Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study

The Journal of Headache and Pain

Richard B. Lipton¹  Dawn C. Buse²  Jessica Ailani³  Annika Lindsten⁴  Mette Krog Josiassen⁴  Anders Ettrup⁴  Roger Cady⁵  Lahar Mehta⁶  George Chakhava⁷  Peter McAllister⁸  Paul K. Winner⁹ 

[1] Albert Einstein College of Medicine, Bronx, NY, USA;Albert Einstein College of Medicine, Bronx, NY, USA;Vector Psychometric Group, LLC, Chapel Hill, NC, USA;Department of Neurology, Georgetown University Hospital, Washington, DC, USA;H. Lundbeck A/S, Copenhagen, Denmark;Lundbeck LLC, Deerfield, IL, USA;Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA;Multiprofile Clinic Consilium Medulla, Georgian Association of Medical Specialties, David Tvildiani Medical University, Tbilisi, Georgia;New England Institute for Neurology and Headache, Stamford, CT, USA;Palm Beach Headache Center, West Palm Beach, FL, USA;Neurology Research Institute Palm Beach, West Palm Beach, FL, USA;Premiere Research Institute, West Palm Beach, FL, USA;Palm Beach Neurology, West Palm Beach, FL, USA;Nova Southeastern University, Fort Lauderdale, FL, USA;

关键词: Migraine;    Eptinezumab;    CGRP;    MBS;   

DOI  :  10.1186/s10194-021-01376-7

来源: Springer

【 摘 要 】

BackgroundDemonstrating therapeutic value from the patient perspective is important in patient-centered migraine management. The objective of this study was to investigate the impact of eptinezumab, a preventive migraine treatment, on patient-reported headache impact, acute medication optimization, and perception of disease change when initiated during a migraine attack.MethodsRELIEF was a randomized, double-blind, placebo-controlled trial conducted between 2019 and 2020 in adults with ≥1-year history of migraine and 4–15 migraine days per month in the 3 months prior to screening. Patients were randomized (1:1) to a 30-min infusion of eptinezumab 100 mg or placebo within 1–6 h of a qualifying migraine attack onset. The 6-item Headache Impact Test (HIT-6) and 6-item Migraine Treatment Optimization Questionnaire (mTOQ-6) were administered at baseline and week 4, and the Patient Global Impression of Change (PGIC) at week 4. A post hoc analysis of these measures was conducted in patients who reported headache pain freedom at 2 h after infusion start.ResultsOf 480 patients enrolled and treated, 476 completed the study and are included in this analysis. Mean baseline HIT-6 total scores indicated severe headache impact (eptinezumab, 65.1; placebo, 64.8). At week 4, the eptinezumab-treated group demonstrated clinically meaningful improvement in HIT-6 total score compared with placebo (mean change from baseline: eptinezumab, − 8.7; placebo, − 4.5; mean [95% CI] difference from placebo: − 4.2 [− 5.75, − 2.63], P < .0001), with greater reductions in each item score vs placebo (P < .001 all comparisons). Change in HIT-6 total score in the subgroup with 2-h headache pain freedom was − 13.8 for the eptinezumab group compared with − 4.9 for the placebo group. mTOQ-6 total score mean change from baseline favored eptinezumab (change, 2.1) compared with placebo (1.2; mean [95% CI] difference: 0.9 [0.3, 1.5], P < .01). More eptinezumab-treated patients rated PGIC as much or very much improved than placebo patients (59.3% vs 25.9%).ConclusionsWhen administered during a migraine attack, eptinezumab significantly improved patient-reported outcomes after 4 weeks compared with placebo, with particularly pronounced effects in patients reporting headache pain freedom at 2 h after infusion start.Trial registrationClinicalTrials.gov Identifier: NCT04152083. November 5, 2019.

【 授权许可】

CC BY