The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
266
placebo BID for 16 weeks and then re-randomized into active groups
CP-690,550 5mg BID for 52 weeks
CP-690,550 10mg BID for 52 weeks
Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time frame: Week 16
Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Time frame: Week 16
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.
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Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University
Xicheng District, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hospital of Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Huashan Hospital, Fudan University/Dermatology Department
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital, Dermatology Department
Shanghai, Shanghai Municipality, China
Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
...and 14 more locations
Time frame: Baseline to Week 16
Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90% reduction in PASI relative to Baseline.
Time frame: Week 16
Change From Baseline in DLQI Total Score at Week 16
The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline to Week 16
Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time frame: Week 4
Percentage of Participants Achieving PASI75 Response at Week 4
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Time frame: Week 4
Change From Baseline in DLQI Total Score at Week 4
The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline to Week 4
Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represent more severe psoriasis.
Time frame: Baseline to Week 16
Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among patients achieving PGA response at Week 16 is reported. This is a key secondary endpoint. Percentage of participants maintaining the response and the 95% confidence interval (CI) were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).
Time frame: Week 16 to Week 52
Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16
The PASI quantifies severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response=at least 75% reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among patients achieving PASI75 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).
Time frame: Week 16 to Week 52
Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16
The PASI quantifies severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response=at least 90% reduction in PASI relative to Baseline. Maintenance of PASI90 response at Week 52 among patients achieving PASI90 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).
Time frame: Week 16 to Week 52
Time to PGA Response up to Week 16
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if less than 50% of participants had PGA response by Week 16.
Time frame: Baseline to Week 16
Time to PASI75 Response up to Week 16
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if less than 50% of participants had PASI50 response by Week 16.
Time frame: Baseline up to Week 16
Time to PASI50 Response up to Week 16
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time frame: Baseline up to Week 16
Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants in Each PGA Category Over Time Through Week 52
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual PASI Scores Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52
Change From Baseline in PASI Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
PASI Component Scores Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Change From Baseline in PASI Component Scores Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percent Change From Baseline in PASI Scores Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual BSA Over Time Through Week 52
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percent Change From Baseline in BSA Over Time Through Week 52
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Time frame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With PASI50 Response Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI50 response is reported.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With PASI90 Response Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI90 response up to Week 52 is reported.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With PASI125 Over Time Through Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.
Time frame: Baseline and Weeks 8, 16, 20, 32, 40, and 52
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail was divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.
Time frame: Baseline and weeks 8, 16, 20, 32, 40, and 52
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52
Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported. The total number of affected FINGER nails was reported.
Time frame: Baseline and Weeks 8, 16, 20, 32, 40, and 52
Percent Change From Baseline in NAPSI Over Time Through Week 52
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.
Time frame: Baseline and weeks 8, 16, 20, 32, 40, and 52
Percentage of Participants With NAPSI75 Response Over Time Through Week 52
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.
Time frame: Weeks 8, 16, 20, 32, 40, and 52
Percentage of Participants With NAPSI100 Response Over Time Through Week 52
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.
Time frame: Weeks 8, 16, 20, 32, 40, and 52
Actual Itch Severity Item (ISI) Score Over Time Through Week 52
ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Change From Baseline in ISI Score Over Time Through Week 52
ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Time frame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52
The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Change From Baseline in DLQI Score Over Time Through Week 52
The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear \[no psoriasis\]; 1=almost clear; 2=mild; 3=moderate; 4=severe). the percentage of participants with scores of 0 (clear) and 1 (almost clear) are reported.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a worse health state.
Time frame: Baseline, Weeks 16, 32, 40, 52
Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a worse health state.
Time frame: Baseline and weeks 16, 32, 40, and 52
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline and Weeks 16, 32, 40, and 52
Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline and weeks 16, 32, 40, and 52