依瑞奈玛治疗偏头痛患者的疼痛强度降低：两项关键性随机研究的事后分析。

Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies.

机构信息

The Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.

Mayo Clinic, Phoenix, AZ, USA.

出版信息

Cephalalgia. 2021 Dec;41(14):1458-1466. doi: 10.1177/03331024211028966. Epub 2021 Aug 18.

DOI:10.1177/03331024211028966

PMID:34407654

Abstract

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 ( < 0.001, for episodic migraine and chronic migraine). In addition, monthly average migraine pain intensity decreased significantly with erenumab versus placebo for episodic migraine ( < 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. ClinicalTrials.gov, NCT02456740; ClinicalTrials.gov, NCT02066415.

摘要

背景

依瑞奈umab（美国上市商品名：erenumab-aooe）能有效减少偏头痛发作患者和偏头痛慢性患者每月偏头痛发作天数。但这种传统的终点并不能捕捉偏头痛发作日头痛的严重程度。

方法

本项对依瑞奈umab 治疗偏头痛发作患者和偏头痛慢性患者的两项关键性随机、安慰剂对照研究的事后分析，评估了依瑞奈umab 70mg 和 140mg 对偏头痛疼痛的影响。每月偏头痛疼痛强度的累积是偏头痛发作日中最高疼痛强度评分（0=无偏头痛至 3=偏头痛日严重疼痛）的总和。偏头痛发作患者在 4-6 个月时评估从基线的累积每月偏头痛疼痛和平均每月疼痛强度变化，偏头痛慢性患者在 3 个月时评估；每月偏头痛日应答者和非应答者中平均每月疼痛强度的变化。

结果

疗效分析纳入偏头痛发作研究 946 例患者和偏头痛慢性研究 656 例患者。与安慰剂相比，依瑞奈umab 显著降低累积每月偏头痛疼痛（ < 0.001，偏头痛发作和偏头痛慢性患者）。此外，与安慰剂相比，依瑞奈umab 显著降低偏头痛发作患者的每月平均偏头痛疼痛强度（ < 0.01）；偏头痛慢性患者的降低无统计学意义。与安慰剂治疗的患者相比，无论使用何种阈值，依瑞奈umab 治疗的患者中更多比例为疼痛强度应答者。每月偏头痛发作天数减少≥50%（应答者）的偏头痛发作和偏头痛慢性患者的每月平均疼痛强度降低幅度大于非应答者。