Objective

EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America.

Methods

Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment.

Results

At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was −3.1, −4.2, and −4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed.

Conclusions

This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab’s efficacy and safety to patients under-represented in previous trials.

ClinicalTrials.gov identifier: NCT03333109

中文翻译：

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erenumab 用于预防亚洲、中东和拉丁美洲患者发作性偏头痛的随机对照试验：EMPOwER 研究

客观的

EMPOwER 是一项双盲、随机、3 期研究，评估了 erenumab 对来自亚洲、中东和拉丁美洲的发作性偏头痛成人患者的疗效和安全性。

方法

随机患者 (N = 900) 接受每月皮下注射安慰剂、erenumab 70 mg 或 140 mg (3:3:2) 持续 3 个月。主要终点是第 3 个月每月偏头痛天数与基线相比的变化。其他终点包括每月偏头痛天数减少 ≥50%、≥75% 和 100%，每月急性偏头痛特异性药物治疗天数的变化，患者报告结果和安全性评估。

结果

基线时，平均（标准差）年龄为 37.5（9.9）岁，81.9% 为女性，每月偏头痛天数为 8.2（2.8）。在第 3 个月，安慰剂、erenumab 70 mg 和 erenumab 140 mg 每月偏头痛天数（主要终点）相对于基线的变化分别为 -3.1、-4.2 和 -4.8 天，erenumab 与安慰剂的差异具有统计学意义。 P = 0.002 [70 毫克]，P < 0.001 [140 毫克]）。两种 erenumab 剂量在所有次要终点上也显着优于安慰剂，包括每月偏头痛天数较基线减少 ≥50%、每月急性偏头痛特异性药物治疗天数较基线变化和头痛较基线变化的患者比例Impact Test-6™ 分数。erenumab 的安全性与安慰剂相当；没有观察到新的安全信号。

结论

这项针对亚洲、中东和拉丁美洲发作性偏头痛患者的 erenumab 研究满足了所有主要和次要终点。在所有疗效终点上，erenumab 140 mg 与 erenumab 70 mg 观察到一致的数值益处。这些发现将 erenumab 的有效性和安全性的证据扩展到先前试验中代表性不足的患者。

ClinicalTrials.gov 标识符：NCT03333109