Eptinezumab improved patient-reported outcomes in patients with migraine and medication-overuse headache: Subgroup analysis of the randomized PROMISE-2 trial.

Autor: Starling AJ; Mayo Clinic, Scottsdale, Arizona, USA., Cowan RP; Department of Neurology and Neurological Sciences, Stanford University Headache and Facial Pain Program, Palo Alto, California, USA., Buse DC; Department of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA.; Vector Psychometric Group, LLC, Chapel Hill, North Carolina, USA., Diener HC; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University Duisburg-Essen, Essen, Germany., Marmura MJ; Jefferson Headache Center, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania, USA., Hirman J; Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA., Brevig T; H. Lundbeck A/S, Copenhagen, Denmark., Cady R; Lundbeck LLC, Deerfield, Illinois, USA.; RK Consults, Ozark, Missouri, USA.; Missouri State University, Springfield, Missouri, USA.
Jazyk: angličtina
Zdroj: Headache [Headache] 2023 Feb; Vol. 63 (2), pp. 264-274. Date of Electronic Publication: 2023 Jan 12.
DOI: 10.1111/head.14434
Abstrakt: Objective: To evaluate the effect of eptinezumab on patient-reported outcomes in patients with chronic migraine (CM) and medication-overuse headache (MOH).
Background: MOH is a secondary headache disorder commonly occurring in patients with CM and associated with functional and psychological impairments. Medication overuse and monthly headache and migraine days were reduced with eptinezumab compared with placebo as published previously; however, these outcomes do not fully capture the burden of migraine and treatment effect.
Methods: PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled trial in adults with CM. Patients were randomized (1:1:1) to receive eptinezumab 100 mg, eptinezumab 300 mg, or placebo (up to 2 doses, 12 weeks apart). Patients completed the following patient-reported outcomes: 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), patient-identified most bothersome symptom (PI-MBS), and 36-item Short-Form Health Survey (SF-36).
Results: A total of 431 CM patients (139, 147, and 145 patients in the eptinezumab 100 mg, eptinezumab 300 mg, and placebo groups, respectively) had MOH diagnosed at screening (40.2% of the total PROMISE-2 population [n = 1072]). In CM with MOH patients, both doses of eptinezumab were associated with clinically meaningful improvements in mean HIT-6 total scores by week 4 and remained improved throughout the 24-week study. Responder rates for individual HIT-6 items were greater with eptinezumab than with placebo at all time points. At week 12, almost twice as many eptinezumab-treated patients indicated the PGIC was "much" or "very much" improved (58.5% [79/135, 100 mg] and 67.4% [95/147, 300 mg] vs. 35.8% [48/134, placebo]). Patients in the eptinezumab groups showed numerically greater improvements over placebo in the PI-MBS and SF-36 scores.
Conclusions: This subgroup analysis in patients with CM/MOH at baseline suggests that eptinezumab treatment is associated with early, sustained, and clinically meaningful improvements in patient-reported outcomes.
(© 2023 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.)
Databáze: MEDLINE
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