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

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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)
JournalCephalalgia
DOIs
StatePublished - Jan 1 2019

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Keywords

  • Erenumab
  • migraine
  • safety

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Ashina, M., Goadsby, P. J., Reuter, U., Silberstein, S., Dodick, D. W., 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. https://doi.org/10.1177/0333102419854082