Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of eight clinical trials

作者：Kristian Reich, Richard G. Langley, J.F. Silvestre, D. Staumont‐Sallé, Antonio Costanzo, Andrew Pink, Amy S. Paller, Norito Katoh, Andreas Wollenberg, Richard B. Warren, Andrew Blauvelt, Christian Bjerregård Øland, Ann‐Marie Tindberg, Le Gjerum, Eric L. Simpson · 发表于：British Journal of Dermatology · 年份：2025 · DOI：10.1093/bjd/ljaf309 · 被引用次数：6 · 研究领域：Dermatology and Skin Diseases、Allergic Rhinitis and Sensitization、Asthma and respiratory diseases

BACKGROUND: Patients with moderate-to-severe atopic dermatitis (AD) require long-term management. Understanding the long-term safety of new treatments is a top priority for patients and healthcare professionals. OBJECTIVES: To evaluate the safety of tralokinumab in adults and adolescents with moderate-to-severe AD by conducting an integrated safety analysis of seven placebo-controlled trials and the ongoing, open-label extension study ECZTEND (NCT03587805). METHODS: An initial 16-week placebo-controlled (PBO-CTRL) safety set and an all-tralokinumab (ALL-TRALO) safety set combining the placebo-controlled trials and ECZTEND (data cutoff 30 April 2022) were analysed. All treatment-emergent adverse events were recorded. Adverse events of special interest (AESIs) were predefined. Safety areas of clinical interest for advanced systemic AD treatments were captured retrospectively. Proportions of patients with events and incidence rates (IRs) per 100 patient-years of exposure (PYE) were calculated. PYE was defined as the time until the first event or exposure end, whichever came first, and incidence was defined as the first event. RESULTS: Safety results were similar between the PBO-CTRL safety set and ALL-TRALO safety set. In the latter, 2693 patients received tralokinumab for up to 238.5 weeks (approximately 4.5 years, PYE = 5320.2). Most adverse events (AEs) were nonserious, mild or moderate in severity, and occurred with similar frequencies between tralokinumab and placebo in the...