依瑞奈尤单抗治疗发作性和慢性偏头痛日本患者的长期疗效和安全性：一项随机试验 28 周开放性治疗期间的结果。

Long-term efficacy and safety of erenumab in Japanese patients with episodic and chronic migraine: results from a 28-week open-label treatment period of a randomised trial.

机构信息

Department of Neurology, Dokkyo Ika Daigaku, Shimotsuga-gun, Japan.

Headache Center, Department of Neurology, Tominaga Hospital, Osaka, Japan.

出版信息

BMJ Open. 2023 Aug 18;13(8):e068616. doi: 10.1136/bmjopen-2022-068616.

DOI:10.1136/bmjopen-2022-068616

PMID:37597868

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10441051/

Abstract

OBJECTIVES

To evaluate the 1-year efficacy and safety of once-monthly erenumab 70 mg following a 24-week double-blind treatment period (DBTP) of a phase III randomised study of Japanese patients with episodic migraine (EM) or chronic migraine (CM).

DESIGN

Multicentre open-label study.

SETTING

A total of 41 centres in Japan.

PARTICIPANTS

Patients completing the DBTP continued into the 28-week open-label treatment period (OLTP). 254 of 261 (97.3%) randomised patients continued into the OLTP; 244 (93.5%) completed treatment.

INTERVENTIONS

Once-monthly subcutaneous erenumab 70 mg.

MAIN OUTCOME MEASURES

Changes from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication treatment days (MSMD) reported via patient eDiary; proportion of ≥50% and ≥75% responders in MMD reduction from baseline; incidence and exposure-adjusted incidence of treatment-emergent adverse events (TEAEs).

RESULTS

At week 24 of the DBTP, the mean (SE) change from baseline in MMD for the erenumab group was -3.8 (0.4) days (EM, -3.0 (0.4); CM, -5.2 (0.8)); in MSMD, -2.6 (0.4) days (EM, -2.1 (0.4); CM, -3.4 (0.7)). At the end of the OLTP (52 weeks postbaseline), the mean (SE) change from baseline in MMD was -4.7 (0.3) days (EM, -3.4 (0.3); CM, -6.9 (0.6)); in MSMD, -3.3 (0.3) days (EM, -2.4 (0.3); CM, -4.6 (0.5)). The proportion of ≥50% responders for MMD reduction in the erenumab group was 34.1% at week 24; 44.4% at week 52. The exposure-adjusted incidence of TEAEs was 219.7 per 100 patient-years during the OLTP (DBTP, 251.0 for the erenumab group). The most common TEAEs during the OLTP were nasopharyngitis, constipation and influenza. No new safety concerns were identified.

CONCLUSIONS

Erenumab treatment was associated with reduced migraine frequency in Japanese patients with EM or CM for up to 1 year. Overall safety results from the OLTP were consistent with DBTP results.

TRIAL REGISTRATION NUMBER

NCT03812224.

摘要

目的

评估在一项 III 期随机研究的 24 周双盲治疗期（DBTP）后，每月一次给予 70mg 依瑞奈玛特治疗 1 年的疗效和安全性，该研究纳入日本发作性偏头痛（EM）或慢性偏头痛（CM）患者。

设计

多中心开放标签研究。

地点

日本共 41 个中心。

参与者

完成 DBTP 的患者继续进入 28 周的开放标签治疗期（OLTP）。261 名随机患者中的 254 名（97.3%）继续进入 OLTP；244 名（93.5%）完成了治疗。

干预措施

每月一次皮下注射依瑞奈玛特 70mg。

主要观察指标

通过患者电子日记报告的每月偏头痛天数（MMD）和每月急性偏头痛特异性药物治疗天数（MSMD）自基线的变化；从基线缓解 MMD 中≥50%和≥75%应答者的比例；治疗中出现的不良事件（TEAE）的发生率和暴露调整后的发生率。

结果

在 DBTP 的第 24 周，依瑞奈玛特组的 MMD 自基线的平均（SE）变化为-3.8（0.4）天（EM，-3.0（0.4）；CM，-5.2（0.8））；MSMD 为-2.6（0.4）天（EM，-2.1（0.4）；CM，-3.4（0.7））。在 OLTP 结束时（基线后 52 周），MMD 自基线的平均（SE）变化为-4.7（0.3）天（EM，-3.4（0.3）；CM，-6.9（0.6））；MSMD 为-3.3（0.3）天（EM，-2.4（0.3）；CM，-4.6（0.5））。依瑞奈玛特组 MMD 缓解的≥50%应答者比例在第 24 周为 34.1%；第 52 周为 44.4%。OLTP 期间 TEAE 的暴露调整发生率为每 100 患者-年 219.7 例（DBTP 中依瑞奈玛特组为 251.0）。OLTP 期间最常见的 TEAE 是鼻咽炎、便秘和流感。未发现新的安全性问题。