The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Asahikawa, Hokkaido, Japan
Novartis Investigative Site
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.
Time frame: 16 weeks
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as "very much improved", "much improved", "minimally improved". Two patients did not achieve treatment success at week 52 with CGI evaluated as "missing" and both were imputed as "no treatment success".
Time frame: 52 weeks
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".
Time frame: week 148
Summary of Clinical Global Impression up to End of Trial
Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened. Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as "no treatment success".
Time frame: up to week 148 (End of Trial)
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.
Time frame: up to week 148 (End of Trial)
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Sapporo, Hokkaido, Japan
Novartis Investigative Site
Inashiki-gun, Ibaraki, Japan
Novartis Investigative Site
Shimotsuke, Tochigi, Japan
Novartis Investigative Site
Chiyoda-ku, Tokyo, Japan
Novartis Investigative Site
Hachiōji, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Kofu, Yamanashi, Japan
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin. The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2. The higher the JDA severity index for GPP score the worse the outcome.
Time frame: up to week 148 (end of trial)
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL). Percent change=100 x Absolute change/post baseline.
Time frame: up to week 148 (end of trial)
Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay \& Khan 94). The measure is self-admin. \& includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute \& chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life.
Time frame: Up to week 148 (end of treatment)
Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.
Time frame: up to week 52