Rønnstad Amalie Thorsti Møller, Bunick Christopher G, Chovatiya Raj, Kamata Masahiro, Nielsen Mia-Louise, Isufi Daniel, Thomsen Simon F, Vestergaard Christian, Wollenberg Andreas, Egeberg Alexander, Thyssen Jacob P, Loft Nikolai
Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Program in Translational Biomedicine, Yale School of Medicine, Yale University, New Haven, CT, USA.
Am J Clin Dermatol. 2025 May;26(3):411-424. doi: 10.1007/s40257-025-00927-x. Epub 2025 Mar 5.
Tralokinumab, a first-in-class and second biologic approved for treating moderate-to-severe atopic dermatitis in adolescents and adults, has demonstrated consistent efficacy and safety across multiple clinical trials.
We aimed to assess the real-world effectiveness and safety of tralokinumab by performing a systematic review and meta-analysis on the real-world evidence of tralokinumab.
We systematically searched PubMed and EMBASE from inception until 28 July, 2024 for observational studies describing the effectiveness and safety of tralokinumab for the treatment of atopic dermatitis. The primary outcome was the proportion of patients achieving a ≥75% improvement in the Eczema Area and Severity Index (EASI-75) after 16 weeks and secondary outcomes included the proportion of patients achieving EASI-50 and EASI-90 and the proportion of patients experiencing adverse events.
Nineteen unique studies encompassing 911 bio-naïve and bio-experienced patients with atopic dermatitis treated with tralokinumab were included. After 16 weeks of treatment, 82%, 59% and 26% of patients achieved EASI-50, EASI-75 and EASI-90, respectively, and the proportion of patients developing conjunctivitis was 3.2%.
Tralokinumab demonstrates strong effectiveness and good tolerability in real-world settings, with a high proportion of patients achieving a clinical response and adverse events being observed only infrequently.
曲罗芦单抗是首个获批用于治疗青少年和成人中重度特应性皮炎的一流生物制剂，在多项临床试验中已证明具有一致的疗效和安全性。
我们旨在通过对曲罗芦单抗的真实世界证据进行系统评价和荟萃分析，评估曲罗芦单抗的真实世界有效性和安全性。
我们系统检索了自数据库建库至2024年7月28日的PubMed和EMBASE，以查找描述曲罗芦单抗治疗特应性皮炎有效性和安全性的观察性研究。主要结局是16周后湿疹面积和严重程度指数（EASI-75）改善≥75%的患者比例，次要结局包括达到EASI-50和EASI-90的患者比例以及发生不良事件的患者比例。
纳入了19项独特的研究，涉及911例初治和经治的使用曲罗芦单抗治疗的特应性皮炎患者。治疗16周后，分别有82%、59%和26%的患者达到EASI-50、EASI-75和EASI-90，发生结膜炎的患者比例为3.2%。
曲罗芦单抗在真实世界环境中显示出强大的有效性和良好的耐受性，大部分患者有临床反应，且不良事件发生率低。
