To evaluate the effect of eptinezumab on time to next migraine and the 6-item Headache Impact Test (HIT-6) when administered during a moderate to severe migraine in patients considered candidates for preventive therapy.

Eptinezumab, a humanized anti?calcitonin gene-related peptide monoclonal antibody, is approved in the US for the preventive treatment of migraine in adults.

RELIEF was a parallel-group, double-blind, randomized, placebo-controlled study (NCT04152083). Eligible patients were aged 18–75 years and had migraine 4–15 days/month in the 3 months prior to screening. Patients were randomly assigned (1:1) to infusion with eptinezumab 100mg or placebo within 1–6 hours of qualifying migraine start. Primary and secondary endpoints evaluated efficacy over the first 48 hours and safety, which are presented separately. Exploratory endpoints reported herein included time to next migraine (from day 3 to the start of the next migraine as reported by the patient) and change from baseline to Week 4 in HIT-6 total score.

The eptinezumab and placebo groups comprised 238 and 242 patients, respectively. The median time to next migraine was 10 days in the eptinezumab group and 5 days in the placebo group (hazard ratio=0.60; P<0.0001). Mean HIT-6 total scores at the screening visit indicated severe life impact (eptinezumab, 65.1; placebo, 64.8). At 4 weeks post-infusion, eptinezumab demonstrated clinically meaningful improvement in HIT-6 total score compared with placebo (mean change from baseline: eptinezumab, -8.7; placebo, -4.5; mean [95%CI] difference from placebo: -4.2 [-5.75, -2.63], P<0.0001).

In candidates for preventive migraine therapy, results from the RELIEF study showed that the preventive treatment eptinezumab delayed the time to next migraine vs placebo even when initiated during a migraine attack. In addition, HIT-6 results demonstrated clinically meaningful reductions in patient-reported and migraine-related impact over 4 weeks following eptinezumab versus placebo infusion.