Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Universitätsmedizin Greifswald, Greifswald, Germany.
Cephalalgia. 2022 Feb;42(2):108-118. doi: 10.1177/03331024211053571. Epub 2021 Nov 7.
We compared the tolerability and efficacy of erenumab, a monoclonal antibody binding to the calcitonin gene-related peptide receptor, to topiramate for migraine prophylaxis in adults.
HER-MES was a 24-week, randomised, double-blind, double-dummy, controlled trial conducted in 82 sites in Germany. Patients with ≥4 migraine days per month and naïve to study drugs were randomly assigned (1:1) to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo (erenumab group) or oral topiramate at the individual dose with optimal efficacy (50-100 mg/day) plus erenumab placebo (topiramate group).The primary endpoint was medication discontinuation due to an adverse event during the double-blind phase. The proportion of patients that achieved ≥50% reduction from baseline in monthly migraine days during the last 3 months of the double-blind phase was a secondary endpoint.
Seven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study. In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group (odds ratio, 0.19; 95% confidence interval 0.13-0.27; < 0.001). Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06-3.71; < 0.001). No new safety signals occurred.
Erenumab demonstrated a favourable tolerability and efficacy profile compared to topiramate.Trial registration: ClinicalTrials.gov NCT03828539, URL: https://clinicaltrials.gov/ct2/show/NCT03828539.
我们比较了依瑞奈单抗（一种与降钙素基因相关肽受体结合的单克隆抗体）与托吡酯治疗偏头痛预防的耐受性和疗效，该研究纳入了成年人患者。
HER-MES 是一项为期 24 周的随机、双盲、双模拟、对照试验，在德国 82 个研究地点进行。每月偏头痛发作≥4 天且对研究药物无用药史的患者被随机分配（1:1）至皮下注射依瑞奈单抗（70 或 140mg/月）加托吡酯安慰剂（依瑞奈单抗组）或口服托吡酯（最佳疗效剂量为 50-100mg/天）加依瑞奈单抗安慰剂（托吡酯组）。主要终点是双盲期因不良事件而停药。双盲期最后 3 个月每月偏头痛天数较基线降低≥50%的患者比例是次要终点。
777 例患者被随机分组（2019 年 2 月 22 日至 2020 年 7 月 29 日），95.1%的患者完成了研究。依瑞奈单抗组因不良事件而停药的比例为 10.6%，而托吡酯组为 38.9%（比值比 0.19；95%置信区间 0.13-0.27； < 0.001）。依瑞奈单抗组较基线每月偏头痛天数降低≥50%的患者比例显著更高（55.4%比 31.2%；比值比 2.76；95%置信区间 2.06-3.71； < 0.001）。未发生新的安全性信号。
与托吡酯相比，依瑞奈单抗具有更好的耐受性和疗效。
ClinicalTrials.gov 注册号 NCT03828539，网址：https://clinicaltrials.gov/ct2/show/NCT03828539。
