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真实世界中依瑞奈尤单抗治疗慢性偏头痛成人患者的长期疗效和安全性:一项为期 52 周、单中心、前瞻性、观察性研究。

Real-world long-term efficacy and safety of erenumab in adults with chronic migraine: a 52-week, single-center, prospective, observational study.

机构信息

Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Novartis Pharma AG, 4033, Basel, Switzerland.

出版信息

J Headache Pain. 2022 Jun 2;23(1):61. doi: 10.1186/s10194-022-01433-9.

Abstract

BACKGROUND

Clinical trials have shown that erenumab is effective and well-tolerated for the preventive treatment of chronic migraine. To extend the results from clinical trials, we assessed the real-world efficacy and safety of erenumab in patients with chronic migraine from the outpatient clinic at the Danish Headache Center.

METHODS

A 52-week, single-center, prospective, observation study of erenumab in adults with chronic migraine who are eligible for treatment with monoclonal antibodies against CGRP or its receptor in Denmark. The primary outcome was defined as proportion of patients who achieved ≥ 30% reduction in monthly migraine days (MMDs) from baseline to weeks 9-12.

RESULTS

A total of 300 adult patients with chronic migraine were enrolled and received at least one dose of erenumab. At baseline, the mean (SD) number of monthly headache days was 23 ± 4.9 and mean number of MMDs was 16.8 ± 6.4. Of 300 enrolled patients, 273 (91.0%) patients completed 12 weeks of treatment, and 119 (39.7%) completed 52 weeks of treatment. The number of patients who achieved ≥ 30% reduction in MMDs from baseline to weeks 9-12 was 195 (71.4%) of 273 patients. Sustained ≥ 30% reduction in MMDs at all assessment periods throughout the 52-week treatment period was achieved by 102 (34%) of 300 patients. Adverse events occurred in 220 (73.3%) out of 300 patients. The most common adverse event was constipation. Treatment discontinuation due to lack of tolerability occurred in 41 (13.7%) patients.

CONCLUSIONS

Among adult patients with chronic migraine and previous failure of medications for migraine prevention, erenumab was found to be effective and well-tolerated.

摘要

背景

临床试验表明,依瑞奈单抗对慢性偏头痛的预防性治疗有效且耐受良好。为了将临床试验结果扩展到实际情况,我们评估了丹麦头痛中心门诊中慢性偏头痛患者使用依瑞奈单抗的真实世界疗效和安全性。

方法

这是一项为期 52 周、单中心、前瞻性、观察性研究,纳入丹麦符合使用 CGRP 或其受体单克隆抗体治疗条件的慢性偏头痛成人患者,使用依瑞奈单抗治疗。主要结局定义为从基线到第 9-12 周,每月偏头痛天数(MMD)减少≥30%的患者比例。

结果

共纳入 300 例慢性偏头痛成年患者,至少接受过一次依瑞奈单抗治疗。基线时,每月头痛天数的平均值(标准差)为 23±4.9,每月 MMD 的平均值为 16.8±6.4。在 300 例入组患者中,273 例(91.0%)患者完成了 12 周的治疗,119 例(39.7%)完成了 52 周的治疗。273 例患者中,有 195 例(71.4%)患者从基线到第 9-12 周 MMD 减少≥30%。在整个 52 周治疗期间的所有评估期间,300 例患者中有 102 例(34%)持续 MMD 减少≥30%。300 例患者中有 220 例(73.3%)出现不良事件。最常见的不良事件是便秘。因不耐受而停药的患者有 41 例(13.7%)。

结论

在先前预防偏头痛药物治疗失败的慢性偏头痛成年患者中,依瑞奈单抗被证实是有效且耐受良好的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c63/9164431/821eb4f5a8b2/10194_2022_1433_Fig1_HTML.jpg

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