Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201)

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

Abstract

Background: 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.

Methods: Eligible 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.

Results: One 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.

Conclusion: For 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 registration: ClinicalTrials.gov identifier NCT03266588 .

Keywords: CGRP; Drug treatment; Migraine; Quality of life.

Conflict of interest statement

EP, LP and KJ are employees of Broadstreet HEOR, which received funds from Biohaven for this work. LH, VC and GL are employed by and own stock/stock options in Biohaven Pharmaceuticals. CPS receives grant support from Amgen, Genentech, Roche, Teva, and Lilly and is a speaker on the boards of Abbvie, Amgen, Biogen, Biohaven, Lilly, and Teva.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Mean (SE) MMD and PRN rimegepant 75 mg tablet use over time for patients in BHV3000–201. MMD = monthly migraine days; PRN = as needed
Fig. 2
Fig. 2
Cumulative pain and pain-free hours calculated over 52-weeks, for two scenarios. Figure 2illustrates the following two scenarios: 1) patients switch to rimegepant, and 2) patients continue with baseline standard of care treatment
Fig. 3
Fig. 3
MSQv2 outcomes and mapped utilities for patients in BHV3000–201. EF = Emotional Function, EQ-5D = EuroQoL five-dimension, MSQ = migraine specific questionnaire, QALY = quality adjusted life year, RP = Role Function-Preventive, RR = Role Function-Restrictive

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