Eptinezumab Reduces Severity, Burdensome Features of Headache Episodes

Peter McAllister, MD

Data presented at the 2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6, showed that treatment with eptinezumab (Vyepti; Lundbeck) decreased the monthly frequency of headache days and episodes, as well as reduced the severity of remaining headache episodes and the burdensome features of said episodes.¹

Presented by Peter McAllister, MD, medical director, New England Institute for Neurology and Headache, and chief medical officer, New England Institute for Clinical Research, the results also showed that eptinezumab reduced the percent of remaining headache episodes that were deemed migraine attacks. McAllister and colleagues conducted a post-hoc analysis that examined changes in the characteristics of headache episodes in patients with chronic migraine (CM) in the PROMISE-2 clinical trial (NCT02974153). Patients were randomized to receive eptinezumab 100 mg (n = 356), 300 mg (n = 350), or placebo (n = 366) administered intravenously (IV) every 12 weeks for up to 2 doses.

At baseline, the mean monthly headache days (MHDs) were 20.4, 20.4, and 20.6 in the eptinezumab 100 mg, 300 mg, and placebo groups, respectively. Over weeks 1-24, patients treated with eptinezumab 100 mg had mean MHDs decrease to 11.5, while those in the 300-mg group reported a decrease to 10.8, representing changes of –8.9 and –9.7 days, respectively. Those in the placebo group had mean MHDs decrease to 13.3, a change of –7.3 days.

Headache episodes (non-migraine and migraine) and their characteristics were captured in daily electronic diaries during the 28-day baseline period and throughout the 24-week treatment period. Monthly headache episodes decreased to 8.2 (100 mg), 7.7 (300 mg), and 9.0 (placebo), representing changes of –8.4, –9.0, and –7.1 episodes, respectively.

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In total, 73.3% to 74.5% of baseline headache episodes were reported as migraine attacks, while 36.3% to 38.5% included severe pain, 58.1% to 61.0% included nausea, and 73.5% to 75.0% included phonophobia. The proportion of headache episodes that were migraine attacks decreased to 63.3% in the eptinezumab 100 mg group, 61.4% in the 300-mg group, and 69.4% in the placebo group during weeks 1-24.

The investigators also noticed that treatment with eptinezumab resulted in greater decreases from baseline in the mean percent of headache episodes with severe pain, nausea, and phonophobia compared to those treated with placebo. Furthermore, the proportion of headache episodes with associated aura decreased 2% to 3% in the eptinezumab-treated groups and 1% in the placebo group.

Eptinezumab, anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, received FDA approval for the prevention of migraine in adults in February 2020 based on results from both PROMISE-1 (NCT02559895) and PROMISE-2.² Original data from PROMISE-2 showed that both the 100-mg and 300-mg doses were associated with significant reductions in monthly migraine days, beginning the day after IV administration, providing Class I evidence for a single dose.

The percentages of patients with migraine on day 1 post-infusion were 28.6% and 27.8% for the 100- and 300-mg doses, respectively, compared to 42.3% for placebo. At baseline, the average level was 58% for the cohort during the 28-day lead-in period.³

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REFERENCES

1. McAllister P, Kudrow D, Cady R, Hirman J, Ettrup A. Reduction in migraine-associated burden after eptinezumab treatment in patients with chronic migraine. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P185

2. FDA Approves Lundbeck’s VYEPTI (eptinezumab-jjmr) — The First and Only Intravenous Preventive Treatment for Migraine. News release. Lundbeck. February 21, 2020. Accessed June 4, 2021. businesswire.com/news/home/20200221005507/en/FDA-Approves-Lundbeck’s-VYEPTI™-eptinezumab-jjmr-–-Intravenous. Accessed February 22, 2020.

3. Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020;94(13). Published online March 25, 2020. doi: 10.1212/WNL.0000000000009169.