Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open‐label extension study

作者：Matthias Augustin, M. Tauber, Robert Sidbury, Jonathan I. Silverberg, Kim Papp, Diamant Thaçi, Marjolein de Bruin‐Weller, Adam Reich, Ketty Peris, Kirk Barber, Ryszard Galus, Andrzej Kaszuba, Matthew Zirwas, Walter K. Nahm, Gretel Trullenque, Laura Maintz, Sady Alpizar, Sang Wook Son, Vivian Laquer, Linda Stein Gold, Soo Yeon Cheong, Anna Ryzhkova, Ágnes Drahos, Liliana Ulianov, Christophe Piketty · 发表于：Journal of the European Academy of Dermatology and Venereology · 年份：2025 · DOI：10.1111/jdv.70080 · 被引用次数：6 · 研究领域：Dermatology and Skin Diseases、Allergic Rhinitis and Sensitization、Asthma and respiratory diseases

BACKGROUND: Atopic dermatitis (AD) is a common, chronic, relapsing, pruritic, neuroimmune skin disease, requiring long-term symptom control. OBJECTIVES: The ARCADIA long-term extension (LTE) study evaluates nemolizumab safety and efficacy in ≥12-year-old patients with moderate-to-severe AD up to 200 weeks. METHODS: Patients from previous nemolizumab AD trials (Phase 2/3) or newly recruited adolescents with moderate-to-severe AD were enrolled. A background regimen of topical corticosteroids with/without topical calcineurin inhibitors was permitted based on disease control. Long-term safety was the primary endpoint. Efficacy assessments were secondary endpoints, including the proportion of patients achieving Investigator's Global Assessment (IGA) 0/1 (clear/almost clear), Eczema Area and Severity Index (EASI)-75 (75% improvement from lead-in baseline in EASI), Visual Analogue Scale (VAS) Pruritus and VAS sleep loss ≥4-point improvement from lead-in baseline and quality of life. Observed data up to Week (W) 104 are presented for patients with previous nemolizumab experience (PNE) and no previous nemolizumab experience (NNE) at LTE baseline. RESULTS: At interim analysis data cut-off (21 July 2024), 1062 of 1901 patients completed W104. Exposure to nemolizumab in this study was equal across cohorts. The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were ...