Efficacy of Erenumab For the Treatment of Patients with Episodic Migraine with Aura (P4.094)

Objective: To determine the efficacy of erenumab, a human anti-CGRP receptor antibody, in episodic migraine patents with aura in a subgroup analysis of a phase 3 trial. Background: It is unknown whether monoclonal antibody treatments for migraine, which have little CNS penetration, are equally effective in patients with and without aura. Design/Methods: Patients were randomized 1:1:1 to erenumab (70-mg or 140-mg) or placebo monthly for 6 months. This subgroup analysis of patients with/without history of aura (self-reported) assessed changes in monthly migraine days (MMD), acute migraine-specific medication days (MSMD), and proportion of patients achieving ≥50% reduction in MMD averaged over months 4–6. Nominal p-values presented without multiplicity adjustment and not used for pre-planned hypothesis testing. Results: Of 955 patients randomized, 52% (n=492) had history of aura. Baseline characteristics were similar among groups. Compared with placebo, erenumab induced greater reductions in MMD in both subgroups. In patients without aura history, least-squares mean (SE) changes from baseline were −1.5 (0.3) for placebo vs −2.7 (0.3) for 70-mg (p=0.002) and −3.8 (0.3) for 140-mg (p Conclusions: These data indicate that erenumab is efficacious in migraine patients with and without history of aura. Study Supported by: This study was fully funded by Amgen. Erenumab is co-developed in partnership with Amgen and Novartis. Disclosure: Dr. McAllister has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen Inc., Teva, Allergan. Dr. McAllister has received research support from Allergan, Amgen Inc., Eli Lilly, Teva, Scinovion, San Bio, Novartis. Dr. Pascual has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, and Novartis. Dr. McGill has nothing to disclose. Dr. Newman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Alder,Amgen,Novartis, Teva, and Supernus. Dr. Tassorelli has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Tassorelli has received personal compensation in an editorial capacity for Specialty Section Editor for Frontiers in Neurology and Associated Editor for The Journal of Headache and Pain. Dr. Zhang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Zhang has received compensation for serving on the Board of Directors of Amgen. Dr. Picard has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Picard has received compensation for serving on the Board of Directors of Amgen. Dr. Mikol has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Mikol has received compensation for serving on the Board of Directors of Amgen.