Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine

Messoud Ashina, Peter J. Goadsby, Uwe Reuter, Stephen Silberstein, David Dodick, Gregory A. Rippon, Jan Klatt, Fei Xue, Victoria Chia, Feng Zhang, Sunfa Cheng, Daniel D. Mikol

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

Background: Previously published three-month placebo-controlled and one-year open-label clinical trial data have provided information on the efficacy and safety of erenumab. Methods: Interim analysis was undertaken from an ongoing five-year open-label treatment phase after all patients completed three years in the open-label treatment phase or discontinued the study. Adult patients with episodic migraine enrolled in the open-label treatment phase initially received 70 mg erenumab monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs. Results: Of 383 patients enrolled in the open-label treatment phase, at data cutoff 235 (61.3%) remained in the study, all received 140 mg for ≥1 year. Median (Q1, Q3) exposure (70 or 140 mg) for all patients enrolled was 3.2 (1.3, 3.4) years. The most frequent adverse events (≥4.0/100 patient-years) were reported as viral upper respiratory tract infection, sinusitis, influenza, and back pain. Exposure-adjusted serious adverse event rates were 4.2/100 patient-years. There was no increase in cardiovascular events over time. Conclusions: In this long-term study of a CGRP-receptor antibody, erenumab was found to be safe and well-tolerated with a spectrum and rate of adverse events consistent with shorter-term placebo-controlled studies. Trial registration: ClinicalTrials.gov NCT01952574

Original languageEnglish (US)
Pages (from-to)1455-1464
Number of pages10
JournalCephalalgia
Volume39
Issue number11
DOIs
StatePublished - Oct 1 2019

Keywords

  • Erenumab
  • migraine
  • safety

ASJC Scopus subject areas

  • Clinical Neurology

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    Ashina, M., Goadsby, P. J., Reuter, U., Silberstein, S., Dodick, D., Rippon, G. A., Klatt, J., Xue, F., Chia, V., Zhang, F., Cheng, S., & Mikol, D. D. (2019). Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia, 39(11), 1455-1464. https://doi.org/10.1177/0333102419854082