Characterizing ADRs of Enfortumab vedotin and Erdafitinib in bladder cancer treatment: a descriptive analysis from WHO-VigiAccess

Yuanbin Huang; Meiqi Xu; Xinmiao Ma; Wei Wang; Chen Shen; Fei Liu; Zhiqi Chen; Jiawen Wang; Qian Guo; Xiancheng Li

doi:10.3389/fphar.2024.1503154

Characterizing ADRs of Enfortumab vedotin and Erdafitinib in bladder cancer treatment: a descriptive analysis from WHO-VigiAccess

Front Pharmacol. 2024 Dec 6:15:1503154. doi: 10.3389/fphar.2024.1503154. eCollection 2024.

Authors

Yuanbin Huang^#¹, Meiqi Xu^#¹, Xinmiao Ma^#¹, Wei Wang¹, Chen Shen¹, Fei Liu¹, Zhiqi Chen¹, Jiawen Wang², Qian Guo³, Xiancheng Li¹

Affiliations

¹ Second Affiliated Hospital of Dalian Medical University, Dalian Medical University, Dalian, China.
² Department of Urology, Fujian Provincial Hospital, Fuzhou, China.
³ Department of Rhinology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou University, Zhengzhou, China.

^# Contributed equally.

Abstract

Introduction: Enfortumab vedotin (EV) and Erdafitinib are effective therapeutic drugs for bladder cancer patients following post-chemotherapy and immunotherapy. This study assessed adverse drug reactions (ADRs) from both drugs, comparing their safety profiles to guide clinical use.

Methods: A retrospective descriptive analysis was conducted on ADR reports for EV and Erdafitinib from the World Health Organization (WHO)-VigiAccess database. Data on patient demographics, system organ classes (SOCs), global patient regions, symptoms, and ADRs frequencies were analyzed and compared.

Results: As of 2024, 3,438 ADR reports were identified (2,257 for EV and 1,181 for Erdafitinib). The number of adverse reaction reports for EV is significantly higher than that for Erdafitinib. Among them, the SOC with the most adverse signals is gastrointestinal disorders, with the top five reports being nausea, gastrointestinal disorders, dry mouth, abdominal pain, and diarrhea. The top five reported adverse events (AEs) for EV are as follows: skin and subcutaneous tissue disorders (20.70%), general disorders and administration site conditions (14.23%), nervous system disorders (11.12%), gastrointestinal disorders (7.78%), and metabolism and nutrition disorders (6.47%). In contrast, the top five AEs for Erdafitinib are: general disorders and administration site conditions (25.36%), skin and subcutaneous tissue disorders (10.94%), gastrointestinal disorders (10.19%), eye disorders (9.21%), and injury poisoning and procedural complications (7.31%).

Conclusion: Our study identified and compared potential and novel ADRs between EV and Erdafitinib, providing key insights into their safety profiles and highlighting the need for personalized treatment strategies based on individual patient risk factors.

Keywords: Enfortumab vedotin; Erdafitinib; WHO-VigiAccess database; adverse drug reaction; pharmacovigilance; spontaneous reporting.

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This work was supported by grant from the Applied Basic Research Program Project of Liaoning Province (Grant No. 2023JH2/101300124), the 1 + X Clinical Advantage Project (Grant No. 2022LCJSYS06) and the Cultivation Program for Innovative Talents in Colleges and Universities, Liaoning Provincial Department of Education (Grant No. 507317).