Gharrafat Alrayyan Health Center, Doha, Qatar.
Dr Mohamad Amine Zbeib Polyclinic, Doha, Qatar.
Clin Neurol Neurosurg. 2020 Aug;195:105900. doi: 10.1016/j.clineuro.2020.105900. Epub 2020 May 11.
Calcitonin gene-related peptide (CGRP) antagonists have recently grabbed the attention of clinicians for migraine prophylaxis. The present meta-analysis aimed to assess the efficacy and safety of CGRP monoclonal antibodies (mAbs) in patients with chronic and episodic migraine using a systematic therapeutic regimen. More specifically, double-blind placebo-controlled randomized clinical trials (RCTs) which assessed the therapeutic potential of monthly subcutaneous injections were included. The primary outcomes entailed changes in monthly migraine days (MMDs) and treatment-related adverse events (TRAEs) for: Erenumab 70 mg, fremanezumab 225 mg, and galcanezumab 120 mg. No eligible studies have investigated eptinezumab. A total of 13 RCTs were eligible (6979 patients, 84.81% females, 42.94% received active medications). Compared to placebo, the selected doses of mAbs reduced the MMDs significantly after four weeks (mean difference [MD] -2.07, 95% CI -2.47 to -1.66, P < 0.001), eight weeks (MD -1.78, 95% CI -2.26--1.49, P < 0.001), and 12 weeks (-1.80, 95% CI -2.16 to -1.43, P < 0.001). These effects remained significant with each individual medication across all treatment cycles. In addition, the number of days using acute migraine medications decreased and the proportion of 50% responders increased significantly with mAbs use compared to placebo. No significant differences between groups were noted in TRAEs. CGRP mAbs provide highly efficacious and safe outcomes which start early after the first injection. The tolerability of these medications surpasses that of other small-molecule CGRP antagonists.
降钙素基因相关肽(CGRP)拮抗剂最近引起了临床医生对偏头痛预防的关注。本荟萃分析旨在使用系统治疗方案评估 CGRP 单克隆抗体(mAb)在慢性和发作性偏头痛患者中的疗效和安全性。更具体地说,纳入了评估每月皮下注射治疗潜力的双盲安慰剂对照随机临床试验(RCT)。主要结局包括每月偏头痛天数(MMD)的变化和治疗相关不良事件(TRAEs):依那西普单抗 70mg、雷美替胺 225mg 和加兰他敏 120mg。没有符合条件的研究调查eptinezumab。共有 13 项 RCT 符合条件(6979 名患者,84.81%为女性,42.94%接受了活性药物治疗)。与安慰剂相比,选定剂量的 mAb 在四周后(平均差异 [MD] -2.07,95%置信区间 -2.47 至 -1.66,P<0.001)、八周(MD -1.78,95%置信区间 -2.26--1.49,P<0.001)和十二周(MD -1.80,95%置信区间 -2.16 至 -1.43,P<0.001)显著降低了 MMD。在所有治疗周期中,每种药物的效果均保持显著。此外,与安慰剂相比,mAb 治疗后急性偏头痛药物的使用天数减少,50%应答者的比例显著增加。各组之间的 TRAEs 无显著差异。CGRP mAb 提供了高度有效和安全的结果,在第一次注射后早期开始。这些药物的耐受性超过了其他小分子 CGRP 拮抗剂。