Istituto Dermopatico dell'Immacolata, IDI-IRCCS, Rome, Italy.
Expert Opin Drug Saf. 2024 Apr;23(4):439-447. doi: 10.1080/14740338.2024.2326480. Epub 2024 Mar 12.
Dupilumab is a safe and effective biological drug that revolutionized the treatment of atopic dermatitis (AD). Concerning adverse events (AEs), the most commonly reported included ocular involvement, nasopharyngitis, and injection site reactions in clinical trials. Anyway, its use in daily practice is revealing novel dupilumab-induced manifestations.
Relevant English literature (real-life studies, case series, reviews, and meta-analyses) regarding real-life adverse events induced by dupilumab were searched for up to 10 June 2023.
Dupilumab is an effective treatment for AD, showing favorable safety profile since no routine laboratory monitoring is recommended. However, several cutaneous and extracutaneous AEs have been reported in real-life setting expanding the pool emerged from clinical trials. In detail, dupilumab may determine de-novo onset or exacerbation of preexisting conditions, whose pathogenesis is still unclear and seems to involve Th1/Th2 and Th2/Th17 immune-response imbalance. Also, the heterogeneity and the variable onset time of AEs with respect to dupilumab initiation warrant a thorough patients' history collection and strict short- and long-term monitoring. Finally, the most appropriate management of patients with AEs related to dupilumab should take into consideration efficacy for AD as well as severity and nature of the AE, available treatment and patients' preferences.
度普利尤单抗是一种安全有效的生物药物，彻底改变了特应性皮炎（AD）的治疗方法。关于不良事件（AE），临床试验中最常报告的包括眼部受累、鼻咽炎和注射部位反应。无论如何，其在日常实践中的应用揭示了新的度普利尤单抗诱导的表现。
截至 2023 年 6 月 10 日，检索了有关度普利尤单抗诱导的真实世界不良事件的相关英文文献（真实世界研究、病例系列、综述和荟萃分析）。
度普利尤单抗是 AD 的有效治疗方法，具有良好的安全性，因为不建议常规进行实验室监测。然而，在真实环境中已经报告了几种皮肤和非皮肤 AE，这扩大了从临床试验中出现的不良事件池。具体来说，度普利尤单抗可能会导致新发病或原有疾病恶化，其发病机制尚不清楚，似乎涉及 Th1/Th2 和 Th2/Th17 免疫反应失衡。此外，AE 与度普利尤单抗起始相关的异质性和可变起始时间需要彻底收集患者病史并进行严格的短期和长期监测。最后，对于与度普利尤单抗相关的 AE 患者的最佳管理应考虑 AD 的疗效以及 AE 的严重程度和性质、可用的治疗方法和患者的偏好。
