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Efficacy of spesolimab for the treatment of generalized pustular psoriasis flares across pre‐specified patient subgroups in the Effisayil 1 study

2023; Wiley; Volume: 32; Issue: 8 Linguagem: Inglês

10.1111/exd.14824

1600-0625

A. David Burden, Yukari Okubo, Min Zheng, Diamant Thaçi, P.C.M. van de Kerkhof, Na Hu, Manuel Quaresma, Christian Thoma, Siew Eng Choon,

Dermatology and Skin Diseases

Abstract Effisayil 1 was a multicentre, randomized, double‐blind, placebo‐controlled study of the anti‐interleukin (IL)‐36 receptor monoclonal antibody, spesolimab, in patients presenting with a generalized pustular psoriasis (GPP) flare. Previously published data from this study revealed that within 1 week, rapid pustular and skin clearance were observed in patients receiving spesolimab versus placebo. In this pre‐specified subgroup analysis, the efficacy of spesolimab was evaluated according to patient demographic and clinical characteristics at baseline in patients receiving spesolimab ( n = 35) or placebo ( n = 18) on Day 1. Efficacy was by assessed by achievement of primary endpoint (Generalized Pustular Psoriasis Physician Global Assessment [GPPGA] pustulation subscore of 0 at Week 1) and key secondary endpoint (GPPGA total score of 0 or 1 at Week 1). Safety was assessed at Week 1. Spesolimab was found to be efficacious and had a consistent and favourable safety profile in patients presenting with a GPP flare, regardless of patient demographics and clinical characteristics at baseline.