四种用于预防偏头痛的抗降钙素基因相关肽单克隆抗体的不良事件报告:一项基于美国食品药品监督管理局不良事件报告系统的真实世界研究。
Adverse event reporting of four anti-Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a real-world study based on the FDA adverse event reporting system.
作者信息
Sun Wenfang, Li Yali, Xia Binbin, Chen Jing, Liu Yang, Pang Jingyao, Liu Fang, Cheng Hua
机构信息
Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
出版信息
Front Pharmacol. 2024 Jan 9;14:1257282. doi: 10.3389/fphar.2023.1257282. eCollection 2023.
Anti-Calcitonin gene-related peptide monoclonal antibodies (anti-CGRP mAbs) have shown significant efficacy in preventing migraine. However, there have been limited reports of adverse events (AEs) after marketing, particularly for eptinezumab launched in 2020. The study aimed to mine and analyze the AE signals with four anti-CGRP mAbs from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to gain insights into the safety profile of these medications post-marketing. All AE reports on the four anti-CGRP mAbs (erenumab, galcanezumab, fremanezumab, and eptinezumab) were retrieved from the FAERS database from the first quarter (Q1) of 2018 to Q1 of 2023. Disproportionality analysis was measured by reporting odd ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) to identify potential AE signals. Comparisons were made between the four drugs in terms of AEs. A total of 38,515 reports of erenumab, 19,485 reports of galcanezumab, 5,332 reports of fremanezumab, and 2,460 reports of eptinezumab were obtained, mostly reported in the second to third year after launch in the market. The common AEs to erenumab included constipation (17.93%), injection site pain (14.08%), and alopecia (7.23%). The AEs that occurred more frequently with galcanezumab included injection site pain (24.37%), injection site erythema (5.35%), and injection site haemorrhage (4.97%). Common AEs related to fremanezumab were injection site pain (13.10%), injection site erythema (7.02%), and injection site pruritus (5.47%). Fatigue (13.54%), throat irritation (9.02%), and pruritus (8.20%) were the most common AEs with eptinezumab. In addition, there are new AEs that were not listed in the drug instructions but occurred concurrently with multiple drugs, such as Raynaud's phenomenon, weight increase, menstrual disorders, throat tightness, and paraesthesia oral. Common AE signals of the four anti-CGRP mAbs and new AE signals were found to provide a reference for clinical drug selection in clinical practice.
抗降钙素基因相关肽单克隆抗体(抗CGRP单克隆抗体)在预防偏头痛方面已显示出显著疗效。然而,上市后不良事件(AE)的报道有限,特别是对于2020年推出的eptinezumab。本研究旨在从美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中挖掘和分析四种抗CGRP单克隆抗体的AE信号,以深入了解这些药物上市后的安全性概况。从2018年第一季度(Q1)至2023年Q1,从FAERS数据库中检索了关于四种抗CGRP单克隆抗体(erenumab、galcanezumab、fremanezumab和eptinezumab)的所有AE报告。通过报告比值比(ROR)和贝叶斯置信传播神经网络(BCPNN)进行不成比例分析,以识别潜在的AE信号。对这四种药物在AE方面进行了比较。共获得38515份erenumab报告、19485份galcanezumab报告、5332份fremanezumab报告和2460份eptinezumab报告,大部分报告在上市后的第二年至第三年。erenumab常见的AE包括便秘(17.93%)、注射部位疼痛(14.08%)和脱发(7.23%)。galcanezumab更频繁出现的AE包括注射部位疼痛(24.37%)、注射部位红斑(5.35%)和注射部位出血(4.97%)。与fremanezumab相关的常见AE是注射部位疼痛(13.10%)、注射部位红斑(7.02%)和注射部位瘙痒(5.47%)。疲劳(13.54%)、咽喉刺激(9.02%)和瘙痒(8.20%)是eptinezumab最常见的AE。此外,还有未在药品说明书中列出但与多种药物同时出现的新AE,如雷诺现象、体重增加、月经紊乱、咽喉紧绷和口腔感觉异常。发现了四种抗CGRP单克隆抗体的常见AE信号和新AE信号,为临床实践中的临床药物选择提供参考。
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