Department of Neurology, Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No 197, Ruijin Second Road, Huangpu District, Shanghai, 20025, China.
Department of Neurology, Hainan Branch, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No 41, Kangxiang Road, Qionghai, 517434, China.
J Headache Pain. 2024 Sep 27;25(1):160. doi: 10.1186/s10194-024-01873-5.
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.
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.
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.
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.
Clinicaltrials.gov NCT05709106. Retrospectively registered on 2023-02-01.
利马曲班是一种小分子降钙素基因相关肽（CGRP）受体拮抗剂，已被批准用于美国和其他国家的偏头痛急性和预防性治疗。然而，在中国偏头痛患者中使用利马曲班缺乏前瞻性真实世界证据。
这是一项单臂、前瞻性、真实世界研究。合格参与者在按需使用利马曲班治疗偏头痛发作时，通过数字平台在预给药和给药后 0.5、1、2、24 和 48 小时记录单次发作的疼痛强度、功能能力和伴随症状。记录利马曲班治疗期间的不良事件（AE）。评估预给药和给药后 0.5、1、2、24 和 48 小时有多少参与者经历中度至重度疼痛。此外，还分析了在给药后 0.5、1、2、24 和 48 小时报告疼痛强度、功能能力和伴随症状改善/良好的参与者比例。此外，总队列（全人群，FP）分为既往无应答者（PNR）组，以观察利马曲班治疗相对难治性偏头痛的有效性和安全性，以及利马曲班和依替替班（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，共纳入 133 名参与者（FP，n=133；PNR 组，n=40；RE 组，n=28），99 名参与者（FP，n=99；PNR 组，n=30；RE 组，n=23）被纳入分析。FP 和两个亚组中，利马曲班治疗偏头痛均有效，给药后中度至重度疼痛的参与者比例呈显著下降趋势（p<0.05），与预给药相比，在给药后 0.5、1、2、24 和 48 小时报告疼痛强度、功能能力和伴随症状改善/良好的参与者比例显著增加。FP 中 6%的参与者报告了 AEs，所有 AEs 均为轻度。
在真实世界中，利马曲班在中国偏头痛患者的急性治疗中是有效的。AE 发生率低突显了利马曲班良好的耐受性。
Clinicaltrials.gov NCT05709106。于 2023 年 2 月 1 日进行回顾性注册。
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