Eptinezumab treatment for chronic migraine was associated with a significant reduction in migraine-related burden on work, home, and social functioning, according to study results presented at the 61st Annual Meeting of the American Headache Society, held July 11 to 14, 2019, in Philadelphia, Pennsylvania.
Previous studies have demonstrated that chronic migraine, defined as at least 15 headache days/month, is associated with significant functional disability. The goal of this study was to assess the effect of 12 months with eptinezumab on migraine-related burden and disability in patients with chronic migraine.
In the PREVAIL study, an ongoing open-label phase 3 trial, the researchers assessed the long-term safety of intravenous treatment with eptinezumab at a dose of 300 mg every 3 months in 128 patients aged 18 to 65 years with chronic migraine. All patients were diagnosed ≤50 years and had a history of chronic migraine for at least 12 months before screening.
The effect of migraine on daily functioning was assessed by the Migraine Disability Assessment Score (MIDAS) before and after treatment with eptinezumab. The study included 2 treatment phases, with 4 infusions in the first phase and up to 4 additional infusions in the second phase.
Results show a reduction over time in mean MIDAS total score from baseline (mean, 56.8; median, 43.5), starting at month 3 (mean change from baseline, −36.3; P <.0001), with further reductions at month 6 (mean change from baseline, −40.3; P <.0001) and month 9 (mean change from baseline, −41.2; P <.0001). After that, the total score was generally stable at month 12 (mean change from baseline, −40.2).
Severe disability, based on MIDAS total score, was evident in most patients at baseline (84.4%), but decreased to 26.8% of patients at month 3. Conversely, although 5.5% of patients had little or no disability at baseline, at month 3, disability increased to 43.1% of patients. After the first 3 months, there was no significant change in results when assessed at months 6, 9, and 12. Further, approximately 60% of patients reported mild or no disability at each of the month 3 through month 12 assessments.
Interim analysis indicated acceptable safety and tolerability of eptinezumab.
“Eptinezumab 300 mg was associated with clinically meaningful reductions in migraine-related burden,” the researchers concluded. They added that “[i]mprovements were observed at the first assessment of MIDAS (month 3) after the first infusion, and the magnitude of the therapeutic effect was either maintained or improved with subsequent infusions through month 12”.
Kudrow D, Berman G, Kassel E, et al. Eptinezumab treatment for migraine prevention reduces migraine disability in patients with chronic migraine: an analysis from the PREVAIL open-label safety study. 2019 American Headache Society Annual Meeting; July 11 to 14, 2019; Philadelphia, PA.