Intravenous Eptinezumab Effectively Reduces Monthly Migraine Days
Study investigators randomly assigned 1072 patients with chronic migraine to receive either 100 mg eptinezumab, 300 mg eptinezumab, or placebo.
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SAN FRANCISCO — A single intravenous 100 mg and 300 mg dose of eptinezumab is effective in reducing monthly migraine days (MMD) in patients with chronic migraine, according to a study presented by Paul Winner, DO, of the Palm Beach Headache Center/Premiere Research Institute at the 60th Annual Scientific Meeting of the American Headache Society, June 28-July 1, 2018 in San Francisco, California.
Eptinezumab is an inhibitor of calcitonin gene-related peptide (CGRP), a neuropeptide that is intrinsically involved in the pathophysiology of migraine. In this study, researchers assessed the long-term 50%, 75%, and 100% response rates associated with eptinezumab as well as the overall efficacy of the experimental drug on reducing MMD in patients with chronic migraine patients.
Study investigators randomly assigned (1:1:1) 1072 patients with chronic migraine to receive either 100 mg eptinezumab, 300 mg eptinezumab, or placebo. Participants recorded headache occurrences in a 28-day eDiary, which was used for collecting baseline headache frequency data. At the end of the 12-week infusion period, researchers evaluated the reductions in MMD over 1-12 weeks compared with baseline. Secondary endpoints included ≥50% reductions in MMD over 1-12 weeks as well as ≥75% MMD reductions over 1-4 weeks and 1-12 weeks. The 100% MMD reduction over the 1-12 week period, which comprised another secondary outcome measure, was defined as the average proportion of patients who achieved a migraine-free status each month for a mean of 3 months.
At baseline, the average MMD among patients in the 100 mg, 300 mg, and placebo groups were not significantly different (16.1, 16.1, and 16.2, respectively). Compared with placebo, the average MMD reductions from baseline over the 12-week study period were greater in patients who received 100 mg eptinezumab (-5.6 vs -7.7, respectively; P <.0001). Additionally, there was a significantly greater reduction in MMD among patients who received 300 mg eptinezumab vs placebo at follow-up (-8.2 vs -5.6, respectively; P <.0001).
More patients receiving 100 mg eptinezumab and 300 mg eptinezumab also achieved a ≥50% MMD reduction compared with placebo (57.6% and 61.4% vs 39.3%, respectively; P <.0001 for all). At weeks 1-4, researchers observed similar proportions of patients assigned to eptinezumab vs placebo who achieved ≥50% reductions in MMD (54.5% [100 mg] and 60.6% [300 mg] vs 36.1% [placebo]). In addition, similar findings were found at weeks 5-8 weeks (59.0% [100 mg] and 61.7% [300 mg] vs 40.2% [placebo]).
According to the researchers, a significantly greater proportion of 100 mg and 300 mg eptinezumab-assigned patients achieved a ≥75% reduction in MMD than those assigned to placebo (26.7% [P =.0001] and 33.1% [P <.0001] vs 15.0%, respectively). At weeks 1-4, there were similar significant MMD reductions of ≥75% among those receiving intravenous eptinezumab (30.9% and 36.9% vs 15.6%; P <.0001 for all). Finally, more patients in the 100 mg and 300 mg eptinezumab groups achieved a 100% MMD reduction over weeks 1-12 compared with placebo (10.8% and 15.1% vs 5.1%, respectively; P <.0001 for all).
Overall, the researchers concluded that treatment with eptinezumab was more effective for reducing monthly migraine days than placebo in patients with chronic migraine.
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Winner PK, Goadsby P, Nagy AJ, et al. Eptinezumab reduced migraine activity and achieved high migraine responder rates over weeks 1-12: results from the phase 3 PROMISE-2 trial in chronic migraine. Presented at: The American Headache Society 60th Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 449616.