These data on the preventive migraine treatment confirmed findings from previous studies, with eptinezumab not only reducing total migraine days, but elongating the duration of consecutive migraine-free days.
Peter J. Goadsby, MD, PhD, DSc
Results from the PROMISE-1 (NCT02559895) and PROMISE-2 (NCT02974153) phase 3 trials suggest that the duration of consecutive migraine-free days are increased as early as within the first 2 weeks of treatment with intravenous (IV) eptinezumab (Vyepti; Lundbeck), compared with placebo.1
The data, showed that 29% and 33% patients in PROMISE-1 experienced a maximum of >21 consecutive migraine-free days after starting treatment with 100-mg eptinezumab (n = 63) and 300-mg eptinezumab, respectively, compared to 19% of patients on placebo (n = 41). In PROMISE-2, migraine freedom within the first 2 weeks of treatment was achieved for >21 days in 21% of patients who received eptinezumab 100 mg (n = 73) and 27% of those on eptinezumab 300 mg (n = 94), compared with 12% of placebo patients (n = 42).
The dataset which was accepted for presentation to the American Academy of Neurology (AAN) 2020 Annual Meeting, was compiled by Peter J. Goadsby, MD, PhD, DSc, lead investigator, professor of neurology at King’s College London and University, San Francisco, and colleagues, to examine the impact of eptinezumab versus placebo on duration of consecutive migraine-free days in patients with migraine.
The eptinezumab 100 mg and eptinezumab 300 mg groups both reported 21% of patients (n = 46 for both groups) in the PROMISE-1 study who experienced <7 days of migraine-free duration, whereas 32% of patients on placebo (n = 71) experienced the same duration of migraine-free days. Likewise, in PROMISE-2, a migraine-free duration of <7 days was observed in 41% and 38% of patients who received eptinezumab 100 mg (n = 146) and 300 mg (n = 132), respectively, compared to 62% of placebo patients (n = 226).
Using the double-blind, randomized, placebo-controlled trials of PROMISE-1 and PROMISE-2, researchers focused on the tertiary end point of maximum duration of consecutive migraine-free days that started within 14 days of the first dose. They then divided the 4 categories up into >21 days, 15—21 days, 8–14 days, and <7 days.
Additionally, a second analysis submitted to AAN from this dataset suggested that eptinezumab treatment resulted in not just fewer days with migraine, but a shorter duration of migraine and decreased migraine severity compared with placebo.2
The expected number of migraine days between the 2 treatment groups and placebo groups were 113 days and 109 dasys, respectively, in PROMISE-1. Data showed the total migraine days were 55 (100 mg), 49 (300 mg), and 62 (placebo), resulting in gains of 58 and 64 days with eptinezumab 100 mg and 300 mg, respectively, versus 47 days with placebo. In PROMISE-2, similar results were found, with an expected 210 (100 mg and 300 mg), and 212 (placebo) migraine days for each group. Instead, researchers observed 105 and 97 days for low- and high-dose eptinezumab, respectively, and 132 days for placebo, resulting in gains of 105 and 113 days with eptinezumab versus 79 days with placebo.
Eptinezumab, an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, was approved by the FDA for the prevention of migraine in adults in February 2020 based on results from both PROMISE-1 and PROMISE-2. Data showed that the agent was beneficial over placebo as early as 1 day post-infusion, as well as demonstrated a significant safety profile, with just 1.9% of patients discontinuing due to adverse events (AEs).
Data from the studies showed a mean change of -3.9 migraine days (P = .018) and -4.3 days (P <.001) in months 1 through 3 for the 100 mg and 300 mg doses, respectively, compared to -3.2 days for the placebo group. A >75% reduction in migraine days in months 1 through 3 was reported by 22.2% of the 100-mg group, 29.7% of the 300-mg group (P <.001), and 16.2% of the placebo group.3
The therapy became commercially available through specialty distributors and specialty pharmacies in April of this year. Additional services such as the VYEPTI Go Patient Support Program, which is utilized to offer resources and support during a patient’s eptinezumab treatment journey, was also launched at the time.
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1. Goadsby PJ, Winner P, Grosberg BM, Brandes J, Zhao Y, Cady R. Duration of consecutive migraine-free days experienced after treatment with eptinezumab in patients with migraine. Neurology. 2020;94(15 Suppl): 0669.
2. Winner P, Goadsby PJ, Chua AL, Freidman DI, Zhao Y, Cady R. Impact of Eptinezumab Treatment on Migraine Frequency, Duration, and Severity in Patients with Migraine. Neurology. 2020;94(15 Suppl): 0659.
3. FDA Approves Lundbeck’s VYEPTI (eptinezumab-jjmr) — The First and Only Intravenous Preventive Treatment for Migraine [press release]. Deerfield, IL: Lundbeck; Published February 21, 2020. Accessed April 27, 2020. businesswire.com/news/home/20200221005507/en/FDA-Approves-Lundbeck’s-VYEPTI™-eptinezumab-jjmr-–-Intravenous.