Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2025-02-25 DOI:10.1080/14740338.2025.2470875

Xiangyang Le, Yefu Zhang, Junlong Ma

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引用次数: 0

Abstract

Background: T-cell engagers (TCEs) are transformative immunotherapies with significant potential in treating hematologic malignancies and solid tumors. However, their real-world safety profiles remain inadequately characterized.

Research design and methods: Using the FDA Adverse Event Reporting System (FAERS) database (October 2019 - September 2024, 8,747,158 reports), we analyzed adverse events (AEs) associated with nine TCEs. Disproportionality analysis identified overreported AEs, with 11,963 unique reports analyzed after deduplication.

Results: Blinatumomab was the most reported TCE (n = 4,950), and Tarlatamab the least (n = 185). Predominant AEs included immune system disorders, particularly cytokine release syndrome (IC₀₂₅ range: 6.08-7.47). Drug-specific signals included reproductive system and breast disorders (IC₀₂₅: 2.74) and vascular disorders (IC₀₂₅: 2.25) with Tebentafusp, renal and urinary disorders with Epcoritamab (IC₀₂₅: 1.84), and eye disorders with Elranatamab (IC₀₂₅: 1.81). Novel AEs were also uncovered, including second malignant neoplasms, vasogenic cerebral edema with Mosunetuzumab (IC₀₂₅: 5.77, ROR₀₂₅: 56.29), and hydronephrosis with Epcoritamab (IC₀₂₅: 7.50, ROR₀₂₅: 180.70). Early-onset events (0.5-9.5 days) were linked to four TCEs, while delayed-onset events (>20 days) were linked to five others.

Conclusions: This study highlights diverse AE profiles of TCEs, providing insights for clinicians to optimize their safe use in practice.

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利用 FAERS 数据库全面分析与 T 细胞接合剂相关的不良事件。

背景：T细胞诱导剂（TCEs）是一种变革性免疫疗法，在治疗血液恶性肿瘤和实体瘤方面具有巨大潜力。然而，它们在真实世界中的安全性特征仍不充分：利用FDA不良事件报告系统（FAERS）数据库（2019年10月至2024年9月，8747158份报告），我们分析了与九种TCE相关的不良事件（AEs）。比例失调分析发现了多报的AEs，重复分析后共分析了11963份报告：结果：Blinatumomab是报告最多的TCE（n = 4,950），Tarlatamab最少（n = 185）。主要的AE包括免疫系统紊乱，尤其是细胞因子释放综合征（IC025范围：6.08 - 7.47）。药物特异性信号包括特本福斯普引起的生殖系统和乳腺疾病（IC025：2.74）和血管疾病（IC025：2.25），艾普科瑞他单抗引起的肾脏和泌尿系统疾病（IC025：1.84），以及艾拉那单抗引起的眼部疾病（IC025：1.81）。此外，还发现了一些新的 AE，包括继发性恶性肿瘤、莫苏尼妥珠单抗引起的血管源性脑水肿（IC025：5.77，ROR025：56.29），以及艾普利他单抗引起的肾积水（IC025：7.50，ROR025：180.70）。早发事件（0.5 - 9.5天）与4种TCE有关，而迟发事件（>20天）与另外5种TCE有关：本研究强调了TCE的各种AE特征，为临床医生在实践中优化TCE的安全使用提供了启示。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.