Safety of infliximab and adalimumab in pediatric inflammatory bowel diseases: a real-world analysis from FAERS database

The incidence of pediatric inflammatory bowel disease (IBD) has significantly increased over the past few decades. Infliximab (IFX) and adalimumab (ADA) are the only two Tumor necrosis factor-α (TNF-α) inhibitors that have been approved by the FDA for the treatment of IBD in pediatric patients. However, postmarketing pharmacovigilance of the two TNF-α inhibitors in pediatric IBD is not sufficient and requires ongoing vigilant attention. We aimed to evaluate the safety of IFX and ADA in pediatric IBD using data from FAERS database. We filtered the queries within FAERS database to specifically identify indications of IBD among patients under the age of 18 from the first quarter of 2004 to that of 2024. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) algorithnms were used to identify drug-adverse event associtions. A total of 15, 955 reports of adverse events (AEs) caused by IFX and ADA as the primary suspect (PS) for pediatric IBD were extracted from FAERS database. We detected 95 positive signals of IFX involved in 17 system organ classes (SOCs) and 165 positive signals of ADA involved in 20 SOCs. The most commonly reported AEs for IFX were related to infusion reactions, whereas the predominant AEs for ADA involved injection site reactions. The majority of our detected AEs were disclosed on the product labell; however, certain AEs, including attempted suicide, increased weight, and psoriasis for IFX, as well as suicidal depression for ADA, were not listed. The median time to onset of IFX-related AEs was 579 days (interquartile range [IQR] 159.25–1357 days), with the majority occurring after 360 days initiation of IFX. While the median time to onset of ADA-related AEs was 79 days ([IQR] 21.75–295 days), with the majority occurring within 90 days after initiation of ADA. We conducted a comprehensive assessment and comparison of the safety of IFX and ADA for treating pediatric IBD, using real-world data from the FAERS database. Our study emphasizes the importance for medical practitioners to closely monitor AEs that may result in serious outcomes and are not listed in the labeling, thereby ensuring the safety of IFX and ADA treatments for children with IBD.