Vixarelimab in Patients With Prurigo Nodularis

作者：Sonja Ständer, Gil Yosipovitch, Howard Sofen, Daniel Abramzon, Joshua Galanter, Sheldon Wang, John F. Paolini · 发表于：JAMA Dermatology · 年份：2025 · DOI：10.1001/jamadermatol.2025.4950 · 被引用次数：10 · 研究领域：Dermatology and Skin Diseases、Psoriasis: Treatment and Pathogenesis、Medicine and Dermatology Studies History

Importance: Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by severe pruritus and nodule formation, significantly affecting patients' quality of life. There is an unmet need for effective therapies to address both symptoms and disease progression. Objective: To evaluate the efficacy, safety, tolerability, and pharmacokinetics of monthly dosed vixarelimab in participants with moderate to severe PN. Design, Setting, and Participants: This double-blind (DB), placebo-controlled, phase 2b randomized clinical trial was conducted from December 1, 2020, to August 24, 2023, across 72 centers in the US, Canada, Europe, and Asia. The study included male and female participants aged 18 to 80 years with physician-diagnosed PN of at least 6 months' duration and moderate to severe pruritus. Data were analyzed from October 2023 to March 2024. Interventions: Participants were randomized into 4 arms during the 16-week DB period: vixarelimab, 540 mg (high-dose group); vixarelimab, 360 mg (mid-dose group); vixarelimab, 120 mg (low-dose group); or placebo. Vixarelimab and placebo were administered subcutaneously every 4 weeks. During the 36-week open-label extension, all participants received vixarelimab, 360 mg, every 2 weeks. Main Outcomes and Measures: Key outcomes included percentage change from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) at week 16, the proportion of participants achieving at least a 4-point reduction in WI-NRS at week 16, and the pr...