Efficacy of Erenumab for the Treatment of Patients with Episodic Migraine with Depression and/or Anxiety (P4.105)

Objective: To determine efficacy of erenumab, a human anti-CGRP receptor antibody, in episodic migraine (EM) patients with depression and/or anxiety. Background: Determining treatment outcomes in patients with depression and anxiety, two common migraine comorbidities, is relevant for estimating real-world effectiveness. Design/Methods: Subgroup analysis of phase 3 data in EM patients randomized 1:1:1 to erenumab (70-mg or 140-mg) or placebo monthly for 6 months. Pre-specified data from patients with/without history of depression and/or anxiety (self-reported) assessed for changes from baseline over months 4–6 in monthly migraine days (MMD), acute migraine-specific medication days (MSMD), and proportion of patients achieving ≥50% reduction in MMD. P -values not adjusted for multiple comparisons. Results: 23% (74/319) of placebo patients, 18% (58/317) of 70-mg, and 19% (61/319) of 140-mg had history of depression and/or anxiety. Baseline characteristics were similar among groups. Compared with placebo, erenumab resulted in greater improvement in all three efficacy measures in patients with and without depression/anxiety history. In patients with depression/anxiety history, least-squares mean (SE) changes in MMD were −1.3 (0.4) for placebo vs −4.2 (0.4) for 70-mg (p Conclusions: Results indicate that erenumab is efficacious in migraine patients both with and without depression/anxiety. Study Supported by: This study was fully funded by Amgen. Erenumab is co-developed in partnership with Amgen and Novartis. Disclosure: Dr. Tepper has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Alder, Allergan, Amgen, ATI, Avanir, BioVison, Charleston Laboratories, Dr. Reddy’s, electroCore, eNeura, Eli Lilly, GLG, Guidepoint Global, Kimberly-Clark, Pernix, Pfizer, Scion Neurostim, Supernus, Teva, Zosano. Dr. Broessner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis, Pfizer, Allergan, Reckitt Benkiser,Linde AG. Dr. Broessner has received research support from Novartis, Amgen. Dr. Buse has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Avanir, Amgen, Biohaven, Eli Lilly and Company and Promeius. Dr. Schwedt has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, ATI, Avanir, Dr. Reddy’s, Nocira, Novartis, Teva. Dr. Schwedt has received personal compensation in an editorial capacity for Headache, Pain Medicine, Cephalalgia. Dr. Strauss has nothing to disclose. 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.