A Phase 3 interventional study of CP-690,550 and CP-690,550 in Psoriasis, sponsored by Pfizer. Completed at 74 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-19.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 901 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Drug: CP-690,550
Drug: CP-690,550
Drug: Placebo/CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
5 mg oral BID, Continuous treatment for 52 Weeks
0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Percentage of Participants With 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
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) 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 by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
Time frame: Week 16
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Time frame: Baseline, Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
Time frame: Week 16
Dermatology Life Quality Index (DLQI) Total 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
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16
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: Week 4, 16
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time frame: Week 4
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline.
Time frame: Week 4
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Time frame: Baseline, Week 16
Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
Time frame: Week 52
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52
The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
Time frame: Week 52
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52
The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
Time frame: Week 52
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 was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Baseline up to Week 16
Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) 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. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Baseline up to Week 16
Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) 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. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Baseline up to Week 16
Percentage of Participants With 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, 16, 20, 28, 40, 52
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) 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. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Psoriasis Area and Severity Index (PASI) Score
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Psoriasis Area and Severity Index (PASI) Component Scores
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Total Body Surface Area (BSA) With Psoriasis
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) 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. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) 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. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
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: Baseline, Week 8, 16, 20, 28, 40, 52
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Time frame: Baseline, Week 8, 16, 20, 28, 40, 52
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
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Time frame: Baseline, Week 8, 16, 20, 28, 40, 52
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response
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. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.
Time frame: Week 8, 16, 20, 28, 40, 52
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response
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. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.
Time frame: Week 8, 16, 20, 28, 40, 52
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
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
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
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 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.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
36-Item Short-Form Health Survey Version 2, Acute (SF-36)
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: Baseline, Week 16, 28, 52
Hospital Anxiety and Depression Scale (HADS) Score
HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.
Time frame: Baseline, Week 4, 16, 28, 52
Work Limitation Questionnaire (WLQ) Index Score
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, Week 4, 16, 28, 52
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response
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
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response
The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study treatment.
Time frame: Week 16, 28, 52
Joint Pain Assessment (JPA) Score
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
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Week 16, 28, 40, 52
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Week 16, 28, 40, 52
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Time frame: Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No \[Y/N\]): "Were you absent or on sick leave from work due to psoriasis today?", and participants unemployed (UEmp) at the time of assessment answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Time frame: Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Time frame: Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Time frame: Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Time frame: Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means "ability to work was not affected by psoriasis", and 10 means "ability to work was completely affected by psoriasis". Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
Time frame: Baseline, Week 16
Family Dermatology Life Quality Index (FDLQI) Score
The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life.
Time frame: Baseline, Week 16, 52
| Milestone | CP-690,550 5 mg | CP-690,550 10 mg | Placebo | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|---|
| Started | 363 | 361 | 177 | 0 | 0 |
| Treated | 363 | 360 | 177 | 0 | 0 |
| Completed | 313 | 320 | 132 | 0 | 0 |
| Not completed | 50 | 41 | 45 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 11 | 8 | 11 | 0 | 0 |
| Withdrew: Lack of efficacy | 20 | 15 | 25 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 5 | 3 | 0 | 0 |
| Withdrew: Withdrawal by subject | 8 | 5 | 4 | 0 | 0 |
| Withdrew: Other | 7 | 7 | 2 | 0 | 0 |
| Withdrew: Randomized, but not treated | 0 | 1 | 0 | 0 | 0 |
| Milestone | CP-690,550 5 mg | CP-690,550 10 mg | Placebo | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|---|
| Started | 313 | 320 | 0 | 66 | 66 |
| Completed | 186 | 219 | 0 | 50 | 45 |
| Not completed | 127 | 101 | 0 | 16 | 21 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 10 | 13 | 0 | 1 | 3 |
| Withdrew: Lack of efficacy | 99 | 71 | 0 | 14 | 13 |
| Withdrew: Lost to follow-up | 3 | 1 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 4 | 4 | 0 | 0 | 1 |
| Withdrew: Other | 10 | 12 | 0 | 1 | 3 |
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 | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 | 41.87 | 59.17 | 9.04 |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 | 39.94 | 59.17 | 6.21 |
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
| percent change | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 | -51.94 ± 2.45 | -67.20 ± 2.44 | 1.62 ± 3.59 |
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16 | 19.83 | 39.44 | 0.56 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Dermatology Life Quality Index (DLQI) Total Score | 12.46 ± 6.89 | 12.87 ± 6.91 | 14.01 ± 7.06 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Change at Week 4 | -5.59 ± 0.25 | -6.40 ± 0.25 | -1.69 ± 0.35 |
| Change at Week 16 | -6.91 ± 0.30 | -8.90 ± 0.29 | -1.93 ± 0.44 |
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 | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4 | 17.08 | 23.06 | 2.26 |
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4 | 10.47 | 15.56 | 1.69 |
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.
| percent change | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 | -14.15 ± 9.47 | -41.48 ± 9.22 | 55.55 ± 14.84 |
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. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
| percent probability of response | CP-690,550 5 mg | CP-690,550 10 mg |
|---|---|---|
| Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52 | 60.17 (51.80 to 67.56) | 71.56 (64.81 to 77.24) |
The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
| percent probability of response | CP-690,550 5 mg | CP-690,550 10 mg |
|---|---|---|
| Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52 | 73.75 (65.47 to 80.33) | 79.94 (73.75 to 84.82) |
The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).
| percent probability of response | CP-690,550 5 mg | CP-690,550 10 mg |
|---|---|---|
| Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52 | 61.79 (49.37 to 72.01) | 70.58 (62.12 to 77.49) |
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
| weeks | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | 16.0 (12.0 to NA) | 12.0 (8.0 to 12.0) | NA (NA to NA) |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
| weeks | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response | NA (16.0 to NA) | 12.0 (NA to NA) | NA (NA to NA) |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
| weeks | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response | 8.0 (8.0 to 12.0) | 8.0 (NA to NA) | NA (NA to NA) |
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 | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 2 | 5.23 (2.94 to 7.53) | 10.00 (6.90 to 13.10) | 3.03 (0.00 to 7.17) | 0.00 (0.00 to 0.00) |
| Week 4 | 17.08 (13.21 to 20.95) | 23.06 (18.70 to 27.41) | 6.06 (0.30 to 11.82) | 0.00 (0.00 to 0.00) |
| Week 8 | 31.40 (26.63 to 36.18) | 46.39 (41.24 to 51.54) | 9.09 (2.16 to 16.03) | 6.06 (0.30 to 11.82) |
| Week 12 | 37.74 (32.75 to 42.73) | 56.67 (51.55 to 61.79) | 12.12 (4.25 to 20.00) | 9.09 (2.16 to 16.03) |
| Week 16 | 41.87 (36.80 to 46.95) | 59.17 (54.09 to 64.24) | 13.64 (5.36 to 21.92) | 10.61 (3.18 to 18.03) |
| Week 20 | 45.45 (40.33 to 50.58) | 56.67 (51.55 to 61.79) | 39.39 (27.61 to 51.18) | 30.30 (19.22 to 41.39) |
| Week 28 | 48.76 (43.62 to 53.90) | 62.22 (57.21 to 67.23) | 66.67 (55.29 to 78.04) | 65.15 (53.66 to 76.65) |
| Week 40 | 42.70 (37.61 to 47.79) | 53.06 (47.90 to 58.21) | 53.03 (40.99 to 65.07) | 63.64 (52.03 to 75.24) |
| Week 52 | 35.54 (30.61 to 40.46) | 46.67 (41.51 to 51.82) | 43.94 (31.97 to 55.91) | 59.09 (47.23 to 70.95) |
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline: Clear (n = 363, 360, 66, 66) | 0.00 | 0.00 | 0.00 | 0.00 |
| Baseline: Almost Clear (n = 363, 360, 66, 66) | 0.00 | 0.00 | 0.00 | 0.00 |
| Baseline: Mild (n = 363, 360, 66, 66) | 0.3 | 0.3 | 0.00 | 0.00 |
| Baseline: Moderate (n = 363, 360, 66, 66) | 88.2 | 88.9 | 97.0 | 92.4 |
| Baseline: Severe (n = 363, 360, 66, 66) | 11.6 | 10.8 | 3.0 | 7.6 |
| Week 2: Clear (n = 358, 358, 66, 64) | 0.00 | 0.00 | 0.00 | 0.00 |
| Week 2: Almost Clear (n = 358, 358, 66, 64) | 5.3 | 10.1 | 3.0 | 0.00 |
| Week 2: Mild (n = 358, 358, 66, 64) | 32.7 | 38.8 | 30.3 | 18.8 |
| Week 2: Moderate (n = 358, 358, 66, 64) | 57.0 | 46.1 | 63.6 | 70.3 |
| Week 2: Severe (n = 358, 358, 66, 64) | 5.0 | 5.0 | 3.0 | 10.9 |
| Week 4: Clear (n = 352, 350, 65, 66) | 1.4 | 3.4 | 0.00 | 0.00 |
| Week 4: Almost Clear (n = 352, 350, 65, 66) | 16.2 | 20.3 | 6.2 | 0.00 |
| Week 4: Mild (n = 352, 350, 65, 66) | 43.8 | 45.4 | 33.8 | 21.2 |
| Week 4: Moderate (n = 352, 350, 65, 66) | 35.5 | 28.3 | 55.4 | 71.2 |
| Week 4: Severe (n = 352, 350, 65, 66) | 3.1 | 2.6 | 4.6 | 7.6 |
| Week 8: Clear (n = 347, 350, 65, 66) | 3.7 | 10.6 | 0.00 | 0.00 |
| Week 8: Almost Clear (n = 347, 350, 65, 66) | 29.1 | 37.1 | 9.2 | 6.1 |
| Week 8: Mild (n = 347, 350, 65, 66) | 40.3 | 36.0 | 33.8 | 24.2 |
| Week 8: Moderate (n = 347, 350, 65, 66) | 24.2 | 14.6 | 53.8 | 65.2 |
| Week 8: Severe (n = 347, 350, 65, 66) | 2.6 | 1.7 | 3.1 | 4.5 |
| Week 12: Clear (n = 345, 345, 65, 66) | 7.8 | 17.4 | 1.5 | 0.00 |
| Week 12: Almost Clear (n = 345, 345, 65, 66) | 31.9 | 41.7 | 10.8 | 9.1 |
| Week 12: Mild (n = 345, 345, 65, 66) | 38.0 | 26.1 | 43.1 | 25.8 |
| Week 12: Moderate (n = 345, 345, 65, 66) | 19.4 | 13.0 | 41.5 | 54.5 |
| Week 12: Severe (n = 345, 345, 65, 66) | 2.9 | 1.7 | 3.1 | 10.6 |
| Week 16: Clear (n = 323, 335, 66, 66) | 12.1 | 25.7 | 0.00 | 3.0 |
| Week 16: Almost Clear (n = 323, 335, 66, 66) | 35.0 | 37.9 | 13.6 | 7.6 |
| Week 16: Mild (n = 323, 335, 66, 66) | 32.8 | 23.6 | 47.0 | 21.2 |
| Week 16: Moderate (n = 323, 335, 66, 66) | 17.6 | 11.3 | 34.8 | 62.1 |
| Week 16: Severe (n = 323, 335, 66, 66) | 2.5 | 1.5 | 4.5 | 6.1 |
| Week 20: Clear (n = 312, 321, 66, 65) | 16.3 | 31.2 | 7.6 | 9.2 |
| Week 20: Almost Clear (n = 312, 321, 66, 65) | 36.5 | 32.4 | 31.8 | 21.5 |
| Week 20: Mild (n = 312, 321, 66, 65) | 31.7 | 24.3 | 53.0 | 43.1 |
| Week 20: Moderate (n = 312, 321, 66, 65) | 14.7 | 11.5 | 7.6 | 23.1 |
| Week 20: Severe (n = 312, 321, 66, 65) | 0.6 | 0.6 | 0.00 | 3.1 |
| Week 28: Clear (n = 300, 307, 61, 61) | 23.3 | 34.2 | 14.8 | 29.5 |
| Week 28: Almost Clear (n = 300, 307, 61, 61) | 35.7 | 38.8 | 57.4 | 41.0 |
| Week 28: Mild (n = 300, 307, 61, 61) | 25.7 | 17.6 | 23.0 | 19.7 |
| Week 28: Moderate (n = 300, 307, 61, 61) | 14.3 | 8.8 | 4.9 | 6.6 |
| Week 28: Severe (n = 300, 307, 61, 61) | 1.0 | 0.7 | 0.00 | 3.3 |
| Week 40: Clear (n = 203, 242, 53, 57) | 35.5 | 45.9 | 18.9 | 55.3 |
| Week 40: Almost Clear (n = 203, 242, 53, 57) | 40.9 | 33.1 | 47.2 | 34.0 |
| Week 40: Mild (n = 203, 242, 53, 57) | 18.2 | 15.3 | 26.4 | 8.5 |
| Week 40: Moderate (n = 203, 242, 53, 57) | 4.9 | 5.4 | 7.5 | 2.1 |
| Week 40: Severe (n = 203, 242, 53, 57) | 0.5 | 0.4 | 0.00 | 0.00 |
| Week 52: Clear (n = 180, 219, 47, 46) | 31.7 | 43.4 | 19.1 | 54.3 |
| Week 52: Almost Clear (n = 180, 219, 47, 46) | 40.0 | 33.3 | 42.6 | 30.4 |
| Week 52: Mild (n = 180, 219, 47, 46) | 19.4 | 19.6 | 36.2 | 15.2 |
| Week 52: Moderate (n = 180, 219, 47, 46) | 8.9 | 3.7 | 2.1 | 0.00 |
| Week 52: Severe (n = 180, 219, 47, 46) | 0.00 | 0.00 | 0.00 | 0.00 |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 2 | 1.38 (0.18 to 2.58) | 2.22 (0.70 to 3.74) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
| Week 4 | 10.47 (7.32 to 13.62) | 15.56 (11.81 to 19.30) | 4.55 (0.00 to 9.57) | 0.00 (0.00 to 0.00) |
| Week 8 | 23.69 (19.32 to 28.07) | 36.67 (31.69 to 41.64) | 6.06 (0.30 to 11.82) | 0.00 (0.00 to 0.00) |
| Week 12 | 35.54 (30.61 to 40.46) | 55.28 (50.14 to 60.41) | 6.06 (0.30 to 11.82) | 7.58 (1.19 to 13.96) |
| Week 16 | 39.94 (34.91 to 44.98) | 59.17 (54.09 to 64.24) | 9.09 (2.16 to 16.03) | 7.58 (1.19 to 13.96) |
| Week 20 | 45.18 (40.06 to 50.30) | 59.44 (54.37 to 64.52) | 31.82 (20.58 to 43.06) | 24.24 (13.90 to 34.58) |
| Week 28 | 49.86 (44.72 to 55.01) | 63.06 (58.07 to 68.04) | 59.09 (47.23 to 70.95) | 68.18 (56.94 to 79.42) |
| Week 40 | 45.45 (40.33 to 50.58) | 56.94 (51.83 to 62.06) | 65.15 (53.66 to 76.65) | 68.18 (56.94 to 79.42) |
| Week 52 | 38.84 (33.83 to 43.86) | 51.39 (46.23 to 56.55) | 54.55 (42.53 to 66.56) | 65.15 (53.66 to 76.65) |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n=363,360,66,66) | 21.95 ± 8.99 | 22.73 ± 8.82 | 21.19 ± 8.54 | 23.03 ± 8.66 |
| Week 2 (n=358,358,66,64) | 18.28 ± 9.63 | 17.30 ± 9.06 | 19.81 ± 10.28 | 22.11 ± 9.84 |
| Week 4 (n=352,350,65,66) | 14.39 ± 8.75 | 13.10 ± 8.90 | 18.36 ± 10.86 | 20.63 ± 9.26 |
| Week 8 (n=347,350,65,66) | 11.41 ± 9.08 | 8.97 ± 8.00 | 17.17 ± 10.32 | 20.13 ± 10.15 |
| Week 12 (n=345,345,65,66) | 9.85 ± 9.38 | 6.94 ± 7.59 | 16.52 ± 10.45 | 19.38 ± 10.07 |
| Week 16 (n=323,335,66,66) | 8.42 ± 9.05 | 5.74 ± 7.21 | 16.08 ± 10.41 | 19.71 ± 11.25 |
| Week 20 (n=312,321,66,65) | 6.82 ± 7.23 | 4.95 ± 6.30 | 9.18 ± 7.21 | 11.79 ± 8.38 |
| Week 28 (n=300,307,61,61) | 5.80 ± 6.87 | 4.01 ± 5.28 | 5.20 ± 5.95 | 5.23 ± 6.42 |
| Week 40 (n=203,242,53,47) | 3.05 ± 3.71 | 2.64 ± 3.85 | 3.22 ± 3.70 | 1.64 ± 2.27 |
| Week 52 (n=180,219,47,46) | 3.28 ± 3.71 | 2.47 ± 3.21 | 3.16 ± 3.22 | 1.64 ± 2.01 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Change at Week 2 | -3.87 ± 0.29 | -5.31 ± 0.29 | -1.79 ± 0.66 | -0.81 ± 0.67 |
| Change at Week 4 | -7.61 ± 0.35 | -9.48 ± 0.35 | -3.14 ± 0.81 | -2.18 ± 0.81 |
| Change at Week 8 | -10.61 ± 0.41 | -13.58 ± 0.41 | -4.45 ± 0.95 | -2.68 ± 0.95 |
| Change at Week 12 | -12.02 ± 0.44 | -15.62 ± 0.44 | -4.97 ± 1.02 | -3.43 ± 1.02 |
| Change at Week 16 | -12.90 ± 0.48 | -16.55 ± 0.48 | -5.51 ± 1.09 | -3.10 ± 1.09 |
| Change at Week 20 | -14.36 ± 0.44 | -17.11 ± 0.44 | -12.41 ± 1.00 | -11.18 ± 1.00 |
| Change at Week 28 | -15.53 ± 0.44 | -18.02 ± 0.43 | -16.21 ± 0.98 | -17.63 ± 0.98 |
| Change at Week 40 | -15.15 ± 0.47 | -17.51 ± 0.46 | -16.16 ± 1.03 | -18.54 ± 1.05 |
| Change at Week 52 | -14.70 ± 0.48 | -17.16 ± 0.47 | -15.69 ± 1.04 | -18.62 ± 1.06 |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline: Erythema (Head\Neck) (n=363,360,66,66) | 2.31 ± 0.99 | 2.23 ± 1.01 | 2.38 ± 0.99 | 2.26 ± 0.90 |
| Baseline: Erythema (Upper Limbs) (n=363,360,66,66) | 2.87 ± 0.64 | 2.88 ± 0.64 | 2.83 ± 0.54 | 2.92 ± 0.54 |
| Baseline: Erythema (Trunk) (n=363,360,66,66) | 2.85 ± 0.77 | 2.91 ± 0.73 | 2.79 ± 0.85 | 3.08 ± 0.56 |
| Baseline: Erythema (Lower Limbs) (n=363,360,66,66) | 3.21 ± 0.60 | 3.19 ± 0.62 | 3.14 ± 0.58 | 3.27 ± 0.62 |
| Baseline: Induration (Head\Neck) (n=363,360,66,66) | 2.08 ± 0.97 | 1.96 ± 1.01 | 2.14 ± 0.97 | 2.02 ± 0.90 |
| Baseline:Induration (Upper Limbs)(n=363,360,66,66) | 2.69 ± 0.71 | 2.65 ± 0.67 | 2.71 ± 0.58 | 2.68 ± 0.59 |
| Baseline: Induration (Trunk) (n=363,360,66,66) | 2.60 ± 0.80 | 2.63 ± 0.77 | 2.53 ± 0.83 | 2.71 ± 0.78 |
| Baseline:Induration (Lower Limbs)(n=363,360,66,66) | 2.91 ± 0.69 | 2.90 ± 0.66 | 2.83 ± 0.69 | 2.98 ± 0.69 |
| Baseline: Scaling (Head\Neck) (n=363,360,66,66) | 2.32 ± 1.05 | 2.23 ± 1.08 | 2.33 ± 1.10 | 2.24 ± 1.07 |
| Baseline: Scaling (Upper Limbs) (n=363,360,66,66) | 2.75 ± 0.78 | 2.71 ± 0.75 | 2.55 ± 0.59 | 2.76 ± 0.70 |
| Baseline: Scaling (Trunk) (n=363,360,66,66) | 2.60 ± 0.86 | 2.60 ± 0.83 | 2.36 ± 0.82 | 2.77 ± 0.86 |
| Baseline: Scaling (Lower Limbs) (n=363,360,66,66) | 2.98 ± 0.72 | 2.91 ± 0.72 | 2.77 ± 0.72 | 2.97 ± 0.78 |
| Week 2: Erythema (Head\Neck) (n=358,358,66,64) | 1.84 ± 1.05 | 1.72 ± 1.05 | 2.14 ± 0.99 | 2.17 ± 0.88 |
| Week 2: Erythema (Upper Limbs) (n=358,358,66,64) | 2.40 ± 0.80 | 2.26 ± 0.86 | 2.64 ± 0.62 | 2.83 ± 0.68 |
| Week 2: Erythema (Trunk) (n=358,358,66,64) | 2.39 ± 0.92 | 2.28 ± 0.89 | 2.58 ± 0.88 | 2.91 ± 0.73 |
| Week 2: Erythema (Lower Limbs) (n=358,358,66,64) | 2.75 ± 0.81 | 2.60 ± 0.83 | 2.98 ± 0.64 | 3.14 ± 0.69 |
| Week 2: Induration (Head\Neck) (n=358,358,66,64) | 1.70 ± 1.05 | 1.48 ± 1.03 | 1.94 ± 0.99 | 1.92 ± 0.95 |
| Week 2: Induration (Upper Limbs) (n=358,358,66,64) | 2.27 ± 0.83 | 2.11 ± 0.86 | 2.36 ± 0.76 | 2.58 ± 0.71 |
| Week 2: Induration (Trunk) (n=358,358,66,64) | 2.20 ± 0.90 | 2.10 ± 0.92 | 2.32 ± 0.90 | 2.58 ± 0.75 |
| Week 2: Induration (Lower Limbs) (n=358,358,66,64) | 2.50 ± 0.82 | 2.38 ± 0.84 | 2.62 ± 0.80 | 2.72 ± 0.74 |
| Week 2: Scaling (Head\Neck) (n=358,358,66,64) | 1.85 ± 1.11 | 1.67 ± 1.11 | 2.03 ± 1.07 | 2.08 ± 1.13 |
| Week 2: Scaling (Upper Limbs) (n=358,358,66,64) | 2.29 ± 0.93 | 2.08 ± 0.91 | 2.26 ± 0.75 | 2.58 ± 0.87 |
| Week 2: Scaling (Trunk) (n=358,358,66,64) | 2.12 ± 1.00 | 2.00 ± 1.00 | 2.14 ± 1.04 | 2.50 ± 0.99 |
| Week 2: Scaling (Lower Limbs) (n=358,358,66,64) | 2.50 ± 0.91 | 2.33 ± 0.92 | 2.53 ± 0.85 | 2.75 ± 0.82 |
| Week 4: Erythema (Head\Neck) (n=352,350,65,66) | 1.45 ± 1.03 | 1.33 ± 1.06 | 1.89 ± 1.11 | 1.92 ± 0.97 |
| Week 4: Erythema (Upper Limbs) (n=352,350,65,66) | 2.00 ± 0.88 | 1.85 ± 0.90 | 2.42 ± 0.81 | 2.73 ± 0.69 |
| Week 4: Erythema (Trunk) (n=352,350,65,66) | 1.99 ± 0.99 | 1.83 ± 1.00 | 2.42 ± 0.97 | 2.74 ± 0.69 |
| Week 4: Erythema (Lower Limbs) (n=352,350,65,66) | 2.35 ± 0.90 | 2.15 ± 0.91 | 2.78 ± 0.78 | 2.97 ± 0.68 |
| Week 4: Induration (Head\Neck) (n=352,350,65,66) | 1.28 ± 0.98 | 1.11 ± 0.99 | 1.74 ± 1.06 | 1.74 ± 1.03 |
| Week 4: Induration (Upper Limbs) (n=352,350,65,66) | 1.87 ± 0.90 | 1.73 ± 0.91 | 2.25 ± 0.83 | 2.53 ± 0.79 |
| Week 4: Induration (Trunk) (n=352,350,65,66) | 1.80 ± 0.95 | 1.66 ± 1.00 | 2.15 ± 1.03 | 2.53 ± 0.81 |
| Week 4: Induration (Lower Limbs) (n=352,350,65,66) | 2.06 ± 0.90 | 1.93 ± 0.92 | 2.48 ± 0.87 | 2.71 ± 0.78 |
| Week 4: Scaling (Head\Neck) (n=352,350,65,66) | 1.43 ± 1.10 | 1.23 ± 1.07 | 1.80 ± 1.16 | 1.94 ± 1.07 |
| Week 4: Scaling (Upper Limbs) (n=352,350,65,66) | 1.88 ± 0.98 | 1.71 ± 0.93 | 2.14 ± 0.68 | 2.42 ± 0.79 |
| Week 4: Scaling (Trunk) (n=352,350,65,66) | 1.79 ± 1.03 | 1.57 ± 1.01 | 1.98 ± 1.01 | 2.41 ± 0.94 |
| Week 4: Scaling (Lower Limbs) (n=352,350,65,66) | 2.11 ± 0.96 | 1.93 ± 1.00 | 2.32 ± 0.92 | 2.64 ± 0.80 |
| Week 8: Erythema (Head\Neck) (n=347,350,65,66) | 1.23 ± 1.05 | 0.95 ± 0.98 | 1.92 ± 1.11 | 1.86 ± 1.05 |
| Week 8: Erythema (Upper Limbs) (n=347,350,65,66) | 1.76 ± 0.98 | 1.48 ± 0.93 | 2.43 ± 0.77 | 2.61 ± 0.74 |
| Week 8: Erythema (Trunk) (n=347,350,65,66) | 1.67 ± 1.11 | 1.37 ± 1.02 | 2.31 ± 1.01 | 2.55 ± 0.91 |
| Week 8: Erythema (Lower Limbs) (n=347,350,65,66) | 1.99 ± 1.08 | 1.71 ± 0.98 | 2.62 ± 0.78 | 2.91 ± 0.76 |
| Week 8: Induration (Head\Neck) (n=347,350,65,66) | 1.04 ± 1.01 | 0.75 ± 0.88 | 1.68 ± 1.03 | 1.67 ± 1.00 |
| Week 8: Induration (Upper Limbs) (n=347,350,65,66) | 1.62 ± 0.93 | 1.39 ± 0.93 | 2.15 ± 0.80 | 2.44 ± 0.70 |
| Week 8: Induration (Trunk) (n=347,350,65,66) | 1.44 ± 1.02 | 1.26 ± 1.02 | 2.03 ± 1.07 | 2.38 ± 0.99 |
| Week 8: Induration (Lower Limbs) (n=347,350,65,66) | 1.74 ± 1.02 | 1.47 ± 0.97 | 2.35 ± 0.87 | 2.67 ± 0.83 |
| Week 8: Scaling (Head\Neck) (n=347,350,65,66) | 1.18 ± 1.12 | 0.83 ± 0.97 | 1.80 ± 1.11 | 1.88 ± 1.09 |
| Week 8: Scaling (Upper Limbs) (n=347,350,65,66) | 1.66 ± 1.02 | 1.37 ± 0.96 | 2.05 ± 0.78 | 2.35 ± 0.79 |
| Week 8: Scaling (Trunk) (n=347,350,65,66) | 1.41 ± 1.09 | 1.19 ± 1.05 | 1.83 ± 1.01 | 2.20 ± 1.06 |
| Week 8: Scaling (Lower Limbs) (n=347,350,65,66) | 1.80 ± 1.07 | 1.45 ± 1.03 | 2.22 ± 0.96 | 2.55 ± 0.91 |
| Week 12: Erythema (Head\Neck) (n=345,345,65,66) | 1.10 ± 1.09 | 0.83 ± 0.96 | 1.78 ± 0.96 | 1.85 ± 1.00 |
| Week 12: Erythema (Upper Limbs) (n=345,345,65,66) | 1.60 ± 1.07 | 1.28 ± 0.96 | 2.35 ± 0.76 | 2.53 ± 0.75 |
| Week 12: Erythema (Trunk) (n=345,345,65,66) | 1.53 ± 1.18 | 1.12 ± 1.07 | 2.35 ± 0.98 | 2.53 ± 0.95 |
| Week 12: Erythema (Lower Limbs) (n=345,345,65,66) | 1.81 ± 1.13 | 1.39 ± 1.06 | 2.54 ± 0.79 | 2.77 ± 0.86 |
| Week 12: Induration (Head\Neck) (n=345,345,65,66) | 0.90 ± 1.02 | 0.65 ± 0.86 | 1.54 ± 0.97 | 1.56 ± 1.01 |
| Week 12: Induration (Upper Limbs)(n=345,345,65,66) | 1.48 ± 1.02 | 1.17 ± 0.95 | 2.05 ± 0.78 | 2.32 ± 0.84 |
| Week 12: Induration (Trunk) (n=345,345,65,66) | 1.34 ± 1.09 | 0.98 ± 1.03 | 1.89 ± 0.99 | 2.27 ± 0.99 |
| Week 12: Induration (Lower Limbs)(n=345,345,65,66) | 1.58 ± 1.08 | 1.17 ± 0.98 | 2.26 ± 0.82 | 2.55 ± 0.88 |
| Week 12: Scaling (Head\Neck) (n=345,345,65,66) | 1.03 ± 1.06 | 0.72 ± 0.91 | 1.77 ± 1.01 | 1.76 ± 1.10 |
| Week 12: Scaling (Upper Limbs) (n=345,345,65,66) | 1.50 ± 1.07 | 1.18 ± 0.98 | 2.03 ± 0.90 | 2.27 ± 0.83 |
| Week 12: Scaling (Trunk) (n=345,345,65,66) | 1.30 ± 1.12 | 0.95 ± 1.01 | 1.89 ± 1.05 | 2.26 ± 1.09 |
| Week 12: Scaling (Lower Limbs) (n=345,345,65,66) | 1.56 ± 1.10 | 1.14 ± 0.98 | 2.14 ± 0.95 | 2.53 ± 1.00 |
| Week 16: Erythema (Head\Neck) (n=323,335,66,66) | 1.01 ± 1.07 | 0.75 ± 0.95 | 1.73 ± 1.05 | 1.91 ± 1.09 |
| Week 16: Erythema (Upper Limbs) (n=323,335,66,66) | 1.46 ± 1.12 | 1.13 ± 1.00 | 2.30 ± 0.80 | 2.53 ± 0.83 |
| Week 16: Erythema (Trunk) (n=323,335,66,66) | 1.40 ± 1.17 | 1.01 ± 1.09 | 2.14 ± 1.11 | 2.58 ± 1.08 |
| Week 16: Erythema (Lower Limbs) (n=323,335,66,66) | 1.63 ± 1.19 | 1.25 ± 1.10 | 2.52 ± 0.83 | 2.82 ± 0.89 |
| Week 16: Induration (Head\Neck) (n=323,335,66,66) | 0.83 ± 0.97 | 0.60 ± 0.88 | 1.42 ± 1.01 | 1.58 ± 1.12 |
| Week 16: Induration (Upper Limbs)(n=323,335,66,66) | 1.34 ± 1.10 | 1.06 ± 0.99 | 2.06 ± 0.87 | 2.33 ± 0.93 |
| Week 16: Induration (Trunk) (n=323,335,66,66) | 1.22 ± 1.08 | 0.85 ± 1.05 | 1.83 ± 1.14 | 2.29 ± 1.08 |
| Week 16: Induration (Lower Limbs)(n=323,335,66,66) | 1.38 ± 1.07 | 1.01 ± 1.02 | 2.20 ± 0.92 | 2.52 ± 0.86 |
| Week 16: Scaling (Head\Neck) (n=323,335,66,66) | 0.94 ± 1.04 | 0.67 ± 0.91 | 1.59 ± 1.02 | 1.76 ± 1.10 |
| Week 16: Scaling (Upper Limbs) (n=323,335,66,66) | 1.41 ± 1.09 | 1.07 ± 0.98 | 2.08 ± 0.90 | 2.29 ± 0.89 |
| Week 16: Scaling (Trunk) (n=323,335,66,66) | 1.15 ± 1.01 | 0.84 ± 0.99 | 1.83 ± 1.12 | 2.12 ± 1.10 |
| Week 16: Scaling (Lower Limbs) (n=323,335,66,66) | 1.42 ± 1.06 | 1.01 ± 1.02 | 2.15 ± 1.00 | 2.50 ± 1.06 |
| Week 20: Erythema (Head\Neck) (n=312,321,66,65) | 0.94 ± 1.02 | 0.66 ± 0.94 | 1.08 ± 0.93 | 1.23 ± 0.95 |
| Week 20: Erythema (Upper Limbs) (n=312,321,66,65) | 1.29 ± 1.04 | 1.05 ± 1.01 | 1.48 ± 0.79 | 1.80 ± 0.85 |
| Week 20: Erythema (Trunk) (n=312,321,66,65) | 1.23 ± 1.09 | 0.89 ± 1.06 | 1.36 ± 0.97 | 1.68 ± 1.02 |
| Week 20: Erythema (Lower Limbs) (n=312,321,66,65) | 1.45 ± 1.17 | 1.13 ± 1.09 | 1.71 ± 0.82 | 1.94 ± 0.98 |
| Week 20: Induration (Head\Neck) (n=312,321,66,65) | 0.78 ± 0.93 | 0.55 ± 0.83 | 0.83 ± 0.83 | 0.97 ± 0.85 |
| Week 20: Induration (Upper Limbs)(n=312,321,66,65) | 1.21 ± 1.03 | 0.99 ± 1.00 | 1.38 ± 0.78 | 1.52 ± 0.83 |
| Week 20: Induration (Trunk) (n=312,321,66,65) | 1.06 ± 1.03 | 0.78 ± 1.02 | 1.17 ± 1.02 | 1.43 ± 1.02 |
| Week 20: Induration (Lower Limbs)(n=312,321,66,65) | 1.24 ± 1.04 | 0.96 ± 1.03 | 1.52 ± 0.85 | 1.66 ± 1.00 |
| Week 20: Scaling (Head\Neck) (n=312,321,66,65) | 0.86 ± 0.97 | 0.63 ± 0.94 | 0.98 ± 0.90 | 1.09 ± 1.06 |
| Week 20: Scaling (Upper Limbs) (n=312,321,66,65) | 1.23 ± 1.00 | 1.02 ± 1.03 | 1.50 ± 0.88 | 1.63 ± 0.94 |
| Week 20: Scaling (Trunk) (n=312,321,66,65) | 0.99 ± 0.94 | 0.76 ± 1.00 | 1.20 ± 1.03 | 1.49 ± 1.17 |
| Week 20: Scaling (Lower Limbs) (n=312,321,66,65) | 1.30 ± 1.04 | 0.96 ± 1.03 | 1.55 ± 1.00 | 1.80 ± 1.18 |
| Week 28: Erythema (Head\Neck) (n=300,307,61,61) | 0.83 ± 0.99 | 0.65 ± 0.93 | 0.54 ± 0.81 | 0.51 ± 0.87 |
| Week 28: Erythema (Upper Limbs) (n=300,307,61,61) | 1.20 ± 1.08 | 0.96 ± 1.00 | 1.16 ± 0.92 | 1.05 ± 0.88 |
| Week 28: Erythema (Trunk) (n=300,307,61,61) | 1.09 ± 1.14 | 0.77 ± 1.04 | 0.92 ± 0.90 | 0.95 ± 0.97 |
| Week 28: Erythema (Lower Limbs) (n=300,307,61,61) | 1.27 ± 1.19 | 0.97 ± 1.09 | 1.21 ± 0.97 | 1.15 ± 1.00 |
| Week 28: Induration (Head\Neck) (n=300,307,61,61) | 0.66 ± 0.89 | 0.47 ± 0.76 | 0.44 ± 0.70 | 0.31 ± 0.72 |
| Week 28: Induration (Upper Limbs)(n=300,307,61,61) | 1.10 ± 1.05 | 0.90 ± 1.01 | 1.00 ± 0.84 | 0.79 ± 0.82 |
| Week 28: Induration (Trunk) (n=300,307,61,61) | 0.93 ± 1.03 | 0.69 ± 1.00 | 0.75 ± 0.85 | 0.80 ± 1.08 |
| Week 28: Induration (Lower Limbs)(n=300,307,61,61) | 1.09 ± 1.08 | 0.79 ± 0.99 | 0.98 ± 0.83 | 0.87 ± 0.90 |
| Week 28: Scaling (Head\Neck) (n=300,307,61,61) | 0.77 ± 0.95 | 0.57 ± 0.85 | 0.56 ± 0.76 | 0.44 ± 0.85 |
| Week 28: Scaling (Upper Limbs) (n=300,307,61,61) | 1.15 ± 1.06 | 0.90 ± 0.99 | 1.08 ± 0.86 | 0.98 ± 0.92 |
| Week 28: Scaling (Trunk) (n=300,307,61,61) | 0.89 ± 0.97 | 0.64 ± 0.90 | 0.80 ± 0.87 | 0.90 ± 1.14 |
| Week 28: Scaling (Lower Limbs) (n=300,307,61,61) | 1.15 ± 1.07 | 0.79 ± 0.99 | 1.02 ± 0.90 | 1.08 ± 1.08 |
| Week 40: Erythema (Head\Neck) (n=203,242,53,47) | 0.55 ± 0.87 | 0.54 ± 0.85 | 0.51 ± 0.87 | 0.32 ± 0.69 |
| Week 40: Erythema (Upper Limbs) (n=203,242,53,47) | 0.87 ± 0.97 | 0.76 ± 0.92 | 1.06 ± 0.93 | 0.55 ± 0.90 |
| Week 40: Erythema (Trunk) (n=203,242,53,47) | 0.68 ± 0.95 | 0.52 ± 0.87 | 0.68 ± 0.89 | 0.57 ± 0.77 |
| Week 40: Erythema (Lower Limbs) (n=203,242,53,47) | 0.88 ± 1.05 | 0.72 ± 0.97 | 0.92 ± 1.00 | 0.55 ± 0.83 |
| Week 40: Induration (Head\Neck) (n=203,242,53,47) | 0.44 ± 0.73 | 0.45 ± 0.76 | 0.43 ± 0.82 | 0.23 ± 0.52 |
| Week 40: Induration (Upper Limbs)(n=203,242,53,47) | 0.79 ± 0.93 | 0.72 ± 0.87 | 1.00 ± 0.88 | 0.36 ± 0.67 |
| Week 40: Induration (Trunk) (n=203,242,53,47) | 0.56 ± 0.80 | 0.48 ± 0.81 | 0.57 ± 0.75 | 0.32 ± 0.59 |
| Week 40: Induration (Lower Limbs)(n=203,242,53,47) | 0.70 ± 0.91 | 0.62 ± 0.91 | 0.85 ± 0.77 | 0.32 ± 0.59 |
| Week 40: Scaling (Head\Neck) (n=203,242,53,47) | 0.53 ± 0.82 | 0.52 ± 0.90 | 0.51 ± 0.78 | 0.30 ± 0.59 |
| Week 40: Scaling (Upper Limbs) (n=203,242,53,47) | 0.85 ± 0.97 | 0.71 ± 0.91 | 1.06 ± 0.82 | 0.49 ± 0.80 |
| Week 40: Scaling (Trunk) (n=203,242,53,47) | 0.53 ± 0.79 | 0.44 ± 0.77 | 0.58 ± 0.75 | 0.47 ± 0.78 |
| Week 40: Scaling (Lower Limbs) (n=203,242,53,47) | 0.78 ± 0.97 | 0.62 ± 0.90 | 0.85 ± 0.86 | 0.45 ± 0.75 |
| Week 52: Erythema (Head\Neck) (n=180,219,47,46) | 0.50 ± 0.76 | 0.42 ± 0.78 | 0.55 ± 0.83 | 0.39 ± 0.74 |
| Week 52: Erythema (Upper Limbs) (n=180,219,47,46) | 0.93 ± 0.95 | 0.72 ± 0.87 | 1.06 ± 0.94 | 0.50 ± 0.81 |
| Week 52: Erythema (Trunk) (n=180,219,47,46) | 0.64 ± 0.91 | 0.59 ± 0.93 | 0.66 ± 0.94 | 0.50 ± 0.86 |
| Week 52: Erythema (Lower Limbs) (n=180,219,47,46) | 0.93 ± 1.05 | 0.67 ± 0.98 | 0.87 ± 0.99 | 0.63 ± 0.85 |
| Week 52: Induration (Head\Neck) (n=180,219,47,46) | 0.47 ± 0.71 | 0.32 ± 0.66 | 0.40 ± 0.68 | 0.24 ± 0.57 |
| Week 52: Induration (Upper Limbs)(n=180,219,47,46) | 0.86 ± 0.94 | 0.70 ± 0.87 | 0.98 ± 0.82 | 0.43 ± 0.75 |
| Week 52: Induration (Trunk) (n=180,219,47,46) | 0.56 ± 0.81 | 0.54 ± 0.86 | 0.53 ± 0.80 | 0.35 ± 0.77 |
| Week 52: Induration (Lower Limbs)(n=180,219,47,46) | 0.84 ± 0.96 | 0.61 ± 0.89 | 0.79 ± 0.88 | 0.39 ± 0.65 |
| Week 52: Scaling (Head\Neck) (n=180,219,47,46) | 0.51 ± 0.77 | 0.42 ± 0.78 | 0.62 ± 0.87 | 0.39 ± 0.74 |
| Week 52: Scaling (Upper Limbs) (n=180,219,47,46) | 0.91 ± 0.97 | 0.74 ± 0.88 | 1.06 ± 0.87 | 0.57 ± 0.83 |
| Week 52: Scaling (Trunk) (n=180,219,47,46) | 0.54 ± 0.81 | 0.51 ± 0.79 | 0.57 ± 0.83 | 0.43 ± 0.81 |
| Week 52: Scaling (Lower Limbs) (n=180,219,47,46) | 0.89 ± 0.98 | 0.58 ± 0.90 | 0.91 ± 0.95 | 0.50 ± 0.75 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 2: Erythema (Head\Neck) (n=358,358,66,64) | -0.45 ± 0.78 | -0.51 ± 0.82 | -0.24 ± 0.61 | -0.06 ± 0.66 |
| Week 2: Erythema (Upper Limbs) (n=358,358,66,64) | -0.46 ± 0.68 | -0.63 ± 0.71 | -0.20 ± 0.47 | -0.09 ± 0.56 |
| Week 2: Erythema (Trunk) (n=358,358,66,64) | -0.46 ± 0.69 | -0.63 ± 0.74 | -0.21 ± 0.51 | -0.17 ± 0.49 |
| Week 2: Erythema (Lower Limbs) (n=358,358,66,64) | -0.47 ± 0.70 | -0.59 ± 0.74 | -0.15 ± 0.44 | -0.13 ± 0.58 |
| Week 2: Induration (Head\Neck) (n=358,358,66,64) | -0.37 ± 0.67 | -0.48 ± 0.78 | -0.20 ± 0.53 | -0.08 ± 0.57 |
| Week 2: Induration (Upper Limbs) (n=358,358,66,64) | -0.42 ± 0.67 | -0.53 ± 0.74 | -0.35 ± 0.62 | -0.11 ± 0.54 |
| Week 2: Induration (Trunk) (n=358,358,66,64) | -0.40 ± 0.72 | -0.53 ± 0.74 | -0.21 ± 0.48 | -0.14 ± 0.50 |
| Week 2: Induration (Lower Limbs) (n=358,358,66,64) | -0.41 ± 0.66 | -0.52 ± 0.65 | -0.21 ± 0.45 | -0.27 ± 0.48 |
| Week 2: Scaling (Head\Neck) (n=358,358,66,64) | -0.47 ± 0.67 | -0.56 ± 0.86 | -0.30 ± 0.80 | -0.17 ± 0.55 |
| Week 2: Scaling (Upper Limbs) (n=358,358,66,64) | -0.45 ± 0.72 | -0.63 ± 0.81 | -0.29 ± 0.55 | -0.20 ± 0.72 |
| Week 2: Scaling (Trunk) (n=358,358,66,64) | -0.48 ± 0.75 | -0.60 ± 0.81 | -0.23 ± 0.70 | -0.30 ± 0.61 |
| Week 2: Scaling (Lower Limbs) (n=358,358,66,64) | -0.48 ± 0.74 | -0.57 ± 0.74 | -0.24 ± 0.66 | -0.23 ± 0.61 |
| Week 4: Erythema (Head\Neck) (n=352,350,65,66) | -0.84 ± 1.04 | -0.90 ± 1.01 | -0.48 ± 0.87 | -0.33 ± 0.71 |
| Week 4: Erythema (Upper Limbs) (n=352,350,65,66) | -0.86 ± 0.88 | -1.03 ± 0.84 | -0.42 ± 0.73 | -0.20 ± 0.64 |
| Week 4: Erythema (Trunk) (n=352,350,65,66) | -0.86 ± 0.88 | -1.08 ± 0.95 | -0.37 ± 0.86 | -0.33 ± 0.59 |
| Week 4: Erythema (Lower Limbs) (n=352,350,65,66) | -0.86 ± 0.89 | -1.04 ± 0.87 | -0.35 ± 0.62 | -0.30 ± 0.70 |
| Week 4: Induration (Head\Neck) (n=352,350,65,66) | -0.79 ± 0.97 | -0.85 ± 1.00 | -0.40 ± 0.68 | -0.27 ± 0.69 |
| Week 4: Induration (Upper Limbs) (n=352,350,65,66) | -0.82 ± 0.88 | -0.91 ± 0.85 | -0.46 ± 0.69 | -0.15 ± 0.66 |
| Week 4: Induration (Trunk) (n=352,350,65,66) | -0.79 ± 0.89 | -0.95 ± 0.90 | -0.37 ± 0.88 | -0.18 ± 0.63 |
| Week 4: Induration (Lower Limbs) (n=352,350,65,66) | -0.85 ± 0.85 | -0.96 ± 0.82 | -0.35 ± 0.60 | -0.27 ± 0.62 |
| Week 4: Scaling (Head\Neck) (n=352,350,65,66) | -0.88 ± 1.00 | -0.99 ± 1.07 | -0.54 ± 0.95 | -0.30 ± 0.74 |
| Week 4: Scaling (Upper Limbs) (n=352,350,65,66) | -0.86 ± 0.97 | -1.00 ± 0.93 | -0.40 ± 0.72 | -0.33 ± 0.73 |
| Week 4: Scaling (Trunk) (n=352,350,65,66) | -0.81 ± 0.93 | -1.03 ± 0.96 | -0.37 ± 0.84 | -0.36 ± 0.69 |
| Week 4: Scaling (Lower Limbs) (n=352,350,65,66) | -0.87 ± 0.96 | -0.97 ± 0.94 | -0.45 ± 0.73 | -0.33 ± 0.71 |
| Week 8: Erythema (Head\Neck) (n=347,350,65,66) | -1.05 ± 1.16 | -1.28 ± 1.11 | -0.45 ± 1.03 | -0.39 ± 0.99 |
| Week 8: Erythema (Upper Limbs) (n=347,350,65,66) | -1.10 ± 1.04 | -1.41 ± 0.99 | -0.40 ± 0.70 | -0.32 ± 0.73 |
| Week 8: Erythema (Trunk) (n=347,350,65,66) | -1.18 ± 1.10 | -1.54 ± 1.03 | -0.52 ± 0.87 | -0.53 ± 0.81 |
| Week 8: Erythema (Lower Limbs) (n=347,350,65,66) | -1.22 ± 1.10 | -1.48 ± 1.00 | -0.51 ± 0.73 | -0.36 ± 0.65 |
| Week 8: Induration (Head\Neck) (n=347,350,65,66) | -1.02 ± 1.10 | -1.21 ± 1.10 | -0.45 ± 0.87 | -0.35 ± 1.03 |
| Week 8: Induration (Upper Limbs) (n=347,350,65,66) | -1.07 ± 0.98 | -1.26 ± 0.99 | -0.55 ± 0.75 | -0.24 ± 0.66 |
| Week 8: Induration (Trunk) (n=347,350,65,66) | -1.14 ± 1.05 | -1.36 ± 1.06 | -0.54 ± 0.89 | -0.33 ± 0.88 |
| Week 8: Induration (Lower Limbs) (n=347,350,65,66) | -1.16 ± 1.06 | -1.42 ± 0.99 | -0.48 ± 0.69 | -0.32 ± 0.79 |
| Week 8: Scaling (Head\Neck) (n=347,350,65,66) | -1.12 ± 1.17 | -1.39 ± 1.16 | -0.52 ± 1.03 | -0.36 ± 1.06 |
| Week 8: Scaling (Upper Limbs) (n=347,350,65,66) | -1.08 ± 1.07 | -1.33 ± 1.08 | -0.49 ± 0.77 | -0.41 ± 0.86 |
| Week 8: Scaling (Trunk) (n=347,350,65,66) | -1.18 ± 1.11 | -1.40 ± 1.12 | -0.57 ± 0.87 | -0.58 ± 0.86 |
| Week 8: Scaling (Lower Limbs) (n=347,350,65,66) | -1.17 ± 1.11 | -1.44 ± 1.09 | -0.55 ± 0.81 | -0.42 ± 0.84 |
| Week 12: Erythema (Head\Neck) (n=345,345,65,66) | -1.18 ± 1.21 | -1.41 ± 1.16 | -0.58 ± 1.03 | -0.41 ± 0.96 |
| Week 12: Erythema (Upper Limbs) (n=345,345,65,66) | -1.26 ± 1.15 | -1.61 ± 1.06 | -0.48 ± 0.79 | -0.39 ± 0.72 |
| Week 12: Erythema (Trunk) (n=345,345,65,66) | -1.32 ± 1.22 | -1.80 ± 1.15 | -0.43 ± 1.00 | -0.55 ± 0.83 |
| Week 12: Erythema (Lower Limbs) (n=345,345,65,66) | -1.40 ± 1.17 | -1.79 ± 1.10 | -0.60 ± 0.72 | -0.50 ± 0.79 |
| Week 12: Induration (Head\Neck) (n=345,345,65,66) | -1.16 ± 1.18 | -1.32 ± 1.15 | -0.60 ± 0.97 | -0.45 ± 0.91 |
| Week 12: Induration (Upper Limbs)(n=345,345,65,66) | -1.21 ± 1.14 | -1.47 ± 1.05 | -0.66 ± 0.78 | -0.36 ± 0.82 |
| Week 12: Induration (Trunk) (n=345,345,65,66) | -1.25 ± 1.17 | -1.65 ± 1.14 | -0.63 ± 0.88 | -0.44 ± 0.90 |
| Week 12: Induration (Lower Limbs)(n=345,345,65,66) | -1.33 ± 1.18 | -1.72 ± 1.09 | -0.57 ± 0.68 | -0.44 ± 0.84 |
| Week 12: Scaling (Head\Neck) (n=345,345,65,66) | -1.28 ± 1.20 | -1.52 ± 1.20 | -0.57 ± 1.06 | -0.48 ± 1.08 |
| Week 12: Scaling (Upper Limbs) (n=345,345,65,66) | -1.24 ± 1.22 | -1.52 ± 1.17 | -0.51 ± 0.95 | -0.48 ± 0.83 |
| Week 12: Scaling (Trunk) (n=345,345,65,66) | -1.30 ± 1.19 | -1.65 ± 1.16 | -0.46 ± 0.90 | -0.52 ± 0.88 |
| Week 12: Scaling (Lower Limbs) (n=345,345,65,66) | -1.41 ± 1.17 | -1.76 ± 1.13 | -0.63 ± 0.84 | -0.44 ± 0.95 |
| Week 16: Erythema (Head\Neck) (n=323,335,66,66) | -1.28 ± 1.26 | -1.48 ± 1.19 | -0.65 ± 0.97 | -0.35 ± 1.02 |
| Week 16: Erythema (Upper Limbs) (n=323,335,66,66) | -1.41 ± 1.19 | -1.76 ± 1.12 | -0.53 ± 0.86 | -0.39 ± 0.74 |
| Week 16: Erythema (Trunk) (n=323,335,66,66) | -1.45 ± 1.23 | -1.90 ± 1.18 | -0.65 ± 1.10 | -0.50 ± 1.00 |
| Week 16: Erythema (Lower Limbs) (n=323,335,66,66) | -1.59 ± 1.23 | -1.94 ± 1.17 | -0.62 ± 0.84 | -0.45 ± 0.79 |
| Week 16: Induration (Head\Neck) (n=323,335,66,66) | -1.22 ± 1.22 | -1.37 ± 1.16 | -0.71 ± 1.00 | -0.44 ± 1.10 |
| Week 16: Induration (Upper Limbs)(n=323,335,66,66) | -1.35 ± 1.19 | -1.58 ± 1.14 | -0.65 ± 0.83 | -0.35 ± 0.95 |
| Week 16: Induration (Trunk) (n=323,335,66,66) | -1.37 ± 1.18 | -1.75 ± 1.21 | -0.70 ± 1.01 | -0.42 ± 0.95 |
| Week 16: Induration (Lower Limbs)(n=323,335,66,66) | -1.54 ± 1.22 | -1.88 ± 1.19 | -0.64 ± 0.76 | -0.47 ± 0.92 |
| Week 16: Scaling (Head\Neck) (n=323,335,66,66) | -1.37 ± 1.26 | -1.57 ± 1.24 | -0.74 ± 1.06 | -0.48 ± 1.01 |
| Week 16: Scaling (Upper Limbs) (n=323,335,66,66) | -1.35 ± 1.22 | -1.63 ± 1.20 | -0.47 ± 0.88 | -0.47 ± 0.88 |
| Week 16: Scaling (Trunk) (n=323,335,66,66) | -1.44 ± 1.16 | -1.76 ± 1.17 | -0.53 ± 1.00 | -0.65 ± 0.89 |
| Week 16: Scaling (Lower Limbs) (n=323,335,66,66) | -1.56 ± 1.17 | -1.89 ± 1.22 | -0.62 ± 0.91 | -0.47 ± 1.01 |
| Week 20: Erythema (Head\Neck) (n=312,321,66,65) | -1.37 ± 1.20 | -1.57 ± 1.25 | -1.30 ± 0.99 | -1.02 ± 0.99 |
| Week 20: Erythema (Upper Limbs) (n=312,321,66,65) | -1.58 ± 1.18 | -1.84 ± 1.13 | -1.35 ± 0.92 | -1.12 ± 0.93 |
| Week 20: Erythema (Trunk) (n=312,321,66,65) | -1.63 ± 1.20 | -2.03 ± 1.16 | -1.42 ± 1.02 | -1.40 ± 1.06 |
| Week 20: Erythema (Lower Limbs) (n=312,321,66,65) | -1.77 ± 1.20 | -2.06 ± 1.18 | -1.42 ± 0.82 | -1.34 ± 1.08 |
| Week 20: Induration (Head\Neck) (n=312,321,66,65) | -1.29 ± 1.20 | -1.44 ± 1.18 | -1.30 ± 0.96 | -1.03 ± 1.03 |
| Week 20: Induration (Upper Limbs)(n=312,321,66,65) | -1.48 ± 1.18 | -1.65 ± 1.13 | -1.33 ± 0.79 | -1.15 ± 1.00 |
| Week 20: Induration (Trunk) (n=312,321,66,65) | -1.53 ± 1.16 | -1.83 ± 1.21 | -1.36 ± 1.00 | -1.28 ± 0.96 |
| Week 20: Induration (Lower Limbs)(n=312,321,66,65) | -1.68 ± 1.22 | -1.93 ± 1.21 | -1.32 ± 0.95 | -1.32 ± 1.05 |
| Week 20: Scaling (Head\Neck) (n=312,321,66,65) | -1.47 ± 1.21 | -1.63 ± 1.26 | -1.35 ± 1.17 | -1.15 ± 1.11 |
| Week 20: Scaling (Upper Limbs) (n=312,321,66,65) | -1.52 ± 1.18 | -1.69 ± 1.21 | -1.05 ± 1.01 | -1.14 ± 1.13 |
| Week 20: Scaling (Trunk) (n=312,321,66,65) | -1.60 ± 1.12 | -1.84 ± 1.20 | -1.17 ± 1.02 | -1.28 ± 1.10 |
| Week 20: Scaling (Lower Limbs) (n=312,321,66,65) | -1.68 ± 1.19 | -1.94 ± 1.23 | -1.23 ± 1.11 | -1.18 ± 1.16 |
| Week 28: Erythema (Head\Neck) (n=300,307,61,61) | -1.47 ± 1.24 | -1.59 ± 1.23 | -1.80 ± 1.08 | -1.70 ± 0.99 |
| Week 28: Erythema (Upper Limbs) (n=300,307,61,61) | -1.67 ± 1.24 | -1.92 ± 1.13 | -1.67 ± 1.04 | -1.89 ± 1.00 |
| Week 28: Erythema (Trunk) (n=300,307,61,61) | -1.77 ± 1.29 | -2.15 ± 1.17 | -1.89 ± 0.98 | -2.13 ± 1.02 |
| Week 28: Erythema (Lower Limbs) (n=300,307,61,61) | -1.95 ± 1.22 | -2.23 ± 1.22 | -1.92 ± 0.99 | -2.11 ± 0.98 |
| Week 28: Induration (Head\Neck) (n=300,307,61,61) | -1.40 ± 1.20 | -1.53 ± 1.16 | -1.69 ± 1.13 | -1.64 ± 1.03 |
| Week 28: Induration (Upper Limbs)(n=300,307,61,61) | -1.58 ± 1.23 | -1.75 ± 1.13 | -1.70 ± 0.95 | -1.92 ± 1.02 |
| Week 28: Induration (Trunk) (n=300,307,61,61) | -1.66 ± 1.19 | -1.92 ± 1.21 | -1.80 ± 1.01 | -1.93 ± 1.14 |
| Week 28: Induration (Lower Limbs)(n=300,307,61,61) | -1.81 ± 1.27 | -2.11 ± 1.21 | -1.89 ± 1.00 | -2.11 ± 1.10 |
| Week 28: Scaling (Head\Neck) (n=300,307,61,61) | -1.55 ± 1.28 | -1.71 ± 1.23 | -1.72 ± 1.29 | -1.79 ± 1.13 |
| Week 28: Scaling (Upper Limbs) (n=300,307,61,61) | -1.59 ± 1.28 | -1.81 ± 1.22 | -1.48 ± 1.03 | -1.84 ± 1.07 |
| Week 28: Scaling (Trunk) (n=300,307,61,61) | -1.72 ± 1.23 | -1.97 ± 1.14 | -1.61 ± 1.07 | -1.90 ± 1.14 |
| Week 28: Scaling (Lower Limbs) (n=300,307,61,61) | -1.81 ± 1.24 | -2.12 ± 1.21 | -1.80 ± 1.09 | -1.95 ± 1.12 |
| Week 40: Erythema (Head\Neck) (n=203,242,53,47) | -1.78 ± 1.15 | -1.69 ± 1.16 | -1.83 ± 1.14 | -1.81 ± 1.15 |
| Week 40: Erythema (Upper Limbs) (n=203,242,53,47) | -2.02 ± 1.15 | -2.11 ± 1.09 | -1.75 ± 1.12 | -2.40 ± 0.99 |
| Week 40: Erythema (Trunk) (n=203,242,53,47) | -2.19 ± 1.14 | -2.40 ± 1.03 | -2.11 ± 0.95 | -2.45 ± 0.93 |
| Week 40: Erythema (Lower Limbs) (n=203,242,53,47) | -2.34 ± 1.10 | -2.45 ± 1.11 | -2.21 ± 1.10 | -2.68 ± 0.89 |
| Week 40: Induration (Head\Neck) (n=203,242,53,47) | -1.68 ± 1.10 | -1.56 ± 1.14 | -1.72 ± 1.26 | -1.72 ± 1.16 |
| Week 40: Induration (Upper Limbs)(n=203,242,53,47) | -1.94 ± 1.09 | -1.93 ± 1.04 | -1.70 ± 1.01 | -2.32 ± 0.98 |
| Week 40: Induration (Trunk) (n=203,242,53,47) | -2.09 ± 1.02 | -2.15 ± 1.10 | -2.00 ± 0.98 | -2.30 ± 1.10 |
| Week 40: Induration (Lower Limbs)(n=203,242,53,47) | -2.29 ± 1.10 | -2.28 ± 1.15 | -2.04 ± 1.00 | -2.64 ± 1.03 |
| Week 40: Scaling (Head\Neck) (n=203,242,53,47) | -1.85 ± 1.18 | -1.77 ± 1.27 | -1.87 ± 1.35 | -1.96 ± 1.23 |
| Week 40: Scaling (Upper Limbs) (n=203,242,53,47) | -1.95 ± 1.22 | -2.01 ± 1.19 | -1.55 ± 0.99 | -2.34 ± 1.05 |
| Week 40: Scaling (Trunk) (n=203,242,53,47) | -2.15 ± 1.07 | -2.20 ± 1.07 | -1.81 ± 1.06 | -2.26 ± 1.01 |
| Week 40: Scaling (Lower Limbs) (n=203,242,53,47) | -2.20 ± 1.16 | -2.30 ± 1.19 | -2.00 ± 1.09 | -2.57 ± 0.90 |
| Week 52: Erythema (Head\Neck) (n=180,219,47,46) | -1.81 ± 1.08 | -1.75 ± 1.18 | -1.70 ± 1.20 | -1.74 ± 1.04 |
| Week 52: Erythema (Upper Limbs) (n=180,219,47,46) | -1.95 ± 1.13 | -2.13 ± 1.04 | -1.77 ± 1.16 | -2.46 ± 0.98 |
| Week 52: Erythema (Trunk) (n=180,219,47,46) | -2.22 ± 1.12 | -2.31 ± 1.13 | -2.15 ± 1.02 | -2.52 ± 1.03 |
| Week 52: Erythema (Lower Limbs) (n=180,219,47,46) | -2.29 ± 1.16 | -2.50 ± 1.12 | -2.26 ± 1.13 | -2.61 ± 0.98 |
| Week 52: Induration (Head\Neck) (n=180,219,47,46) | -1.65 ± 1.11 | -1.69 ± 1.13 | -1.68 ± 1.09 | -1.72 ± 1.13 |
| Week 52: Induration (Upper Limbs)(n=180,219,47,46) | -1.86 ± 1.12 | -1.95 ± 1.07 | -1.70 ± 1.04 | -2.24 ± 1.02 |
| Week 52: Induration (Trunk) (n=180,219,47,46) | -2.08 ± 1.03 | -2.11 ± 1.16 | -2.04 ± 1.04 | -2.24 ± 1.14 |
| Week 52: Induration (Lower Limbs)(n=180,219,47,46) | -2.17 ± 1.17 | -2.30 ± 1.18 | -2.13 ± 1.10 | -2.54 ± 1.03 |
| Week 52: Scaling (Head\Neck) (n=180,219,47,46) | -1.86 ± 1.16 | -1.87 ± 1.23 | -1.68 ± 1.29 | -1.89 ± 1.20 |
| Week 52: Scaling (Upper Limbs) (n=180,219,47,46) | -1.87 ± 1.20 | -1.99 ± 1.11 | -1.53 ± 1.10 | -2.26 ± 1.00 |
| Week 52: Scaling (Trunk) (n=180,219,47,46) | -2.17 ± 1.05 | -2.16 ± 1.08 | -1.85 ± 1.12 | -2.28 ± 1.07 |
| Week 52: Scaling (Lower Limbs) (n=180,219,47,46) | -2.12 ± 1.16 | -2.35 ± 1.16 | -1.98 ± 1.24 | -2.52 ± 0.98 |
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.
| percent change | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Change at Week 2 | -18.50 ± 1.11 | -24.86 ± 1.11 | -8.99 ± 2.59 | -5.85 ± 2.61 |
| Change at Week 4 | -34.60 ± 1.45 | -43.08 ± 1.46 | -15.75 ± 3.38 | -10.76 ± 3.38 |
| Change at Week 8 | -47.72 ± 1.68 | -60.48 ± 1.68 | -20.27 ± 3.89 | -13.02 ± 3.88 |
| Change at Week 12 | -54.07 ± 1.83 | -69.11 ± 1.83 | -23.02 ± 4.21 | -15.26 ± 4.21 |
| Change at Week 16 | -57.25 ± 1.97 | -72.71 ± 1.96 | -25.66 ± 4.51 | -13.33 ± 4.51 |
| Change at Week 20 | -63.73 ± 1.74 | -75.05 ± 1.73 | -56.71 ± 3.93 | -49.48 ± 3.94 |
| Change at Week 28 | -68.62 ± 1.69 | -78.91 ± 1.67 | -73.49 ± 3.75 | -76.64 ± 3.78 |
| Change at Week 40 | -67.06 ± 1.82 | -76.36 ± 1.77 | -73.52 ± 3.93 | -81.21 ± 4.01 |
| Change at Week 52 | -64.15 ± 1.91 | -74.61 ± 1.85 | -70.60 ± 4.11 | -80.94 ± 4.17 |
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
| percentage of BSA | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n = 363, 360, 66, 66) | 28.48 ± 16.42 | 31.13 ± 17.64 | 28.03 ± 16.99 | 30.17 ± 16.34 |
| Week 2 (n = 358, 358, 66, 64) | 27.08 ± 16.85 | 27.86 ± 17.24 | 28.21 ± 19.27 | 30.32 ± 16.99 |
| Week 4 (n = 352, 350, 65, 66) | 23.69 ± 16.56 | 22.79 ± 17.52 | 27.15 ± 20.08 | 29.52 ± 17.01 |
| Week 8 (n = 347, 350, 65, 66) | 18.99 ± 16.28 | 16.49 ± 16.23 | 26.82 ± 19.93 | 29.43 ± 17.45 |
| Week 12 (n = 345, 345, 65, 66) | 15.73 ± 16.03 | 12.64 ± 15.01 | 25.89 ± 20.50 | 29.02 ± 17.58 |
| Week 16 (n = 323, 335, 66, 66) | 13.08 ± 15.75 | 9.48 ± 12.99 | 25.89 ± 21.77 | 29.14 ± 19.18 |
| Week 20 (n = 312, 321, 66, 65) | 10.77 ± 14.23 | 7.59 ± 11.45 | 18.57 ± 20.49 | 21.73 ± 17.48 |
| Week 28 (n = 300, 307, 61, 61) | 8.92 ± 13.07 | 6.05 ± 9.36 | 9.54 ± 15.85 | 9.96 ± 12.39 |
| Week 40 (n = 203, 242, 53, 47) | 4.37 ± 7.58 | 3.51 ± 6.03 | 4.47 ± 6.96 | 3.02 ± 4.19 |
| Week 52 (n = 180, 219, 47, 46) | 4.42 ± 6.93 | 2.94 ± 5.29 | 3.79 ± 4.37 | 2.09 ± 2.80 |
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
| percent change | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Change at Week 2 | -6.89 ± 0.97 | -10.44 ± 0.97 | -1.92 ± 2.25 | -1.23 ± 2.27 |
| Change at Week 4 | -18.31 ± 1.58 | -26.73 ± 1.58 | -5.29 ± 3.67 | -1.81 ± 3.66 |
| Change at Week 8 | -34.86 ± 1.93 | -46.27 ± 1.93 | -6.73 ± 4.46 | -1.57 ± 4.45 |
| Change at Week 12 | -45.72 ± 2.13 | -59.20 ± 2.13 | -9.62 ± 4.91 | -0.84 ± 4.91 |
| Change at Week 16 | -51.87 ± 2.41 | -67.12 ± 2.41 | -11.22 ± 5.50 | 2.03 ± 5.50 |
| Change at Week 20 | -58.67 ± 2.22 | -71.96 ± 2.21 | -37.66 ± 5.03 | -26.49 ± 5.04 |
| Change at Week 28 | -64.74 ± 2.27 | -76.82 ± 2.24 | -66.75 ± 5.03 | -64.11 ± 5.07 |
| Change at Week 40 | -73.29 ± 1.72 | -80.78 ± 1.67 | -73.67 ± 3.69 | -79.92 ± 3.78 |
| Change at Week 52 | -74.95 ± 1.55 | -82.36 ± 1.48 | -74.84 ± 3.26 | -84.79 ± 3.33 |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 2 | 9.09 (6.13 to 12.05) | 17.22 (13.32 to 21.12) | 3.03 (0.00 to 7.17) | 0.00 (0.00 to 0.00) |
| Week 4 | 28.65 (24.00 to 33.30) | 39.72 (34.67 to 44.78) | 9.09 (2.16 to 16.03) | 1.52 (0.00 to 4.46) |
| Week 8 | 47.93 (42.79 to 53.07) | 65.56 (60.65 to 70.46) | 18.18 (8.88 to 27.49) | 12.12 (4.25 to 20.00) |
| Week 12 | 58.95 (53.89 to 64.01) | 73.89 (69.35 to 78.43) | 24.24 (13.90 to 34.58) | 12.12 (4.25 to 20.00) |
| Week 16 | 60.33 (55.30 to 65.36) | 76.94 (72.59 to 81.30) | 22.73 (12.62 to 32.84) | 21.21 (11.35 to 31.08) |
| Week 20 | 66.12 (61.25 to 70.98) | 75.83 (71.41 to 80.26) | 63.64 (52.03 to 75.24) | 54.55 (42.53 to 66.56) |
| Week 28 | 66.39 (61.53 to 71.25) | 76.11 (71.71 to 80.52) | 77.27 (67.16 to 87.38) | 83.33 (74.34 to 92.32) |
| Week 40 | 53.99 (48.87 to 59.12) | 63.61 (58.64 to 68.58) | 75.76 (65.42 to 86.10) | 71.21 (60.29 to 82.14) |
| Week 52 | 48.21 (43.07 to 53.35) | 59.44 (54.37 to 64.52) | 66.67 (55.29 to 78.04) | 69.70 (58.61 to 80.78) |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 2 | 0.28 (0.00 to 0.81) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
| Week 4 | 1.65 (0.34 to 2.96) | 3.89 (1.89 to 5.89) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
| Week 8 | 9.64 (6.61 to 12.68) | 18.61 (14.59 to 22.63) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
| Week 12 | 15.43 (11.71 to 19.14) | 28.06 (23.41 to 32.70) | 1.52 (0.00 to 4.46) | 0.00 (0.00 to 0.00) |
| Week 16 | 19.83 (15.73 to 23.94) | 39.44 (34.40 to 44.49) | 0.00 (0.00 to 0.00) | 1.52 (0.00 to 4.46) |
| Week 20 | 23.14 (18.80 to 27.48) | 40.28 (35.21 to 45.34) | 7.58 (1.19 to 13.96) | 9.09 (2.16 to 16.03) |
| Week 28 | 31.13 (26.37 to 35.89) | 43.61 (38.49 to 48.73) | 25.76 (15.21 to 36.31) | 39.39 (27.61 to 51.18) |
| Week 40 | 28.10 (23.48 to 32.72) | 41.39 (36.30 to 46.48) | 34.85 (23.35 to 46.34) | 54.55 (42.53 to 66.56) |
| Week 52 | 23.42 (19.06 to 27.77) | 36.94 (31.96 to 41.93) | 31.82 (20.58 to 43.06) | 53.03 (40.99 to 65.07) |
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 2 (n = 358, 358, 66, 64) | 0.56 (0.00 to 1.33) | 1.12 (0.03 to 2.21) | 4.55 (0.00 to 9.57) | 3.13 (0.00 to 7.39) |
| Week 4 (n = 352, 350, 65, 66) | 1.14 (0.03 to 2.24) | 0.57 (0.00 to 1.36) | 1.54 (0.00 to 4.53) | 4.55 (0.00 to 9.57) |
| Week 8 (n = 347, 350, 65, 66) | 2.02 (0.54 to 3.50) | 0.29 (0.00 to 0.84) | 3.08 (0.00 to 7.28) | 7.58 (1.19 to 13.96) |
| Week 12 (n = 345, 345, 65, 66) | 2.90 (1.13 to 4.67) | 1.16 (0.03 to 2.29) | 6.15 (0.31 to 12.00) | 9.09 (2.16 to 16.03) |
| Week 16 (n = 323, 335, 66, 66) | 2.48 (0.78 to 4.17) | 0.90 (0.00 to 1.90) | 6.06 (0.30 to 11.82) | 12.12 (4.25 to 20.00) |
| Week 20 (n = 312, 321, 66, 65) | 1.60 (0.21 to 3.00) | 0.62 (0.00 to 1.48) | 1.52 (0.00 to 4.46) | 4.62 (0.00 to 9.72) |
| Week 28 (n = 300, 307, 61, 61) | 1.00 (0.00 to 2.13) | 0.33 (0.00 to 0.96) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
| Week 40 (n = 203, 242, 53, 47) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
| Week 52 (n = 180, 219, 47, 46) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n=247,250,34,46) | 26.64 ± 20.65 | 28.24 ± 20.89 | 26.76 ± 18.33 | 23.91 ± 16.21 |
| Week 8 (n=236,242,33,46) | 24.32 ± 20.60 | 22.47 ± 19.43 | 25.55 ± 18.50 | 24.61 ± 16.76 |
| Week 16 (n=215,233,34,46) | 20.09 ± 18.79 | 16.53 ± 17.87 | 27.82 ± 17.64 | 25.46 ± 18.57 |
| Week 20 (n=210,227,34,45) | 16.53 ± 17.35 | 12.96 ± 16.11 | 23.97 ± 18.18 | 21.18 ± 18.69 |
| Week 28 (n=202,213,30,44) | 13.42 ± 16.17 | 9.49 ± 13.92 | 16.77 ± 14.69 | 14.77 ± 17.29 |
| Week 40 (n=125,167,24,33) | 7.36 ± 10.04 | 7.19 ± 12.71 | 5.67 ± 7.92 | 8.85 ± 11.27 |
| Week 52 (n=110,148,21,32) | 6.94 ± 9.48 | 6.73 ± 12.44 | 5.90 ± 8.92 | 6.66 ± 9.09 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Change at Week 8 (n= 236, 242, 33, 46) | -2.58 ± 10.98 | -5.55 ± 12.64 | -0.82 ± 7.26 | 0.70 ± 6.89 |
| Change at Week 16 (n= 215, 233, 34, 46) | -6.91 ± 13.93 | -11.70 ± 16.68 | 1.06 ± 9.37 | 1.54 ± 11.34 |
| Change at Week 20 (n= 210, 227, 34, 45) | -10.51 ± 15.17 | -15.16 ± 17.51 | -2.79 ± 11.83 | -2.53 ± 13.00 |
| Change at Week 28 (n= 202, 213, 30, 44) | -13.08 ± 16.53 | -19.07 ± 18.62 | -10.30 ± 13.90 | -8.50 ± 14.18 |
| Change at Week 40 (n= 125, 167, 24, 33) | -18.40 ± 17.47 | -21.63 ± 19.61 | -16.38 ± 15.34 | -13.21 ± 13.07 |
| Change at Week 52 (n= 110, 148, 21, 32) | -18.49 ± 17.03 | -22.28 ± 20.33 | -17.19 ± 14.32 | -15.97 ± 12.47 |
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.
| nails | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n= 247, 250, 34, 46) | 7.21 ± 3.14 | 7.71 ± 3.12 | 7.73 ± 3.05 | 7.24 ± 3.39 |
| Week 8 (n= 234, 242, 32, 46) | 6.87 ± 3.58 | 6.65 ± 3.80 | 8.00 ± 3.01 | 7.48 ± 3.00 |
| Week 16 (n= 215, 233, 33, 45) | 6.25 ± 3.79 | 5.44 ± 4.16 | 8.27 ± 2.65 | 7.56 ± 3.03 |
| Week 20 (n= 209, 227, 33, 44) | 5.53 ± 3.83 | 4.65 ± 4.13 | 7.48 ± 3.01 | 6.43 ± 3.70 |
| Week 28 (n= 202, 213, 30, 44) | 4.77 ± 3.92 | 3.76 ± 4.03 | 6.63 ± 3.32 | 5.09 ± 3.84 |
| Week 40 (n= 125, 167, 24, 33) | 3.49 ± 3.68 | 2.91 ± 3.61 | 3.13 ± 3.69 | 3.94 ± 4.00 |
| Week 52 (n= 110, 148, 21, 32) | 3.44 ± 3.60 | 2.64 ± 3.57 | 3.10 ± 3.70 | 3.25 ± 3.88 |
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.
| percent change | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Percent Change at Week 8 | 2.58 ± 6.46 | -19.37 ± 6.40 | 16.91 ± 17.18 | 36.22 ± 14.67 |
| Percent Change at Week 16 | -14.13 ± 9.39 | -42.26 ± 9.16 | 78.80 ± 24.22 | 50.19 ± 20.82 |
| Percent Change at Week 20 | -32.74 ± 9.20 | -52.62 ± 8.93 | 43.82 ± 23.46 | 38.66 ± 20.24 |
| Percent Change at Week 28 | -43.52 ± 7.22 | -65.20 ± 7.06 | 12.39 ± 18.71 | -18.71 ± 15.95 |
| Percent Change at Week 40 | -64.55 ± 4.05 | -75.41 ± 3.57 | -57.01 ± 9.38 | -54.83 ± 8.02 |
| Percent Change at Week 52 | -58.27 ± 5.98 | -73.56 ± 5.54 | -45.67 ± 14.67 | -72.42 ± 12.31 |
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. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 8 | 9.72 (6.02 to 13.41) | 14.40 (10.05 to 18.75) | 8.82 (0.00 to 18.36) | 4.35 (0.00 to 10.24) |
| Week 16 | 14.98 (10.53 to 19.43) | 29.20 (23.56 to 34.84) | 5.88 (0.00 to 13.79) | 6.52 (0.00 to 13.66) |
| Week 20 | 21.05 (15.97 to 26.14) | 39.20 (33.15 to 45.25) | 8.82 (0.00 to 18.36) | 23.91 (11.59 to 36.24) |
| Week 28 | 31.17 (25.40 to 36.95) | 49.20 (43.00 to 55.40) | 17.65 (4.83 to 30.46) | 28.26 (15.25 to 41.27) |
| Week 40 | 28.34 (22.72 to 33.96) | 48.80 (42.60 to 55.00) | 41.18 (24.63 to 57.72) | 36.96 (23.01 to 50.91) |
| Week 52 | 25.51 (20.07 to 30.94) | 41.20 (35.10 to 47.30) | 35.29 (19.23 to 51.36) | 43.48 (29.15 to 57.80) |
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. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week 8 | 8.10 (4.70 to 11.50) | 12.40 (8.31 to 16.49) | 5.88 (0.00 to 13.79) | 4.35 (0.00 to 10.24) |
| Week 16 | 10.12 (6.36 to 13.88) | 20.00 (15.04 to 24.96) | 5.88 (0.00 to 13.79) | 4.35 (0.00 to 10.24) |
| Week 20 | 13.77 (9.47 to 18.06) | 27.20 (21.68 to 32.72) | 8.82 (0.00 to 18.36) | 13.04 (3.31 to 22.78) |
| Week 28 | 19.43 (14.50 to 24.37) | 32.00 (26.22 to 37.78) | 5.88 (0.00 to 13.79) | 17.39 (6.44 to 28.34) |
| Week 40 | 18.22 (13.40 to 23.03) | 30.40 (24.70 to 36.10) | 29.41 (14.10 to 44.73) | 26.09 (13.40 to 38.78) |
| Week 52 | 15.79 (11.24 to 20.34) | 28.80 (23.19 to 34.41) | 29.41 (14.10 to 44.73) | 28.26 (15.25 to 41.27) |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n=343,341,62,58) | 5.49 ± 2.81 | 5.59 ± 2.72 | 5.64 ± 2.65 | 5.94 ± 2.94 |
| Week 2 (n=357,358,66,64) | 3.74 ± 2.51 | 3.32 ± 2.56 | 5.45 ± 2.87 | 5.61 ± 3.04 |
| Week 4 (n=351,350,64,66) | 2.89 ± 2.44 | 2.41 ± 2.28 | 5.36 ± 2.86 | 5.56 ± 3.05 |
| Week 8 (n=347,348,65,66) | 2.56 ± 2.60 | 1.87 ± 2.20 | 5.51 ± 2.94 | 5.50 ± 3.35 |
| Week 12 (n=343,344,65,66) | 2.38 ± 2.66 | 1.62 ± 2.18 | 4.83 ± 3.11 | 5.42 ± 3.30 |
| Week 16 (n=322,335,66,66) | 2.44 ± 2.70 | 1.48 ± 2.14 | 4.82 ± 3.11 | 5.83 ± 3.27 |
| Week 20 (n=312,319,66,65) | 1.94 ± 2.20 | 1.43 ± 2.23 | 2.48 ± 2.27 | 2.48 ± 2.63 |
| Week 28 (n=293,306,61,61) | 1.96 ± 2.41 | 1.41 ± 2.11 | 2.02 ± 2.31 | 1.62 ± 2.09 |
| Week 40 (n=202,242,53,47) | 1.47 ± 2.15 | 1.01 ± 1.77 | 1.43 ± 2.03 | 0.83 ± 1.54 |
| Week 52 (n=179,218,47,46) | 1.35 ± 2.00 | 0.83 ± 1.53 | 1.60 ± 2.09 | 0.93 ± 1.44 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Change at Week 2 | -1.76 ± 0.10 | -2.25 ± 0.11 | -0.13 ± 0.25 | -0.06 ± 0.26 |
| Change at Week 4 | -2.62 ± 0.11 | -3.16 ± 0.11 | -0.27 ± 0.26 | -0.11 ± 0.27 |
| Change at Week 8 | -2.95 ± 0.13 | -3.72 ± 0.13 | -0.01 ± 0.29 | -0.18 ± 0.30 |
| Change at Week 12 | -3.02 ± 0.13 | -3.91 ± 0.13 | -0.79 ± 0.30 | -0.25 ± 0.31 |
| Change at Week 16 | -2.85 ± 0.14 | -3.97 ± 0.14 | -0.77 ± 0.31 | 0.17 ± 0.32 |
| Change at Week 20 | -3.31 ± 0.13 | -3.98 ± 0.13 | -3.11 ± 0.29 | -3.16 ± 0.30 |
| Change at Week 28 | -3.25 ± 0.14 | -3.94 ± 0.13 | -3.59 ± 0.30 | -4.16 ± 0.32 |
| Change at Week 40 | -3.07 ± 0.15 | -3.88 ± 0.14 | -3.84 ± 0.32 | -4.40 ± 0.34 |
| Change at Week 52 | -3.05 ± 0.15 | -3.89 ± 0.14 | -3.50 ± 0.32 | -4.17 ± 0.33 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n=363,359,66,66) | 12.46 ± 6.89 | 12.87 ± 6.91 | 13.83 ± 6.97 | 14.68 ± 6.80 |
| Week 2 (n=356,357,66,64) | 8.65 ± 6.11 | 8.32 ± 6.45 | 11.44 ± 7.02 | 12.67 ± 7.06 |
| Week 4 (n=351,349,65,66) | 6.98 ± 5.97 | 6.50 ± 5.94 | 11.45 ± 6.87 | 13.05 ± 7.14 |
| Week 8 (n=345,347,65,66) | 5.88 ± 6.00 | 4.95 ± 5.58 | 10.89 ± 6.23 | 13.05 ± 7.49 |
| Week 12 (n=340,344,65,66) | 5.36 ± 6.06 | 4.17 ± 5.10 | 10.29 ± 6.82 | 13.06 ± 7.58 |
| Week 16 (n=319,331,66,66) | 5.45 ± 6.07 | 3.85 ± 5.17 | 10.05 ± 6.23 | 12.83 ± 7.80 |
| Week 20 (n=310,319,66,65) | 4.28 ± 5.18 | 3.26 ± 4.67 | 5.89 ± 4.88 | 7.17 ± 6.69 |
| Week 28 (n=289,303,61,61) | 3.94 ± 5.05 | 3.24 ± 4.83 | 4.34 ± 4.88 | 3.46 ± 4.27 |
| Week 40 (n=200,239,53,46) | 2.53 ± 4.11 | 2.11 ± 3.79 | 3.25 ± 4.43 | 1.63 ± 2.17 |
| Week 52 (n=177,216,47,46) | 2.86 ± 4.35 | 1.91 ± 3.72 | 3.40 ± 4.43 | 1.78 ± 2.44 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Change at Week 2 | -4.02 ± 0.23 | -4.56 ± 0.23 | -1.94 ± 0.54 | -1.07 ± 0.54 |
| Change at Week 4 | -5.65 ± 0.25 | -6.41 ± 0.25 | -1.90 ± 0.57 | -0.77 ± 0.57 |
| Change at Week 8 | -6.68 ± 0.27 | -7.95 ± 0.27 | -2.45 ± 0.61 | -0.77 ± 0.61 |
| Change at Week 12 | -7.09 ± 0.27 | -8.70 ± 0.27 | -3.08 ± 0.63 | -0.75 ± 0.63 |
| Change at Week 16 | -6.97 ± 0.29 | -8.90 ± 0.28 | -3.33 ± 0.65 | -0.98 ± 0.65 |
| Change at Week 20 | -8.01 ± 0.27 | -9.42 ± 0.27 | -7.48 ± 0.61 | -6.48 ± 0.61 |
| Change at Week 28 | -8.25 ± 0.28 | -9.36 ± 0.28 | -9.02 ± 0.62 | -9.72 ± 0.62 |
| Change at Week 40 | -8.50 ± 0.30 | -9.51 ± 0.29 | -9.26 ± 0.63 | -10.89 ± 0.65 |
| Change at Week 52 | -8.26 ± 0.31 | -9.56 ± 0.30 | -9.23 ± 0.65 | -10.90 ± 0.66 |
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).
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline: Physical Health Score (n=358,355,66,66) | 47.36 ± 9.10 | 47.02 ± 9.05 | 47.12 ± 8.95 | 44.86 ± 9.12 |
| Baseline: Mental Health Score (n=358,355,66,66) | 42.98 ± 12.53 | 43.35 ± 11.57 | 42.53 ± 11.77 | 42.97 ± 11.44 |
| Week 16: Physical Health Score (n=318,329,65,65) | 49.83 ± 8.34 | 50.99 ± 8.63 | 48.04 ± 8.75 | 45.60 ± 8.87 |
| Week 16: Mental Health Score (n=318,329,65,65) | 47.23 ± 10.93 | 49.06 ± 9.50 | 44.47 ± 10.77 | 43.07 ± 12.34 |
| Week 28: Physical Health Score (n=286,303,60,61) | 51.01 ± 7.67 | 51.92 ± 7.86 | 51.11 ± 8.08 | 49.63 ± 8.52 |
| Week 28: Mental Health Score (n=286,303,60,61) | 48.59 ± 10.47 | 49.64 ± 9.35 | 48.63 ± 9.57 | 49.69 ± 9.71 |
| Week 52: Physical Health Score (n=177,216,46,46) | 51.98 ± 7.10 | 52.42 ± 7.93 | 50.90 ± 8.75 | 52.12 ± 7.64 |
| Week 52: Mental Health Score (n=177,216,46,46) | 49.05 ± 10.33 | 50.73 ± 8.38 | 50.77 ± 9.43 | 49.58 ± 9.67 |
HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline: Anxiety Subscale (n=362,358,66,66) | 6.58 ± 4.21 | 6.21 ± 4.08 | 6.94 ± 4.21 | 7.06 ± 4.02 |
| Baseline: Depression Subscale (n=362,358,66,66) | 5.20 ± 4.27 | 5.09 ± 4.09 | 5.61 ± 3.98 | 5.68 ± 3.93 |
| Week 4: Anxiety Subscale (n=350,349,65,66) | 5.66 ± 3.96 | 5.30 ± 3.90 | 6.82 ± 4.11 | 6.70 ± 4.12 |
| Week 4: Depression Subscale (n=350,349,65,66) | 4.34 ± 3.59 | 4.23 ± 3.75 | 5.28 ± 4.06 | 5.26 ± 4.12 |
| Week 16: Anxiety Subscale (n=317,333,65,66) | 5.50 ± 4.18 | 4.74 ± 3.76 | 6.20 ± 4.39 | 6.85 ± 4.50 |
| Week 16: Depression Subscale (n=317,333,65,66) | 3.97 ± 3.87 | 3.51 ± 3.71 | 4.92 ± 3.65 | 5.50 ± 4.07 |
| Week 28: Anxiety Subscale (n=286,304,60,61) | 4.98 ± 4.04 | 4.47 ± 4.00 | 4.60 ± 3.89 | 4.82 ± 3.88 |
| Week 28: Depression Subscale (n=286,304,60,61) | 3.63 ± 3.64 | 3.21 ± 3.65 | 3.65 ± 3.66 | 3.59 ± 3.25 |
| Week 52: Anxiety Subscale (n=177,215,46,46) | 3.97 ± 3.65 | 3.84 ± 3.88 | 4.33 ± 4.21 | 4.00 ± 3.81 |
| Week 52:Depression Subscale (n= 177, 215, 46, 46) | 3.05 ± 3.48 | 2.80 ± 3.49 | 3.11 ± 3.16 | 3.09 ± 3.03 |
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 \[complete loss of work\]).
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n= 309, 305, 55, 56) | 7.40 ± 6.38 | 7.90 ± 6.51 | 7.16 ± 5.84 | 8.40 ± 6.01 |
| Week 4 (n= 291, 298, 53, 55) | 6.92 ± 6.68 | 6.64 ± 6.42 | 6.67 ± 6.41 | 9.66 ± 6.55 |
| Week 16 (n= 273, 279, 51, 55) | 6.68 ± 6.37 | 5.72 ± 5.93 | 6.53 ± 5.97 | 7.13 ± 5.69 |
| Week 28 (n= 241, 254, 51, 53) | 6.12 ± 6.37 | 5.77 ± 6.29 | 6.03 ± 6.29 | 6.24 ± 6.36 |
| Week 52 (n= 148, 183, 41, 41) | 6.02 ± 6.26 | 5.95 ± 6.65 | 6.73 ± 6.54 | 5.29 ± 6.49 |
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).
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline: Clear (n = 360, 359, 66, 66) | 0.0 | 0.0 | 0.0 | 0.0 |
| Baseline: Almost Clear (n = 360, 359, 66, 66) | 0.0 | 0.0 | 0.0 | 0.0 |
| Baseline: Mild (n = 360, 359, 66, 66) | 1.9 | 3.6 | 3.0 | 1.5 |
| Baseline: Moderate (n = 360, 359, 66, 66) | 35.3 | 35.7 | 31.8 | 34.8 |
| Baseline: Severe (n = 360, 359, 66, 66) | 62.8 | 60.7 | 65.2 | 63.6 |
| Week 2: Clear (n = 357, 358, 66, 64) | 0.0 | 0.3 | 0.0 | 0.0 |
| Week 2: Almost Clear (n = 357, 358, 66, 64) | 1.1 | 3.9 | 0.0 | 0.0 |
| Week 2: Mild (n = 357, 358, 66, 64) | 14.8 | 17.6 | 7.6 | 6.3 |
| Week 2: Moderate (n = 357, 358, 66, 64) | 51.0 | 48.0 | 37.9 | 40.6 |
| Week 2: Severe (n = 357, 358, 66, 64) | 33.1 | 30.2 | 54.5 | 53.1 |
| Week 4: Clear (n = 350, 348, 65, 65) | 0.0 | 0.9 | 0.0 | 0.0 |
| Week 4: Almost Clear (n = 350, 348, 65, 65) | 10.0 | 12.1 | 1.5 | 0.0 |
| Week 4: Mild (n = 350, 348, 65, 65) | 24.6 | 29.9 | 7.7 | 4.6 |
| Week 4: Moderate (n = 350, 348, 65, 65) | 42.9 | 40.5 | 46.2 | 36.9 |
| Week 4: Severe (n = 350, 348, 65, 65) | 22.6 | 16.7 | 44.6 | 58.5 |
| Week 8: Clear (n = 345, 346, 65, 66) | 1.7 | 3.8 | 0.0 | 0.0 |
| Week 8: Almost Clear (n = 345, 346, 65, 66) | 19.7 | 27.7 | 1.5 | 1.5 |
| Week 8: Mild (n = 345, 346, 65, 66) | 29.3 | 28.9 | 12.3 | 6.1 |
| Week 8: Moderate (n = 345, 346, 65, 66) | 30.1 | 27.2 | 43.1 | 39.4 |
| Week 8: Severe (n = 345, 346, 65, 66) | 19.1 | 12.4 | 43.1 | 53.0 |
| Week 12: Clear (n = 341, 344, 65, 65) | 3.8 | 8.7 | 0.0 | 0.0 |
| Week 12: Almost Clear (n = 341, 344, 65, 65) | 24.9 | 35.2 | 3.1 | 3.1 |
| Week 12: Mild (n = 341, 344, 65, 65) | 29.6 | 27.9 | 23.1 | 7.7 |
| Week 12: Moderate (n = 341, 344, 65, 65) | 24.3 | 19.5 | 32.3 | 33.8 |
| Week 12: Severe (n = 341, 344, 65, 65) | 17.3 | 8.7 | 41.5 | 55.4 |
| Week 16: Clear (n = 320, 331, 66, 66) | 3.4 | 10.9 | 0.0 | 0.0 |
| Week 16: Almost Clear (n = 320, 331, 66, 66) | 28.4 | 37.8 | 6.1 | 3.0 |
| Week 16: Mild (n = 320, 331, 66, 66) | 30.6 | 24.8 | 15.2 | 10.6 |
| Week 16: Moderate (n = 320, 331, 66, 66) | 22.5 | 19.0 | 42.4 | 25.8 |
| Week 16: Severe (n = 320, 331, 66, 66) | 15.0 | 7.6 | 36.4 | 60.6 |
| Week 20: Clear (n = 311, 319, 65, 64) | 6.1 | 16.3 | 0.0 | 1.6 |
| Week 20: Almost Clear (n = 311, 319, 65, 64) | 34.1 | 35.7 | 23.1 | 20.3 |
| Week 20: Mild (n = 311, 319, 65, 64) | 28.6 | 27.3 | 26.2 | 20.3 |
| Week 20: Moderate (n = 311, 319, 65, 64) | 23.5 | 13.5 | 46.2 | 35.9 |
| Week 20: Severe (n = 311, 319, 65, 64) | 7.7 | 7.2 | 4.6 | 21.9 |
| Week 28: Clear (n = 290, 303, 61, 61) | 11.7 | 20.8 | 6.6 | 14.8 |
| Week 28: Almost Clear (n = 290, 303, 61, 61) | 36.9 | 40.6 | 32.8 | 39.3 |
| Week 28: Mild (n = 290, 303, 61, 61) | 19.3 | 17.5 | 39.3 | 29.5 |
| Week 28: Moderate (n = 290, 303, 61, 61) | 25.2 | 15.8 | 19.7 | 11.5 |
| Week 28: Severe (n = 290, 303, 61, 61) | 6.9 | 5.3 | 1.6 | 4.9 |
| Week 40: Clear (n = 200, 239, 53, 46) | 18.5 | 30.5 | 11.3 | 28.3 |
| Week 40: Almost Clear (n = 200, 239, 53, 46) | 44.0 | 41.4 | 50.9 | 56.5 |
| Week 40: Mild (n = 200, 239, 53, 46) | 18.5 | 15.5 | 20.8 | 15.2 |
| Week 40: Moderate (n = 200, 239, 53, 46) | 16.0 | 11.3 | 15.1 | 0.0 |
| Week 40: Severe (n = 200, 239, 53, 46) | 3.0 | 1.3 | 1.9 | 0.0 |
| Week 52: Clear (n = 177, 216, 47, 46) | 14.1 | 32.9 | 19.1 | 34.8 |
| Week 52: Almost Clear (n = 177, 216, 47, 46) | 45.8 | 39.8 | 31.9 | 45.7 |
| Week 52: Mild (n = 177, 216, 47, 46) | 17.5 | 15.3 | 23.4 | 13.0 |
| Week 52: Moderate (n = 177, 216, 47, 46) | 16.4 | 9.3 | 21.3 | 6.5 |
| Week 52: Severe (n = 177, 216, 47, 46) | 6.2 | 2.8 | 4.3 | 0.0 |
The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study treatment.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Week16:Not Satisfied/Dissatisfied(n=317,332,65,66) | 6.0 | 6.3 | 12.3 | 13.6 |
| Week 16:Slightly Dissatisfied (n=317,332,65,66) | 3.2 | 1.5 | 9.2 | 7.6 |
| Week 16:Slightly Satisfied (n=317,332,65,66) | 7.9 | 6.9 | 9.2 | 12.1 |
| Week 16:Somewhat Dissatisfied (n=317,332,65,66) | 6.0 | 3.0 | 9.2 | 18.2 |
| Week 16:Somewhat Satisfied (n=317,332,65,66) | 22.1 | 22.9 | 16.9 | 7.6 |
| Week 16:Very Dissatisfied (n=317,332,65,66) | 5.4 | 4.2 | 29.2 | 33.3 |
| Week 16:Very Satisfied (n=317,332,65,66) | 49.5 | 55.1 | 13.8 | 7.6 |
| Week28:Not Satisfied/Dissatisfied(n=285,303,60,61) | 2.1 | 4.0 | 1.7 | 3.3 |
| Week 28:Slightly Dissatisfied (n=285,303,60,61) | 4.6 | 3.3 | 1.7 | 1.6 |
| Week 28:Slightly Satisfied (n=285,303,60,61) | 10.5 | 6.9 | 11.7 | 3.3 |
| Week 28:Somewhat Dissatisfied (n=285,303,60,61) | 3.9 | 0.7 | 0.0 | 1.6 |
| Week 28:Somewhat Satisfied (n=285,303,60,61) | 27.0 | 26.1 | 40.0 | 31.1 |
| Week 28:Very Dissatisfied (n=285,303,60,61) | 2.5 | 3.6 | 0.0 | 0.0 |
| Week 28:Very Satisfied (n=285,303,60,61) | 49.5 | 55.4 | 45.0 | 59.0 |
| Week52:Not Satisfied/Dissatisfied(n=176,217,46,46) | 2.8 | 0.9 | 0.0 | 0.0 |
| Week 52:Slightly Dissatisfied (n=176,217,46,46) | 1.1 | 0.9 | 2.2 | 0.0 |
| Week 52:Slightly Satisfied (n=176,217,46,46) | 5.1 | 5.5 | 13.0 | 0.0 |
| Week 52:Somewhat Dissatisfied (n=176,217,46,46) | 2.3 | 0.9 | 2.2 | 0.0 |
| Week 52:Somewhat Satisfied (n=176,217,46,46) | 33.5 | 25.3 | 34.8 | 28.3 |
| Week 52:Very Dissatisfied (n=176,217,46,46) | 0.0 | 0.9 | 0.0 | 0.0 |
| Week 52:Very Satisfied (n=176,217,46,46) | 55.1 | 65.4 | 47.8 | 71.7 |
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."
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n= 363, 359, 66, 65) | 3.42 ± 3.21 | 2.96 ± 2.99 | 3.00 ± 2.94 | 3.69 ± 3.15 |
| Week 4 (n= 351, 349, 64, 66) | 2.24 ± 2.57 | 2.13 ± 2.56 | 3.13 ± 2.68 | 3.18 ± 3.19 |
| Week 16 (n= 319, 333, 65, 66) | 2.41 ± 2.76 | 1.89 ± 2.59 | 3.20 ± 3.07 | 3.45 ± 3.22 |
| Week 28 (n= 287, 304, 60, 60) | 2.08 ± 2.53 | 1.71 ± 2.46 | 1.93 ± 2.18 | 1.93 ± 2.36 |
| Week 52 (n= 176, 215, 46, 46) | 1.60 ± 2.25 | 1.38 ± 2.25 | 1.46 ± 2.24 | 1.50 ± 2.41 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n= 363, 359, 66, 65) | 0.77 ± 0.19 | 0.77 ± 0.19 | 0.78 ± 0.17 | 0.74 ± 0.19 |
| Week 16 (n= 319, 333, 65, 65) | 0.86 ± 0.16 | 0.88 ± 0.15 | 0.81 ± 0.18 | 0.76 ± 0.19 |
| Week 28 (n= 288, 303, 60, 61) | 0.86 ± 0.15 | 0.89 ± 0.14 | 0.89 ± 0.14 | 0.88 ± 0.13 |
| Week 40 (n= 201, 239, 53, 46) | 0.91 ± 0.13 | 0.91 ± 0.15 | 0.92 ± 0.14 | 0.90 ± 0.16 |
| Week 52 (n= 176, 217, 47, 46) | 0.89 ± 0.12 | 0.90 ± 0.14 | 0.89 ± 0.14 | 0.90 ± 0.13 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
| mm | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n= 361, 359, 65, 66) | 67.28 ± 22.53 | 66.97 ± 22.63 | 68.65 ± 21.20 | 65.24 ± 19.61 |
| Week 16 (n= 316, 330, 64, 66) | 76.00 ± 18.96 | 77.95 ± 17.36 | 69.00 ± 17.95 | 59.85 ± 22.92 |
| Week 28 (n= 287, 303, 60, 61) | 77.99 ± 17.89 | 78.89 ± 17.38 | 76.37 ± 18.10 | 79.13 ± 12.80 |
| Week 40 (n= 201, 240, 53, 46) | 81.47 ± 17.74 | 83.84 ± 15.09 | 82.96 ± 12.25 | 83.80 ± 12.62 |
| Week 52 (n= 175, 216, 47, 45) | 80.23 ± 17.42 | 84.59 ± 13.80 | 81.23 ± 14.54 | 82.38 ± 13.73 |
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
| events | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: General Practitioner (n= 28, 39, 15) | 3 | 5 | 2 |
| Baseline: Dermatologist (n= 28, 39, 15) | 24 | 34 | 14 |
| Baseline: Rheumatologist (n= 28, 39, 15) | 0 | 1 | 0 |
| Baseline: Cardiologist (n= 28, 39, 15) | 0 | 1 | 0 |
| Baseline: Gastroenterologist (n= 28, 39, 15) | 0 | 0 | 0 |
| Baseline: Psychiatrist (n= 28, 39, 15) | 0 | 0 | 0 |
| Baseline: Surgeon (n= 28, 39, 15) | 0 | 0 | 0 |
| Baseline: Nurse (n= 28, 39, 15) | 9 | 5 | 3 |
| Baseline: Other (n= 28, 39, 15) | 1 | 2 | 1 |
| Week 16: General Practitioner (n= 56, 57, 23) | 33 | 32 | 12 |
| Week 16: Dermatologist (n= 56, 57, 23) | 14 | 22 | 8 |
| Week 16: Rheumatologist (n= 56, 57, 23) | 0 | 0 | 0 |
| Week 16: Cardiologist (n= 56, 57, 23) | 1 | 0 | 1 |
| Week 16: Gastroenterologist (n= 56, 57, 23) | 0 | 0 | 2 |
| Week 16: Psychiatrist (n= 56, 57, 23) | 2 | 3 | 0 |
| Week 16: Surgeon (n= 56, 57, 23) | 4 | 3 | 1 |
| Week 16: Nurse (n= 56, 57, 23) | 2 | 4 | 2 |
| Week 16: Other (n= 56, 57, 23) | 23 | 18 | 7 |
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No \[Y/N\]): "Were you absent or on sick leave from work due to psoriasis today?", and participants unemployed (UEmp) at the time of assessment answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
| participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: Emp, Absent/Sick Leave:Y (n=237,232,114) | 55 | 47 | 27 |
| Baseline: Emp, Absent/Sick Leave:N (n=237,232,114) | 182 | 185 | 87 |
| Baseline: UEmp, due to Psoriasis:Y (n=97,103,49) | 15 | 24 | 4 |
| Baseline: UEmp, due to Psoriasis:N (n=97,103,49) | 82 | 79 | 45 |
| Week 16: Emp, Absent/Sick Leave:Y (n=224,221,88) | 47 | 37 | 24 |
| Week 16: Emp, Absent/Sick Leave:N (n=224,221,88) | 177 | 184 | 64 |
| Week 16: UEmp, due to Psoriasis:Y (n=77,87,42) | 10 | 13 | 6 |
| Week 16:UEmp, due to Psoriasis: N (n=77,87,42) | 67 | 74 | 36 |
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Healthcare Resource Use Events (n=30,37,5) | 100.00 | 94.59 | 100.00 |
| Employment (n=301,310,130) | 74.42 | 71.94 | 66.92 |
| Work Impacted Events (n=79,88,42) | 12.66 | 14.77 | 14.29 |
| Absence/Sick Leave Due to Psoriasis (n=224,221,90) | 20.98 | 16.74 | 27.78 |
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
| hours | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: Hours Scheduled to Work (n=54,48,25) | 8.61 ± 1.31 | 8.15 ± 1.75 | 7.92 ± 0.91 |
| Baseline: Hours Absent From Work (n=54,47,27) | 5.15 ± 3.09 | 6.00 ± 3.03 | 5.81 ± 2.48 |
| Week 16: Hours Scheduled to Work (n=47,39,25) | 8.49 ± 1.80 | 8.31 ± 1.08 | 8.40 ± 1.63 |
| Week 16: Hours Absent From Work (n=46,38,24) | 5.41 ± 3.15 | 5.24 ± 2.39 | 5.88 ± 2.40 |
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
| percentage of scheduled hours | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=53,47,25) | 60.32 ± 33.29 | 72.84 ± 32.96 | 75.76 ± 30.04 |
| Week 16 (n=46,38,24) | 64.15 ± 35.08 | 65.21 ± 31.55 | 71.81 ± 30.99 |
The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means "ability to work was not affected by psoriasis", and 10 means "ability to work was completely affected by psoriasis". Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=238,234,114) | 2.23 ± 2.81 | 2.13 ± 2.64 | 2.89 ± 3.07 |
| Week 16 (n=223,222,89) | 1.13 ± 2.13 | 1.26 ± 2.60 | 1.94 ± 2.53 |
The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg |
|---|---|---|---|---|
| Baseline (n= 22, 27, 5, 5) | 9.45 ± 7.40 | 9.41 ± 7.45 | 9.40 ± 3.78 | 8.80 ± 3.03 |
| Week 16 (n= 17, 17, 5, 5) | 3.76 ± 4.25 | 3.53 ± 4.16 | 6.20 ± 5.26 | 6.40 ± 4.28 |
| Week 52 (n= 6, 9, 3, 2) | 1.17 ± 2.40 | 2.00 ± 4.21 | 5.67 ± 3.51 | 0.50 ± 0.71 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CP-690,550 5 mg | — | 24/363 (6.6%) | 189/363 (52.1%) |
| CP-690,550 10 mg | — | 19/360 (5.3%) | 222/360 (61.7%) |
| Placebo, CP-690,550 5 mg | — | 1/66 (1.5%) | 44/66 (66.7%) |
| Placebo, CP-690,550 10 mg | — | 6/66 (9.1%) | 38/66 (57.6%) |
| Placebo | — | 2/45 (4.4%) | 22/45 (48.9%) |
| Event | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg | Placebo |
|---|---|---|---|---|---|
| Mycobacterium test positiveInvestigations | 0/363 | 0/360 | 0/66 | 0/66 | 1/45 |
| Alcohol abusePsychiatric disorders | 0/363 | 0/360 | 0/66 | 0/66 | 1/45 |
| Atrial fibrillationCardiac disorders | 0/363 | 0/360 | 0/66 | 1/66 | 0/45 |
| Hepatic failureHepatobiliary disorders | 0/363 | 0/360 | 0/66 | 1/66 | 0/45 |
| Burn infectionInfections and infestations | 0/363 | 0/360 | 0/66 | 1/66 | 0/45 |
| Lung infectionInfections and infestations | 0/363 | 0/360 | 0/66 | 1/66 | 0/45 |
| Meningitis asepticInfections and infestations | 0/363 | 0/360 | 1/66 | 0/66 | 0/45 |
| Viral infectionInfections and infestations | 0/363 | 0/360 | 0/66 | 1/66 | 0/45 |
| Rib fractureInjury, poisoning and procedural complications | 0/363 | 0/360 | 0/66 | 1/66 | 0/45 |
| Thermal burnInjury, poisoning and procedural complications | 0/363 | 0/360 | 0/66 | 1/66 | 0/45 |
| Event | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, CP-690,550 5 mg | Placebo, CP-690,550 10 mg | Placebo |
|---|---|---|---|---|---|
| Dermatitis contactSkin and subcutaneous tissue disorders | 0/363 | 2/360 | 0/66 | 0/66 | 13/45 |
| NasopharyngitisInfections and infestations | 38/363 | 55/360 | 11/66 | 9/66 | 4/45 |
| Blood creatine phosphokinase increasedInvestigations | 26/363 | 38/360 | 3/66 | 7/66 | 0/45 |
| Upper respiratory tract infectionInfections and infestations | 33/363 | 35/360 | 4/66 | 4/66 | 0/45 |
| HeadacheNervous system disorders | 28/363 | 28/360 | 4/66 | 3/66 | 0/45 |
| NauseaGastrointestinal disorders | 12/363 | 13/360 | 1/66 | 5/66 | 0/45 |
| Urinary tract infectionInfections and infestations | 12/363 | 12/360 | 5/66 | 0/66 | 0/45 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/363 | 11/360 | 5/66 | 1/66 | 0/45 |
| Abdominal painGastrointestinal disorders | 4/363 | 3/360 | 0/66 | 4/66 | 0/45 |
| Gamma-glutamyltransferase increasedInvestigations | 8/363 | 9/360 | 0/66 | 4/66 | 0/45 |
Safety analysis set included all participants who received at least 1 dose of investigational drug (CP-690,550 or placebo).
| Age, Continuous(years) | CP-690,550 5 mg | CP-690,550 10 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 45.6 ± 13.4 | 45.2 ± 12.8 | 45.0 ± 12.6 | 45.3 ± 13.0 |
| Sex: Female, Male(Participants) | CP-690,550 5 mg | CP-690,550 10 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 102 | 99 | 56 | 257 |
| Male | 261 | 261 | 121 | 643 |
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