Department of Neurology, Danish Headache Center, Faculty of Health and Medical Sciences, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.
NIHR/Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.
Eur J Neurol. 2021 May;28(5):1716-1725. doi: 10.1111/ene.14715. Epub 2021 Jan 20.
Although erenumab has demonstrated significant reduction in migraine frequency and improved quality of life in studies lasting 3 to 12 months, little is known about long-term therapy.
This study was an open-label, 5-year treatment phase following a 12-week, double-blind, placebo-controlled trial in adults with episodic migraine. Patients initially received open-label erenumab 70 mg, which increased to 140 mg following a protocol amendment. Efficacy analyses included change from baseline in monthly migraine days (MMDs), monthly acute migraine-specific medication (AMSM) days, and health-related quality of life.
Of 383 patients enrolled, 250 switched to 140 mg; 215 (56.1%) completed open-label treatment. Mean (standard error) change in MMDs from baseline of 8.7 (0.2) days was -5.3 (0.3) days; an average reduction of 62.3% at year 5. Among patients using AMSM at baseline (6.3 [2.8] treatment days), mean change in monthly AMSM days was -4.4 (0.3) days at the end of 5 years. Patient-reported outcomes indicated stable improvements in disability, headache impact, and migraine-specific quality of life. Exposure-adjusted patient incidence rates of adverse events (AEs) were 123.0/100 patient-years; AEs were most frequently nasopharyngitis, upper respiratory tract infection, and influenza. Serious AEs (SAEs) reported by 49 patients (3.8/100 patient-years) were mostly single occurrence. Two fatal adverse events were reported. There were no increases in incidence of AEs, SAEs, or AEs leading to treatment discontinuation over 5 years of exposure.
Treatment with erenumab was associated with reductions in migraine frequency and improvements in health-related quality of life that were maintained for at least 5 years. No new safety signals were observed.
依瑞奈玛在为期 3 至 12 个月的研究中显示出偏头痛发作频率的显著降低和生活质量的改善，但对长期治疗知之甚少。
这是一项在成人发作性偏头痛患者中进行的为期 12 周、双盲、安慰剂对照试验后的开放标签、5 年治疗阶段。患者最初接受依瑞奈玛 70mg 开放标签治疗，随后根据方案修正案增加至 140mg。疗效分析包括从基线开始的每月偏头痛天数（MMD）、每月急性偏头痛特异性药物（AMSM）天数和健康相关生活质量的变化。
383 名入组患者中，250 名患者转为 140mg；215 名（56.1%）完成了开放标签治疗。从基线开始，MMD 的平均（标准误差）变化为 8.7（0.2）天，-5.3（0.3）天；第 5 年时平均减少 62.3%。基线时使用 AMSM 的患者（6.3[2.8]治疗天数），第 5 年时每月 AMSM 天数的平均变化为-4.4（0.3）天。患者报告的结果表明，残疾、头痛影响和偏头痛特异性生活质量均稳定改善。经暴露调整的不良事件（AE）患者发生率为 123.0/100 患者年；AE 最常见的是鼻咽炎、上呼吸道感染和流感。49 名患者（3.8/100 患者年）报告了严重不良事件（SAE），大多为单次发生。报告了两例致命不良事件。5 年暴露期间，AE、SAE 或导致治疗中断的 AE 的发生率没有增加。
依瑞奈玛治疗与偏头痛发作频率降低和健康相关生活质量改善相关，这些改善至少维持 5 年。未观察到新的安全性信号。
