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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1459067
This article is part of the Research Topic Advances in Drug-induced Diseases Volume II View all 40 articles

Pharmacovigilance analysis of Polatuzumab plus Bendamustine and Rituximab treatment protocol: Identifying Comprehensive Safety Signals using FDA Database

Provisionally accepted
Fang Wu Fang Wu 1Siliang Wang Siliang Wang 2Xihui Xu Xihui Xu 3*Weihui Zhang Weihui Zhang 1*Jie Zhou Jie Zhou 1*Runyang Niu Runyang Niu 1*Wenting Cai Wenting Cai 1Yonggong Yang Yonggong Yang 3*Mengying Liu Mengying Liu 2*Jinping Zhang Jinping Zhang 2*
  • 1 Department of Pharmacy, Nanjing Drum Tower Hospital, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 210008, China, Nanjing, Liaoning Province, China
  • 2 Department of Pharmacy, Nanjing Drum Tower Hospital, Nanjing, China
  • 3 Department of Hematology, Nanjing Drum Tower Hospital, Nanjing, Jiangsu Province, China

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

    Background: The combination of polatuzumab, bendamustine and rituximab (pola+BR) was authorized for the treatment of relapsed or refractory Diffuse large B cell lymphoma (DLBCL) . This study used the FDA database to identify safety signals related to the treatment protocol.Methods: The adverse events (AEs) from 2019Q1 to 2023Q3 were analyzed by calculating the reporting odds ratio. Severe and non-severe cases were compared using either an independent samples t-test or chi-squared (χ 2 ) test. Additionally, a score sheet was employed to prioritize the signals.Results: In all database, 58 significant signals were detected within 1597 patients accepting the treatment protocol. Common AEs like neutropenia, thrombocytopenia, and peripheral neuropathy, as well as other AEs like anaemia, sepsis, cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS) were a major focus. In addtion, 51.7%, 45.6% and 1.7% were sorted into low, moderate and high priority in term of clinical importance, respectively. Unexpected significant signals included intestinal obstruction, epilepsy, deep vein thrombosis, haemorrhage, increased blood lactate dehydrogenase and hypercalcemia.Conclusions: Our study identified significant AE signals for pola+BR through realworld disproportionality analysis data and analyzed the severity and clinical priority of these signals, which can assist clinicians in managing related AEs.

    Keywords: Pharmacovigilance, polatuzumab vediton, drug safety, Disproportionality analysis, FAERS

    Received: 26 Aug 2024; Accepted: 27 Jan 2025.

    Copyright: © 2025 Wu, Wang, Xu, Zhang, Zhou, Niu, Cai, Yang, Liu and Zhang. 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:
    Xihui Xu, Department of Hematology, Nanjing Drum Tower Hospital, Nanjing, 210008, Jiangsu Province, China
    Weihui Zhang, Department of Pharmacy, Nanjing Drum Tower Hospital, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 210008, China, Nanjing, Liaoning Province, China
    Jie Zhou, Department of Pharmacy, Nanjing Drum Tower Hospital, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 210008, China, Nanjing, Liaoning Province, China
    Runyang Niu, Department of Pharmacy, Nanjing Drum Tower Hospital, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 210008, China, Nanjing, Liaoning Province, China
    Yonggong Yang, Department of Hematology, Nanjing Drum Tower Hospital, Nanjing, 210008, Jiangsu Province, China
    Mengying Liu, Department of Pharmacy, Nanjing Drum Tower Hospital, Nanjing, China
    Jinping Zhang, Department of Pharmacy, Nanjing Drum Tower Hospital, Nanjing, 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.