Discussion
migraine, CM, headache
MIGRAINE, SECONDARY
The objective of this study was to evaluate the efficacy and safety of eptinezumab to prevent migraine and headache in a predominantly Asian patient population with a dual diagnosis of migraine and MOH. Although the study’s primary endpoint did not meet statistical significance and the hierarchical testing strategy was stopped after the first primary endpoint hypothesis test, the data consistently trended in favor of eptinezumab treatment versus placebo, with p-values below 0.05 observed in 3 out of the 6 key secondary endpoints (migraine on the day after dosing, ≥ 75% reduction from baseline in MMDs [Weeks 1–4], ≥ 75% reduction from baseline in MMDs [Weeks 1–12], as well as in the PGIC and PI-MBS patient perception of change).There can be many reasons why the primary endpoint of the study was not met. One reason is a smaller effect size than anticipated, and another reason is that the sample size was smaller than previous studies of eptinezumab in migraine prevention studies [Patients with MOH were included in this study and there are differences between Asian and European patients, including the overused medications and clinical manifestations of MOH, which can also partly explain the results [Of note, in the SUNLIGHT patient population, 57% of the enrolled patients had no previous preventive treatment failures. In the previous subgroup analysis of patients with CM and MOH in a larger study from the US and Europe, all patients treated with eptinezumab reported prior use of an oral preventive [