Wang Qi, Liu Jingfang, Sun Hao, Dong YongFei, Tan WeiLiang, Tang Zaixiang, Jiang YiGuo
Department of Biostatistics, School of Public Health, Medical College of Soochow University, Suzhou, China.
Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.
Expert Opin Drug Saf. 2024 Jan;23(1):107-117. doi: 10.1080/14740338.2023.2250720. Epub 2023 Sep 18.
Four CGRP Monoclonal Antibodies (mAbs) have been approved for migraine prophylaxis by the Food and Drug Administration (FDA) since 2018. However, there are concerns about the safety of these four drugs for real-world use.
To compare the adverse event profiles of four CGRP-mAbs with FAERS data.
The study was based on records from the FAERS database. Only reports containing one of the active ingredients with CGRP-mAbs were included in this study. Disproportionality analyses including but not limited to reporting odds ratio (ROR) and information components (IC) were conducted to identify drug-AE associations.
In total, 58110 reports were identified for CGRP-mAbs. 80 overlapping signals were disproportionately reported. They affected a range of organs and systems, including the gastrointestinal and cardiovascular systems, skin, and hair. Additionally, the rare cardiovascular adverse events were significantly different among the four CGRP-mAbs.
We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.
自2018年以来，四种降钙素基因相关肽单克隆抗体（mAbs）已被美国食品药品监督管理局（FDA）批准用于偏头痛预防。然而，对于这四种药物在实际应用中的安全性存在担忧。
将四种降钙素基因相关肽单克隆抗体的不良事件谱与FDA不良事件报告系统（FAERS）数据进行比较。
该研究基于FAERS数据库的记录。本研究仅纳入包含降钙素基因相关肽单克隆抗体活性成分之一的报告。进行了包括但不限于报告比值比（ROR）和信息成分（IC）的不成比例分析，以确定药物-不良事件关联。
总共识别出58110份关于降钙素基因相关肽单克隆抗体的报告。80个重叠信号报告不成比例。它们影响一系列器官和系统，包括胃肠道和心血管系统、皮肤和毛发。此外，四种降钙素基因相关肽单克隆抗体的罕见心血管不良事件存在显著差异。
我们识别出降钙素基因相关肽单克隆抗体在多个系统和器官中作为可疑药物存在大量共同潜在信号（重叠信号）。未标注的常见信号可能表明潜在的安全问题。此外，四种降钙素基因相关肽单克隆抗体的潜在安全信号各不相同，尤其是在心血管系统方面，需要进一步研究来证实这些关联及其潜在的临床意义。
