Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant \u2013 post hoc results from an open label safety study (BHV3000\u2013201)

Karissa Johnston,Evan Popoff,Gilbert L’Italien,Linda Harris,Curtis P Schreiber,Vladimir Coric,Lauren Powell

doi:10.1186/s10194-021-01378-5

Abstract

BackgroundThe objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks.MethodsEligible subjects were adults with ≥1 year history of migraine and ≥ 6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000–201; NCT03266588). Mean MMD were calculated at each 4-week period, along with mean monthly tablets taken. Migraine-specific quality of life (MSQv2) data were mapped to EQ-5D utilities and used to characterize HRQoL over time. A published network meta-analysis was used to characterize pain hours as well as time periods spent migraine free.ResultsOne thousand forty four subjects were included in this post-hoc analysis. Overall mean MMD were 10.9 at baseline and decreased to 8.9 by week 52. Tablet use remained stable over the follow-up period. A total of 0.08 incremental QALYs were associated with rimegepant use.ConclusionFor subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one-year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks.Trial registrationClinicalTrials.gov identifier NCT03266588.

Highlights

Migraine is a common, chronic neurological disorder clinically manifested by severe episodic headaches, resulting in significant burden to patient, health care payers, and society [1, 2]
The analysis described here was conducted in the 1044 subjects with 6 or more monthly migraine days (MMD) from the combined patients treated as needed (PRN) 2–8 and PRN 9–14 study groups
The observed MMD reduction supports the hypothesized that patients with ≥6 MMD at baseline may experience a preventative benefit of rimegepant with PRN dosing, given the interictal carryover of calcitonin gene-related peptide (CGRP) antagonism between attacks

Summary

Introduction

Chronic neurological disorder clinically manifested by severe episodic headaches, resulting in significant burden to patient, health care payers, and society [1, 2]. Goals of acute treatment of migraine are to reduce pain, disability, recurrence, and resource use [1]. In a long-term (1year) open-label safety study (BHV3000–201; NCT03266588), a reduction in monthly migraine days (MMD) was observed for patients taking rimegepant on an as needed basis to treat their acute attacks [23]. Other acute migraine therapies, including triptans, have not been associated with a reduction in MMD with long term use [24]. The long-term health-related quality of life (HRQoL) impact of using a novel acute therapy that has preventive effects on migraine is currently unknown. The objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks

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