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

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

Journal

Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864

Informations de publication

Date de publication:
Oct 2021
Historique:
received: 15 07 2021
accepted: 18 08 2021
pubmed: 30 8 2021
medline: 12 10 2021
entrez: 29 8 2021
Statut: ppublish

Résumé

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. 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. 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. 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. Clinical Trials NCT03266588.

Identifiants

pubmed: 34455556
doi: 10.1007/s12325-021-01897-2
pii: 10.1007/s12325-021-01897-2
pmc: PMC8478726
doi:

Substances chimiques

Piperidines 0
Pyridines 0
rimegepant sulfate 1383NM3Q0H

Banques de données

ClinicalTrials.gov
['NCT03266588']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Pagination

5209-5220

Informations de copyright

© 2021. The Author(s).

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Auteurs

Karissa M Johnston (KM)

Broadstreet Health Economics and Outcomes Research, 203-343 Railway St., Vancouver, BC, V6A 1A4, Canada. kjohnston@broadstreetheor.com.
Memorial University, St John's, NL, Canada. kjohnston@broadstreetheor.com.

Gilbert L'Italien (G)

Biohaven Pharmaceuticals, New Haven, CT, USA.

Evan Popoff (E)

Broadstreet Health Economics and Outcomes Research, 203-343 Railway St., Vancouver, BC, V6A 1A4, Canada.

Lauren Powell (L)

Broadstreet Health Economics and Outcomes Research, 203-343 Railway St., Vancouver, BC, V6A 1A4, Canada.

Robert Croop (R)

Biohaven Pharmaceuticals, New Haven, CT, USA.

Alexandra Thiry (A)

Biohaven Pharmaceuticals, New Haven, CT, USA.

Linda Harris (L)

Biohaven Pharmaceuticals, New Haven, CT, USA.

Vladimir Coric (V)

Biohaven Pharmaceuticals, New Haven, CT, USA.

Richard B Lipton (RB)

Albert Einstein College of Medicine, Bronx, NY, USA.

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Classifications MeSH