Adverse reactions associated with the use of ustekinumab in Crohn's disease treatment：an analysis based on the FAERS database

Background: Approved in 2016 for Crohn’s disease(CD), ustekinumab’s adverse reaction signals(ADRs) remain largely unclear. This study aims to enhance clinical safety by identifying ADRs through mining the FAERS database. Methods: We collected adverse drug event (ADE) data for ustekinumab used in the treatment of CD, reported in the FDA’s Adverse Event Reporting System from the fourth quarter of 2016 to 2023. For signal mining, we employed the Reported Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Belief Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). Additionally, we conducted a statistical classification of ADRs according to the System Organ Class (SOC). Results: The timeframe was limited to Q4 2016 to Q4 2023. For CD, 17,187 ADRs were identified, resulting in 44,232 signals affecting 24 SOCs and 258 PTs. The most numerous reports were for injury, poisoning, and procedural complications. Infections and infestations had the highest ROR signals. Among PTs, congenital pulmonary airway malformation had the strongest ROR signal and the highest off-label use instances. Conclusion: When administering ustekinumab for CD, in addition to monitoring common AEs like infections and tumors, vigilance is crucial for potential AEs involving the heart, hepatobiliary system, and emerging genetic diseases.