Cephalalgia

, volume 39 , issue 11 , pages 1455-1464

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

M. Ashina ¹

Peter J. Goadsby ²

Uwe Reuter ³

Stephen D. Silberstein ⁴

David J. Dodick ⁵

Gregory A. Rippon ⁶

Jan Klatt ⁷

Fei Xue ⁶

Victoria Chia ⁶

Feng Zhang ⁶

Sunfa Cheng ⁶

Daniel D. Mikol ⁶

Hide authors affiliations Show authors affiliations: 7 affiliations

Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark |

NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK |

Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany |

⁴

Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA |

⁵

Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA |

⁶

Amgen Inc., Thousand Oaks, CA, USA |

⁷

Novartis Pharma Ag, Basel, Switzerland |

Publication type: Journal Article

Publication date: 2019-05-30

SAGE

Cephalalgia

scimago Q1

wos Q1

SJR: 1.367

CiteScore: 9.4

Impact factor: 4.6

ISSN: 03331024, 14682982

DOI: 10.1177/0333102419854082

Copy DOI

PubMed ID: 31146544

General Medicine

Neurology (clinical)

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

Found

1 citation

Maestrini Ilaria

47 publications, 910 citations, 70 reviews

h-index: 15

Sapienza University of Rome

University of Rome Tor Vergata

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GOST |

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GOST Copy

Ashina M. et al. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine // Cephalalgia. 2019. Vol. 39. No. 11. pp. 1455-1464.

GOST all authors (up to 50) Copy

Ashina M., Goadsby P. J., Reuter U., Silberstein S. D., Dodick D. J., Rippon G. A., Klatt J., Xue F., Chia V., Zhang F., Cheng S., Mikol D. D. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine // Cephalalgia. 2019. Vol. 39. No. 11. pp. 1455-1464.

RIS |

Cite this

RIS Copy

TY - JOUR

DO - 10.1177/0333102419854082

UR - https://doi.org/10.1177/0333102419854082

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

T2 - Cephalalgia

AU - Ashina, M.

AU - Goadsby, Peter J.

AU - Reuter, Uwe

AU - Silberstein, Stephen D.

AU - Dodick, David J.

AU - Rippon, Gregory A.

AU - Klatt, Jan

AU - Xue, Fei

AU - Chia, Victoria

AU - Zhang, Feng

AU - Cheng, Sunfa

AU - Mikol, Daniel D.

PY - 2019

DA - 2019/05/30

PB - SAGE

SP - 1455-1464

IS - 11

VL - 39

PMID - 31146544

SN - 0333-1024

SN - 1468-2982

ER -

BibTex |

Cite this

BibTex (up to 50 authors) Copy

@article{2019_Ashina,

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

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

journal = {Cephalalgia},

year = {2019},

volume = {39},

publisher = {SAGE},

month = {may},

url = {https://doi.org/10.1177/0333102419854082},

number = {11},

pages = {1455--1464},

doi = {10.1177/0333102419854082}

}

MLA

Cite this

MLA Copy

Ashina, M., et al. “Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine.” Cephalalgia, vol. 39, no. 11, May. 2019, pp. 1455-1464. https://doi.org/10.1177/0333102419854082.

Publisher

SAGE

Journal

Cephalalgia

scimago Q1

wos Q1

SJR

1.367

CiteScore

9.4

Impact factor

4.6

ISSN

03331024 (Print)

14682982 (Electronic)