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Cephalalgia. 2019 May 30:333102419854082. doi: 10.1177/0333102419854082. [Epub ahead of print]

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

Author information

1
1 Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
2
2 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.
3
3 Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.
4
4 Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.
5
5 Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.
6
6 Amgen Inc., Thousand Oaks, CA, USA.
7
7 Novartis Pharma AG, Basel, Switzerland.

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.

KEYWORDS:

Erenumab; migraine; safety

PMID:
31146544
DOI:
10.1177/0333102419854082

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