Reversion from chronic migraine to episodic migraine following treatment with erenumab: Results of a post-hoc analysis of a randomized, 12-week, double-blind study and a 52-week, open-label extension.

Richard B Lipton, Stewart J Tepper, Stephen D Silberstein, David Kudrow, Messoud Ashina, Uwe Reuter, David W Dodick, Feng Zhang, Gregory A Rippon, Sunfa Cheng, Daniel D Mikol
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引用次数: 24

Abstract

Objective: To determine reversion rates from chronic migraine to episodic migraine during long-term erenumab treatment.

Methods: A daily headache diary was completed during the 12-week, double-blind treatment phase of a placebo-controlled trial comparing erenumab 70 mg, 140 mg, and placebo, and weeks 1-12, 21-24, 37-40, and 49-52 of the open-label treatment phase. Chronic migraine to episodic migraine reversion rates were assessed over the double-blind treatment phase; persistent reversion to episodic migraine over 24 weeks (double-blind treatment phase through the first 12 weeks in the open-label treatment phase), long-term persistent reversion to episodic migraine over 64 weeks (double-blind treatment phase plus open-label treatment phase); delayed reversion to episodic migraine through the first 12 weeks of the open-label treatment phase among patients remaining in chronic migraine during the double-blind treatment phase.

Results: In the double-blind treatment phase, 53.1% (95% confidence interval: 47.8-58.3) of 358 erenumab-treated completers had reversion to episodic migraine; monthly reversion rates to episodic migraine were typically higher among patients receiving 140 mg versus 70 mg. Among 181 completers (receiving erenumab for 64 weeks), 98 (54.1% [95% confidence interval: 46.6-61.6]) had reversion to episodic migraine during the double-blind treatment phase; of those, 96.9% (95% confidence interval: 91.3-99.4) had persistent reversion to episodic migraine, 96.8% (95% confidence interval: 91.1-99.3) of whom had long-term persistent reversion to episodic migraine. Delayed reversion to episodic migraine occurred in 36/83 (43.4% [95% confidence interval: 32.5-54.7]) patients; of these, 77.8% (95% confidence interval: 60.9-89.9) persisted in reversion through week 64.

Conclusions: Patients with reversion to episodic migraine at week 12 will likely persist as episodic migraine with longer-term erenumab; others may achieve delayed reversion to episodic migraine.Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02066415.

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erenumab治疗后从慢性偏头痛逆转为发作性偏头痛:一项随机,12周,双盲研究和52周开放标签延长的事后分析结果。
目的:确定长期伊列单抗治疗期间从慢性偏头痛到发作性偏头痛的逆转率。方法:在为期12周的安慰剂对照试验的双盲治疗阶段和开放标签治疗阶段的1-12周、21-24周、37-40周和49-52周期间完成每日头痛日记。在双盲治疗阶段评估慢性偏头痛到发作性偏头痛的逆转率;持续恢复到阵发性偏头痛超过24周(双盲治疗阶段至开放标签治疗阶段的前12周),长期持续恢复到阵发性偏头痛超过64周(双盲治疗阶段加开放标签治疗阶段);在双盲治疗期仍患有慢性偏头痛的患者中,在开放标签治疗期的前12周延迟复发为发作性偏头痛。结果:在双盲治疗阶段,358名接受erenumab治疗的完成者中有53.1%(95%可信区间:47.8-58.3)复发为阵发性偏头痛;每月发作性偏头痛的恢复率在服用140毫克的患者中高于70毫克的患者。在181名完成者(接受erenumab治疗64周)中,98名(54.1%[95%置信区间:46.6-61.6])在双盲治疗阶段复发为阵发性偏头痛;其中,96.9%(95%可信区间:91.3-99.4)的患者持续复发为阵发性偏头痛,96.8%(95%可信区间:91.1-99.3)的患者长期复发为阵发性偏头痛。36/83(43.4%[95%可信区间:32.5-54.7])患者延迟复发为发作性偏头痛;其中,77.8%(95%可信区间:60.9-89.9)的逆转持续到第64周。结论:在第12周复发为阵发性偏头痛的患者可能会持续为阵发性偏头痛,并伴有较长期的复发。其他人可能延迟恢复为发作性偏头痛。临床试验注册:网址:https://www.clinicaltrials.gov。唯一标识符:NCT02066415。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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