Deng Yanhong, Shi Shengying, Feng Senling, Tan Xiangping, Wang Yinling, Yin Jinjin, Liu Shaozhi, Gao Yuanmei
Department of Pharmacy, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Critical Care Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
BMC Gastroenterol. 2025 Aug 7;25(1):560. doi: 10.1186/s12876-025-04154-w.
The incidence of pediatric inflammatory bowel disease (IBD) significantly increased recently. Infliximab (IFX) and adalimumab (ADA), both TNF-α inhibitors, are the only FDA-approved treatments for pediatric IBD. Due to the unique physiological and developmental characteristics of children, postmarketing pharmacovigilance requires ongoing attention. We aimed to evaluate the safety of IFX and ADA in pediatric IBD using FAERS database data from Q1 2004 to Q1 2024.
Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms were used to identify drug-related adverse events (AEs).
In total, we retrieved 10,905 IFX-related reports and 5,446 ADA-related reports in pediatric IBD. Common AEs associated with IFX were infusion reactions; for ADA, they were injection site reactions. While most AEs align with approved labeling, continued vigilant monitoring appears important for specific postmarketing AEs observed with IFX, including suicide attempts, weight increased, and psoriasis. The median onset (TTO) for IFX-related AEs was 579 days (interquartile range [IQR]: 159.25-1357 days), occurring mostly after 360 days. For ADA, TTO was 79 days (IQR: 21.75-295 days), with most within 90 days of treatment initiation.
Our study revealed that although most AEs matched labeled information, rigorous post-marketing monitoring of severe AEs remains important for IFX and ADA in pediatric IBD, with additional confirmatory research warranted.
小儿炎症性肠病（IBD）的发病率最近显著增加。英夫利昔单抗（IFX）和阿达木单抗（ADA）均为肿瘤坏死因子-α（TNF-α）抑制剂，是美国食品药品监督管理局（FDA）批准的仅有的用于小儿IBD的治疗药物。由于儿童独特的生理和发育特征，上市后药物警戒需要持续关注。我们旨在利用2004年第一季度至2024年第一季度的FDA不良事件报告系统（FAERS）数据库数据评估IFX和ADA在小儿IBD中的安全性。
采用报告比值比（ROR）和比例报告比值（PRR）算法识别药物相关不良事件（AE）。
我们总共检索到10905份小儿IBD中与IFX相关的报告和5446份与ADA相关的报告。与IFX相关的常见AE为输液反应；对于ADA，常见AE为注射部位反应。虽然大多数AE与批准的标签一致，但对于IFX观察到的特定上市后AE，包括自杀未遂、体重增加和银屑病，持续的警惕监测似乎很重要。与IFX相关AE的中位发病时间（TTO）为579天（四分位间距[IQR]：159.25 - 1357天），大多发生在360天后。对于ADA，TTO为79天（IQR：21.75 - 295天），大多数在治疗开始后90天内。
我们的研究表明，虽然大多数AE与标签信息相符，但对小儿IBD中的IFX和ADA进行严格的上市后严重AE监测仍然很重要，需要进行额外的验证性研究。
