Goadsby PJ, et al. - Herein, erenumab (a fully human monoclonal antibody that inhibits the calcitonin gene–related peptide receptor) was tested as a preventive for episodic migraine. Researchers observed a significant reduction in the frequency of migraine as well as the impacts of migraines on daily activities, and the use of acute migraine–specific medication over a period of 6 months as a result of subcutaneous administration of erenumab at a monthly dose of 70 mg or 140 mg.

Methods

• In a random manner, a subcutaneous injection of either erenumab, at a dose of 70 mg or 140 mg, or placebo monthly for 6 months was received by patients in this study.
• The change from baseline to months 4 through 6 in the mean number of migraine days per month was the primary end point.
• Secondary end points included: 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 were randomized: 317 were assigned to the 70-mg erenumab group, 319 to the 140-mg erenumab group, and 319 to the placebo group.
• In the overall population, the reported mean number of migraine days per month at baseline was 8.3; by months 4 through 6, when compared with 1.8 days in the placebo group, 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. (P<0.001 for each dose vs placebo).
• Findings demonstrated that for 43.3% of patients in the 70-mg erenumab group and 50.0% of patients in the 140-mg erenumab group, achievement of a 50% or greater reduction in the mean number of migraine days per month was reported relative to 26.6% in the placebo group (P<0.001 for each dose vs placebo), moreover, in the 70-mg erenumab group, a reduction by 1.1 days was visible in the number of days of use of acute migraine–specific medication, which reduced 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).
• Researchers noted improvement in the physical-impairment scores 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 improvement in the everyday-activities scores 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).
• In addition, data reported similar rates of adverse events between erenumab and placebo.