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Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant
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 th...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478726/ https://www.ncbi.nlm.nih.gov/pubmed/34455556 http://dx.doi.org/10.1007/s12325-021-01897-2 |
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author | Johnston, Karissa M. L’Italien, Gilbert Popoff, Evan Powell, Lauren Croop, Robert Thiry, Alexandra Harris, Linda Coric, Vladimir Lipton, Richard B. |
author_facet | Johnston, Karissa M. L’Italien, Gilbert Popoff, Evan Powell, Lauren Croop, Robert Thiry, Alexandra Harris, Linda Coric, Vladimir Lipton, Richard B. |
author_sort | Johnston, Karissa M. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8478726 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-84787262021-10-08 Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant Johnston, Karissa M. L’Italien, Gilbert Popoff, Evan Powell, Lauren Croop, Robert Thiry, Alexandra Harris, Linda Coric, Vladimir Lipton, Richard B. Adv Ther Original Research 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. Springer Healthcare 2021-08-29 2021 /pmc/articles/PMC8478726/ /pubmed/34455556 http://dx.doi.org/10.1007/s12325-021-01897-2 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Johnston, Karissa M. L’Italien, Gilbert Popoff, Evan Powell, Lauren Croop, Robert Thiry, Alexandra Harris, Linda Coric, Vladimir Lipton, Richard B. Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant |
title | Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant |
title_full | Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant |
title_fullStr | Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant |
title_full_unstemmed | Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant |
title_short | Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant |
title_sort | mapping migraine-specific quality of life to health state utilities in patients receiving rimegepant |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478726/ https://www.ncbi.nlm.nih.gov/pubmed/34455556 http://dx.doi.org/10.1007/s12325-021-01897-2 |
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