Assessment of distributions and gender difference in adverse events related to faricimab: a real-world study based on FDA adverse event reporting system

Faricimab is a novel bispecific antibody drug for treating retinal disease. We aim to study the adverse events of faricimab based on the FDA Adverse Event Reporting System (FAERS) database. The FAERS data from 2020 to 2024 was extracted to conduct disproportionality analysis. The risk signals were mined by using reporting odds ratio (ROR) and proportional reporting ratio (PRR). A total of 1401 cases with adverse events were reported. Eye disorders were the most frequent AEs. New ocular AEs were identified, such as diplopia, metamorphopsia, blindness transient, visual field defect, subretinal fibrosis. New non-ocular AEs were also found such as cellulitis, acute respiratory failure, end stage renal disease, proteinuria, nephropathy, VIth nerve paralysis, and deafness. It was found that there is a difference between men and women on the ocular adverse events. Adverse events happened in the initial month of the treatment, but mostly happened between the 91 to 180 days. Faricimab have ocular and non-ocular adverse events, in which some ocular adverse events differ across genders. Important potential adverse events should be considered in the clinical practice to provide better individualized treatment.

法瑞昔单抗（Faricimab）是一款用于治疗视网膜疾病的新型双特异性抗体（bispecific antibody）药物。本研究基于FDA不良事件报告系统（FDA Adverse Event Reporting System, FAERS），旨在探究法瑞昔单抗的不良事件（adverse events, AEs）情况。研究提取了2020年至2024年的FAERS数据以开展不成比例分析（disproportionality analysis），通过报告比值比（reporting odds ratio, ROR）与比例报告比值比（proportional reporting ratio, PRR）挖掘风险信号。本研究共纳入1401例不良事件报告病例，其中眼部不良事件为最常见的不良事件。本研究识别出多种新型眼部不良事件，包括复视、视物变形症、一过性失明、视野缺损及视网膜下纤维化；同时也发现了新型非眼部不良事件，如蜂窝织炎、急性呼吸衰竭、终末期肾病、蛋白尿、肾病、展神经麻痹及耳聋。研究发现，男性与女性在眼部不良事件的发生上存在差异。不良事件多发生于治疗初始月份，但主要集中在治疗后91至180天区间。法瑞昔单抗可引发眼部及非眼部不良事件，其中部分眼部不良事件的发生存在性别差异。临床实践中应重视此类潜在重要不良事件，以提供更优质的个体化治疗方案。