Patients who received erenumab achieved a 50% or greater reduction in the mean number of migraine days per month and cut the number of days of acute migraine-specific medication, according to phase 3 STRIVE study data published in The New England Journal of Medicine.
“Commonly used migraine-prevention therapies, such as topiramate, propranolol and amitriptyline, may not be entirely effective or may have unacceptable side effects, leading to poor adherence,” Peter J. Goadsby, MD, PhD, from the National Institute for Health Research/Wellcome Trust King’s Clinical Research Facility at King’s College Hospital in London, and colleagues wrote. “In phase 2 trials, erenumab was found to significantly reduce the number of migraine days per month in patients with episodic migraine at a monthly dose of 70 mg and in patients with chronic migraine at doses of 70 mg and 140 mg in the last month of a 3-month double-blind treatment phase.”
Researchers randomly assigned 955 patients to a subcutaneous injection of erenumab (Amgen and Novartis; 70 mg or 140 mg) or placebo monthly for 6 months to determine whether erenumab changed the mean number of migraine days per month from baseline to 4 months. They also assessed whether erenumab elicited a 50% or greater reduction in mean migraine days per month, change in the number of days patients used acute migraine-specific medication, and change in physical impairment and everyday activities.
Of 955 patients, 317 received 70 mg erenumab, 319 received 140 mg erenumab and 319 received placebo. Overall, the mean number of migraine days per month at baseline was 8.3. By months 4 through 6, the number of days was reduced by 3.2 in the 70-mg group and by 3.7 in the 140-mg group, whereas the reduction was only 1.8 days in the placebo group (P < .001 for each dose vs. placebo).
About 43% of the patients who received 70 mg erenumab and 50% of those who received 140 mg erenumab experienced a 50% or greater decrease in the mean number of migraine days per month vs. 26.6% in the placebo group (P < .001). Patients in the 70-mg and 140-mg groups also had a higher reduction in the number of days using acute migraine-specific medication compared with the placebo group (1.1 days for 70 mg; 1.6 days for 140 mg; 0.2 days for placebo; P < .001). All patients who received erenumab showed more improvement in the areas of physical impairment and everyday activity vs. placebo (P < .001). Erenumab and placebo had similar rates of adverse events.
“Migraine-preventive treatment with subcutaneous erenumab ... at a monthly dose of 70 mg or 140 mg resulted in a mean reduction in the frequency of migraine days that was significantly greater (by almost 2 days) than that associated with placebo,” Goadsby and colleagues wrote. “The double-blind treatment phase of this trial, conducted over a period of 6 months in patients with episodic migraine, together with other phase 2 and 3 trials of erenumab for the treatment of episodic and chronic migraine, suggest that erenumab may be useful for the prevention of episodic migraine.” – by Savannah Demko
: The study was supported by Amgen and Novartis. Goadsby reports he receives personal fees from Akita Biomedical, Alder Biopharmaceuticals, Avanir Pharma, Cipla, Dr. Reddy's Laboratories, Novartis, Pfizer, Quest Diagnostics, Scion, Teva Pharmaceuticals and ElectroCore; grants and personal fees from Allergan, Amgen, Eli Lilly and Company, eNeura and Trigemina; and has a patent licensed to eNeura. Please see the study for all other authors’ relevant financial disclosures.