Post-marketing safety of tralokinumab: a real-world pharmacovigilance study based on the FDA adverse event reporting system.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-10-01 DOI:10.1080/14740338.2024.2410434
Zeping Yang, Kejing Tang, Jie Chen
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引用次数: 0

Abstract

Background: Tralokinumab is a fully human IgG4 monoclonal antibody targeting IL-13, used for treating atopic dermatitis. This study analyzed tralokinumab-related adverse drug events by mining the Food and Drug Administration Adverse Event Reporting System (FAERS) database to provide a safety reference for clinical application.

Methods: Adverse drug event reports from Q1 2022 to Q2 2024 were extracted from the FAERS database. After standardizing the data, various signal detection methods were used for analysis, including ROR, PRR, BCPNN, and MGPS.

Results: A total of 1,820 reports of adverse events (AEs) with tralokinumab as the primary suspected drug were identified. 70 preferred terms (PTs) met the criteria across four signal detection methods, involving 11 system organ classes (SOCs). These included known adverse reactions like conjunctivitis and injection site reactions, and signals not previously reported in clinical trials, such as eye pruritus, dry eye, eye swelling, pneumonia pneumococcal, and cutaneous T-cell lymphoma. Most AEs occurred within one month of initiating tralokinumab treatment.

Conclusions: Based on the FAERS database, this study comprehensively and systematically analyzed AE signals in tralokinumab treatment. The results enhance the understanding of tralokinumab's safety and serve as valuable references for reducing the risk of adverse reactions during clinical use.

曲妥珠单抗上市后的安全性:基于美国食品药品管理局不良事件报告系统的真实世界药物警戒研究。
背景介绍曲洛单抗是一种靶向IL-13的全人源IgG4单克隆抗体,用于治疗特应性皮炎。本研究通过挖掘美国食品和药物管理局不良事件报告系统(FAERS)数据库,对曲洛单抗相关药物不良事件进行分析,为临床应用提供安全性参考:方法:从FAERS数据库中提取2022年第一季度至2024年第二季度的药物不良事件报告。方法:从 FAERS 数据库中提取 2022 年第一季度至 2024 年第二季度的药物不良事件报告,对数据进行标准化处理后,采用多种信号检测方法进行分析,包括 ROR、PRR、BCPNN 和 MGPS:结果:共发现 1,820 份以曲妥珠单抗为主要可疑药物的不良事件 (AE) 报告。在四种信号检测方法中,有 70 个首选术语 (PT) 符合标准,涉及 11 个系统器官类别 (SOC)。其中包括结膜炎和注射部位反应等已知不良反应,以及以前在临床试验中未报告过的信号,如眼睛瘙痒、干眼症、眼睛肿胀、肺炎球菌肺炎和皮肤 T 细胞淋巴瘤。大多数AE发生在开始曲妥珠单抗治疗的一个月内:本研究基于 FAERS 数据库,全面系统地分析了曲妥珠单抗治疗中的 AE 信号。结论:这项研究基于 FAERS 数据库,全面系统地分析了曲妥珠单抗治疗过程中的不良反应信号,其结果加深了人们对曲妥珠单抗安全性的理解,对降低临床使用过程中的不良反应风险具有重要参考价值。
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
CiteScore
5.90
自引率
3.20%
发文量
97
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.
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