Impact of Eptinezumab Treatment on Migraine Frequency, Duration, and Severity in Patients with Migraine (659)

Objective: To quantify the amount of time gained back after treatment with eptinezumab in patients with migraine. Background: Disruption due to migraine can be mitigated by several factors including reducing the number, shortening duration, and lessening severity of migraine, all resulting in time gained back to patients. Eptinezumab, a CGRP monoclonal antibody administered intravenously, has demonstrated migraine preventive efficacy in patients with episodic migraine (EM) and chronic migraine (CM). Design/Methods: PROMISE-1 (NCT02559895) and PROMISE-2 (NCT02974153) were double-blind, randomized, placebo-controlled trials evaluating eptinezumab for migraine prevention (PROMISE-1: 888 patients with EM, four 12-week dosing intervals; PROMISE-2: 1072 patients with CM, two 12-week dosing intervals). Post hoc analyses calculated the expected number of migraine days over a year (baseline rate carried forward for 365 days) vs the number observed (normalized to a 365-day year). A daily eDiary captured duration and severity of migraine as secondary endpoints. Results: In PROMISE-1, the expected number of migraine days over 1 year was 113 (100mg), 113 (300mg), and 109 (placebo). The observed number of migraine days was 55, 49, and 62, resulting in gains of 58 and 64 days with eptinezumab vs 47 days with placebo. In PROMISE-2, the expected number of migraine days was 210 (100mg), 210 (300mg), and 212 (placebo). The observed number was 105, 97, and 132, resulting in gains of 105 and 113 days with eptinezumab vs 79 days with placebo. In addition, in both PROMISE-1 and PROMISE-2, treatment with eptinezumab resulted in greater decreases in the median duration of migraine and number of severe migraines vs placebo. Conclusions: Treatment with eptinezumab resulted in more days without migraine, shorter duration of migraine, and decreased migraine severity versus placebo. Over 6 months, patients with EM and CM can expect to gain back ~1 and ~2 months of migraine-free days, respectively. Disclosure: Dr. Winner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, Supernus, Teva, Novartis, Avanir, and Promius..Dr. Goadsby has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Reports personal fees from Amgen, Eli Lilly, Alder Biopharmaceuticals, Allergan, Biohaven Pharmaceuticals Inc., Clexio, Electrocore LLC, eNeura, Impel NeuroPharma, MundiPharma, Novartis, Teva Pharmaceuticals, Trigemina Inc., and WL Gore. Dr. Goadsby has received personal compensation in an editorial capacity for Journal Watch- Massachusetts Medical Society. Dr. Goadsby has received research support from Amgen and Eli-Lilly and Company.Dr. Chua has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan: Advisory Board, Amgen/Novartis: Speakers Bureau, electrocore: Speakers Bureau. Dr. Friedman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder Biopharmaceuticals, Allergan, Amgen, Biohaven, electroCore, Eli Lilly, Promius, Revance, Supernus, Teva, Theranica and Zosano. Dr. Friedman has received personal compensation in an editorial capacity for Neurology Reviews. Dr. Friedman has received research support from Allergan, Autonomic Technologies, Eli Lilly, Merck, and Zosano. Dr. Zhao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder Biopharmaceuticals. Dr. Cady has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Full time employee at Alder BioPharmaceuticals Inc..