Pharmacovigilance analysis of FcRn antagonists in the treatment of myasthenia gravis: A disproportionality analysis based on the FAERS database

This study aimed to evaluate the safety profiles of FcRn antagonists, efgartigimod alfa and rozanolixizumab, in the treatment of myasthenia gravis using real-world adverse event data from the FAERS database. A disproportionality analysis was conducted employing Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods on reports from Q1 2022 to Q2 2025. The most frequently reported adverse events for efgartigimod alfa included falls, urinary tract infections, and symptom recurrence, with signals also detected for atrial fibrillation, peripheral neuropathy, and prostate cancer. For rozanolixizumab, common events were headache, diarrhea, and vomiting, with potential signals such as meningitis, hypersomnia, and feeding disorder. Subgroup analysis revealed gender-specific differences in adverse reactions. Most events occurred within 30 days of treatment initiation, though efgartigimod alfa showed a sustained risk beyond 180 days. The study identifies novel safety signals and highlights clinically relevant risk patterns, supporting enhanced monitoring in clinical use. It is crucial to emphasize that this disproportionality analysis is exploratory in nature and identifies potential associations, which do not establish causality and require confirmation through further dedicated studies.

本研究旨在借助FDA不良事件报告系统（FAERS）的真实世界不良事件数据，评估FcRn拮抗剂（FcRn antagonists）依法吉单抗α（efgartigimod alfa）与罗沙利珠单抗（rozanolixizumab）治疗重症肌无力（myasthenia gravis）的安全性特征。研究针对2022年第一季度至2025年第二季度的报告数据，采用报告比值比（Reporting Odds Ratio, ROR）与比例报告比值比（Proportional Reporting Ratio, PRR）方法开展不成比例性分析。依法吉单抗α报告频次最高的不良事件包括跌倒、尿路感染及症状复发，同时还检测到心房颤动、周围神经病与前列腺癌相关的潜在安全信号。罗沙利珠单抗的常见不良事件则为头痛、腹泻与呕吐，同时存在脑膜炎、嗜睡及进食障碍等潜在信号。亚组分析显示，不良反应存在性别特异性差异。多数不良事件发生于治疗启动后30天内，但依法吉单抗α在180天后仍存在持续风险。本研究识别出新型安全信号并明确了具有临床意义的风险模式，可为临床用药中的强化监测提供支持。需特别强调的是，本次不成比例性分析属于探索性研究，仅识别出潜在关联，并未确立因果关系，相关结论需通过后续专门研究予以验证。