Real-world safety profile of eculizumab: an analysis of FDA adverse event reporting system and systematic review of case reports.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-26 DOI:10.1080/14740338.2024.2392885

Zhihui Zhang, Xin Liu, Jinlan Zhang, Bo Zhang

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引用次数: 0

Abstract

Background: Most of the safety data regarding eculizumab came from clinical trials, while its safety information in the real world is still limited.

Research design and methods: The data of eculizumab in the FDA Adverse Event Reporting System (FAERS) database (from the first quarter of 2007 to the first quarter of 2023) was collected and analyzed. The case reports of adverse drug reactions (ADRs) related to eculizumab in PubMed, Embase and Web of Science before May 2023 were systematically reviewed.

Results: A total of 464 ADRs of eculizumab were identified in the FAERS database. The top five ADRs with the highest proportional reporting ratio (PRR) are total complement activity decreased, extravascular hemolysis, hemoglobinuria, total complement activity increased and breakthrough hemolysis. Fifty-one cases of ADR related to eculizumab were identified from 44 publications. The number of reported cases of eculizumab associated Neisseria gonorrhoeae infection in case reports was observed to be comparable to the number of cases of Neisseria meningitidis infection.

Conclusions: Clinicians must pay close attention to the risk of infections in patients receiving eculizumab, including severe N. meningitidis infection and other potentially fatal infections such as N. gonorrhoeae infection. In addition, The possible emergence of new ADRs should be vigilant during clinical medication.

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依库珠单抗的实际安全性概况：美国食品药品管理局不良事件报告系统分析和病例报告系统回顾。

研究背景有关依库珠单抗的安全性数据大多来自临床试验，而其在现实世界中的安全性信息仍然有限：研究设计和方法：收集并分析了美国食品药品管理局不良事件报告系统（FAERS）数据库中有关依库珠单抗的数据（从2007年第一季度到2023年第一季度）。系统回顾了2023年5月之前PubMed、Embase和Web of Science中与依库珠单抗相关的药物不良反应（ADRs）病例报告：结果：FAERS数据库共发现464例依库珠单抗ADR。比例报告率（PRR）最高的前五种ADR是总补体活性降低、血管外溶血、血红蛋白尿、总补体活性升高和突破性溶血。从 44 篇文献中发现了 51 例与依库珠单抗有关的 ADR。据观察，病例报告中与依库珠单抗相关的淋病奈瑟菌感染病例数与脑膜炎奈瑟菌感染病例数相当：临床医生必须密切关注接受依库珠单抗治疗的患者的感染风险，包括严重的脑膜炎奈瑟菌感染和其他可能致命的感染，如淋病奈瑟菌感染。此外，在临床用药期间还应警惕可能出现的新的ADR。

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.