Two-year data for eptinezumab 300 mg i.v. demonstrate a favourable safety profile, limited long-term immunogenicity, early and sustained reductions in migraine-related burden, and improvements in health-related quality of life, conclude the authors of the newly published PREVAIL study.
Results were reported from the Phase 3 open label study of 128 adults with chronic migraine who received up to eight doses of eptinezumab 300 mg i.v. and were followed for 20 weeks after the final infusion.
During the two years of the study, the most frequently reported treatment-emergent adverse events (TEAEs) were nasopharyngitis (14.1%), upper respiratory tract infection (7.8%), sinusitis (7.8%), influenza (6.3%), bronchitis (5.5%), and migraine (5.5%). Eight patients (6.3%) experienced a TEAE that led to study-drug discontinuation, including three patients with infusion-related hypersensitivity.
A total of 23 patients (18%) developed anti-eptinezumab antibodies during the study. Levels peaked at week 24 and declined to non-detectable levels at week 104.
Improvements in patient-reported outcomes were observed at first assessment (week 4) and were generally sustained through week 104. Migraine disability assessment (MIDAS) total score decreased from 56.8 at baseline to 20.0 at week 12 and 22.0 at week 104. At baseline 84.4% of patients reported severe disability and this fell to 26.8 at week 12 and 20.8% at week 104. Similarly, the proportion of patients reporting severe life impact, as measured by Headache Impact Test-6 (HIT-6), fell from 92.2% at baseline to 39.7% at week 4 and 38.5% at week 104.
Kudrow D, Cady RK, Allan B et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurology 2021; 21:126