Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine.
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.
['Ashina|Messoud|M|', 'Goadsby|Peter J|PJ|https://orcid.org/0000-0003-3260-5904', 'Reuter|Uwe|U|', 'Silberstein|Stephen|S|', 'Dodick|David|D|', 'Rippon|Gregory A|GA|', 'Klatt|Jan|J|', 'Xue|Fei|F|', 'Chia|Victoria|V|', 'Zhang|Feng|F|', 'Cheng|Sunfa|S|', 'Mikol|Daniel D|DD|']
D000328:Adult D061067:Antibodies, Monoclonal, Humanized D000077221:Calcitonin Gene-Related Peptide Receptor Antagonists D004311:Double-Blind Method D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D008881:Migraine Disorders D016896:Treatment Outcome
safety Erenumab migraine