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. 2024 Sep 27;25(1):160.
doi: 10.1186/s10194-024-01873-5.

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

Zhao Yang  1 , Xiaodan Wang  1 , Mengyue Niu  1 , Qiao Wei  2 , Huizhu Zhong  2 , Xiaoyan Li  2 , Weihong Yuan  3 , Wenli Xu  1 , Shuo Zhu  1 , Shengyuan Yu  4 , Jun Liu  1 , Jianzhou Yan  5   6 , Wenyan Kang  7   8 , Peijian Huang  9   10   11
Affiliations

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

Zhao Yang et al. J Headache Pain. .

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.

Keywords: Effectiveness; Migraine; Real-world; Rimegepant; Tolerability.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Percentage of participants who experienced moderate to severe pain at different time points in the study population. Abbreviations FP, full population; PNR, prior nonresponder; RE, rimegepant and eptinezumab
See this image and copyright information in PMC

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