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首页> 外文期刊>European journal of neurology: the official journal of the European Federation of Neurological Societies >Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials
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Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials

机译：Galcanezumab在癫痫发作性偏头痛患者中的疗效和预防性治疗失败的历史：两种全球随机临床试验结果

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Abstract Background and purpose The efficacy of galcanezumab, a monoclonal antibody for migraine prevention, has been demonstrated in two pivotal trials in patients with episodic migraine. Methods EVOLVE‐1 and EVOLVE‐2 were identical phase 3, randomized, double‐blind, placebo‐controlled studies in patients with episodic migraine. Mean migraine headache days per month at baseline was 9. Patients were randomized 2:1:1 to monthly injections of placebo, galcanezumab 120?mg/240?mg during the 6‐month double‐blind treatment period. Key efficacy outcomes were assessed in subgroups amongst patients for whom, previously, for efficacy and/or safety/tolerability reasons (i) one or more (≥1) preventives failed, (ii) two or more (≥2) preventives failed and (iii) preventives were never used, or used but not failed (no prior failure). Results In an integrated analysis of EVOLVE studies, galcanezumab 120?mg/240?mg versus placebo led to larger overall mean (SE) reductions in monthly migraine headache days across 6?months in patients with prior preventive failures ( P ??0.001): ≥1 failure: 120?mg: ?4.0 (0.4); 240?mg: ?4.2 (0.5); placebo: ?1.3 (0.4); ≥2 failures: 120?mg: ?3.1 (0.7); 240?mg: ?3.8 (0.8); placebo: ?0.5 (0.6). Similar results were observed amongst patients with no prior failure, but the placebo response was larger: 120?mg: ?4.7 (0.2); 240?mg: ?4.5 (0.2); placebo: ?3.0 (0.2) ( P ??0.001 versus placebo). Significant improvements were observed with galcanezumab versus placebo for ≥50% and ≥75% reduction in monthly migraine headache days. Conclusion In patients with episodic migraine treated with galcanezumab, those with ≥1 or ≥2 prior preventive failures had significantly larger improvements, versus placebo, in efficacy outcomes. Similar results were observed in patients with no prior failure, with a larger placebo response.
机译：摘要背景论和目的Galcanezumab（一种单克隆抗体为偏头痛预防的疗效都已在偶像偏头痛患者的两种关键试验中证明。方法Evolve-1和Evolve-2是相同的相同相3，可随机，双盲，安慰剂对照研究，患者患者患者。平均偏头痛每月在基线时的头痛日为9.患者随机分配2：1：1，每月注射安慰剂，加葫芦动物120？Mg / 240？MG在6个月的双盲治疗期间。在患者的亚组中评估关键疗效结果，以前，以疗效和/或安全/可耐受性原因（i）一个或多个（≥1）预防失败，（ii）两个或更多（≥2）预防失败和（ iii）从未使用过的预防或使用但未使用但未失败（未发生故障）。导致对进化研究的综合分析，Galcanezumab 120？Mg / 240？Mg与安慰剂导致每月偏头痛的总体平均值（SE）减少6？患者在预防失败的患者中每月偏头痛（P？＆ 0.001 ）：≥1故障：120？MG：？4.0（0.4）; 240？mg：4.2（0.5）;安慰剂：？1.3（0.4）; ≥2故障：120？MG：？3.1（0.7）; 240？MG：3.8（0.8）;安慰剂：0.5（0.6）。在没有现有故障的患者中观察到类似的结果，但安慰剂反应较大：120？MG：？4.7（0.2）; 240？mg：？4.5（0.2）;安慰剂：？3.0（0.2）（p≤≤0.001与安慰剂）。通过Galcanezumab与安慰剂观察到显着的改进≥50％，每月偏头痛的日期降低≥75％。结论在用Galcanezumab处理的偶像偏头痛患者中，患有≥1或≥2的预防失败的患者有显着的改善，与安慰剂在疗效结果中。在没有现有故障的患者中观察到类似的结果，具有较大的安慰剂反应。

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