Department of Neurology, Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia.
Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia.
Clin Exp Pharmacol Physiol. 2022 Nov;49(11):1156-1168. doi: 10.1111/1440-1681.13700. Epub 2022 Jul 20.
Migraine, the third most common neurological disorders worldwide, can cause significant burden to the patients. Currently, it has been found that calcitonin gene-related peptide (CGRP) has a significant role in pathophysiology of migraine. This study sought to analyse the efficacy and safety of eptinezumab, one of the CGRP-monoclonal antibody as preventive treatment for episodic/chronic migraine. Specific keywords were used to comprehensively go through the potential articles on ClinicalTrials.gov, Europe PMC, Scopus and PubMed databases until April 2022. All published randomized clinical trials (RCTs) on eptinezumab and migraine were gathered. Statistical analysis was conducted by using Review Manager 5.4 and Comprehensive Meta-Analysis version 3 software. There were four RCTs with 2739 migraine patients in the meta-analysis. In terms of efficacy, our analysis revealed that eptinezumab corresponded with higher reduction in monthly migraine days from baseline to week 12 (standardized mean difference, -0.34 [95% confidence interval (CI), -0.41, -0.28], P < 0.00001; I = 0%), higher 75% and 50% migraine responder rate, reduction in rate of migraine on day-1 after dosing, lower headache impact test-6 score on week 4 and week 12. In terms of safety, eptinezumab has comparable adverse events when compared with placebo (risk ratio, 1.01 [95% CI 0.96-1.07], P = 0.63, I = 0%). Further regression analysis also revealed that the association between eptinezumab and each outcomes of interest were not influenced by age, gender, body mass index and duration of migraine. This study proposes that eptinezumab is generally effective and safe for the preventive treatment of episodic or chronic migraine.
偏头痛是全球第三常见的神经疾病,会给患者带来巨大负担。目前,降钙素基因相关肽(CGRP)已被发现于偏头痛的病理生理学中具有重要作用。本研究旨在分析 CGRP 单克隆抗体依替尤单抗作为发作性/慢性偏头痛预防性治疗的疗效和安全性。使用特定关键词全面检索 ClinicalTrials.gov、Europe PMC、Scopus 和 PubMed 数据库中截至 2022 年 4 月的潜在文章。收集所有关于依替尤单抗和偏头痛的已发表随机临床试验(RCT)。使用 Review Manager 5.4 和 Comprehensive Meta-Analysis version 3 软件进行统计分析。荟萃分析共纳入 4 项 RCT,涉及 2739 例偏头痛患者。在疗效方面,我们的分析表明,依替尤单抗治疗 12 周后与基线相比,每月偏头痛天数减少(标准化均数差,-0.34 [95%置信区间(CI),-0.41,-0.28],P < 0.00001;I ²=0%),75%和 50%的偏头痛缓解率更高,给药后第 1 天偏头痛发作率降低,第 4 周和第 12 周头痛影响测试-6 评分降低。在安全性方面,依替尤单抗与安慰剂相比不良反应发生率相当(风险比,1.01 [95% CI 0.96-1.07],P=0.63,I ²=0%)。进一步回归分析还表明,依替尤单抗与每个感兴趣结局之间的关联不受年龄、性别、体重指数和偏头痛持续时间的影响。本研究表明,依替尤单抗作为发作性或慢性偏头痛的预防性治疗,通常是有效且安全的。