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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1503154

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

Provisionally accepted
Yuanbin Huang Yuanbin Huang 1Meiqi Xu Meiqi Xu 1Xinmiao Ma Xinmiao Ma 1Wang Wei Wang Wei 1Shen Chen Shen Chen 1Fei Liu Fei Liu 1Zhiqi Chen Zhiqi Chen 1Qian Guo Qian Guo 2Xiancheng Li Xiancheng Li 1*
  • 1 Second Affiliated Hospital of Dalian Medical University, Dalian, China
  • 2 First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China

The final, formatted version of the article will be published soon.

    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: Adverse Drug Reaction, Enfortumab vedotin, Erdafitinib, Pharmacovigilance, Spontaneous reporting, WHO-VigiAccess database

    Received: 28 Sep 2024; Accepted: 21 Nov 2024.

    Copyright: © 2024 Huang, Xu, Ma, Wei, Chen, Liu, Chen, Guo and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Xiancheng Li, Second Affiliated Hospital of Dalian Medical University, Dalian, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.