OBJECTIVE  To unearth the adverse events(AE) risk signals associated with infliximab, ustekinumab, and vedolizumab, and to explore the differences in safety profiles among these three biologic agents used in the treatment of inflammatory bowel disease(IBD), which could provide valuable insights for the clinical rational use of these novel biologics in IBD management.

METHODS  Obtaining FAERS data from the first quarter of 2004 to the fourth quarter of 2022, after deduplication and standardization using the Medical Dictionary for Regulatory Activities(MedDRA, version 26.0), AE reports specific in the background population with IBD were firstly extracted, and subsequently these reports with infliximab, ustekinumab, and vedolizumab as primary suspected drugs were following screened respectively. Then, the signal mining and analysis using the reporting odds ratio(ROR) combined with the bayesian confidence propagation neural network(BCPNN) methods were finally performed to assess the identified signals.

RESULTS  A total of 70 508 AE reports associated with infliximab as the primary suspected drug were extracted, resulting in 460 signal occurrences. For ustekinumab, there were 18 121 AE reports with 193 signal occurrences. As for vedolizumab, there were 34 270 AE reports with 235 signal occurrences. Among the AE reports for these 3 drugs, the number of female patients were more than male patients, and the age of patients was primarily concentrated between 18 and 65 years, with the main age group being 18−45 years. The highest number of reports originated from the United States and Canada. The severe AE for all 3 drugs contained other important medical events, hospitalization, prolonged hospital stay, and death. Among them, vedolizumab reported a higher incidence rate of severe AE. The 3 drugs had similar system organ class(SOC) profiles, all of which increased the risk of opportunistic infections, tumor occurrence, various examination abnormalities, systemic diseases, and reactions at the administration site. However, there were differences in the high-intensity preferred terms(PT) and high ROR signal intensity AE under each major SOC category. The newly identified potential AE signals for the 3 drugs were different. There was a signal for developmental abnormalities with infliximab, hepatotoxicity with ustekinumab, and adverse effects on the kidneys, eyes, nervous system, nutritional metabolism, and muscles with vedolizumab. These findings warranted clinical attention.

CONCLUSION  The differences in PT, high ROR signal intensity AE of infliximab, ustekinumab, and vedolizumab indicate the need for individualized dosing in the clinical use of biologics for treating IBD, taking into account the specific circumstances of each patient.