|The following article is part of conference coverage from the 2018 American Headache Society Annual Scientific Meeting in San Francisco, California. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AHS 2018.|
SAN FRANCISCO — Erenumab, a human monoclonal anti-CGRP receptor antibody, is safe and tolerable among patients with episodic migraine, according to study findings from an extension trial presented by Messoud Ashina, MD, PhD, DMSc, of the University of Copenhagen in Denmark, at the 2018 American Headache Society Annual Scientific Meeting, June 28-July 1, 2018 in San Francisco, California.
“Previously published 3-month placebo-controlled and 1-year open-label clinical trial data have provided information on efficacy and safety of erenumab,” the researchers wrote. “In this analysis we sought to assess the long-term safety and tolerability of erenumab in patients with migraine after ≥3 years of treatment.”
In their interim analysis of a 5-year open-label extension trial, study investigators evaluated the safety and tolerability of erenumab treatment in episodic migraine patients who completed ≥3 years of the trial or discontinued treatment. Patients were enrolled in the open-label extension trial after completing a placebo-controlled study of 7 mg, 21 mg, or 70 mg erenumab for 12 weeks (n=383). The initial treatment in the extension trial consisted of 70 mg erenumab per month. Dosage increased to 140 mg per month following a protocol amendment. The researchers assessed adverse events (AEs), laboratory test results, vital signs, and electrocardiograms to determine the long-term safety of the higher erenumab dose.
A total of 235 patients who received 140 mg erenumab for ≥1 year remained in the extension study at data cutoff. The exposure-adjusted rate of AEs was 128.1/100-patient-years after dosage increase. The most frequent AEs included upper influenza, viral upper respiratory tract infection, back pain, and sinusitis.
The rate of exposure-adjusted serious AEs was 4.2/100-patient-years. After 1 year in the open-label extension study and before dosage increase, 1 death occurred which was confounded by comorbidities. Over the 3.3-year study period, the researchers observed no increases in cardiovascular events, including no clinically meaningful changes in heart rate or systolic/diastolic blood pressure.
“In this first, and so far only, long-term study of a CGRP-pathway antibody, erenumab was found to be safe and well-tolerated with a spectrum and rate of AEs consistent with shorter-term placebo-controlled studies and no dose-dependent AEs,” the researchers concluded.
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Ashina M, Goadsby P, Reuter U, et al. Long-term safety and tolerability of erenumab: three-plus year results from an ongoing open-label extension study in episodic migraine. Presented at: 2018 American Headache Society Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 431139.