Autor:innen:
Julio Pascual | University Hospital Marqués de Valdecilla and IDIVAL | Spain
Frank Hong | Novartis Pharma AG
Daniel Mikol | Amgen Inc.
Jan Klatt | Novartis Pharma AG | Switzerland
Objective: To assess the frequency of injection site reaction-related adverse events (ISR-AEs) observed in erenumab clinical trials in subjects with either episodic or chronic migraine.
Background: Erenumab is a fully human monoclonal antibody that selectively inhibits the calcitonin gene-related peptide (CGRP) receptor and is under investigation for migraine prevention.
Design/Methods: Data were obtained from four randomized, placebo-controlled trials (clinicaltrials.gov: NCT01952574, NCT02066415/NCT02174861, NCT02456740, and NCT02483585). Analysis was performed for the 12-week double-blind placebo-controlled treatment period (DBTP; erenumab and placebo) and the entire erenumab exposure period (EEP), including the open-label extension phase (erenumab only). AEs were graded according to the Common Terminology Criteria Version 4.03.
Results: Over the 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 site pain, erythema and pruritus was comparable in the placebo, erenumab 70 mg, and erenumab 140 mg groups. Over the EEP, which extended erenumab exposure to median 46 weeks (mean 47 weeks, range 0–159), incidence of ISR-AEs was 6.1% and 4.2% in the erenumab 70 mg and 140 mg groups, respectively. Most ISR-AEs were mild (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, injection site induration, and injection site urticaria (n=1 each, < 0.1%). There were no ISR-AEs of Grade > 2, and no serious ISR-AEs. Across 2519 subject-years of erenumab exposure, one subject discontinued due to injection site pain, one due to injection site rash, and one due to injection site urticaria.
Conclusion: ISR-AEs occurred in a small proportion of subjects treated with either dose of erenumab, with little change over time. Most ISR-AEs were mild and did not require discontinuation.