Half of the episodic migraine patients given a new drug, Erenumab, experienced significantly fewer days with migraine symptoms, according to a new study.
The global Phase III STRIVE study, published in the New England Journal of Medicine (NEJM), found that 50% of patients given a 140 mg dose of erenumab for six months, instead of placebo, saw the amount of migraines they experienced over a month reduced by at least half.
Erenumab is the first fully human monoclonal antibody specifically designed to block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation.
Researchers randomly prescribed 955 patients with either once-monthly subcutaneous placebo, or erenumab, 70mg or 140mg, in a 1:1:1 ratio.
They concluded that erenumab can significantly reduce the number of monthly migraine days experienced by patients, from an average of over eight days to fewer than four. Patients treated with erenumab also reported improved physical health and ability to participate in daily activities over the six month trial period.
Peter Goadsby, professor of neurology and director of the NIHR-Wellcome Trust Clinical Research Facility at King’s College Hospital, London, welcomed the results.
He said: ‘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.
‘The results 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.’
Simon Evans, chief executive of Migraine Action, said: ‘Migraine is too often trivialised as just a headache when, in reality, it can be a debilitating, chronic condition that can destroy lives.
‘An option that can prevent migraine and 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.’
But Dr Andrew Green, the BMA GP Committee’s prescribing lead, struck a note of caution.
He said: ‘It is far too early to say if this will prove to be a useful addition to our options in treating migraine patients, particularly in the light of the high cost of these new agents. Even if it has a place, it will be a hospital and not a primary care treatment.
‘The problem for us is that drug companies extol the virtues of their products in advance of them becoming available in order to create a demand, patients then attend their GPs and are disappointed when it turns out that they cannot have the latest wonder-cure that they have read about in the newspapers.’
This comes after Pulse reported that GPs will be banned from prescribing for mild migraine, and 33 other self-limiting conditions, under new NHS England proposals to be released early next year.