Across the UK, an estimated 8.5 million people live with migraine and research suggests the condition is likely to impact the lives of almost 200,000 people every day.
There is an urgent need for new treatment options and erenumab is the first and only fully human monoclonal antibody of its kind designed to specifically prevent migraine. It works by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation.
Amgen and Novartis, the codevelopers of erenumab, funded this Phase III STRIVE study.
‘STRIVE is the first fully reported Phase III study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine,’ said Peter Goadsby, Director, NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College London. ‘The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy. STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment.’
These data show erenumab can significantly reduce the number of monthly migraine days experienced by patients, with a 3.7-day and 3.2-day reduction with erenumab 140 mg and 70 mg, respectively, from a baseline of 8.3-days (1.8-day reduction with placebo). Additionally, 50 per cent of patients treated with erenumab 140 mg had the number of days with migraine symptoms cut by at least half (this figure was 43.3 per cent following treatment with erenumab 70 mg, and 26.6 per cent with placebo). Results from the Migraine Physical Function Impact Diary (MPFID) show patients treated with erenumab also reported improved physical health and ability to participate in daily activities over the six month trial period. Erenumab has also been shown to be effective and tolerable over the long term with a safety profile comparable to placebo.
‘Migraine is too often trivialized as just a headache when, in reality, it can be a debilitating, chronic condition that can destroy lives’ said Simon Evans, Chief Executive, Migraine Action. ‘The effects can last for hours – even days in many cases. An option that can prevent migraine and that is well tolerated is therefore sorely needed and we hope that this marks the start of real change in how this condition is treated and perceived.’
They tested erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene–related peptide receptor, for the prevention of episodic migraine.
They randomly assigned patients to receive a subcutaneous injection of either erenumab, at a dose of 70 mg or 140 mg, or placebo monthly for 6 months. The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month. Secondary end points were a 50% or greater reduction in mean migraine days per month, change in the number of days of use of acute migraine–specific medication, and change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary (scale transformed to 0 to 100, with higher scores representing greater migraine burden on functioning).
Erenumab administered subcutaneously at a monthly dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine–specific medication over a period of 6 months