title: Efficacy and safety of secukinumab in patients with generalized pustular psoriasis: A 52-week analysis from phase III open-label multicenter Japanese study.
abstract: Generalized pustular psoriasis (GPP) is a severe inflammatory skin disease characterized by the presence of sterile pustules covering almost the entire body and systemic symptoms such as fever. Secukinumab, a fully human-recombinant anti-interleukin-17A monoclonal antibody was indicated for psoriasis vulgaris and psoriatic arthritis in Japan but is not yet investigated for GPP. In this phase III, open-label multicenter single arm study, the efficacy and safety of secukinumab as monotherapy or with co-medication was evaluated in 12 Japanese patients with GPP. All the patients received secukinumab 150 mg s.c. at baseline, week 1, 2, 3 and 4, and then every 4 weeks. Two non-responders were up-titrated to 300 mg. Change in GPP severity from baseline was evaluated by clinical global impression (CGI) categorized as "worsened", "no change", "minimally improved", "much improved" or "very much improved". Treatment success was achieved by 83.3% (n = 10) of patients at week 16 (primary end-point) with CGI evaluated as "very much improved" (n = 9) and "much improved" (n = 1). Moreover, the area of erythema with pustules improved as early as week 1 and resolved by week 16 in most of the patients. The improvements were sustained throughout 52 weeks. Over the 52-week treatment period, secukinumab was well tolerated with no unexpected safety signals. Nasopharyngitis, urticaria, diabetes mellitus and arthralgia were the frequent adverse events reported. The data from this study shows that secukinumab can become one of the potent treatment options for GPP.
authors.affiliation: Department of Dermatology, Fukuoka University, Fukuoka, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Imafuku
authors.affiliation: Department of Dermatology, Asahikawa Medical University, Asahikawa, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Honma
authors.affiliation: Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Yukari
authors.initials: Y
authors.lastname: Okubo
authors.affiliation: Department of Dermatology, Jichi Medical University, Shimotsuke, Japan.
authors.forename: Mayumi
authors.initials: M
authors.lastname: Komine
authors.affiliation: Department of Dermatology, Jichi Medical University, Shimotsuke, Japan.
authors.forename: Mamitaro
authors.initials: M
authors.lastname: Ohtsuki
authors.affiliation: Department of Dermatology, Nagoya City University, Nagoya, Japan.
authors.forename: Akimichi
authors.initials: A
authors.lastname: Morita
authors.affiliation: Department of Biometrics and Statistical Sciences, Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Seko
authors.affiliation: Clinical Trial Management Group, Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Kawashima
authors.affiliation: Department of Clinical Resource and Development, Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Saori
authors.initials: S
authors.lastname: Ito
authors.affiliation: Department of Immunology and Dermatology Clinical Franchise, Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Shima
authors.affiliation: Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Hidemi
authors.initials: H
authors.lastname: Nakagawa
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018771:Arthralgia / Q000139:chemically induced; D003920:Diabetes Mellitus / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020381:Interleukin-17 / Q000037:antagonists & inhibitors*; D007564:Japan; D008297:Male; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D017410:Practice Guidelines as Topic; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014581:Urticaria / Q000139:chemically induced
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C508717:IL17A protein, human; D020381:Interleukin-17; C555450:secukinumab
keywords: Psoriasis Area and Severity Index; clinical global impression; generalized pustular psoriasis; interleukin-17A; secukinumab