Nemolizumab in prurigo nodularis up to 100 weeks: OLYMPIA LTE interim analysis

作者：Franz J. Legat, Shawn G. Kwatra, Adam Reich, Serge Boulinguez, Athanasios Tsianakas, Maxwell Sauder, S. Barbarot, Jacek C. Szepietowski, Curdin Conrad, Andrew Pink, Elke Weißhaar, L. Misery, Martin Metz, Vivian Laquer, Raja Sivamani, Gil Yosipovitch, Diamant Thaçi, Lone Skov, Xiaoxiao Chen, Aliene Noda, Zarif K. Jabbar‐Lopez, Christophe Piketty, Sonja Ständer · 发表于：Journal of the European Academy of Dermatology and Venereology · 年份：2025 · DOI：10.1111/jdv.70266 · 被引用次数：6 · 研究领域：Dermatology and Skin Diseases、Psoriasis: Treatment and Pathogenesis、Medicine and Dermatology Studies History

BACKGROUND: Prurigo nodularis (PN) is a neuroimmune skin disease characterized by the presence of chronic itch (≥6 weeks) and multiple white-pink papules, nodules and/or plaques. OBJECTIVES: The OLYMPIA long-term extension (OLYMPIA-LTE) trial evaluates long-term, over 184 weeks, safety and efficacy of nemolizumab in adults with moderate-to-severe PN. METHODS: Adults with moderate-to-severe PN, who completed phase 2b (NCT03181503) and phase 3 (OLYMPIA 1&2) lead-in trials, were eligible for the ongoing OLYMPIA-LTE trial. Patients receiving nemolizumab monotherapy (continuous-nemolizumab) during lead-in trials continued their regimen, while those on placebo (nemolizumab-naïve) initiated nemolizumab monotherapy. The primary endpoint was long-term safety. Efficacy assessments included the proportion of patients achieving a ≥4-point improvement from baseline Peak Pruritus Numerical Rating Scale (PP-NRS4), Sleep Disturbance Numerical Rating Scale (SD-NRS4) and Dermatology Life Quality Index (DLQI4) scores, Investigator's Global Assessment (IGA) score 0/1 (clear/almost clear), and 75% healed pruriginous lesions (Prurigo Activity and Severity score item-5b). Observed cases up to week 100, regardless of rescue medication, are presented, without imputation of missing data. RESULTS: At interim analysis data cut-off (21 July 2024), 290/508 (57%) patients completed week 100 (median exposure: 839.5 days). Treatment-emergent adverse events (TEAEs) occurred in 89% of patients (452/508; exposu...