First real-world study on the effectiveness and tolerability of rimegepant for acute migraine therapy in Chinese patients.

IF 7.3 1区医学 Q1 CLINICAL NEUROLOGY

Journal of Headache and Pain Pub Date : 2024-09-27 DOI:10.1186/s10194-024-01873-5

Zhao Yang, Xiaodan Wang, Mengyue Niu, Qiao Wei, Huizhu Zhong, Xiaoyan Li, Weihong Yuan, Wenli Xu, Shuo Zhu, Shengyuan Yu, Jun Liu, Jianzhou Yan, Wenyan Kang, Peijian Huang

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引用次数: 0

Abstract

Background: Rimegepant, a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, is indicated for acute and preventive migraine treatment in the United States and other countries. However, there is a lack of prospective real-world evidence for the use of rimegepant in Chinese migraine patients.

Methods: This was a single-arm, prospective, real-world study. While taking rimegepant to treat migraine attacks as needed, eligible participants were asked to record their pain intensity, functional ability, and accompanying symptoms for a single attack at predose and 0.5, 1, 2, 24, and 48 h postdose via a digital platform. Adverse events (AEs) during the rimegepant treatment period were recorded and analysed. The percentages of participants who experienced moderate to severe pain at predose and 0.5, 1, 2, 24, and 48 h postdose were assessed. Additionally, the percentages of participants who reported better/good outcomes in terms of pain intensity, functional ability, and accompanying symptoms at 0.5, 1, 2, 24, and 48 h postdose were analysed. In addition, the total cohort (full population, FP) was stratified into a prior nonresponder (PNR) group to observe the effectiveness and safety of rimegepant for relatively refractory migraine and a rimegepant and eptinezumab (RE) group to observe the effectiveness and safety of the combination of these drugs.

Results: By November 24th, 2023, 133 participants (FP, n = 133; PNR group, n = 40; RE group, n = 28) were enrolled, and 99 participants (FP, n = 99; PNR group, n = 30; RE group, n = 23) were included in the analysis. Rimegepant was effective in treating migraine in the FP and both subgroups, with a significant decreasing trend in the percentages of participants experiencing moderate to severe pain postdose (p < 0.05) and a marked increase in the percentages of participants who reported better/good outcomes in terms of pain intensity, functional ability, and accompanying symptoms at 0.5, 1, 2, 24, and 48 h postdose compared with predose. AEs were reported by 6% of participants in the FP, and all AEs were mild.

Conclusions: In the real world, rimegepant is effective in the acute treatment of migraine patients in China. The low incidence rate of AEs highlighted the favourable tolerability profile of rimegepant.

Trial registration: Clinicaltrials.gov NCT05709106. Retrospectively registered on 2023-02-01.

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首次在中国患者中开展关于利美泮治疗急性偏头痛的有效性和耐受性的真实世界研究。

背景：利美君是一种小分子降钙素基因相关肽（CGRP）受体拮抗剂，在美国和其他国家被用于偏头痛的急性和预防性治疗。然而，在中国偏头痛患者中使用利美昔康还缺乏前瞻性的实际证据：这是一项单臂、前瞻性、真实世界研究。在根据需要服用利美君治疗偏头痛发作时，符合条件的参与者需要通过数字平台记录用药前、用药后 0.5、1、2、24 和 48 小时内单次发作的疼痛强度、功能能力和伴随症状。对利美喷剂治疗期间的不良事件（AEs）进行了记录和分析。评估了用药前、用药后 0.5、1、2、24 和 48 小时内出现中度至重度疼痛的参与者百分比。此外，还分析了用药后 0.5、1、2、24 和 48 小时在疼痛强度、功能能力和伴随症状方面表现较好/良好的参与者百分比。此外，还将所有队列（全人群、FP）分为两组，一组是既往无应答者（PNR）组，以观察利美君治疗相对难治性偏头痛的有效性和安全性；另一组是利美君和依昔单抗（RE）组，以观察这两种药物联合治疗的有效性和安全性：截至2023年11月24日，133名参与者（FP，n = 133；PNR组，n = 40；RE组，n = 28）被纳入研究，99名参与者（FP，n = 99；PNR组，n = 30；RE组，n = 23）被纳入分析。在FP组和两个亚组中，利美君治疗偏头痛效果显著，用药后出现中度至重度疼痛的参与者比例呈显著下降趋势（p 结论：利美君对偏头痛的治疗效果显著：在现实世界中，利美喷对中国偏头痛患者的急性期治疗是有效的。低AEs发生率凸显了利美君良好的耐受性：试验注册：Clinicaltrials.gov NCT05709106。回顾注册日期：2023-02-01。

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来源期刊

Journal of Headache and Pain 医学-临床神经学

CiteScore

11.80

自引率

13.50%

发文量

143

审稿时长

6-12 weeks

期刊介绍： The Journal of Headache and Pain, a peer-reviewed open-access journal published under the BMC brand, a part of Springer Nature, is dedicated to researchers engaged in all facets of headache and related pain syndromes. It encompasses epidemiology, public health, basic science, translational medicine, clinical trials, and real-world data. With a multidisciplinary approach, The Journal of Headache and Pain addresses headache medicine and related pain syndromes across all medical disciplines. It particularly encourages submissions in clinical, translational, and basic science fields, focusing on pain management, genetics, neurology, and internal medicine. The journal publishes research articles, reviews, letters to the Editor, as well as consensus articles and guidelines, aimed at promoting best practices in managing patients with headaches and related pain.