According to results of a new analysis, erenumab (Aimovig) demonstrates efficacy within 1 week of treatment in patients with both chronic and episodic migraine. The calcitonin gene-related peptide (CGRP) inhibitor, which received FDA approval in May, also demonstrated sustained efficacy through week 4.
Erenumab was the first CGRP inhibitor to receive FDA approval for the prevention of migraine in adults following positive results of the LIBERTY trial
, which assessed the once-monthly self-injected treatment in patients with episodic migraine who had previously failed on 2 to 4 treatments.
With the approval came hope of a fast-acting treatment for the affected population. “Most commonly prescribed preventive medications (beta-blockers, tricyclic antidepressants, topiramate, and valproate) require titration, and once the proper dose is attained, efficacy can still be delayed,” wrote the researchers. “This delay in efficacy, coupled with tolerability issues, contributes to poor adherence and, ultimately, failed migraine prevention.”
In addition to the LIBERTY trial, a 24-week, double-blind, placebo-controlled clinical trial in episodic migraine and a pivotal 12-week double-blind, placebo-controlled clinical trial in chronic migraine demonstrated efficacy and safety of erenumab 70 mg and 140 mg. In both studies, both doses of the treatment resulted in a reduction of monthly migraine days at all monthly time points, including the earliest prespecified time point of week 4, suggesting that both doses could also be effective at even earlier time points, according to the researchers.
To determine earlier efficacy, the researchers compiled data from both studies, including 955 patients with episodic migraine and 667 patients with chronic migraine.
Weekly migraine days at baseline were 2.1 for episodic migraine and 4.5 days for chronic migraine. In the episodic migraine study, erenumab led to a significant reduction in migraine days compared to placebo as early as week 1 (least squares mean [LSM] change from baseline 95% CI: placebo -0.1 [-0.3, 0.0], 70 mg -0.3 [-0.5, -0.2], 140 mg -0.6 [-0.7, -0.4]) and for all doses by week 4 (LSM change from baseline 95% CI: placebo -0.4 [-0.5, -0.2], 70 mg -0.6 [-0.8, -0.5], 140 mg -0.6 [-0.8, -0.5]).
Meanwhile, for chronic migraine, treatment with erenumab resulted in significant reductions in weekly migraine days compared to placebo for both doses at week 1 (LSM change from baseline 95% CI: placebo -0.5 [-0.8, -0.3], 70 mg -0.9 [-1.2, -0.7], 140 mg -0.8 [-1.1, -0.5]) and efficacy was sustained through week 4 (LSM change from baseline 95% CI: placebo -0.8 [-1.0, -0.6], 70 mg -1.5 [-1.7, -1.2], 140 mg -1.4 [-1.6, -1.1]).
In both studies, the odds of experiencing a 50% or more reduction from baseline in weekly migraine days were higher in patients receiving erenumab than those receiving placebo as early as week 1 and sustained through week 4. Notably, at week 1, 43% of patients with episodic migraine and 26% of patients with chronic migraine receiving erenumab 140 mg experienced a 50% or more reduction, compared to a 15% increase when treated with placebo in episodic migraine and a 10% increase when treated with placebo in chronic migraine.
Based on the results, the researchers suggested that erenumab may prove an important benefit to patients with a high burden of disease.
Schwedt T, Reuter U, Tepper, et al. Early onset efficacy with erenumab in patients with episodic and chronic migraine [published online October 1, 2018]. J Headache Pain
. doi: https://doi.org/10.1186/s10194-018-0923-6.