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ORIGINAL RESEARCH article

Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 15 - 2024 | doi: 10.3389/fimmu.2024.1397692

Post-marketing drug safety surveillance of Enfortumab Vedotin: An observation,pharmacovigilance study based on real-world database

Provisionally accepted
Mingming Yu Mingming Yu 1Lijun Zhou Lijun Zhou 2Mengda Cao Mengda Cao 3Chunmei Ji Chunmei Ji 4*Yuanyi Zheng Yuanyi Zheng 1*
  • 1 Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, China
  • 2 Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, China
  • 3 Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, China
  • 4 First Affiliated Hospital, Nanjing Medical University, Nanjing, China

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

    Background: Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC), which is approved by FDA for patients with locally advanced or metastatic urothelial carcinoma (UC). This study present a comprehensive pharmacovigilance analysis of the post-marketing safety profile of EV in real-world based on the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Adverse event(AE) reports regarding EV during January 2020 to December 2023 were obtained from the FAERS database. The standardized MedDRA query (SMQ) narrow search AEs on the preferred term (PT) level were used. Disproportionality analysis was performed to identify the AE signals for EV with reporting odds ratio (ROR), proportional reporting ratio (PRR), and multi-item gamma poisson shrinker (MGPS), bayesian confidence propagation neural network (BCPNN). Results: Totally 2216 reports regarding EV were included in the present study. SMQ analysis result indicated that a stronger strength signal was found in severe cutaneous adverse reactions, retroperitoneal fibrosis and peripheral neuropathy. Totally 116 significant disproportionality PTs refer to 14 system organ class(SOC) were retained by disproportionality analysis, with 49 PTs were not list in EV the drug label. Frequently reported EV-related AEs included rash, peripheral neuropathy, decreased appetite, alopecia, pruritus,etc.The time to onset of majority EV-related AEs were reported within 30 days(66.05%), with only 0.73% events after 1 year.The disproportionality analysis highlights that dermatologic toxicity and peripheral neuropathy were the major AEs induced by EV. The potential AEs without listing in drug label main foucs on gastrointestinal, hepatic, pulmonary events. Further research is need to confirm and explore the EV-related AEs in clinical .

    Keywords: Enfortumab vedotin, FDA Adverse Event Reporting System, Real-world, Disproportionality analysis, Adverse event

    Received: 08 Mar 2024; Accepted: 29 Jul 2024.

    Copyright: © 2024 Yu, Zhou, Cao, Ji and Zheng. 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:
    Chunmei Ji, First Affiliated Hospital, Nanjing Medical University, Nanjing, China
    Yuanyi Zheng, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, 200233, Shanghai Municipality, 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.