A real-world pharmacovigilance study of brentuximab vedotin based on the FAERS database from 2011 to 2024

Abstract Brentuximab vedotin (BV) is an antibody-drug conjugate (ADC) that targets CD30 and is primarily used in the treatment of CD30-positive lymphoma. While BV has shown success in treating patients with this type of lymphoma, there have been reports of serious adverse drug events (ADEs) associated with its use. This study aims to investigate the ADEs related to BV reported in the FDA Adverse Event Reporting System (FAERS) database from the third quarter of 2011 (Q3 2011) to the second quarter of 2024 (Q2 2024). Furthermore, the possibility and potential targets of peripheral neuropathy and acute kidney injury (AKI) caused by BV were analyzed. Targets associated with occurrence of ADEs were obtained by applying GeneCards database and key genes were enriched by GO and KEGG methods. A total of 6,515 adverse event reports and 21,055 ADEs related to BV were retrieved, half of which occurred within 21 days after first medication. The most frequently preferred terms (PTs) included peripheral sensory neuropathy, pneumocystis jirovecii pneumonia, and febrile neutropenia. The analysis of FAERS data allows for a thorough understanding of the real-world use of BV and helps to proper utilize and manage these potential adverse events.