Proof-of-concept study exploring the effect of spesolimab in patients with moderate-to-severe hidradenitis suppurativa: a randomized double-blind placebo-controlled clinical trial

作者：Afsáneh Alavi, Errol P. Prens, Alexa B. Kimball, John W. Frew, James G. Krueger, Sutirtha Mukhopadhyay, Heli Gao, Usha Ranganathan, Nathalie Ivanoff, Ana C Hernandez Daly, Christos C. Zouboulis · 发表于：British Journal of Dermatology · 年份：2024 · DOI：10.1093/bjd/ljae144 · 被引用次数：39 · 研究领域：Hidradenitis Suppurativa and Treatments、Acne and Rosacea Treatments and Effects、Anorectal Disease Treatments and Outcomes

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with a considerable disease burden. Existing treatment options are limited and often suboptimal; a high unmet need exists for effective targeted therapies. OBJECTIVES: To explore the effects of spesolimab treatment in patients with HS. METHODS: This randomized double-blind placebo-controlled proof-of-clinical-concept (PoCC) study was conducted at 25 centres across 12 countries from 3 May 2021 to 21 April 2022. Patients had moderate-to-severe HS for ≥ 1 year before enrolment. Patients were randomized (2 : 1) to receive a loading dose of 3600-mg intravenous spesolimab (1200 mg at weeks 0, 1 and 2) or matching placebo, followed by maintenance with either 1200-mg subcutaneous spesolimab every 2 weeks from weeks 4 to 10 or matching placebo. The primary endpoint was the percentage change from baseline in total abscess and inflammatory nodule (AN) count at week 12. Secondary endpoints were the absolute change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), percentage change from baseline in draining tunnel (dT) count, the proportion of patients achieving a dT count of 0, absolute change from baseline in the revised Hidradenitis Suppurativa Area and Severity Index (HASI-R), the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR50), the proportion of patients with ≥ 1 flare (all at week 12) and patient-reported outcomes. RESULTS: In...