We tested erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene–related peptide receptor, for the prevention of episodic migraine.
Methods
We 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).
Results
A total of 955 patients underwent randomization: 317 were assigned to the 70-mg erenumab group, 319 to the 140-mg erenumab group, and 319 to the placebo group. The mean number of migraine days per month at baseline was 8. 3 in the overall population; by months 4 through 6, the number of days was reduced by 3. 2 in the 70-mg erenumab group and by 3. 7 in the 140-mg erenumab group, as compared with 1. 8 days in the placebo group (P<0. 001 for each dose vs. placebo).
A 50% or greater reduction in the mean number of migraine days per month was achieved for 43. 3% of patients in the 70-mg erenumab group and 50. 0% of patients in the 140-mg erenumab group, as compared with 26. 6% in the placebo group (P<0. 001 for each dose vs. placebo), and the number of days of use of acute migraine–specific medication was reduced by 1. 1 days in the 70-mg erenumab group and by 1. 6 days in the 140-mg erenumab group, as compared with 0. 2 days in the placebo group (P<0. 001 for each dose vs. placebo).
Physical-impairment scores improved by 4. 2 and 4. 8 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 2. 4 points in the placebo group (P<0. 001 for each dose vs. placebo), and everyday-activities scores improved by 5. 5 and 5. 9 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 3. 3 points in the placebo group (P<0. 001 for each dose vs. placebo). The rates of adverse events were similar between erenumab and placebo.
Conclusions
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. The long-term safety and durability of the effect of erenumab require further study. (Funded by Amgen and Novartis; STRIVE ClinicalTrials. gov number, NCT02456740. )
