依瑞奈尤单抗治疗重度治疗抵抗性偏头痛患者：首个德国真实世界证据。
Erenumab in highly therapy-refractory migraine patients: First German real-world evidence.
机构信息
Department of Neurology, West German Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.
Department of Neurology, Division of Clinical Neurooncology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.
出版信息
J Headache Pain. 2020 Jul 3;21(1):84. doi: 10.1186/s10194-020-01151-0.
BACKGROUND
Calcitonin gene related peptide (CGRP) monoclonal antibodies (mAB) are the first specific migraine prophylactic medication. Erenumab is the only CGRP mAB targeting the CGRP receptor. Clinical data regarding efficacy and tolerability of erenumab in highly therapy-refractory patients are not available, yet, although many patients treated with CGRP mAB under real world conditions can be considered as highly therapy-refractory.
METHODS
Clinical routine data of highly therapy-refractory migraine patients treated with erenumab 70 mg for 3 months between November 2018 and December 2019 in the West German Headache Center, University Hospital Essen, Germany, were analysed. Monthly migraine days (MMD), monthly headache days (MHD) and days of acute medication intake (AMD) were assessed. Statistical analysis was performed using the Wilcoxon test. Descriptive statistics were performed to evaluate changes of vegetative symptoms, acute medication response, side effects, as well as treatment satisfaction.
RESULTS
Complete clinical data were available for 26 episodic (EM) and 74 chronic (CM) migraineurs. Sixty-six % (n = 49) of CM patients had an additional medication overuse headache (MOH). After 3 months 57.7% of EM patients and 41.9% of CM patients had a 50% or greater reduction of MMD. The mean number of MMD was reduced by 3.43 (SE 1.26) in EM, and by 4.72 (SE 0.87) in CM. Thirty-nine patients (52.7%) returned from chronic to episodic course of migraine. After 3 months, 23 patients (46.9%) were not suffering from a MOH anymore.
CONCLUSIONS
Erenumab seems to be a promising therapeutic option in highly therapy-refractory migraine patients.
TRIAL REGISTRATION
Retrospective registered.
背景
降钙素基因相关肽（CGRP）单克隆抗体（mAB）是第一种专门用于预防偏头痛的药物。依瑞奈umab 是唯一一种针对 CGRP 受体的 CGRP mAB。尽管在现实世界中接受 CGRP mAB 治疗的许多患者可以被认为是高度难治性的，但目前还没有关于依瑞奈umab 在高度难治性患者中的疗效和耐受性的临床数据。
方法
分析了 2018 年 11 月至 2019 年 12 月期间在德国埃森大学医院西德头痛中心接受依瑞奈umab 70mg 治疗的 3 个月的高度难治性偏头痛患者的临床常规数据。评估每月偏头痛天数（MMD）、每月头痛天数（MHD）和急性药物摄入天数（AMD）。使用 Wilcoxon 检验进行统计分析。使用描述性统计评估植物性症状、急性药物反应、副作用以及治疗满意度的变化。
结果
26 例发作性偏头痛（EM）和 74 例慢性偏头痛（CM）患者的完整临床数据可用。66%（n=49）的 CM 患者存在额外的药物滥用性头痛（MOH）。治疗 3 个月后，57.7%的 EM 患者和 41.9%的 CM 患者的 MMD 减少了 50%或更多。EM 的 MMD 平均值减少了 3.43（SE 1.26），CM 减少了 4.72（SE 0.87）。39 例（52.7%）患者从慢性偏头痛转为发作性偏头痛。治疗 3 个月后，23 例（46.9%）患者不再患有 MOH。
结论
依瑞奈umab 似乎是一种有前途的治疗高度难治性偏头痛患者的方法。
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