Eptinezumab, an intravenous calcitonin gene-related peptide monoclonal antibody, is associated with more migraine-free days, shorter migraine duration, and decreased severity of migraine compared with placebo. These findings were presented virtually at the 2020 American Academy of Neurology Science Highlights.
Paul Winner, DO, director of the Premiere Research Institute and the Palm Beach Headache Center in Florida, and colleagues arrived at their conclusion after performing the double-blind, randomized, placebo-controlled PROMISE-1 and PROMISE-2 trials, in which they investigated the effects of eptinezumab for the prevention of migraine.
In PROMISE-1, 888 participants with episodic migraine were administered eptinezumab in 4 dosing intervals lasting 12 weeks each. In PROMISE-2, 1072 participants with chronic migraine were treated with eptinezumab in 2 dosing intervals lasting 12 weeks each.
The anticipated number of migraine days per year (the baseline rate carried forward for 365 days) compared with the number of migraine days observed (normalized to a 365-day year) were calculated in post-hoc analyses. Secondary endpoints included migraine duration and severity, which were measured via a daily e-Diary.
Among PROMISE-1 participants, the researchers expected 113 migraine days per year among participants treated with 100 mg eptinezumab, 113 days among participants treated with 300 mg eptinezumab, and 109 among those who received placebo. They observed 55, 49, and 62 migraine days per year among these groups, respectively. This translated to 58 and 64 days, respectively, gained back among eptinezumab-treated participants compared with 47 days among those who received placebo.
The researchers anticipated 210 migraine days per year among PROMISE-2 participants treated with 100 mg eptinezumab, 210 days among participants treated with 300 mg eptinezumab, and 212 among those who received placebo. A total of 105, 97, and 132 migraine days per year were observed for these groups, respectively, translating to 105 and 113 days gained back with eptinezumab compared with 79 days with placebo.
Notably, the results of both the PROMISE-1 and PROMISE-2 trials indicated that eptinezumab use was associated with greater decreases in the median migraine duration and number of severe migraines compared with placebo.
“Over 6 months, patients with [episodic migraine] and [chronic migraine] can expect to gain back ~1 and ~2 months of migraine-free days, respectively,” the researchers concluded.
—Christina Vogt
Reference:
Winner PK, Goadsby PJ, Chua AL, Friedman DI, Zhao Y, Cady R. Impact of eptinezumab treatment on migraine frequency, duration, and severity in patients with migraine. Paper presented at: American Academy of Neurology Science Highlights; May 2020; Virtual. https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/2667?q=eptinezumab