Safety and Tolerability of 3 CGRP Monoclonal Antibodies in Practice: A Retrospective Cohort Study
Safety and Tolerability of 3 CGRP Monoclonal Antibodies in Practice: A Retrospective Cohort Study
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DOI：
10.1111/head.13956
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发表时间：
2020-09-23
期刊：
影响因子：
5
通讯作者：
Rayhill, Melissa
中科院分区：
文献类型：
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作者：
Alex, Ashley;Vaughn, Caila;Rayhill, Melissa
目的：我们试图评估3种降钙素基因相关肽（CGRP）单克隆抗体在多类偏头痛预防治疗失败的慢性偏头痛患者中的安全性和耐受性。CGRP是偏头痛发病机制中重要的神经调节剂。它们被批准用于治疗发作性和慢性偏头痛。在目前的临床实践中，CGRP单克隆抗体用于多种预防药物无效的患者，但在临床试验之外的现实人群中，安全性、耐受性和有效性尚未得到很好的描述。方法：2018年5月1日至2019年9月30日，在接受CGRP单克隆抗体治疗的成人慢性偏头痛患者中进行单中心、观察性、回顾性研究。在治疗后0、3、6个月复查图表。结果2018年5月1日至2019年9月30日，77例慢性偏头痛患者接受了90项CGRP单克隆抗体治疗试验。使用erenumab 70 mg的患者中有2/5（40.0%）报告了不良后果，使用erenumab 140 mg的患者中有32/46(69.6%)，使用fremanezumab的患者中有8/16(50.0%)，使用galcanezumab的患者中有15/23（65.2%）报告了不良后果。最常见的不良反应是便秘和注射部位反应。导致停药的不良反应报告如下：erenumab 70 mg 1/5 (20.0%), erenumab 140 mg 10/46 (22.7%), fremanezumab 1/16（6.3%）和galcanezumab 1/23(4.3%)，总体停药率为13/90（14.4%）。最常见的停药原因是缺乏改善（17/90,18.9%）和便秘（4/90,4.4%）。3个月时32/66（48.5%）和6个月时17/48（35.4%）的患者每月严重头痛天数减少50%或更多。结论在慢性偏头痛患者中，3 CGRP单克隆抗体耐受性良好，可减少严重头痛天数。
Objective We sought to assess the safety and tolerability of 3 calcitonin gene-related peptide (CGRP) monoclonal antibodies in patients with chronic migraine who have failed multiple classes of migraine preventive therapies. Background CGRP is an important neuromodulator implicated in the pathogenesis of migraine. They are approved for the treatment of episodic and chronic migraine. In current clinical practice, CGRP monoclonal antibodies are used in patients who have failed multiple preventive agents, but safety, tolerability, and efficacy have not been well described in real-world populations outside of clinical trials. Methods This was a single-center, observational, retrospective study in adults with chronic migraine treated with a CGRP monoclonal antibody between May 1, 2018 and September 30, 2019. Charts were reviewed at 0, 3, and 6 months after treatment. Results From May 1, 2018 to September 30, 2019, 77 patients with chronic migraine were prescribed 90 treatment trials of a CGRP monoclonal antibody. Patients reported adverse outcomes in 2/5 (40.0%) with erenumab 70 mg, 32/46 (69.6%) with erenumab 140 mg, 8/16 (50.0%) with fremanezumab, and 15/23 (65.2%) with galcanezumab. The most frequent adverse effects were constipation and injection site reactions. Adverse effects leading to discontinuation were reported as follows: erenumab 70 mg 1/5 (20.0%), erenumab 140 mg 10/46 (22.7%), fremanezumab 1/16 (6.3%), and galcanezumab 1/23 (4.3%), with 13/90 (14.4%) discontinuation rate overall. The most frequent reasons for discontinuation were lack of improvement in 17/90 (18.9%) and constipation in 4/90 (4.4%). A 50% or greater reduction in the number of severe headache days per month was achieved for 32/66 (48.5%) at 3 months and 17/48 (35.4%) at 6 months. Conclusions In patients with chronic migraine, the 3 CGRP monoclonal antibodies were well tolerated, and reduced the number of severe headache days.