TY - JOUR
T1 - Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant
AU - Johnston, Karissa M.
AU - L’Italien, Gilbert
AU - Popoff, Evan
AU - Powell, Lauren
AU - Croop, Robert
AU - Thiry, Alexandra
AU - Harris, Linda
AU - Coric, Vladimir
AU - Lipton, Richard B.
N1 - Funding Information:
Karissa Johnston, Evan Popoff, and Lauren Powell are employees of Broadstreet HEOR, which received funds from Biohaven for this work. Gilbert L’Italien, Robert Croop, Alexandra Thiry, and Vladimir Coric are employed by and own stock/stock options in Biohaven Pharmaceuticals. Richard B. Lipton receives research support from the NIH. He also receives support from the Migraine Research Foundation and the National Headache Foundation. He serves on the editorial board of Neurology, as a senior advisor to Headache, and as an associate editor of Cephalalgia. He has reviewed for the NIA and NINDS; holds stock options in Biohaven Holdings; and serves as consultant, advisory board member, or has received honoraria from: American Academy of Neurology, Allergan, American Headache Society, Amgen, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy’s (Promius), Electrocore, Eli Lilly, eNeura Therapeutics, Equinox, GlaxoSmithKline, Lundbeck (Alder), Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, Vedanta. He receives royalties from Oxford University Press (Wolff’s Headache and Other Head Pain, 7th Edition [2001] and 8th Edition [2007]), Wiley, and Informa.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/10
Y1 - 2021/10
N2 - 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.
AB - 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.
KW - EQ-5D
KW - Mapping
KW - Migraine
KW - Migraine-specific quality of life (MSQv2)
KW - Patient-reported outcome
KW - Preference-based instrument
KW - Utility
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U2 - 10.1007/s12325-021-01897-2
DO - 10.1007/s12325-021-01897-2
M3 - Article
C2 - 34455556
AN - SCOPUS:85113755061
SN - 0741-238X
VL - 38
SP - 5209
EP - 5220
JO - Advances in Therapy
JF - Advances in Therapy
IS - 10
ER -