Transcript: Chronic Migraine: How Eptinezumab Affects Headache Impact Test-6 Scores

Richard Lipton, MD: My name is Richard Lipton. I’m a professor of neurology and epidemiology at the Albert Einstein College of Medicine, where I also direct the Montefiore Headache Center. Today, we're going to be talking about an analysis of data from a randomized trial treating chronic migraine with an intravenous monoclonal antibody that targets CGRP. The antibody is called eptinezumab, and the secondary endpoint we're going to be focusing on is a test called the Headache Impact Test, which is a 4-week, recall-based measure of overall impact of migraine on life.

The primary endpoints of the PROMISE-2 trial were reduction in monthly migraine days over 12 weeks following administration of either intravenous eptinezumab in 2 doses, 100 mg or 300 mg, or placebo and on that primary endpoint, the study showed rapid reduction in monthly headache days, which was actually statistically significant on the very next day relative to placebo after drug administration. And, in addition to that, the study gave a test called the Headache Impact Test [HIT-6] at 4, 12, 16, 24, and 32 weeks, and we plotted the trajectory of HIT-6 change over that time course. We found that, over the first 4 weeks following treatment, in both active doses of eptinezumab, there was a very sharp reduction in headache impact, and we found that that benefit in headache impact relative to placebo was maintained for the entire duration of the study.

So, the Headache Impact Test has 6 questions. It asks about pain severity, limitations on daily activity, need to lie down, too tired to engage in usual activities, feeling fed up or irritable, and limitations in concentration and ability to work. So, the questionnaire casts a pretty broad net looking at those domains of function that are most limited by migraine, and again, the results show rapid reduction in migraine impact over 4 weeks at both doses of eptinezumab, with maintenance of those benefits for the duration of the study.