The number of migraine days per month has been significantly cut in people with episodic migraine, results from a phase III trial of the monoclonal antibody erenumab have found.
The findings of the STRIVE trial, published in the New England Journal of Medicine, showed that erenumab at two different doses cut the number of monthly migraine days by 3.2 and 3.7 respectively, down from an average of 8.3 at the start of the trial.
The trial recruited 955 adults with at least a 12-month history of migraine, and an average of fewer than 15 migraine days per month. Migraine on more than 15 days per month is classed as chronic migraine and affects only 5–8% of people with migraine.
Patients were randomly assigned to erenumab 70mg, erenumab 140mg or placebo, by monthly subcutaneous injection for six months.
At months four to six, 43.3% of patients assigned to the 70mg dose had achieved at least a 50% reduction in the mean number of migraine days per month, as did 50.0% of those assigned to the higher dose. This compared with 26.6% of those assigned to placebo.
Both doses of erenumab were also associated with significantly fewer days of acute migraine medication, reduced physical impairment and improved everyday activity scores, compared with placebo.
The rates of adverse events were similar between erenumab and placebo but the authors say the long-term safety of the drug needs further study.
Erenumab is a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, a key part of a pathway shown to be involved in migraine activation.
“The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy,” said lead author Peter Goadsby from King’s College Hospital London.
“STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment.”
The drug is currently under regulatory review in both the [United States] US and Europe.