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

• Published in: Experimental dermatology 2023-08, Vol.32 (8), p.1279-1283
• Main Authors: Burden, A. D., Okubo, Y., Zheng, M., Thaçi, D., Kerkhof, P., Hu, N., Quaresma, M., Thoma, C., Choon, S. E.
• Format: Article
• Language: English
• Subjects: Antibodies, Monoclonal, Humanized - therapeutic use; autoinflammatory disorders; clinical trial; Demography; Humans; Monoclonal antibodies; Patients; Placebos; Psoriasis; Skin; Treatment Outcome
• ISSN: 0906-6705; 1600-0625
• DOI: 10.1111/exd.14824

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. This study reveals spesolimab is efficacious and has a consistent safety profile in patients presenting with a GPP flare, regardless of patient demographics and clinical characteristics at baseline.