Zhang Zhihui, Liu Xin, Zhang Jinlan, Zhang Bo
Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, China.
Expert Opin Drug Saf. 2024 Aug 26:1-7. doi: 10.1080/14740338.2024.2392885.
Most of the safety data regarding eculizumab came from clinical trials, while its safety information in the real world is still limited.
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.
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.
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.
关于依库珠单抗的大多数安全性数据来自临床试验，而其在现实世界中的安全信息仍然有限。
收集并分析了美国食品药品监督管理局不良事件报告系统（FAERS）数据库中依库珠单抗的数据（从2007年第一季度至2023年第一季度）。系统回顾了2023年5月之前PubMed、Embase和科学网中与依库珠单抗相关的药物不良反应（ADR）病例报告。
在FAERS数据库中总共识别出464例依库珠单抗的ADR。报告比例最高（PRR）的前五种ADR是总补体活性降低、血管外溶血、血红蛋白尿、总补体活性增加和突破性溶血。从44篇出版物中识别出51例与依库珠单抗相关的ADR病例。观察到病例报告中依库珠单抗相关淋病奈瑟菌感染的报告病例数与脑膜炎奈瑟菌感染的病例数相当。
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潜在致命感染，如淋病奈瑟菌感染。此外，临床用药期间应警惕可能出现的新的ADR。
