在实践中 3 种 CGRP 单克隆抗体的安全性和耐受性：一项回顾性队列研究。

Safety and Tolerability of 3 CGRP Monoclonal Antibodies in Practice: A Retrospective Cohort Study.

机构信息

Department of Neurology, University at Buffalo, State University of New York, Buffalo, NY, USA.

出版信息

Headache. 2020 Nov;60(10):2454-2462. doi: 10.1111/head.13956. Epub 2020 Sep 23.

DOI:10.1111/head.13956

PMID:32969035

Abstract

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.

摘要

目的

我们旨在评估 3 种降钙素基因相关肽（CGRP）单克隆抗体在慢性偏头痛患者中的安全性和耐受性，这些患者已接受了多种偏头痛预防疗法。

背景

CGRP 是一种重要的神经调节剂，参与偏头痛的发病机制。它们已被批准用于治疗发作性和慢性偏头痛。在当前的临床实践中，CGRP 单克隆抗体用于已接受多种预防药物治疗但未在临床试验以外的真实人群中充分描述安全性、耐受性和疗效的患者。

方法

这是一项单中心、观察性、回顾性研究，纳入了 2018 年 5 月 1 日至 2019 年 9 月 30 日期间接受 CGRP 单克隆抗体治疗的慢性偏头痛成人患者。治疗后 0、3 和 6 个月时对图表进行了回顾。

结果

2018 年 5 月 1 日至 2019 年 9 月 30 日期间，77 例慢性偏头痛患者接受了 90 次 CGRP 单克隆抗体治疗试验。2/5（40.0%）例依瑞奈单抗 70mg、32/46（69.6%）例依瑞奈单抗 140mg、8/16（50.0%）例 fremanezumab 和 15/23（65.2%）例 galcanezumab 的患者报告出现不良结局。最常见的不良反应为便秘和注射部位反应。报告导致停药的不良反应如下：依瑞奈单抗 70mg 1/5（20.0%）、依瑞奈单抗 140mg 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%）。停药的最常见原因是 17/90（18.9%）无改善和 4/90（4.4%）便秘。在 3 个月时，32/66（48.5%）达到每月严重头痛天数减少 50%或更多，在 6 个月时，17/48（35.4%）达到每月严重头痛天数减少 50%或更多。