Neurology, Saitama International Headache Center, Saitama, Japan.
Headache Center, Department of Neurology, Tominaga Hospital, Osaka, Japan.
Headache. 2021 Apr;61(4):653-661. doi: 10.1111/head.14096. Epub 2021 Mar 25.
To assess long-term (up to 2 years) efficacy, tolerability, and safety of erenumab for the prevention of episodic migraine (EM) in Japanese patients.
Previously published results from the double-blind treatment phase (DBTP) of a phase 2 clinical study have demonstrated the efficacy and safety of erenumab in Japanese patients with EM.
Patients completing the 24-week placebo-controlled DBTP could continue into the 76-week open-label treatment phase (OLTP), receiving erenumab 70 mg or 140 mg subcutaneously once monthly. The initial dose in the OLTP was erenumab 70 mg monthly, which was later changed to 140 mg. After study completion, the following were assessed: change from baseline in monthly migraine days (MMD), change from baseline in monthly acute migraine-specific medication days (MSMD), percentage of patients achieving ≥50% and ≥75% reduction in MMD, change from baseline in the 6-item Headache Impact Test (HIT-6™) score, and safety (exposure-adjusted patient-incidence of adverse events [AEs], calculated as number of patients per 100 patient-years).
Of 475 patients enrolled in the DBTP, 459 (96.6%) continued in the OLTP. The mean (SD) MMD was 7.9 (2.3) at baseline with the overall change from baseline at week 100 of -2.9 (4.1) days. The monthly acute MSMD was 5.7 (2.8) at baseline with change from baseline at week 100 of -1.7 (3.7) days. The proportion of patients who achieved ≥50% and ≥75% reduction in MMD from baseline at week 100 was 177/398 (44.5%) and 94/398 (23.6%), respectively. The HIT-6™ score was 58.4 (5.4) at baseline with a change of -6.4 (8.2) at week 100. The exposure-adjusted patient-incidence of AEs during the OLTP was 207.1/100 patient-years for the combined erenumab group, similar to that observed for either erenumab (271.0/100 patient-years) or placebo (257.3/100 patient-years) during the DBTP, and no new safety signals were detected during the OLTP.
Long-term erenumab treatment in Japanese patients with EM demonstrated sustained efficacy for up to 2 years, with a safety profile similar to previous studies, supporting erenumab as a potential new therapy for EM prevention in Japan.
评估依那西普预防日本患者发作性偏头痛（EM）的长期（长达 2 年）疗效、耐受性和安全性。
此前发表的一项 2 期临床研究双盲治疗阶段（DBTP）的结果表明，依那西普对日本 EM 患者有效且安全。
完成 24 周安慰剂对照 DBTP 的患者可继续进入 76 周开放标签治疗阶段（OLTP），每月接受依那西普 70mg 或 140mg 皮下注射。OLTP 的初始剂量为每月依那西普 70mg，后来改为 140mg。研究结束后评估以下内容：从基线到每月偏头痛天数（MMD）的变化、从基线到每月急性偏头痛特异性药物天数（MSMD）的变化、达到 MMD 减少≥50%和≥75%的患者比例、从基线到 6 项头痛影响测试（HIT-6™）评分的变化以及安全性（经暴露调整的不良事件患者发生率[AE]，计算为每 100 患者年的患者数）。
在 475 名进入 DBTP 的患者中，459 名（96.6%）继续进入 OLTP。基线时的平均（SD）MMD 为 7.9（2.3）天，第 100 周的总体变化为-2.9（4.1）天。基线时每月急性 MSMD 为 5.7（2.8）天，第 100 周的变化为-1.7（3.7）天。第 100 周时，达到 MMD 基线减少≥50%和≥75%的患者比例分别为 177/398（44.5%）和 94/398（23.6%）。基线时 HIT-6™评分 58.4（5.4）分，第 100 周时变化为-6.4（8.2）分。OLTP 期间，依那西普联合组的经暴露调整的 AE 患者发生率为 207.1/100 患者年，与 DBTP 期间依那西普（271.0/100 患者年）或安慰剂（257.3/100 患者年）的发生率相似，OLTP 期间未发现新的安全性信号。
依那西普治疗日本 EM 患者长达 2 年的疗效持久，安全性与既往研究相似，支持依那西普作为日本 EM 预防的一种潜在新疗法。
