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Almost Clear | 27.3 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Severe (n=39, 32, 71) | 0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Almost Clear (n=43, 41, 84) | 51.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Clear (n=43, 39, 82) | 35.4 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Mild (n=43, 39, 82) | 29.3 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Mild (n=41, 38, 79) | 26.6 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Moderate (n=39, 32, 71) | 4.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Clear | 0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Almost Clear | 11.5 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Mild | 41.4 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Moderate | 40.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 2: Severe | 6.9 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Clear | 5.7 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Almost Clear | 28.7 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Mild | 42.5 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Moderate | 19.5 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 4: Severe | 3.4 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Clear (n=43, 41, 84) | 16.7 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Almost Clear (n=43, 41, 84) | 45.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Mild (n=43, 41, 84) | 26.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Moderate (n=43, 41, 84) | 11.9 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 8: Severe (n=43, 41, 84) | 0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Clear (n=43, 41, 84) | 25.0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Mild (n=43, 41, 84) | 15.5 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Moderate (n=43, 41, 84) | 8.3 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 12: Severe (n=43, 41, 84) | 0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Clear (n=43, 40, 83) | 33.7 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Almost Clear (n=43, 40, 83) | 37.3 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Mild (n=43, 40, 83) | 21.7 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Moderate (n=43, 40, 83) | 6.0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 16: Severe (n=43, 40, 83) | 1.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Clear (n=43, 39, 82) | 32.9 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Almost Clear (n=43, 39, 82) | 36.6 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Mild (n=43, 39, 82) | 22.0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Moderate (n=43, 39, 82) | 8.5 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 20: Severe(n=43, 39, 82) | 0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Almost Clear (n=43, 39, 82) | 29.3 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Moderate (n=43, 39, 82) | 6.1 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 28: Severe (n=43, 39, 82) | 0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Clear (n=41, 38, 79) | 39.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Almost Clear (n=41, 38, 79) | 27.8 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Moderate (n=41, 38, 79) | 6.3 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 40: Severe (n=41, 38, 79) | 0 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Clear (n=39, 32, 71) | 42.3 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Almost Clear (n=39, 32, 71) | 28.2 Percentage of participants |
| Total | Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category | Week 52: Mild (n=39, 32, 71) | 25.4 Percentage of participants |
Secondary
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.
Time frame: Week 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 28 | 93.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 52 | 65.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 20 | 100 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 40 | 82.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 28 | 73.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 52 | 60.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 40 | 66.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 20 | 83.3 Percentage of participants |
| Total | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 52 | 62.7 Percentage of participants |
| Total | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 20 | 91.5 Percentage of participants |
| Total | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 28 | 83.1 Percentage of participants |
| Total | Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 40 | 74.6 Percentage of participants |
Secondary
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported.
Time frame: Week 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 40 | 81.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 52 | 70.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 28 | 92.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 20 | 96.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 20 | 87.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 28 | 78.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 52 | 62.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 40 | 71.9 Percentage of participants |
| Total | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 52 | 66.1 Percentage of participants |
| Total | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 20 | 91.5 Percentage of participants |
| Total | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 28 | 84.7 Percentage of participants |
| Total | Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 | Week 40 | 76.3 Percentage of participants |
Secondary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 2, 4, 8, 12, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 8 | 75.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 2 | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 12 | 100 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 40 | 75.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 4 | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 20 | 100 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 52 | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 28 | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 4 | 75.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 28 | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 2 | 62.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 40 | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 52 | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 8 | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 12 | 87.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 20 | 87.5 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 52 | 83.3 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 2 | 41.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 4 | 66.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 8 | 91.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 12 | 91.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 20 | 91.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 28 | 100 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 40 | 91.7 Percentage of participants |
Secondary
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 12 | 75.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 52 | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 20 | 100 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 16 | 75.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 2 | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 40 | 75.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 8 | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 4 | 25.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 28 | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 16 | 87.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 2 | 25.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 4 | 50.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 8 | 62.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 12 | 75.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 20 | 87.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 28 | 75.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 40 | 87.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 52 | 87.5 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 8 | 58.3 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 2 | 16.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 28 | 83.3 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 4 | 41.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 52 | 75.0 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 16 | 83.3 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 12 | 75.0 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 40 | 83.3 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 20 | 91.7 Percentage of participants |
Secondary
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
ACR70 response: greater than or equal to (\>=) 70 percent (%) improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 12 | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 2 | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 4 | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 8 | 25.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 16 | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 20 | 75.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 28 | 75.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 40 | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 52 | 50.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 52 | 75.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 12 | 62.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 16 | 62.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 8 | 62.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 2 | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 40 | 75.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 28 | 50.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 4 | 37.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 20 | 75.0 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 4 | 25.0 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 8 | 50.0 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 12 | 58.3 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 16 | 58.3 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 20 | 75.0 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 40 | 66.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 52 | 66.7 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 2 | 0.0 Percentage of participants |
| Total | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 28 | 58.3 Percentage of participants |
Secondary
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear \[no psoriasis\]; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Almost Clear (n=43, 41, 84) | 14.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Clear | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Moderate (n=43, 39, 82) | 23.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Mild (n=43, 41, 84) | 32.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Moderate (n=39, 32, 71) | 15.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Mild (n=43, 39, 82) | 25.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Moderate (n=43, 41, 84) | 39.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Severe (n=41, 38, 79) | 4.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Almost Clear (n=43, 39, 82) | 37.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Severe (n=43, 41, 84) | 9.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Almost Clear | 2.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Clear (n=43, 39, 82) | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Clear (n=43, 41, 84) | 2.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Mild | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Severe (n=43, 40, 83) | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Almost Clear (n=43, 41, 84) | 20.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Moderate (n=41, 38, 79) | 22.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Mild (n=43, 40, 83) | 23.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Mild (n=43, 41, 84) | 34.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Mild | 2.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Almost Clear (n=43, 40, 83) | 32.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Moderate (n=43, 41, 84) | 34.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Severe (n=39, 32, 71) | 15.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Clear (n=43, 40, 83) | 4.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Severe (n=43, 41, 84) | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Mild (n=41, 38, 79) | 19.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Moderate | 60.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Mild (n=39, 32, 71) | 28.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Almost Clear (n=41, 38, 79) | 46.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Severe | 34.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Moderate | 41.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Clear (n=41, 38, 79) | 7.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Clear (n=43, 43, 86) | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Almost Clear | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Severe (n=43, 39, 82) | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Almost Clear (n=43, 43, 86) | 4.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Moderate (n=43, 40, 83) | 32.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Moderate (n=43, 39, 82) | 20.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Mild (n=43, 43, 86) | 18.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Almost Clear (n=39, 32, 71) | 20.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Mild (n=43, 39, 82) | 23.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Moderate (n=43, 43, 86) | 53.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Severe | 58.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Almost Clear (n=43, 39, 82) | 37.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Severe (n=43, 43, 86) | 23.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Clear | 0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Clear (n=43, 39, 82) | 11.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Clear (n=43, 41, 84) | 4.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Clear (n=39, 32, 71) | 20.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Severe (n=43, 39, 82) | 7.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Almost Clear (n=43, 43, 86) | 9.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Moderate (n=43, 40, 83) | 22.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Clear | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Almost Clear | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Mild | 2.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Moderate | 43.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Severe | 54.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Clear | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Almost Clear | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Mild | 29.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Moderate | 36.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Severe | 34.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Clear (n=43, 43, 86) | 2.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Mild (n=43, 43, 86) | 25.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Moderate (n=43, 43, 86) | 48.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Severe (n=43, 43, 86) | 14.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Clear (n=43, 41, 84) | 7.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Almost Clear (n=43, 41, 84) | 17.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Mild (n=43, 41, 84) | 34.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Moderate (n=43, 41, 84) | 34.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Severe (n=43, 41, 84) | 7.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Clear (n=43, 41, 84) | 7.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Almost Clear (n=43, 41, 84) | 26.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Mild (n=43, 41, 84) | 41.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Moderate (n=43, 41, 84) | 17.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Severe (n=43, 41, 84) | 7.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Clear (n=43, 40, 83) | 10.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Almost Clear (n=43, 40, 83) | 22.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Mild (n=43, 40, 83) | 35.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Severe (n=43, 40, 83) | 10.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Clear (n=43, 39, 82) | 12.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Almost Clear (n=43, 39, 82) | 23.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Mild (n=43, 39, 82) | 33.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Moderate (n=43, 39, 82) | 25.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Severe (n=43, 39, 82) | 5.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Clear (n=43, 39, 82) | 5.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Almost Clear (n=43, 39, 82) | 35.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Mild (n=43, 39, 82) | 20.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Moderate (n=43, 39, 82) | 33.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Severe (n=43, 39, 82) | 5.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Clear (n=41, 38, 79) | 18.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Almost Clear (n=41, 38, 79) | 31.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Mild (n=41, 38, 79) | 18.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Moderate (n=41, 38, 79) | 26.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Severe (n=41, 38, 79) | 5.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Clear (n=39, 32, 71) | 18.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Almost Clear (n=39, 32, 71) | 31.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Mild (n=39, 32, 71) | 25.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Moderate (n=39, 32, 71) | 21.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Severe (n=39, 32, 71) | 3.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Almost Clear | 0 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Moderate (n=43, 39, 82) | 24.4 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Clear (n=43, 41, 84) | 6.0 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Severe (n=41, 38, 79) | 5.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Severe (n=43, 39, 82) | 6.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Severe (n=43, 43, 86) | 18.6 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Severe | 56.3 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Clear (n=43, 39, 82) | 8.5 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Moderate (n=43, 43, 86) | 51.2 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Severe (n=39, 32, 71) | 9.9 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Almost Clear (n=43, 39, 82) | 36.6 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Mild (n=43, 43, 86) | 22.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Clear (n=39, 32, 71) | 19.7 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Mild (n=43, 39, 82) | 22.0 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Almost Clear (n=43, 43, 86) | 7.0 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Moderate | 42.5 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Moderate (n=43, 39, 82) | 26.8 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 4: Clear (n=43, 43, 86) | 1.2 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Moderate (n=39, 32, 71) | 18.3 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 28: Severe (n=43, 39, 82) | 6.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Severe | 34.5 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Almost Clear (n=39, 32, 71) | 25.4 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Clear (n=41, 38, 79) | 12.7 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Moderate | 48.3 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Mild | 1.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Almost Clear (n=41, 38, 79) | 39.2 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Severe (n=43, 41, 84) | 7.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Moderate (n=43, 41, 84) | 26.2 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Mild | 16.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Clear (n=43, 40, 83) | 7.2 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Mild (n=43, 41, 84) | 38.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Baseline: Clear | 0 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Almost Clear (n=43, 40, 83) | 27.7 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Almost Clear (n=43, 41, 84) | 23.8 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Mild (n=41, 38, 79) | 19.0 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Mild (n=43, 40, 83) | 28.9 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Moderate (n=43, 40, 83) | 27.7 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 12: Clear (n=43, 41, 84) | 4.8 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Almost Clear | 1.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 16: Severe (n=43, 40, 83) | 8.4 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Severe (n=43, 41, 84) | 8.3 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 52: Mild (n=39, 32, 71) | 26.8 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Clear (n=43, 39, 82) | 9.8 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Moderate (n=43, 41, 84) | 36.9 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 40: Moderate (n=41, 38, 79) | 24.1 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Almost Clear (n=43, 39, 82) | 30.5 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Mild (n=43, 41, 84) | 33.3 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 2: Clear | 0 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 20: Mild (n=43, 39, 82) | 29.3 Percentage of participants |
| Total | Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category | Week 8: Almost Clear (n=43, 41, 84) | 15.5 Percentage of participants |
Secondary
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time frame: Week 2, 4, 8, 12, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 28 | 67.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 8 | 58.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 52 | 58.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 20 | 72.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 12 | 72.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 40 | 67.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 4 | 30.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 2 | 7.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 52 | 56.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 40 | 54.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 2 | 15.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 4 | 38.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 8 | 61.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 12 | 75.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 20 | 59.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 28 | 54.5 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 20 | 65.5 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 4 | 34.5 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 12 | 73.6 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 28 | 60.9 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 2 | 11.5 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 40 | 60.9 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 8 | 59.8 Percentage of participants |
| Total | Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | Week 52 | 57.5 Percentage of participants |
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
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 assessed 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. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 12 | 81.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 52 | 90.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 20 | 79.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 16 | 76.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 2 | 9.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 40 | 88.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 8 | 60.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 4 | 34.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 28 | 90.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 16 | 79.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 2 | 22.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 4 | 56.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 8 | 81.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 12 | 84.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 20 | 75.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 28 | 72.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 40 | 79.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 52 | 68.2 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 8 | 71.3 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 2 | 16.1 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 28 | 81.6 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 4 | 46.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 52 | 79.3 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 16 | 78.2 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 12 | 82.8 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 40 | 83.9 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response | Week 20 | 77.0 Percentage of participants |
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
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 assessed 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 at the each visit relative to Baseline.
Time frame: Week 2, 4, 8, 12, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 2 | 2.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 4 | 7.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 8 | 41.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 12 | 60.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 20 | 67.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 28 | 69.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 40 | 69.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 52 | 62.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 8 | 54.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 40 | 63.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 12 | 70.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 20 | 63.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 28 | 65.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 2 | 4.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 4 | 22.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 52 | 63.6 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 8 | 48.3 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 4 | 14.9 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 2 | 3.4 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 12 | 65.5 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 40 | 66.7 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 28 | 67.8 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 20 | 65.5 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response | Week 52 | 63.2 Percentage of participants |
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
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 assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 12 | 37.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 52 | 51.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 20 | 58.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 16 | 37.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 2 | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 40 | 58.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 8 | 16.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 4 | 4.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 28 | 55.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 16 | 54.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 2 | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 4 | 13.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 8 | 29.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 12 | 45.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 20 | 56.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 28 | 45.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 40 | 47.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 52 | 47.7 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 8 | 23.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 2 | 0.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 28 | 50.6 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 4 | 9.2 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 52 | 49.4 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 16 | 46.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 12 | 41.4 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 40 | 52.9 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response | Week 20 | 57.5 Percentage of participants |
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
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.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 2 | 2.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 12 (n=43, 41, 84) | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 8 (n=43, 41, 84) | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 4 | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 16 (n=43, 40, 83) | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 52 (n=39, 32, 71) | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 40 (n=41, 38, 79) | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 20 (n=43, 39, 82) | 0.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 28 (n=43, 39, 82) | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 20 (n=43, 39, 82) | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 28 (n=43, 39, 82) | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 40 (n=41, 38, 79) | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 52 (n=39, 32, 71) | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 8 (n=43, 41, 84) | 0.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 12 (n=43, 41, 84) | 2.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 16 (n=43, 40, 83) | 2.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 4 | 2.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 2 | 0.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 52 (n=39, 32, 71) | 0.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 2 | 1.1 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 4 | 1.1 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 8 (n=43, 41, 84) | 0.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 12 (n=43, 41, 84) | 1.2 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 16 (n=43, 40, 83) | 1.2 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 20 (n=43, 39, 82) | 0.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 40 (n=41, 38, 79) | 0.0 Percentage of participants |
| Total | Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score | Week 28 (n=43, 39, 82) | 0.0 Percentage of participants |
Secondary
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Week 16
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg BID | Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | 8.0 Week |
| CP-690,550 10 mg BID | Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | 8.0 Week |
| Total | Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | 8.0 Week |
Secondary
Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed 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. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Week 16
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg BID | Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response | 8.0 Week |
| CP-690,550 10 mg BID | Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response | 4.0 Week |
| Total | Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response | 8.0 Week |
Secondary
Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Week 16
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg BID | Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response | 12.0 Week |
| CP-690,550 10 mg BID | Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response | 8.0 Week |
| Total | Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response | 12.0 Week |
Secondary
Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Week 16
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg BID | Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response | NA Week |
| CP-690,550 10 mg BID | Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response | 12.0 Week |
| Total | Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response | 16.0 Week |
Secondary
Work Limitation Questionnaire (WLQ)
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Baseline (BL), Week (W) 4, 16, 28, 52
Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W52:Mental/Interpersonal Demands Scale(n=30,30,60) | 25.56 Units on a scale | Standard Deviation 36.007 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W28: Physical Demands scale (n=32, 34, 66) | 76.02 Units on a scale | Standard Deviation 31.041 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W4: WLQ Index Score (n=32, 37, 69) | 7.23 Units on a scale | Standard Deviation 5.591 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | BL: Physical Demands scale (n=33, 35, 68) | 66.67 Units on a scale | Standard Deviation 33.522 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W28: Time Management scale (n=34, 34, 68) | 38.68 Units on a scale | Standard Deviation 40.1 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W16: Time Management scale (n=31, 35, 66) | 35.07 Units on a scale | Standard Deviation 38.894 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W52: Output Demands scale (n=30, 29, 59) | 22.63 Units on a scale | Standard Deviation 33.75 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W16: WLQ Index Score (n=32, 35, 67) | 6.88 Units on a scale | Standard Deviation 4.715 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W16: Physical Demands scale (n=30, 32, 62) | 81.60 Units on a scale | Standard Deviation 26.982 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | BL: Mental/Interpersonal Demands Scale(n=34,38,72) | 28.61 Units on a scale | Standard Deviation 29.012 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W16: Output Demands scale (n=32, 33, 65) | 11.88 Units on a scale | Standard Deviation 20.111 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W16:Mental/Interpersonal Demands Scale(n=31,35,66) | 13.33 Units on a scale | Standard Deviation 21.038 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W4: Physical Demands scale (n=29, 36, 65) | 77.16 Units on a scale | Standard Deviation 33.013 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W52: Physical Demands scale (n=29, 29, 58) | 78.16 Units on a scale | Standard Deviation 30.205 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | BL: Output Demands scale (n=33, 37, 70) | 22.61 Units on a scale | Standard Deviation 26.832 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W52: Time Management scale (n=31, 31, 62) | 50.32 Units on a scale | Standard Deviation 43.683 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | BL: WLQ Index Score (n=34, 38, 72) | 9.55 Units on a scale | Standard Deviation 6.716 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W28: WLQ Index Score (n=34, 36, 70) | 7.43 Units on a scale | Standard Deviation 6.493 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W4: Time Management scale (n=31, 36, 67) | 35.32 Units on a scale | Standard Deviation 42.425 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W52: WLQ Index Score (n=32, 31, 63) | 9.44 Units on a scale | Standard Deviation 8.127 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W28: Output Demands scale (n=33, 34, 67) | 13.94 Units on a scale | Standard Deviation 27.408 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W4:Mental/Interpersonal Demands Scale(n=32,36,68) | 17.94 Units on a scale | Standard Deviation 26.979 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | BL: Time Management scale (n=34, 37, 71) | 44.49 Units on a scale | Standard Deviation 37.783 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W28:Mental/Interpersonal Demands Scale(n=33,35,68) | 16.84 Units on a scale | Standard Deviation 28.242 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) | W4: Output Demands scale (n=30, 36, 66) | 13.50 Units on a scale | Standard Deviation 21.978 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W28: Time Management scale (n=34, 34, 68) | 29.78 Units on a scale | Standard Deviation 39.092 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | BL: Output Demands scale (n=33, 37, 70) | 30.27 Units on a scale | Standard Deviation 35.295 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | BL: WLQ Index Score (n=34, 38, 72) | 10.74 Units on a scale | Standard Deviation 8.045 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W4: Physical Demands scale (n=29, 36, 65) | 83.59 Units on a scale | Standard Deviation 29.593 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | BL: Physical Demands scale (n=33, 35, 68) | 78.40 Units on a scale | Standard Deviation 31.122 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | BL: Mental/Interpersonal Demands Scale(n=34,38,72) | 31.52 Units on a scale | Standard Deviation 30.93 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W4: Time Management scale (n=31, 36, 67) | 31.39 Units on a scale | Standard Deviation 36.715 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W4:Mental/Interpersonal Demands Scale(n=32,36,68) | 23.39 Units on a scale | Standard Deviation 32.878 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W4: Output Demands scale (n=30, 36, 66) | 20.14 Units on a scale | Standard Deviation 33.306 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W4: WLQ Index Score (n=32, 37, 69) | 8.66 Units on a scale | Standard Deviation 7.754 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W16: Time Management scale (n=31, 35, 66) | 33.29 Units on a scale | Standard Deviation 39.182 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W16: Physical Demands scale (n=30, 32, 62) | 86.52 Units on a scale | Standard Deviation 25.548 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W16:Mental/Interpersonal Demands Scale(n=31,35,66) | 20.28 Units on a scale | Standard Deviation 33.419 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W16: Output Demands scale (n=32, 33, 65) | 19.55 Units on a scale | Standard Deviation 32.485 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W16: WLQ Index Score (n=32, 35, 67) | 8.35 Units on a scale | Standard Deviation 7.425 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | BL: Time Management scale (n=34, 37, 71) | 42.36 Units on a scale | Standard Deviation 33.716 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W28: Physical Demands scale (n=32, 34, 66) | 85.42 Units on a scale | Standard Deviation 24.73 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W28:Mental/Interpersonal Demands Scale(n=33,35,68) | 16.39 Units on a scale | Standard Deviation 27.736 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W28: Output Demands scale (n=33, 34, 67) | 14.71 Units on a scale | Standard Deviation 28.761 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W28: WLQ Index Score (n=34, 36, 70) | 7.26 Units on a scale | Standard Deviation 6.829 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W52: Time Management scale (n=31, 31, 62) | 31.88 Units on a scale | Standard Deviation 40.686 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W52: Physical Demands scale (n=29, 29, 58) | 89.74 Units on a scale | Standard Deviation 24.41 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W52:Mental/Interpersonal Demands Scale(n=30,30,60) | 16.89 Units on a scale | Standard Deviation 27.293 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W52: Output Demands scale (n=30, 29, 59) | 12.24 Units on a scale | Standard Deviation 24.589 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) | W52: WLQ Index Score (n=32, 31, 63) | 7.34 Units on a scale | Standard Deviation 6.429 |
| Total | Work Limitation Questionnaire (WLQ) | W28: Physical Demands scale (n=32, 34, 66) | 80.86 Units on a scale | Standard Deviation 28.151 |
| Total | Work Limitation Questionnaire (WLQ) | W4:Mental/Interpersonal Demands Scale(n=32,36,68) | 20.82 Units on a scale | Standard Deviation 30.149 |
| Total | Work Limitation Questionnaire (WLQ) | BL: Physical Demands scale (n=33, 35, 68) | 72.71 Units on a scale | Standard Deviation 32.606 |
| Total | Work Limitation Questionnaire (WLQ) | W28:Mental/Interpersonal Demands Scale(n=33,35,68) | 16.61 Units on a scale | Standard Deviation 27.774 |
| Total | Work Limitation Questionnaire (WLQ) | W4: Physical Demands scale (n=29, 36, 65) | 80.72 Units on a scale | Standard Deviation 31.083 |
| Total | Work Limitation Questionnaire (WLQ) | W52:Mental/Interpersonal Demands Scale(n=30,30,60) | 21.22 Units on a scale | Standard Deviation 31.977 |
| Total | Work Limitation Questionnaire (WLQ) | W28: Output Demands scale (n=33, 34, 67) | 14.33 Units on a scale | Standard Deviation 27.892 |
| Total | Work Limitation Questionnaire (WLQ) | BL: WLQ Index Score (n=34, 38, 72) | 10.18 Units on a scale | Standard Deviation 7.42 |
| Total | Work Limitation Questionnaire (WLQ) | W4: Time Management scale (n=31, 36, 67) | 33.21 Units on a scale | Standard Deviation 39.203 |
| Total | Work Limitation Questionnaire (WLQ) | W28: WLQ Index Score (n=34, 36, 70) | 7.34 Units on a scale | Standard Deviation 6.62 |
| Total | Work Limitation Questionnaire (WLQ) | BL: Output Demands scale (n=33, 37, 70) | 26.66 Units on a scale | Standard Deviation 31.602 |
| Total | Work Limitation Questionnaire (WLQ) | W52: WLQ Index Score (n=32, 31, 63) | 8.41 Units on a scale | Standard Deviation 7.358 |
| Total | Work Limitation Questionnaire (WLQ) | W52: Time Management scale (n=31, 31, 62) | 41.10 Units on a scale | Standard Deviation 42.883 |
| Total | Work Limitation Questionnaire (WLQ) | W16:Mental/Interpersonal Demands Scale(n=31,35,66) | 17.01 Units on a scale | Standard Deviation 28.296 |
| Total | Work Limitation Questionnaire (WLQ) | W16: Physical Demands scale (n=30, 32, 62) | 84.14 Units on a scale | Standard Deviation 26.153 |
| Total | Work Limitation Questionnaire (WLQ) | BL: Mental/Interpersonal Demands Scale(n=34,38,72) | 30.15 Units on a scale | Standard Deviation 29.865 |
| Total | Work Limitation Questionnaire (WLQ) | W16: Output Demands scale (n=32, 33, 65) | 15.77 Units on a scale | Standard Deviation 27.175 |
| Total | Work Limitation Questionnaire (WLQ) | W16: Time Management scale (n=31, 35, 66) | 34.12 Units on a scale | Standard Deviation 38.756 |
| Total | Work Limitation Questionnaire (WLQ) | W52: Output Demands scale (n=30, 29, 59) | 17.52 Units on a scale | Standard Deviation 29.813 |
| Total | Work Limitation Questionnaire (WLQ) | W16: WLQ Index Score (n=32, 35, 67) | 7.65 Units on a scale | Standard Deviation 6.276 |
| Total | Work Limitation Questionnaire (WLQ) | W4: WLQ Index Score (n=32, 37, 69) | 8.00 Units on a scale | Standard Deviation 6.827 |
| Total | Work Limitation Questionnaire (WLQ) | W52: Physical Demands scale (n=29, 29, 58) | 83.95 Units on a scale | Standard Deviation 27.838 |
| Total | Work Limitation Questionnaire (WLQ) | W28: Time Management scale (n=34, 34, 68) | 34.23 Units on a scale | Standard Deviation 39.557 |
| Total | Work Limitation Questionnaire (WLQ) | W4: Output Demands scale (n=30, 36, 66) | 17.12 Units on a scale | Standard Deviation 28.704 |
| Total | Work Limitation Questionnaire (WLQ) | BL: Time Management scale (n=34, 37, 71) | 43.38 Units on a scale | Standard Deviation 35.479 |