전신 농포성 건선 또는 홍피성 건선이 있는 성인 참가자를 대상으로 한 TAK-279 연구

Participants with generalized pustular psoriasis will receive TAK-279 from Day 1 up to Week 52.

Specified drug on specified days.

Participants with erythrodermic psoriasis will receive TAK-279 from Day 1 up to Week 52.

Specified drug on specified days.

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1.

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score were reported.

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.

ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicated worsening. The results will be disclosed during final posting.

ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicated worsening. The results will be disclosed during final posting.

PGA is a 5-point scale and a score of 0 to 4 was assigned, based on the category that best described the severity of active psoriasis of the participant's hands and feet, where 0=clear and 4=severe. Higher scores indicated worsening of severity. It was evaluated for participants with the presence of active hand or foot psoriasis on Day 1. The results will be disclosed during final posting.

The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicated: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The results will be disclosed during final posting.

The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicated: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The results will be disclosed during final posting.

The NAPSI quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on the lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail was scored for both nail matrix and nail bed psoriasis for each quadrant (ranging 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 fingernails evaluated and ranged from 0 to 80. Higher scores indicated more severe psoriasis. The results will be disclosed during final posting.

Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting.

Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting.

The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.

The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.

The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.

The GPPASI is a common endpoint in clinical studies of generalized pustular psoriasis (GPP) and is a skin-based scoring system. The GPPASI is a modified composite index and an adaptation of the PASI score. The induration component was substituted with a pustule component, with an overall score ranging from 0 (least severe) to 72 (most severe). Higher scores indicated more severe GPP. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The score for each body region was calculated as the product of the sum of severity scores and the corresponding BSA score for erythema, scaling, and pustulation, multiplied by a weighting factor for each body region. The total GPPASI score was determined as the sum of the individual scores from all body regions. The results will be disclosed during final posting.

The Japanese Dermatological Association Severity Index (JDASI) assessed systemic symptoms based on laboratory changes. With the JDASI, the skin was evaluated using 3 criteria: (1) erythema area overall, (2) erythema area with pustules, and (3) oedema area. Scoring ranged from 3 to 0 (severe, moderate, mild, none), with a maximum of 9 points. For systemic involvement, pyrexia, white blood cell count, C-reactive protein (CRP), and serum albumin were assessed, with scores ranging from 2 to 0 and a maximum of 8 points. The total JDASI score for GPP was the sum of both categories and was categorized as severe (17-11 points), moderate (10-7 points), or mild (0-6 points). Higher scores indicated more severe GPP. The results will be disclosed during final posting.