Long-Term Reductions in Headache Frequency, Severity, and Disability with Eptinezumab in Adults with Chronic Migraine: Results from the PREVAIL Trial

INTRODUCTION: Individuals with chronic migraine (CM) experience substantial headache-related disability. Post hoc analyses from the PREVAIL trial assessed the long-term impact of eptinezumab preventive treatment for CM on patient-centered measures of headache frequency, headache pain severity, disability, and quality of life. METHODS: In the 104-week, open-label PREVAIL trial, which evaluated long-term safety and patient-reported outcomes, participants received eptinezumab 300 mg intravenously every 12 weeks to week 84 for preventive treatment of CM. The Migraine Disability Assessment (MIDAS) scale was used to evaluate proportions of participants with sustained ≥ 50% and ≥ 75% reductions in mean monthly headache days (MHDs) through 12-week dosing intervals to week 84 and changes in mean MHD frequency category (e.g., 0, 1- < 4 MHDs), Frequency-Severity Index (FSI) scores (composite of MIDAS-derived mean MHDs and headache pain severity), and days with headache-related disability through week 104. RESULTS: Over half of participants with ≥ 50% or ≥ 75% reduction in mean MHDs after the first eptinezumab dose (weeks 1-12: 78% and 54%, respectively) or second dose (weeks 13-24: 83% and 69%, respectively) experienced sustained reductions in headache frequency through all subsequent dosing intervals until the last dose (week 84). At baseline, participants reported a mean (standard deviation [SD]) of 15.8 (7.6) MHDs. More than 60% of participants reported < 4 mean MHDs at week 12 and at all subsequent assessments through week 104 (20 weeks after last infusion) after initiating eptinezumab; 23% reported 0 mean MHDs by week 104. The mean FSI score decreased from baseline (11.4) to week 12 (3.5), with decreases maintained through week 104. Monthly days with headache-related impact also decreased from baseline to week 12, with improvements maintained through week 104. CONCLUSIONS: Treatment with eptinezumab 300 mg is associated with substantial early and long-term reductions in headache frequency, severity, and disability, indicating its ability to improve multiple aspects of the broader burden of CM. Graphical abstract available for this article. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02985398.