Data confirmed the prior results of the PROMISE-1 and PROMISE-2 studies, indicating the preventive effect on migraine with eptinezumab begins as early as day 1 post-infusion.
David W. Dodick, MD
Post-hoc analysis of the PROMISE-1 (NCT02559895) and PROMISE-2 (NCT02974153) studies suggest that the onset of the migraine preventive effect of intravenous (IV) eptinezumab (Vyepti; Lundbeck) occurs on the day following the initial dose.
As well, in both studies, all tests from Day 84 to Day 1 alone achieved nominal significance (P <.5), indicating the drug response was sustained throughout the entire 12 weeks following the initial dose.
PROMISE-1 and PROMISE-2 were both double-blind, randomized, placebo-controlled phase 3 trials that evaluated eptinezumab for migraine prevention. Results from the PROMISE-2 trial were released in early April 2020 and suggested that both the 100- and 300-mg doses of eptinezumab were associated with significant reductions in monthly migraine days.
On day 1 post-infusion, 28.6% and 27.8% of patients that received 100-mg and 300-mg doses had migraine, respectively, compared to 42.3% of those on placebo (both P <.0001 vs placebo). During the 28-day lead-in period at baseline, the average level of migraine was 58% for the cohort.
The post-hoc analysis, led by David W. Dodick, MD, professor of neurology, Mayo Clinic Scottsdale, and colleagues, aimed to confirm the percentage of patients with migraine on Day 1 with eptinezumab administration. Comparatively older migraine treatments have shown they can require up to 6 months of treatment to demonstrate clinical benefit. This specific data set from PROMISE-1 and PROMISE-2 were accepted to the American Academy of Neurology (AAN) 2020 Annual Meeting.
Patients who received eptinezumab 100 mg, 300 mg, or placebo in PROMISE-1 (100 mg: n = 221; 300 mg: n = 222; placebo: n = 222) or PROMISE-2 (100 mg: n = 356; 300 mg: n = 350; placebo: n = 366) were included in the post-hoc analysis.
Dodick and colleagues examined the percentage of patients experiencing a migraine on progressively smaller time intervals beginning with the primary time point (weeks 1—12; days 1–84). Intervals decreased by 1 day (days 1­–83, days 1–82, etc.) and treatment effect was tested again after every interval demonstrated statistical significance (P <.05).
The FDA approved eptinezumab for the prevention of migraine in adults in February 2020 based on results from both PROMISE-1 and PROMISE-2. The humanized monoclonal antibody was the first-ever intravenous migraine prophylactic. In April 2020, Lundbeck announced the therapy was commercially available in the US and could be obtained via select distributors and specialty pharmacies. In addition to Vyeti reaching pharmacies, the company announced patients may be entitled to its VYEPTI Go Patient Support Program, which provides support and resources to those who are prescribed to the drug.
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Dodick DW, Gottschalk C, Tepper SJ, et al. Eptinezumab demonstrated migraine preventive efficacy on day 1 after dosing: closed testing analysis from PROMISE-1 and PROMISE-2. Neurology. 2020;94(15 Suppl). 0617.