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Eptinezumab shows acute benefits during migraine attack

Conference
EAN 2021
Trial
Phase 3, RELIEF
Eptinezumab is an approved migraine-preventive treatment, but can also be effective as a treatment for acute migraine. In the placebo-controlled RELIEF study, infusion of this CGRP monoclonal antibody during a migraine attack resulted in rapid and sustained freedom from headache pain and most bothersome symptom (MBS).

The results of the phase 3 RELIEF study (NCT04152083) were presented at the EAN Virtual Congress and simultaneously published in JAMA [1,2]. Participants were 18–75 years of age and had migraine on 4­–15 days per month in the 3 months prior to screening. During a moderate-to-severe migraine attack, they were randomised to eptinezumab 100 mg (n=238) or placebo (n=242), administered intravenously. There were 2 primary efficacy endpoints: time to headache pain freedom and time to absence of MBS (nausea, photophobia, or phonophobia).

The eptinezumab group achieved significantly faster headache pain freedom than the placebo group (median 4 vs 9 hours; HR 1.54; P<0.001) as well as absence of MBS (median 2 vs 3 hours; HR 1.75; P<0.001). Two hours after infusion, the percentage of patients reporting headache pain freedom was 23.5% and 12.0% (P=0.0009), respectively. The percentage reporting absence of MBS was 55.5% and 35.8% (P<0.0001). This difference remained significant after 4 hours.

In the eptinezumab group, statistically significantly fewer patients used rescue medication within 24 hours than in the placebo group (31.5% vs 59.9%; P<0.0001). There was no difference in treatment-emergent adverse events, occurring in 10.9% and 10.3% of eptinezumab and placebo-treated patients. The most common was hypersensitivity (2.1% vs 0%). No notable safety findings were identified.

  1. Winner P, et al. Efficacy and safety of eptinezumab initiated during a migraine attack: Results from the RELIEF study. EPR-101, EAN 2021 Virtual Congress, 19–22 June.
  2. Winner PK, et al. JAMA. 2021;325(23):2348–56.

 

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