Examining the safety of belimumab, especially in children: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database.

Background: Belimumab was approved in the US in 2019 for children with Systemic lupus erythematosus (SLE), making it the only medicine that can treat SLE in both adults and children. The authors retrospectively investigated adverse events (AEs) by data-mining a self-reported database.

Research design and methods: PRR, ROR, and BCPNN were used to assess the association between belimumab and AEs. The definition relied on system organ class (SOC) and peferred terms (PT) by the Medical Dictionary for Regulatory Activities (MedDRA).

Results: A total of 15,316,605 AE reports were retrieved from the FAERS database, and 19,832 AE reports were identified after the data cleaning process. Based on the disproportionality analysis at the PT level, depressive (N = 420), ill-defined disorder (N = 304), injection site hemorrhage (N = 297), lupus nephritis (N = 198), live birth (N = 96) and proteinuria (N = 77) had relatively higher frequencies than other AEs, suggesting that these AEs are more likely to occur in the real world for patients taking belimumab.

Conclusions: This study explores valuable potential AEs of belimumab at the SOC and PT levels, respectively. To provide a reference for decision-making on belimumab, including its use in children, and to promote rational clinical dosing.