Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study
Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study
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DOI：
10.1186/s10194-020-01136-z
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发表时间：
2020-06-03
影响因子：
7.4
通讯作者：
Schytz, Henrik Winther
中科院分区：
文献类型：
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作者：
Ashina, Hakan;Iljazi, Afrim;Schytz, Henrik Winther
降钙素基因相关肽（CGRP）最近被认为与创伤后头痛（PTH）的发病机制有关，这为靶向CGRP或其受体的单克隆抗体的治疗应用提供了前景。因此，我们决定评估erenumab预防轻度外伤性脑损伤引起的持续性PTH的有效性、耐受性和安全性。方法采用单中心、非随机、单组、开放标签的研究方法，对18-65岁成人持续性甲状旁腺激素患者进行erenumab治疗。患者被分配每月接受140毫克的伊瑞那单皮下注射，每次注射1毫升，每4周注射一次，持续12周。主要结局指标是从基线（4周预处理期）到第9至12周每月中度至重度头痛天数的平均变化。耐受性和安全性终点是不良事件（即数量和类型）。结果100例患者中有89例完成了开放标签试验。基线时，中度至重度头痛的月平均天数为15.7天。从第9周到第12周，这个数字减少了2.8天。最常见的不良事件是便秘（n = 30）和注射部位反应（n = 15）。在接受至少一剂erenumab治疗的100名患者中，有2名患者因不良事件而停止了治疗方案。结论：在这项为期12周的开放标签试验中，在持续性PTH患者中，erenumab导致中度至重度头痛天数的频率较低。此外，erenumab耐受性良好，因为不良事件引起的停药率很低。需要安慰剂对照随机临床试验来充分评估erenumab对持续性PTH患者的疗效和安全性。
Background Calcitonin gene-related peptide (CGRP) has recently been implicated in the pathogenesis of post-traumatic headache (PTH), which raises the prospect for therapeutic use of monoclonal antibodies targeting CGRP or its receptor. Therefore, we decided to assess the efficacy, tolerability, and safety of erenumab for prevention of persistent PTH attributed to mild traumatic brain injury. Methods A single-center, non-randomized, single-arm, open-label study of erenumab for adults aged 18-65 years with persistent PTH. Patients were assigned to receive 140-mg erenumab monthly by two subcutaneous 1-mL injections, given every 4 weeks for 12 weeks. The primary outcome measure was the mean change in number of monthly headache days of moderate to severe intensity from baseline (4-week pretreatment period) to week 9 through 12. Tolerability and safety endpoints were adverse events (i.e. number and type). Results Eighty-nine of 100 patients completed the open-label trial. At baseline, the mean monthly number of headache days of moderate to severe intensity was 15.7. By week 9 through 12, the number was reduced by 2.8 days. The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15). Of 100 patients who received at least one dose of erenumab, two patients discontinued the treatment regimen due to adverse events. Conclusions Among patients with persistent PTH, erenumab resulted in a lower frequency of moderate to severe headache days in this 12-week open-label trial. In addition, erenumab was well-tolerated as discontinuations due to adverse events were low. Placebo-controlled randomized clinical trials are needed to adequately evaluate the efficacy and safety of erenumab in patients with persistent PTH.