依瑞奈尤单抗治疗慢性偏头痛伴急性药物过度使用患者的长期疗效和安全性：亚组分析。

Long-term efficacy and safety of erenumab in patients with chronic migraine and acute medication overuse: A subgroup analysis.

机构信息

Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.

Albert Einstein College of Medicine, New York, New York, USA.

出版信息

Headache. 2023 Jun;63(6):730-742. doi: 10.1111/head.14536. Epub 2023 Jun 14.

DOI:10.1111/head.14536

PMID:37313616

Abstract

OBJECTIVE

Assess the long-term efficacy and safety of erenumab in patients with chronic migraine with acute medication overuse.

BACKGROUND

Overuse of acute medication in patients with chronic migraine has been linked to greater pain intensity and disability and may diminish the effectiveness of preventive therapies.

METHODS

This 52-week open-label extension study followed a 12-week double-blind placebo-controlled study in which patients with chronic migraine were randomized 3:2:2 to placebo or once-monthly erenumab 70 mg or 140 mg. Patients were stratified by region and medication overuse status. Patients received erenumab 70 mg or 140 mg throughout or switched from erenumab 70 to 140 mg (based on protocol amendment to augment safety data at higher dose). Efficacy was assessed in patients with and without medication overuse at parent study baseline.

RESULTS

Of 609 patients enrolled in the extension study, 252/609 (41.4%) met the criteria for medication overuse at parent study baseline. At Week 52, the mean change in monthly migraine days from parent study baseline was -9.3 (95% confidence interval: -10.4, -8.1 days) in the medication overuse subgroup versus -9.3 (-10.1, -8.5 days) in the non-medication overuse subgroup (combined erenumab doses); proportion of patients achieving ≥50% reduction in monthly migraine days at Week 52 was 55.9% (90/161; 48.2%, 63.3%) versus 61.3% (136/222; 54.7%, 67.4%), respectively. Among baseline users of acute migraine-specific medication, the mean change in monthly migraine-specific medication days at Week 52 was -7.4 (-8.3, -6.4 days) in the medication overuse subgroup versus -5.4 (-6.1, -4.7 days) in the non-medication overuse subgroup. Most patients (197/298; 66.1%) in the medication overuse subgroup transitioned to non-overuse status by Week 52. Erenumab 140 mg was associated with numerically greater efficacy than erenumab 70 mg across all endpoints. No new safety signals were identified.

CONCLUSION

Long-term erenumab treatment demonstrated sustained efficacy and safety in patients with chronic migraine with and without acute medication overuse.

摘要

目的

评估依瑞奈umab 在慢性偏头痛伴急性药物过度使用患者中的长期疗效和安全性。

背景

慢性偏头痛患者过度使用急性药物与更高的疼痛强度和残疾有关，并且可能降低预防治疗的效果。

方法

这项为期 52 周的开放性扩展研究是在一项为期 12 周的双盲安慰剂对照研究之后进行的，该研究将慢性偏头痛患者随机分为 3:2:2 组，分别接受安慰剂或每月一次依瑞奈umab70mg 或 140mg。患者按地区和药物过度使用情况分层。患者在整个研究期间接受依瑞奈umab70mg 或 140mg 治疗，或根据方案修正案从依瑞奈umab70mg 转为 140mg（以增加高剂量安全性数据）。在母研究基线时，评估有无药物过度使用的患者的疗效。

结果

在扩展研究中，609 名患者中，252/609 名（41.4%）在母研究基线时符合药物过度使用标准。在第 52 周时，与无药物过度使用亚组相比（依瑞奈umab 联合剂量），药物过度使用亚组每月偏头痛天数从母研究基线的平均变化为-9.3（95%置信区间：-10.4，-8.1 天）；第 52 周时，每月偏头痛天数减少≥50%的患者比例分别为 55.9%（90/161；48.2%，63.3%）和 61.3%（136/222；54.7%，67.4%）。在基线时使用急性偏头痛特异性药物的患者中，药物过度使用亚组在第 52 周时每月偏头痛特异性药物天数的平均变化为-7.4（-8.3，-6.4 天），而非药物过度使用亚组为-5.4（-6.1，-4.7 天）。在药物过度使用亚组中，大多数患者（197/298；66.1%）在第 52 周时转变为非过度使用状态。依瑞奈umab140mg 在所有终点均显示出优于依瑞奈umab70mg 的疗效。未发现新的安全性信号。