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
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
5209-5220Informations de copyright
© 2021. The Author(s).
Références
Cephalalgia. 2018 Jan;38(1):1-211
pubmed: 29368949
Qual Life Res. 2011 May;20(4):601-8
pubmed: 21063786
Cephalalgia. 2011 Feb;31(3):301-15
pubmed: 20813784
Value Health. 2012 May;15(3):485-94
pubmed: 22583459
Headache. 1998 Apr;38(4):295-302
pubmed: 9595870
Health Qual Life Outcomes. 2019 Nov 12;17(1):171
pubmed: 31718662
Health Qual Life Outcomes. 2012 Jun 12;10:65
pubmed: 22691697
Headache. 2019 Jan;59(1):1-18
pubmed: 30536394
Pain Ther. 2019 Dec;8(2):203-216
pubmed: 31350710
Lancet. 2021 Jan 2;397(10268):51-60
pubmed: 33338437
J Med Econ. 2018 Jul;21(7):666-675
pubmed: 29571276
Cephalalgia. 2020 Sep;40(10):1026-1044
pubmed: 32722936
Cephalalgia. 2013 Jul;33(9):629-808
pubmed: 23771276
J Headache Pain. 2016;17:9
pubmed: 26879832
Headache. 2012 Mar;52(3):409-21
pubmed: 21929662
Cephalalgia. 2009 Nov;29(11):1180-7
pubmed: 19830883
J Patient Rep Outcomes. 2019 Jul 11;3(1):39
pubmed: 31297622
Headache. 2017 Nov;57(10):1532-1544
pubmed: 28984356
Cephalalgia. 2018 Apr;38(5):815-832
pubmed: 29504482
Lancet. 2019 Aug 31;394(10200):737-745
pubmed: 31311674
Mayo Clin Proc. 2009 May;84(5):422-35
pubmed: 19411439
Am Fam Physician. 2018 Feb 15;97(4):243-251
pubmed: 29671521
Neurol Ther. 2020 Dec;9(2):535-549
pubmed: 32542532