Background

Erenumab (erenumab-aooe in the US) effectively reduces monthly migraine days in episodic and chronic migraine. This traditional outcome does not capture the intensity of headache pain on days with migraine.

Methods

This post hoc analysis of two pivotal randomized, placebo-controlled studies in patients with episodic migraine and chronic migraine examined the effect of erenumab 70 and 140 mg on migraine pain. Cumulative monthly migraine pain intensity is the sum of the peak pain intensity scores (0 = no migraine to 3 = migraine day with severe pain) on migraine days. Change from baseline in cumulative monthly migraine pain and average monthly pain intensity was assessed over months 4 to 6 for episodic migraine and month 3 for chronic migraine; change in average monthly pain intensity was assessed among monthly migraine days responders/non-responders.

Results

Efficacy analysis included 946 patients for the episodic migraine study and 656 patients for the chronic migraine study. Cumulative monthly migraine pain decreased significantly with erenumab versus placebo (p < 0.001, for episodic migraine and chronic migraine). In addition, monthly average migraine pain intensity decreased significantly with erenumab versus placebo for episodic migraine (p < 0.01); decreases were non-significant for chronic migraine. In comparison with placebo-treated patients, a greater proportion of erenumab-treated patients were pain intensity responders regardless of threshold used. Episodic migraine and chronic migraine patients with a ≥50% reduction in monthly migraine days (responders) had a greater reduction in monthly average pain intensity than non-responders.

Conclusions

Erenumab reduced cumulative monthly migraine pain in episodic migraine and chronic migraine patients and significantly reduced monthly average migraine pain in episodic migraine, demonstrating treatment benefit beyond reduction in migraine frequency.

Clinical Trial Registration: ClinicalTrials.gov, NCT02456740; ClinicalTrials.gov, NCT02066415

中文翻译：

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erenumab 治疗患者偏头痛强度的降低：两项关键随机研究的事后分析

背景

Erenumab（美国的erenumab-aooe）有效减少偶发性和慢性偏头痛的每月偏头痛天数。这种传统的结果无法捕捉到偏头痛几天头痛的强度。

方法

这项对发作性偏头痛和慢性偏头痛患者的两项关键随机、安慰剂对照研究的事后分析检查了 erenumab 70 和 140 mg 对偏头痛的影响。累积的每月偏头痛疼痛强度是偏头痛天数峰值疼痛强度评分的总和（0 = 无偏头痛到 3 = 偏头痛日伴有剧烈疼痛）。在发作性偏头痛的第 4 至 6 个月和慢性偏头痛的第 3 个月内评估累积每月偏头痛疼痛和平均每月疼痛强度相对于基线的变化；在每月偏头痛天数反应者/非反应者中评估平均每月疼痛强度的变化。

结果

疗效分析包括用于发作性偏头痛研究的 946 名患者和用于慢性偏头痛研究的 656 名患者。与安慰剂相比，erenumab 的累积每月偏头痛疼痛显着降低（p  < 0.001，对于发作性偏头痛和慢性偏头痛）。此外，与安慰剂相比，erenumab 对发作性偏头痛的月平均偏头痛强度显着降低（p < 0.01); 慢性偏头痛的减少并不显着。与安慰剂治疗的患者相比，更大比例的erenumab治疗患者是疼痛强度反应者，无论使用的阈值如何。每月偏头痛天数减少 ≥50% 的发作性偏头痛和慢性偏头痛患者（响应者）的月平均疼痛强度降低幅度大于无响应者。

结论

Erenumab 降低了发作性偏头痛和慢性偏头痛患者的每月累积偏头痛疼痛，并显着降低了发作性偏头痛的月平均偏头痛疼痛，证明了治疗益处超过了偏头痛频率的降低。

临床试验注册： ClinicalTrials.gov，NCT02456740；ClinicalTrials.gov，NCT02066415