Two infusions of eptinezumab provided relief for 24 weeks for individuals who experience chronic migraine. These findings, from a phase 3, randomized, double-blind, placebo-controlled trial, were published in The Journal of Headache and Pain.
Between 2016 and 2018, investigators conducted this study at 128 sites across 13 countries. They randomly assigned adults who had an at-least 12-month-long history of chronic migraine (N=1072) in a 1:1:1 ratio to receive 100 mg (n=356) or 300 mg (n=350) eptinezumab or a placebo (n=366) intravenously at day 0 and at week 12. Patients kept a daily diary through week 24 to record symptoms.
Patients were a mean age of 40.5 (±11.2 years), were mostly White (91%) and female (88.2%), and had received their chronic migraine diagnosis an average of 11.8 (±11.2) years prior. During the 28-day screening period, patients experienced an average of 20.5 (±3.1) headache and 16.1 (±4.6) migraine days.
Treatment with eptinezumab significantly reduced average monthly migraine days. Participants in the low-dose group experienced an average decrease in migraine days of -2.03 (95% CI, -2.88 to -1.18) during the first 12 weeks and -1.98 (95% CI, -2.94 to -1.01) during weeks 13 to 24 compared with control participants. The participants in the high-dose group reported changes of -2.6 (95% CI, -3.45 to -1.74) and -2.65 (95% CI, -3.62 to -1.68) migraine days compared with control participants for the first and last 12 weeks, respectively.
Patients reported at least a 50% reduction of their monthly migraine days throughout the study period among 31.5% of the 100-mg, 36.3% of the 300-mg, and 20.5 % of placebo groups. The odds ratio of reducing migraine days by at least 50% compared with control participants was 1.974 (95% CI, 1.52-2.56) among the low-dose group and 2.389 (95% CI, 1.84-3.11) among the high-dose group.
Patients reported at least a 75% reduction of their monthly migraine days among 13% of the low-dose and 17% of the high-dose cohorts. Throughout the study, 7.9% to 19.4% of the 100-mg, 13.4% to 21.7% of the 300-mg, and 2.7% to 9.6% of the placebo groups reported complete relief of monthly migraine days.
About the same percentage of low-dose (17.2%) and high-dose (17%) recipients observed maximal antidrug antibodies at week 24. Incidence of antibody-positive patients declined after week 24 to 11.4% of the 100-mg and 9% of the 300-mg groups.
Nearly half (47.4%) of the study participants reported treatment-emergent adverse events. Three of the 300-mg eptinezumab recipients observed hypersensitivity.
The major limitation of this study is the low diversity of the study population, potentially limiting the generalizability of these findings.
The study authors concluded that both 100- and 300-mg injections of eptinezumab every 12 weeks successfully reduced the number of migraine days compared with placebo. More than half of the recipients experienced at least a 50% reduction of monthly migraine days.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of authors’ disclosures.
Silberstein S, Diamond M, Hindiyeh NA, et al. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study. J Headache Pain. 2020;21(1):120. doi: 10.1186/s10194-020-01186-3