Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.
Cephalalgia. 2019 Oct;39(11):1455-1464. doi: 10.1177/0333102419854082. Epub 2019 May 30.
Previously published three-month placebo-controlled and one-year open-label clinical trial data have provided information on the efficacy and safety of erenumab.
Interim analysis was undertaken from an ongoing five-year open-label treatment phase after all patients completed three years in the open-label treatment phase or discontinued the study. Adult patients with episodic migraine enrolled in the open-label treatment phase initially received 70 mg erenumab monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs.
Of 383 patients enrolled in the open-label treatment phase, at data cutoff 235 (61.3%) remained in the study, all received 140 mg for ≥1 year. Median (Q1, Q3) exposure (70 or 140 mg) for all patients enrolled was 3.2 (1.3, 3.4) years. The most frequent adverse events (≥4.0/100 patient-years) were reported as viral upper respiratory tract infection, sinusitis, influenza, and back pain. Exposure-adjusted serious adverse event rates were 4.2/100 patient-years. There was no increase in cardiovascular events over time.
In this long-term study of a CGRP-receptor antibody, erenumab was found to be safe and well-tolerated with a spectrum and rate of adverse events consistent with shorter-term placebo-controlled studies.
ClinicalTrials.gov NCT01952574.
先前发表的三个月安慰剂对照和一年开放标签临床试验数据提供了依那西普治疗疗效和安全性的信息。
在所有患者完成开放标签治疗阶段三年或退出研究后，正在进行为期五年的开放标签治疗阶段的中期分析。最初，患有阵发性偏头痛的成年患者在开放标签治疗阶段每月接受 70 毫克依那西普治疗。一项方案修正案将剂量增加到每月 140 毫克，以评估更高剂量的长期安全性。通过监测不良事件、心电图、实验室评估和生命体征来评估安全性和耐受性。
在开放标签治疗阶段入组的 383 名患者中，数据截止时有 235 名（61.3%）仍在研究中，所有患者均接受了至少 1 年的 140 毫克治疗。所有入组患者的中位（Q1，Q3）暴露（70 或 140 毫克）时间为 3.2（1.3，3.4）年。报告的最常见不良事件（≥4.0/100 患者年）为病毒上呼吸道感染、鼻窦炎、流感和背痛。暴露调整后的严重不良事件发生率为 4.2/100 患者年。随着时间的推移，心血管事件没有增加。
在这项针对 CGRP 受体抗体的长期研究中，依那西普被发现安全且耐受良好，其不良事件谱和发生率与短期安慰剂对照研究一致。
ClinicalTrials.gov NCT01952574。
