Analysis of Injection Site Reactions across Four Placebo Controlled Trials of Erenumab for Migraine Prevention (P4.116)

Objective: To assess the frequency of injection site reaction-related adverseevents (ISR-AEs) observed in erenumab clinical trials in subjects with eitherepisodic or chronic migraine. Background: Erenumabis a fully human monoclonal antibody that selectively inhibits the calcitoningene-related peptide (CGRP) receptor and is under investigation for migraineprevention. Design/Methods: Data wereobtained from four randomized, placebo-controlled trials (clinicaltrials.gov: NCT01952574, NCT02066415/NCT02174861, NCT02456740, and NCT02483585). Analysis was performedfor the 12-week double-blind placebo-controlled treatment period (DBTP;erenumab and placebo) and the entire erenumab exposure period (EEP), includingthe open-label extension phase (erenumab only). AEs were graded according to theCommon Terminology Criteria Version 4.03. Results: Overthe 12-week DBTP, incidence of ISR-AEs was 3.2%, 5.6%, and 4.5% in the placebo, erenumab 70 mg, and 140 mg groups, respectively. Incidence of injection sitepain, erythema and pruritus was comparable in the placebo, erenumab 70 mg, anderenumab 140 mg groups. Over the EEP, which extended erenumab exposure tomedian 46 weeks (mean 47 weeks, range 0–159), incidence of ISR-AEs was 6.1% and4.2% in the erenumab 70 mg and 140 mg groups, respectively. Most ISR-AEs weremild (Grade 1). Moderate ISR-AEs (Grade 2) were injection site erythema (n=4,0.2%), injection site pain (n=3, 0.1%), and injection site reaction, injectionsite induration, and injection site urticaria (n=1 each, 2, and no serious ISR-AEs. Across 2519 subject-years oferenumab exposure, one subject discontinued due to injection site pain, one dueto injection site rash, and one due to injection site urticarial. Conclusions: ISR-AEs occurred in a small proportion of subjectstreated with either dose of erenumab, with little change over time. Most ISR-AEswere mild and did notrequire discontinuation. Study Supported by: Novartis/Amgen Disclosure: Dr. Pascual has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, and Novartis. Dr. Doleuil has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, Biogen Idec, Novartis, Bayer, and Teva. Dr. Davies has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Midlands headache clinic, University Hospital of North Midlands,ALLERGAN, NOVARTIS and TEVA. Dr. Davies has received research support from UK research study funding via the UK NIHR from AMGEN, NOVARTIS, ALDER, ALLERGAN and Eli Lilly. 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. Hong has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. 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. Xue has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Xue 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.