Potential heterogeneity of epcoritamab associated adverse events in demographics and dosing regimens.

BACKGROUND: Epcoritamab shows potentially curable efficacy in relapsed or refractory B-cell non-Hodgkin's lymphoma, but potential heterogeneity in its adverse events (AEs) across demographics and dosing regimens remain unexplored. METHODS: This study comprehensively analyzed potential heterogeneity of epcoritamab associated AEs using the data from the FDA Adverse Event Reporting System (FAERS) database and supplemented it with data from the Japanese Adverse Drug Event Report (JADER) database. Based on the clinical characteristics of the epcoritamab-associated AE reports, the potential heterogeneity of AEs across demographic and dosing regimen subgroups was investigated via reporting odds ratio algorithm and Fisher's exact test with Bonferroni correction. Subsequently, sensitivity analysis was performed to validate the potential variations. RESULTS: Patients receiving 0.16 mg dose reported significantly higher frequency of cytokine release syndrome (CRS), especially within the first four treatment weeks. Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported with a significantly higher frequency among patients over the age of 65 compared to those aged 18-65. CONCLUSION: This study revealed the potential heterogeneity of epcoritamab associated AEs in demographics and dosing regimens. Enhanced CRS monitoring should be prioritized during the initial administration of epcoritamab treatment. Monitoring ICANS may be of particular importance in older patients. Further research is warranted to elucidate the case causality of these associations.