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

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

Novel Medications for the Treatment of Migraine

“…69,70 Patients receiving 70 mg every 4 weeks had significant reduction in MDD at week 64, with 65% of patients achieving ≥50% reduction and 26% achieving 100% reduction. Interim analysis of a 5-year open label extension study of erenumab provides further efficacy and safety information.…”

“…Interim analysis of a 5-year open label extension study of erenumab provides further efficacy and safety information. 69 Erenumab 140 mg administration has also been studied in patients with stable angina and was not shown to adversely affect treadmill exercise time. 68 A protocol amendment increased to dose to 140 mg every 4 weeks to assess safety at the higher dose, with a median exposure to the medication of 3.2 years.…”

Acceptance and Commitment Therapy (ACT) vs Erenumab for High Frequency Episodic Migraine Without Aura: Time to Take the Gloves Off!

“…Also, studies on the use of mindfulness and ACT in migraine have demonstrated improvement in patients’ ability to tolerate pain, reduce the use of symptomatic medications and to modulate specific characteristics of the migraine personality (rigidity, low acceptance, and low resilience) . Recently, the calcitonin gene‐related peptide monoclonal antibodies (MAbs), innovative and specific, but costly pharmacological therapies have been introduced and have shown benefit in the management of both episodic and chronic migraine . Real‐world experiences with some of these drugs are just being published …”

“…Recently, the calcitonin gene‐related peptide monoclonal antibodies (MAbs), innovative and specific, but costly pharmacological therapies have been introduced and have shown benefit in the management of both episodic and chronic migraine . Real‐world experiences with some of these drugs are just being published …”

Anti‐Calcitonin Gene‐Related Peptide (CGRP) Therapies: Update on a Previous Review After the American Headache Society 60th Scientific Meeting, San Francisco, June 2018

“…As noted in the previous review, 1 year of open label data on erenumab was published for safety and efficacy in EM prevention . At the AHS meeting, the investigators provided an interim analysis for what is planned as a 5‐year OLE for EM prevention in which 61.3% (235 patients) completed ≥3 years in the trial …”