Real-World Adverse Events of Isatuximab: Analysis of the FDA Adverse Event Reporting System (FAERS) Database and a Comparison with Daratumumab
Year: 2025
Type: article
Study design: Observational Study
Abstract: Isatuximab, a cluster of differentiation 38 (CD38)-targeting monoclonal antibody, is used to treat relapsed or refractory multiple myeloma.This study aimed to detect the safety signal of isatuximab and to compare the reporting ratio with daratumumab, another CD38-targeting monoclonal antibody.Food and Drug Administration Adverse Event Reporting System (FAERS) data from Q1 2020 to Q1 2022 were analyzed.A disproportionality analysis was performed, and adverse events (AEs) that satisfied the criteria for a safety signal were identified.The reporting odds ratio (ROR) of the safety signal was calculated for both isatuximab and daratumumab.The relative index (ROR ratio for fatigue) was compared between isatuximab and daratumumab.From 347 isatuximab-AE pairs, 14 were identified as safety signals.Three AEs (pulmonary embolism, atrial fibrillation, and tumor lysis syndrome) were not included on the drug label, although pulmonary embolism might be a complication of multiple myeloma or an AE of coadministered immunomodulatory agents instead.Squamous cell skin cancer (ROR, 84.25 vs. 6.12),pneumocystis jirovecii pneumonia (ROR, 67.78 vs. 2.94), lymphopenia (ROR, 26.66 vs. 1.96), bronchitis (ROR, 23.31 vs. 2.55), pneumonia (ROR, 19.52 vs. 3.39), pulmonary embolism (ROR, 18.22 vs. 3.97), atrial fibrillation (ROR, 12.51 vs. 3.93), and neutropenia (ROR, 4.48 vs. 1.47) were frequently reported with isatuximab.These AEs need to be considered when using isatuximab.
Source: Drug Targets and Therapeutics
DOI: 10.58502/dtt.24.0017
Authors: Eunjung Kim, Jae-Hee Kwon, Ja-Young Han, Minjung Kim, Minjung Kim, Myeong Gyu Kim, Myeong Gyu Kim
Institution: Ewha Womans University
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W4408914946