Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant

Abstract

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.

Keywords: EQ-5D; Mapping; Migraine; Migraine-specific quality of life (MSQv2); Patient-reported outcome; Preference-based instrument; Utility.

Fig. 1

Absolute monthly migraine days over time in Study 201, stratified by treatment group. The QOD + PRN enrollment group only contributed data to Week 12, and thus Week 24, 36, and 52 data are only available for PRN enrollment groups. MMD monthly migraine days; PRN as needed; QOD every other day

Fig. 2

MSQv2 domains over time in Study 201, stratified by treatment group; p < 0.001 for all outcomes in all enrollment groups over time. The QOD + PRN enrollment group only contributed data to Week 12, and thus Week 24, 36, and 52 data are only available for PRN enrollment groups

Fig. 3

EQ-5D-3L utilities mapped from MSQv2 data; p < 0.001 for all outcomes in all enrollment groups over time. The QOD + PRN enrollment group only contributed data to Week 12, and thus Week 24, 36, and 52 data are only available for PRN enrollment groups. MSQv2 migraine-specific quality of life; PRN as needed; QOD every other day

Fig. 4

Relationship between baseline absolute MMD and EQ-5D, and changes from baseline (52 weeks for the PRN groups and 12 weeks for the QOD + PRN group). From left to right baseline MMD versus baseline EQ-5D-3L, baseline MMD versus CFB EQ-5D-3L, and CFB MMD versus CFB EQ-5D-3L. CFB change from baseline; MMD monthly migraine days