Use of Acute Headache and Migraine Medications in Patients with Episodic Migraine in the STRIVE Phase 3 Trial of Erenumab for Migraine Prevention (P4.118)

Objective: Toanalyze (A) change in acute headache medication days/month (AHM, includingacute migraine-specific medications (AMSM) as well as paracetamol, NSAIDS etc.)in the overall population as 97.7% used AHM during baseline; (B) change in AMSM days/month in the subgroup who used AMSM during baseline. Background: Erenumab is a fully human monoclonal antibody that selectively inhibits the calcitonin gene-related peptide (CGRP) receptor. In the STRIVE placebo-controlled Phase 3 trial (NCT02456740), erenumab 70 mg and 140 mg administered subcutaneously to patients with episodic migraine (EM) significantly reduced monthly migraine days versus placebo. Erenumab also reduced the number of days/month on which patients used AMSM, versus placebo. Design/Methods: Patients recorded medication use with a daily eDiary throughout the 4-week baseline period and subsequent 6-month double-blind treatment period. The number of days/month on which AMSM and AHM were taken was calculated. Change from baseline was analyzed using a linear mixed effects model including covariates of treatment, visit, treatment by visit interaction, stratification factors (region and migraine prophylaxis medication status), and baseline value. Nominal p-values were provided without multiplicity adjustment. Results: (A) During baseline, the mean number of AHM days/month in the overall population was 6.91, 6.58, and 6.60 in the placebo, erenumab 70 mg, and 140 mg groups, respectively. Erenumab significantly reduced AHM days/month versus placebo from Month 1 onward. (B) Mean number of AMSM days/month in patients who used AMSM during baseline was 5.68, 5.67, and 5.67 in the placebo, erenumab 70 mg, and 140 mg groups, respectively. Erenumab significantly reduced AMSM days/month versus placebo; mean (95% confidence interval) treatment difference −1.57 days (−2.04, −1.10; p Conclusions: Erenumab significantly reduced both AHM and AMSM days/month versus placebo in patients with EM. Study Supported by: Novartis/Amgen Disclosure: Dr. Reuter has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, Novartis, Pharm Allergan; EliLily, TEVA. Dr. Reuter has received research support from Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, Novartis,EliLilly and TEVA. Dr. Pascual has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, and Novartis. 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. Hallstrom has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen and Sanofi. 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. Cheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Cheng has received compensation for serving on the Board of Directors of Amgen. 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. 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. Dr. Klatt has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. Klatt has received compensation for serving on the Board of Directors of Novartis.