Risk factors and subgroups analysis of Enasidenib in treating Acute Myelogenous Leukemia : a pharmacovigilance study based on FAERS database

Abstract Enasidenib, an isocitrate dehydrogenase inhibitor (IDHI) that selectively inhibits IDHI-2, is currently approved for treating Acute Myelogenous Leukemia(AML). This study identified and characterized adverse events (AEs) significantly related to IDHI in treating AML and compared the differences of subgroups to provide clinical reference. AEs reports were collected from the United States Food and Drug Administration Adverse Event Reporting System(FAERS). Enasidenib’s AEs were collected from Q3 2017 to Q3 2024. The reporting odds ratio (ROR) and Bayesian confidence propagation neural network(BCPNN) were used. When the lower limit of the 95% confidence interval (CI) of ROR > 1.0 and (IC-2SD)>0 was considered the threshold for a signal. A total of 2098 AE reports were retrieved from FAERS. Reports for males were higher than females, and patients aged 65–85 years reported the highest number of AEs. Interestingly, 52 PTs were classified as unexpected AEs, such as fatigue, asthenia, platelet count decreased, etc. There are similarities and differences in the presentation of enasidenib-related AEs in subgroups of different genders and ages. Gender-specific and age-specific patients should be concerned about the occurrence of appropriate AEs when taking enasidenib. Our study provided evidence for enasidenib in the treatment of AML.