Chen Junchen, Huang Shunqiu, Chen Yashi, Luo Cheng, Li Yong
Department of Neurosurgery, The First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Shantou, 515041, Guangdong, China.
Sci Rep. 2025 Jul 8;15(1):24491. doi: 10.1038/s41598-025-09490-1.
Migraine significantly impacts quality of life, with eptinezumab emerging as a promising calcitonin gene-related peptide-targeting therapy. Real-world data and clinical trials are crucial for evaluating its safety and effectiveness comprehensively. This study evaluated its safety using a dual approach: pharmacovigilance analysis of the FDA's Adverse Event Reporting System (FAERS) database (2020-2024) and a systematic review with meta-analysis of clinical trials. FAERS data identified 5,306 adverse event (AE) reports, with "drug ineffective" (ROR = 6.71) and "migraine" (ROR = 67.45) as the strongest signals. Serious adverse events (SAEs) included anaphylactic reactions (ROR = 4.19) and rare events like increased intracranial pressure. Most AEs occurred within the first treatment month. A meta-analysis of six trials (n = 3,148) found no increased overall AE risk versus placebo (RR = 1.02, 95% CI 0.95-1.10) but a higher SAE incidence (RR = 2.87, 95% CI 1.27-6.48). Upper respiratory infections were more frequent (RR = 1.49, P = 0.04), while dizziness, nausea, and fatigue showed no significant differences. Eptinezumab shows promise but warrants further research on safety in vulnerable populations and real-world settings.
偏头痛对生活质量有显著影响，而eptinezumab作为一种有前景的靶向降钙素基因相关肽的疗法逐渐崭露头角。真实世界数据和临床试验对于全面评估其安全性和有效性至关重要。本研究采用双重方法评估其安全性：对美国食品药品监督管理局不良事件报告系统（FAERS）数据库（2020 - 2024年）进行药物警戒分析，以及对临床试验进行系统评价和荟萃分析。FAERS数据识别出5306份不良事件（AE）报告，“药物无效”（风险比[ROR]=6.71）和“偏头痛”（ROR = 67.45）为最强信号。严重不良事件（SAE）包括过敏反应（ROR = 4.19）以及颅内压升高之类的罕见事件。大多数不良事件发生在治疗的第一个月内。对六项试验（n = 3148）的荟萃分析发现，与安慰剂相比，总体不良事件风险没有增加（风险比[RR]=1.02，95%置信区间[CI]为0.95 - 1.10），但严重不良事件发生率更高（RR = 2.87，95% CI为1.27 - 6.48）。上呼吸道感染更常见（RR = 1.49，P = 0.04），而头晕、恶心和疲劳无显著差异。Eptinezumab显示出前景，但在弱势群体和真实世界环境中的安全性仍需进一步研究。
