戈利木单抗的不良事件报告：FDA不良事件报告系统（FAERS）数据库的不比例分析

文献信息

中文摘要

本研究对FDA不良事件报告系统（FAERS）数据库中2009年第二季度至2025年第三季度的50,031份不良药物事件（ADE）报告进行了回顾性不比例分析，其中戈利木单抗被确定为主要可疑药物。同时应用了四种不比例算法：报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松缩略器（MGPS）。在25个系统器官分类（SOC）中共识别出397个阳性信号。在四种算法中均一致出现阳性信号的SOC为感染和侵染以及外科和医疗操作。高频信号包括肺炎、下呼吸道感染、流感、鼻咽炎、鼻窦炎和蜂窝织炎。与当前处方信息比较，发现了若干既往未记录的不良药物事件，包括尿路感染、耳部感染、黄病毒感染、寨卡病毒感染和登革热。识别出29个处方信息中未包含的阳性恶性肿瘤信号，包括基底细胞癌、结直肠癌、宫颈癌和乳腺癌。发病时间分析显示，不良药物事件风险在治疗开始后的最初几个月内最高。临床医生在开具戈利木单抗时应严格监测感染性并发症和恶性肿瘤，以确保患者安全。

英文摘要

This study conducted a retrospective disproportionality analysis of 50,031 adverse drug event (ADE) reports from the FDA Adverse Event Reporting System (FAERS) database spanning Q2 2009 to Q3 2025, in which golimumab was identified as the primary suspect drug. Four disproportionality algorithms were simultaneously applied: the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). A total of 397 positive signals were identified across 25 system organ classes (SOCs). The SOCs with concordant positive signals across all four algorithms were identified for infections and infestations and surgical and medical procedures. High-frequency signals included pneumonia, lower respiratory tract infection, influenza, nasopharyngitis, sinusitis and cellulitis. Comparison with the current prescribing information revealed several previously undocumented ADEs, including urinary tract infection, ear infection, flavivirus infection, Zika virus infection and Dengue fever. Twenty-nine positive malignancy signals absent from the prescribing information were identified, including basal cell carcinoma, colorectal cancer, cervical cancer and breast cancer. Time-to-onset analysis revealed that the risk of ADEs was the highest within the first few months of treatment initiation. Clinicians should rigorously monitor for infectious complications and malignancies when prescribing golimumab to ensure patient safety.