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在加拿大患者中进行的依瑞奈umab 预防偏头痛的真实世界、观察性研究。

A real-world, observational study of erenumab for migraine prevention in Canadian patients.

机构信息

Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.

Division of Neurology, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Headache. 2022 Apr;62(4):522-529. doi: 10.1111/head.14291. Epub 2022 Apr 10.

Abstract

OBJECTIVES

To assess real-world effectiveness, safety, and usage of erenumab in Canadian patients with episodic and chronic migraine with prior ineffective prophylactic treatments.

BACKGROUND

In randomized controlled trials, erenumab demonstrated efficacy for migraine prevention in patients with ≤4 prior ineffective prophylactic migraine therapies. The "Migraine prevention with AimoviG: Informative Canadian real-world study" (MAGIC) assessed real-world effectiveness of erenumab in Canadian patients with migraine.

METHODS

MAGIC was a prospective open-label, observational study conducted in Canadian patients with chronic migraine (CM) and episodic migraine (EM) with two to six categories of prior ineffective prophylactic therapies. Participants were administered 70 mg or 140 mg erenumab monthly based on physician's assessment. Migraine attacks were self-assessed using an electronic diary and patient-reported outcome questionnaires. The primary outcome was the proportion of subjects achieving ≥50% reduction in monthly migraine days (MMD) after the 3-month treatment period.

RESULTS

Among the 95 participants who mostly experienced two (54.7%) or three (32.6%) prior categories of ineffective prophylactic therapies and who initiated erenumab, treatment was generally safe and well tolerated; 89/95 (93.7%) participants initiated treatment with 140 mg erenumab. At week 12, 32/95 (33.7%) participants including 17/64 (26.6%) CM and 15/32 (48.4%) EM achieved ≥50% reduction in MMD while 30/86 (34.9%) participants including 19/55 (34.5%) CM and 11/31 (35.5%) EM achieved ≥50% reduction in MMD at week 24. Through patient-reported outcome questionnaires, 62/95 (65.3%) and 45/86 (52.3%) participants reported improvement of their condition at weeks 12 and 24, respectively. Physicians observed improvement in the condition of 78/95 (82.1%) and 67/86 (77.9%) participants at weeks 12 and 24, respectively.

CONCLUSION

One-third of patients with EM and CM achieved ≥50% MMD reduction after 3 months of erenumab treatment. This study provides real-world evidence of erenumab effectiveness, safety, and usage for migraine prevention in adult Canadian patients with multiple prior ineffective prophylactic treatments.

摘要

目的

评估依那西普在加拿大既往预防治疗无效的发作性和慢性偏头痛患者中的真实世界疗效、安全性和使用情况。

背景

在随机对照试验中,依那西普在≤4 种既往预防治疗无效的偏头痛患者中显示出预防偏头痛的疗效。“偏头痛预防用 AimoviG:加拿大真实世界研究”(MAGIC)评估了依那西普在加拿大偏头痛患者中的真实世界疗效。

方法

MAGIC 是一项在加拿大慢性偏头痛(CM)和发作性偏头痛(EM)患者中进行的前瞻性、开放性、观察性研究,这些患者有 2-6 种既往预防治疗无效的类别。根据医生的评估,每月给患者 70mg 或 140mg 依那西普。偏头痛发作情况使用电子日记和患者报告的结果问卷进行自我评估。主要结局是在 3 个月治疗期后,每月偏头痛天数(MMD)减少≥50%的受试者比例。

结果

在 95 名主要经历了两种(54.7%)或三种(32.6%)既往无效预防治疗类别的患者中,有 89/95(93.7%)名患者开始使用 140mg 依那西普治疗,依那西普治疗一般安全且耐受性良好。12 周时,32/95(33.7%)名患者(包括 17/64(26.6%)名 CM 和 15/32(48.4%)名 EM)实现了 MMD 减少≥50%,而 30/86(34.9%)名患者(包括 19/55(34.5%)名 CM 和 11/31(35.5%)名 EM)在 24 周时实现了 MMD 减少≥50%。通过患者报告的结果问卷,62/95(65.3%)名和 45/86(52.3%)名患者分别在第 12 周和第 24 周报告病情改善,医生分别在第 12 周和第 24 周观察到 78/95(82.1%)名和 67/86(77.9%)名患者病情改善。

结论

3 个月依那西普治疗后,有三分之一的 EM 和 CM 患者实现了 MMD 减少≥50%。这项研究提供了依那西普在加拿大既往预防治疗无效的偏头痛成年患者中的有效性、安全性和使用情况的真实世界证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/03f3/9320807/88aea232af7a/HEAD-62-522-g002.jpg

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