Vyepti demonstrates efficacy in patients with migraine
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Among patients who experienced a moderate to severe migraine attack, IV treatment with Vyepti shortened time to headache and symptom resolution compared with placebo, according to results from a randomized clinical trial.
The FDA approved Vyepti (eptinezumab, Lundbeck) more than a year ago for migraine prevention in adults.
For the phase 3 trial, researchers asked 476 patients with moderate to severe migraine (mean age, 44 years; 84% women) not to take rescue medications 24 hours before or within 2 hours of starting eptinezumab. These patients were randomly assigned in an approximate 1:1 ratio and received 100 mg eptinezumab or placebo within 1 to 6 hours of migraine onset.
Results showed that eptinezumab met the co-primary efficacy endpoints. Specifically, freedom from headache pain occurred faster compared with placebo (median time = 4 vs. 9 hours; HR = 1.54, P < .001) and patients’ most bothersome symptom — nausea, photophobia or phonophobia — resolved more quickly (median time = 2 vs. 3 hours; HR = 1.75, P < .001).
Two hours after infusion, headache pain freedom was achieved by 23.5% of patients in the eptinezumab group vs. 12% in the placebo group (between-group difference = 11.6% [95% CI, 4.78-18.31]; OR = 2.27 [95% CI, 1.39-3.72]), and absence of the most bothersome symptom was seen in 55.5% vs. 35.8% (between-group difference = 19.6% [95% CI, 10.87-28.39]; OR = 2.25 [95% CI, 1.55-3.25]). Four hours after infusion, 46.6% of patients who received eptinezumab achieved headache pain freedom vs. 26.4% in the placebo group (between group difference = 20.2% [95% CI, 11.76-28.62]; OR = 2.43 [95% CI, 1.66-3.56]), and 65.1% vs. 37.5% experienced an absence of their most bothersome symptom (between group difference = 27.6 [95% CI, 19.01-36.24]; OR = 3.07 [95% CI, 2.12-4.46]).
Also, significantly fewer patients who were administered eptinezumab vs. placebo used a rescue medication within 24 hours of infusion (31.5% vs. 59.9%; between-group difference = –28.4% [95% CI, –36.95 to –19.86]; OR = 0.31 [95% CI, 0.21-0.45]), according to the researchers.
Adverse events related to treatment — the most common of which was hypersensitivity — were reported in 10.9% of patients who received eptinezumab and 10.3% of those in the placebo group.
The trial data “may be valuable because historically, patients with migraine have had to wait several weeks for the effect of their preventive medications to manifest,” Roger Cady, MD, vice president of neurology at Lundbeck and a board member of the National Headache Foundation, told Healio Primary Care. It “may also be one of the first studies to question the historical distinctions between acute and preventive migraine treatment. In the future, this data could bring new insights into patient care.”
One billion people worldwide experience migraine, making these headaches “the third most prevalent illness in the world,” according to the Migraine Research Foundation.
References:
Migraine Research Foundation. About Migraine. Available at: https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed June 22, 2021.
Winner PK, et al. JAMA. 2021;doi:10.1001/jama.2021.7665.