A Real-World Safety Analysis of Infection-Related Adverse Events Associated with Belimumab, Rituximab, and TNF-α Inhibitors Using the FAERS Database

Objective The study aims to evaluate infection-related safety profiles of belimumab, rituximab, and TNF-α inhibitors using the FDA Adverse Event Reporting System (FAERS) database. Methods A disproportionality analysis combining Reporting Odds Ratios (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) was conducted on FAERS data from Q1 2014 to Q2 2024. Results Belimumab and rituximab are more likely to cause progressive multifocal leukoencephalopathy(PML), while infliximab show a greater variety tuberculosis(TB)-related AEs than other biological agents. Rituximab exhibited a risk association with hepatitis B virus reactivation and sepsis-related AEs. Most of these infection AEs are listed in drug packaging labels, our study also identified some rare and potential AEs such as cutaneous leishmaniasis, gallbladder empyema, leprosy, chikungunya virus infection and dengue fever. Conclusion Belimumab, rituximab, and TNF-α inhibitors exhibit distinct infection risks.. Clinicians should prioritize monitoring for severe events like PML, TB, and hepatitis B viral reactivation. However, epidemiological investigations and further causality assessments are required.