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首页> 外文期刊>The journal of headache and pain >Galcanezumab in episodic migraine: subgroup analyses of efficacy by high versus low frequency of migraine headaches in phase 3 studies (EVOLVE-1 & EVOLVE-2)
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Galcanezumab in episodic migraine: subgroup analyses of efficacy by high versus low frequency of migraine headaches in phase 3 studies (EVOLVE-1 & EVOLVE-2)

机译：在eGisodic偏头痛中的Galcanezumab：亚群分析效果的高与低频偏头痛在第3期研究中（Evolve-1和Evolve-2）

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Patients with high-frequency episodic migraine (HFEM) have a greater disease burden than those with low-frequency episodic migraine (LFEM). Acute treatment overuse increases the risk of migraine chronification in patients with HFEM. Galcanezumab, a humanized monoclonal antibody binding calcitonin gene-related peptide (CGRP), is effective for migraine prevention with a favorable safety profile. Here, we investigate whether there are differences in galcanezumab efficacy in patients with LFEM or with HFEM. Data were pooled from two double-blind, placebo-controlled phase 3 trials; EVOLVE-1 and EVOLVE-2. Patients were 18-65?years old, experienced 4-14 monthly migraine headache days (MHDs) for ≥1?year prior, with onset at ?50?years of age. Migraine headaches were tracked via electronic patient-reported outcome system and randomization was stratified by low (LFEM; 4-7 monthly MHDs) or high (HFEM; 8-14 monthly MHDs) frequency. Subgroup analysis compared the HFEM and LFEM subgroups with a linear or generalized linear mixed model repeated measures approach. The intent-to-treat patients (N?=?1773) had a mean age of 41.3?years, were mostly white (75%), female (85%), and 66% of patients had HFEM. In both the LFEM and HFEM subgroups, the overall (Months 1-6) and monthly changes from baseline in monthly MHDs and monthly MHDs with acute medication use compared with placebo were statistically significantly reduced for galcanezumab 120-mg and 240-mg. Galcanezumab (120-mg and 240-mg) significantly decreased the overall and monthly MHDs with nausea and/or vomiting, and with photophobia and phonophobia versus placebo in patients with LFEM or HFEM. In both subgroups, the mean overall (Months 1-6) and monthly percentages of patients with ≥50%, ≥75%, and 100% reduction in monthly MHDs from baseline were statistically significantly greater in patients receiving either dose of galcanezumab versus placebo. Galcanezumab (120-mg and 240-mg) significantly improved the Migraine-Specific Quality of Life Questionnaire role function-restrictive domain score as well as the Migraine Disability Assessment total score versus placebo for patients with LFEM or HFEM. There were no significant subgroup-by-treatment interactions. Galcanezumab was as effective in patients with HFEM as in those with LFEM. Associated symptoms, quality of life, and disability were similarly improved in patients with HFEM or LFEM. NCT02614183 , NCT02614196 .
机译：高频脑偏振患者（HFEM）的疾病负担较大，而不是低频率的偏振偏头痛（LFEM）。急性治疗过度使用增加了HFEM患者偏头痛量计量的风险。 Galcanezumab是一种人源化的单克隆抗体结合转析素基因相关肽（CGRP），对偏头痛预防有效，具有良好的安全性。在这里，我们调查LFEM或HFEM患者的Galcanezumab疗效是否存在差异。从两次双盲，安慰剂控制第3阶段试验中汇集了数据;进化-1和进化-2。患者是18-65岁？岁月，经历了4-14个月偏头痛的日子（MHDS）≥1-一年，发病在<50？岁月。通过电子患者报告的结果系统跟踪偏头痛，随机化由低（LFEM; 4-7个月MHD）或高（HFEM; 8-14每月MHD）频率分层。亚组分析与线性或广义线性混合模型重复测量方法的HFEM和LFEM子组进行了比较。意图对治疗患者（N？= 1773）的平均年龄为41.3？多年，大多数是白色（75％），女性（85％）和66％的患者有HFEM。在LFEM和HFEM亚组中，对于Galcanezumab 120-Mg和240 mg，每月MHD和每月MHD和每月MHD的每月MHD的每月MHD每月MHD的每月变化和每月MHD的每月变化有统计学显着降低。 Galcanezumab（120毫克和240毫克）显着降低了恶心和/或呕吐的整体和每月MHD，以及噬菌体患者的噬菌体和阴影与LFEM或HFEM的患者。在两个亚组中，在接受任何剂量的半月内zumab与安慰剂的患者中，每月MHD≥50％，≥75％和100％的患者的平均总体（月1-6）和每月MHD的百分比统计学显着更大。 Galcanezumab（120毫克和240毫克）显着提高了偏头痛特异性生活质量问卷角色作用限制域评分以及偏头痛残疾评估总成绩与LFEM或HFEM患者的患者。逐个逐个治疗的相互作用没有显着的亚组。 Galcanezumab在HEFEM患者中有效，如LFEM的患者。 HFEM或LFEM的患者同样改善了相关的症状，生活质量和残疾。 NCT02614183，NCT02614196。

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