Exploration of adverse event profiles for glofitamab: A disproportionality analysis using the FDA adverse event reporting system

Abstract

Background Glofitamab offers a promising option for the treatment of diffuse large B-cell lymphoma. It is crucial to gather comprehensive safety information of glofitamab through large-scale post market monitoring. Methods This study conducted a comprehensive analysis of glofitamab-related adverse events (AEs) based on FDA Adverse Event Reporting System database. Four disproportionality analysis methods were employed to mining the significant signals. The clinical characteristics of all AE and cytokine release syndrome reports were analyzed. Sensitivity analyses were performed to exam the potential bias. The differences in AE signals among different subgroups were investigated. Results A total of 641 reports and 1,542 AEs with glofitamab were identified. Cytokine release syndrome was the most significant signal. Notably, American and European reporters demonstrated higher cytokine release syndrome reporting frequency. Cytokine release syndrome was often reported by professionals and occurred within 30 days, especially with glofitamab at a dose of 2.5 mg. Hypogammaglobulinaemia was discovered as a new significant AE signal. Conclusions The findings suggest potential reporting differences in glofitamab-related AEs across different continents. Educating consumers on how to recognize the early symptoms of cytokine release syndrome is essential to improve safety. Close monitoring of cytokine release syndrome is recommended within 30 days of administration of glofitamab, especially at a dose of 2.5 mg. Furthermore, it is essential to stay vigilant about the emergence of the newly identified AE. These findings contribute to a broader understanding of the AE profiles of glofitamab.