基于FAERS的依瑞奈尤单抗不良事件信号挖掘与分析

Mining and Analysis of Adverse Event Signals of Erenumab Based on FAERS

摘要: 目的：基于美国FDA不良事件报告系统(FAERS)挖掘依瑞奈尤单抗上市后药品不良事件(ADE)信号，分析不良反应特征及严重不良反应危险因素，为临床安全合理用药提供真实世界数据参考。方法：提取2018年5月17日到2025年12月31日FAERS数据库中依瑞奈尤单抗相关数据，采用ROR、MHRA、IC法进行ADE信号挖掘，通过SPSS 27.0开展二元Logistic回归分析，并依据MedDRA 24.0版进行系统器官分类。结果：共纳入ADE报告51,149例，患者以成人、老年人为主，女性占69.65%；筛选出有效ADE信号58个，涉及11个系统器官，注射部位凹陷等新信号报告数多、信号强度高；Logistic回归显示，性别与依瑞奈尤单抗所致神经毒性严重不良反应的发生存在显著关联(P = 0.001, OR = 23.310, 95% CI: 3.524~154.189)。结论：依瑞奈尤单抗存在说明书未收录的潜在不良反应风险，临床需加强女性患者神经系统不良反应监测，重视注射部位相关新信号的防控。

Abstract: Aim: To mine adverse drug event (ADE) signals of erenumab post-marketing based on the FDA Adverse Event Reporting System (FAERS), analyze the characteristics of adverse reactions and risk factors for serious adverse reactions, and provide real-world data references for safe and rational clinical use of the drug. Methods: Data related to erenumab in the FAERS database from May 17, 2018 to December 31, 2025 were extracted. ADE signals were mined using ROR, MHRA, and IC methods; binary Logistic regression analysis was performed with SPSS 27.0; and ADEs were classified by System Organ Class (SOC) according to MedDRA 24.0. Results: A total of 51,149 ADE reports were included, with adults and the elderly as the main population, females accounting for 69.65%. Fifty-eight valid ADE signals were screened, involving 11 SOCs; injection site depression and other new signals had high report counts and strong signal intensity. Logistic regression showed a significant association between gender and serious neurotoxic adverse reactions induced by erenumab (P = 0.001, OR = 23.310, 95% CI: 3.524~154.189). Conclusion: Erenumab has potential adverse reaction risks not included in the package insert. Clinical monitoring of the nervous system in female patients should be strengthened, and prevention and control of new signals related to injection sites should be emphasized.