Introduction

Migraine is a debilitating neurological condition, affecting up to 15% of Americans. Recent estimates from a long-term safety study of rimegepant showed evidence of decreased monthly migraine days (MMD) in people with episodic migraine treated with rimegepant 75 mg. The objective of this study was to characterize migraine-specific quality of life version 2.1 (MSQv2) scores and corresponding mapped EuroQol-5 Dimensions-3 Level (EQ-5D-3L) utility values.

Methods

Study participants were randomized into two treatment regimens: individuals with 2–14 MMD received rimegepant 75 mg as needed (PRN), and those with 4–14 MMD at baseline who received rimegepant on a fixed every-other-day schedule plus an as needed dose on days they did not treat (QOD + PRN). MSQv2 was mapped to EQ-5D-3L utilities using a validated algorithm. Outcomes were assessed for the PRN arm at baseline weeks 12, 24, 36, and 52 and for the QOD + PRN arm at baseline and week 12.

Results

At baseline, MSQv2 data were available for 1,800 patients: 1,033 with 2–8 MMD in the PRN group, 481 with 9–14 MMD in the PRN group, and 286 with 4–14 MMD in the QOD + PRN group. For all MSQv2 domains as well as mapped utility values, outcomes improved over each study visit. At baseline, EQ-5D-3L utilities were 0.66, 0.63, and 0.65 for the 2–8 MMD PRN, 9–14 MMD PRN, and 4–14 MMD QOD + PRN groups, respectively. At end-of-study, utilities had increased by + 0.09, + 0.10, and + 0.12 for the three groups, respectively (p < 0.001 for all comparisons with baseline). Similar trends in improvement were observed across MSQv2 subdomains; all differences were statistically significant.

Conclusions

Rimegepant 75 mg, which has been shown to be associated with reduced MMD, is associated with improvement in MSQv2 domains over time, leading to estimated improvement in EQ-5D-3L utilities. While this improvement was observed in all patient-groups, it was most pronounced in those with higher MMD and those taking rimegepant QOD + PRN.

Trial registration

Clinical Trials NCT03266588.

中文翻译：

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将偏头痛特定的生活质量映射到接受 Rimegepant 的患者的健康状态实用程序

介绍

偏头痛是一种使人衰弱的神经系统疾病，影响多达 15% 的美国人。最近对 rimegepant 的一项长期安全性研究的估计显示，有证据表明，使用 rimegepant 75 mg 治疗的发作性偏头痛患者的每月偏头痛天数 (MMD) 有所减少。本研究的目的是表征偏头痛特定的生活质量版本 2.1 (MSQv2) 分数和相应映射的 EuroQol-5 Dimensions-3 水平 (EQ-5D-3L) 效用值。

方法

研究参与者被随机分配到两种治疗方案中：MMD 为 2-14 的个体根据需要接受 rimegepant 75 mg (PRN)，而基线时 MMD 为 4-14 的个体按照固定的每隔一天的时间表接受 rimegepant 并根据需要接受 rimegepant在他们没有治疗的日子里服用剂量 (QOD + PRN)。使用经过验证的算法将 MSQv2 映射到 EQ-5D-3L 实用程序。在基线第 12、24、36 和 52 周评估 PRN 组的结果，在基线和第 12 周评估 QOD + PRN 组的结果。

结果

在基线时，可获得 1,800 名患者的 MSQv2 数据：PRN 组中有 1,033 名患者有 2-8 MMD，PRN 组中有 481 名患者有 9-14 MMD，QOD + PRN 组中有 286 名患者有 4-14 MMD。对于所有 MSQv2 域以及映射的效用值，每次研究访问的结果都会有所改善。在基线时，2-8 MMD PRN、9-14 MMD PRN 和 4-14 MMD QOD + PRN 组的 EQ-5D-3L 效用分别为 0.66、0.63 和 0.65。在研究结束时，三组的效用分别增加了 + 0.09、+ 0.10 和 + 0.12（ 所有与基线比较的p < 0.001）。在 MSQv2 子域中观察到类似的改进趋势；所有差异均具有统计学意义。

结论

Rimegepant 75 mg 已被证明与减少 MMD 相关，随着时间的推移与 MSQv2 域的改善相关，导致 EQ-5D-3L 效用的估计改善。虽然在所有患者组中都观察到这种改善，但在 MMD 较高的患者和服用 rimegepant QOD + PRN 的患者中最为明显。

试用注册

临床试验 NCT03266588。