Efficacy and safety of eptinezumab in acute migraine

In the phase 3 RELIEF study, preventive therapy with eptinezumab during a migraine attack resulted in rapid and sustained freedom from headache and most bothersome symptom (MBS) compared with placebo. Eptinezumab also delayed the time to a next migraine attack by a median of 10 days, versus 5 days with placebo.

In the parallel-group, double-blind RELIEF study (NCT04152083), adult migraine patients were randomised to eptinezumab 100 mg (n=238) or placebo (n=242), administered intravenously within 1–6 hours of a moderate-to-severe migraine attack onset [1].

Patients in the eptinezumab group achieved freedom from headache significantly faster (median 4 vs 9 h, respectively; HR 1.54; P=0.0006), as well as absence of their MBS (median 2 vs 3 h; HR 1.75; P<0.0001). Two hours after the start of infusion, freedom from headache was reported by 23.5% and 12.0%, respectively (P=0.0009), and absence of MBS by 55.5% and 35.5% (P<0.0001); differences were still significant after 4 hours. Significantly fewer patients in the eptinezumab group used rescue medication within 24 hours (31.5% vs 59.9%; P<0.0001). There were similar rates of treatment-emergent adverse events (10.9% vs 10.3%); no serious adverse events occurred.

In a second presentation, results of exploratory endpoints were reported [2]. The median time to next migraine was 10 days in the eptinezumab group and 5 days in the placebo group (HR 0.60; P<0.0001). Results also showed that 4 weeks after infusion, eptinezumab improved the total score of the 6-item Headache Impact Test (HIT-6) to a clinically meaningful extent compared with placebo. Mean change from baseline was -8.7 and -4.5 points, respectively (P<0.0001).

1. Winner P, et al. Efficacy and Safety of Eptinezumab Initiated During a Migraine Attack: Results from the RELIEF Study. P10.033, AAN 2021 Virtual Congress, 17-22 April.
2. McAllister P, et al. Eptinezumab Treatment Initiated During a Migraine Attack Prolonged the Time to Next Migraine and Improved HIT-6 Outcomes in the RELIEF Study. P10.022, AAN 2021 Virtual Congress, 17-22 April.

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Posted on 16 June 2021