Alder presents data on eptinezumab's efficacy in reducing migraine severity
The company said, "A second post-hoc analysis examined eptinezumab's efficacy in reducing migraine severity, which is a significant contributor to reduced quality of life and increased burden of disease. In the PROMISE-2 trial for chronic migraine, impact scores as measured by the Headache Impact Test were significantly elevated at baseline. The analysis, conducted within PROMISE-2, evaluated the efficacy and related functional and health-related quality of life outcomes of eptinezumab in those patients enrolled in the trial who, during a screening, reported very often or always experiencing severe headaches per HIT-6. Efficacy endpoints that were evaluated included: change from baseline in HIT-6 total score and frequency of severe pain during headaches, as well as change from baseline in the 36-item Short-Form Health Survey which is a general measure of health-related quality of life. Highlights include: Over half of eptinezumab-treated patients experienced greater than or equal toone-category decrease in the frequency of severe headaches by Month 1, compared to 43.7% for placebo. The decrease for patients treated with eptinezumab or placebo remained relatively consistent through the six-month study period. Eptinezumab treatment resulted in clinically meaningful improvements in HIT-6 scores as early as Month 1 after treatment, which were maintained or further improved throughout the six-month study period, compared to placebo, which did not achieve a clinically meaningful improvement until Month 6. In addition, eptinezumab treatment resulted in clinically meaningful improvements greater than placebo in SF-36 scores as early as Month 1 after treatment and through the six-month study period."