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IF 3.7 4区医学 Q1 DERMATOLOGY

Dermatologic Therapy Pub Date : 2025-04-08 DOI:10.1155/dth/9922950

Zi-Yue Dong, Ming-Jie He, Yuan Hu

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引用次数: 0

摘要

背景：免疫检查点抑制剂（ICIs）是癌症治疗的革命性药物，但经常会引起免疫相关不良事件（irAEs），其中自身免疫性皮肤病（ASDs）是需要谨慎处理的重要毒性反应。研究目的本研究利用 FAERS 数据库探讨 ICI 与 10 种常见 ASD 之间的关联，旨在确定风险特征、发病时间模式和临床影响。研究方法对 FAERS 数据（2011Q1-2024Q4）进行了回顾性药物警戒分析，重点关注涉及七种 ICIs 的报告。采用比例失调算法（ROR、PRR、BCPNN 和 MGPS）和统计方法（包括 Kaplan-Meier 和 Weibull 模型）评估 ASD 风险和发病模式。结果在1670个病例中，大疱性类天疱疮（BP）显示出最强的关联性，尤其是与PD-1/PD-L1抑制剂，以及其他突出的ASD，包括白癜风、银屑病皮炎、扁平苔藓和皮肌炎。硬皮病、过敏性紫癜、丘疹性荨麻疹、斑秃和系统性红斑狼疮在不同的 ICIs 中显示的信号有限或不一致。中位发病时间为143天，早期发病与伊匹单抗和阿特珠单抗有关。报告主要涉及男性（62.8%）和年龄≥65岁的患者（51.7%），其中美国和日本的病例最多。结论BP、白癜风、银屑病样皮炎、扁平苔藓和皮肌炎是 ICIs 的主要 IRAEs，需要警惕监测和个体化管理策略。局限性包括自发报告的偏差和较新 ICIs 的代表性不足。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Risk of Autoimmune Skin Diseases Associated With Immune Checkpoint Inhibitors: A Pharmacovigilance Analysis Using the FAERS Database

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Risk of Autoimmune Skin Diseases Associated With Immune Checkpoint Inhibitors: A Pharmacovigilance Analysis Using the FAERS Database

Background: Immune checkpoint inhibitors (ICIs) revolutionize cancer therapy but frequently cause immune-related adverse events (irAEs), with autoimmune skin diseases (ASDs) being significant toxicities requiring careful management.

Objective: This study explores the association between ICIs and 10 common ASDs using the FAERS database, aiming to identify risk profiles, time-to-onset patterns, and clinical implications.

Methods: A retrospective pharmacovigilance analysis of FAERS data (2011Q1–2024Q4) was conducted, focusing on reports involving seven ICIs. Disproportionality algorithms (ROR, PRR, BCPNN, and MGPS) and statistical methods, including Kaplan–Meier and Weibull models, were employed to evaluate ASD risk and onset patterns.

Results: Among 1670 cases, bullous pemphigoid (BP) showed the strongest association, particularly with PD-1/PD-L1 inhibitors, and other prominent ASDs, including vitiligo, psoriasiform dermatitis, lichen planus, and dermatomyositis. Scleroderma, Henoch–Schönlein purpura, pemphigus, alopecia areata, and systemic lupus erythematosus exhibited limited or inconsistent signals across different ICIs. The median time-to-onset was 143 days, with early onset linked to ipilimumab and atezolizumab. Reports predominantly involved males (62.8%) and patients ≥ 65 years old (51.7%), with the United States and Japan contributing most cases.

Conclusions: BP, vitiligo, psoriasiform dermatitis, lichen planus, and dermatomyositis are key irAEs of ICIs, requiring vigilant monitoring and individualized management strategies. Limitations include biases in spontaneous reporting and underrepresentation of newer ICIs.

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来源期刊

Dermatologic Therapy 医学-皮肤病学

CiteScore

7.00

自引率

8.30%

发文量

711

审稿时长

3 months

期刊介绍： Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.