ORIGINAL RESEARCH article
Front. Med.
Sec. Hematology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1593405
This article is part of the Research TopicUnderstanding and Controlling Adverse Effects in Myeloma Patients treated with T Cell Redirecting ImmunotherapiesView all articles
The Silent Signals: Emerging Safety Concerns in Bispecific Antibody Therapy for Multiple Myeloma
Provisionally accepted
- 1Chengdu Women and Children’s Central Hospital, Chengdu, China
- 2Graduate School of Human Environment Studies, Kyushu University, Fukuoka, Fukuoka, Japan
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Background: Bispecific antibodies (BsAbs) are widely used for the treatment of multiple myeloma (MM), but their long-term safety still provokes concerns. Methods: Adverse event (AE) data on teclistamab, talquetamab and elranatamab between August 1, 2022 and September 30, 2024 were retrieved from the Food and Drug Administration's AE Reporting System (FAERS) database by use of Open Vigil 2.1. AEs were categorized by preferred terms (PTs) and system organ classes (SOCs) as defined by MedDRA. As widely used statistical measures in pharmacovigilance, proportional reporting and reporting odds ratios (PRR and ROR) were employed to identify potential safety signals. Results: In total, 2,789,182 reports on AEs were retrieved, including 811 for teclistamab, 446 for talquetamab and 302 for elranatamab. Significant associations with immune system disorders, nervous system disorders, benign, malignant and unspecified (incl cysts and polyps) neoplasms, and hepatobiliary disorders were found for all three BsAbs. Common PTs included cytokine release syndrome (CRS), neurotoxicity, immune effector cell-associated neurotoxicity syn-drome (ICANS), pyrexia, and neutropenia. Meanwhile, signal values varied among the three BsAbs. Notably, new safety signals numbered 14, 4 and 5 were identified for teclistamab, talquetamab and elranatamab, respectively. Conclusion: AE signals were demonstrated to vary among the three BsAbs used in MM. Significant safety signals identified in the FAERS database which were consistent with previously reported clinical trial data. Furthermore, each BsAb exhibited several novel signals. These findings provide decision-makers and healthcare providers with valuable insights into clinical practice.
Keywords: bispecific antibodies, AES, mm, Pharmacovigilance, FAERS
Received: 14 Mar 2025; Accepted: 28 Jul 2025.
Copyright: © 2025 Zhou, Luo, Chen, Deng, Wu, Jiang, Zhang and Lai. 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:
Xiaoling Zhou, Chengdu Women and Children’s Central Hospital, Chengdu, China
Fan Lai, Chengdu Women and Children’s Central Hospital, Chengdu, 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.