Disproportionality analysis of adverse reaction signals related to CD3/BCMA-directed bispecific antibodies
Objective This study aims to identify and compare adverse drug reaction signals of teclistamab and elranatamab,based on post-marketing safety data in order to provide insights that could improve clinical treatment safety.Methods Data were collected from the U.S.FDA Adverse Event Reporting System(FAERS)from the first quarter of 2014 to the second quarter of 2024 in which teclistamab and elranatamab were primary suspected drugs,while adverse drug reaction signals were detected using reporting odds ratio(ROR)method.Results A total of 1,615 and 311 reports of teclistamab and elranatamab as primary suspected drugs were collected,respectively.We detected 150 adverse drug reaction signals associated with teclistamab and 43 with elranatamab.The system organ class(SOC)most frequently affected with stronger signal intensity was infection and infestations for both drugs.Most of the high-intensity signals and frequently reported adverse reactions were consistent with the respective drug labels,while cytomegalovirus infection showed a stronger signal for elranatamab.Tumor lysis syndrome is not listed in teclistamab's drug label.Conclusion The two bispecific antibodies targeting BCMA and CD3 are generally safe,but caution should be taken in serious and potential new adverse drug reactions such as cytokine release syndrome,infections and tumor lysis syndrome.
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