A real-world pharmacovigilance study of blinatumomab based on the FDA adverse event reporting system.

Abstract

Background: Blinatumomab, the first CD3/CD19 bispecific antibody, is FDA-approved for relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adults and children. This study evaluates its safety profile through pharmacovigilance analysis of adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS).

Method: We conducted a disproportionality analysis using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Data from 2014Q1 to 2023Q4 were analyzed to identify safety signals related to blinatumomab, along with a stratification analysis to examine AE onset timing.

Result: A total of 17,131 AE reports were retrieved from the FAERS database, with 6,266 indicating blinatumomab as the primary suspect. We identified 277 preferred terms (PTs) demonstrating significant disproportionality across all algorithms. Notably, unexpected AEs included Graft Versus Host Disease, myelosuppression, and hypokalaemia. Common AEs were consistent across gender and age groups, predominantly occurring within one month of treatment.

Conclusion: This pharmacovigilance study utilizing the FAERS database identified potential AE signals associated with blinatumomab, providing essential insights for its safe clinical use.