“You don’t always get what you want when you do research, but this was the benefit I was hoping we would see.”

At the 2019 American Headache Society Annual Meeting, July 11-14, in Philadelphia, Pennsylvania, Richard B. Lipton, MD, director, Montefiore Headache Center, presented data on eptinezumab’s impact on Headache Impact Test (HIT)-6 total scores in patients with chronic migraine. The study, dubbed PROMISE 2, included 1072 patients with a mean of 16.1 monthly migraine days. Patients were randomized 1:1:1 to either quarterly 100-mg or 300-mg, or placebo. Through 3 months of treatment, between 10% and 17% of patients who received treatment were migraine-free at some point, with increasing migraine-free months as time passed. 

The findings also showed that those who received the anti-calcitonin gene-related peptide (CGRP) had greater improvements on each of the HIT-6 items compared to placebo. As well, the clinical benefits associated with HIT-6 reductions lasted ≥8 months and patients had “meaningful improvements” in daily functioning, disease status, migraine frequency, severe headache frequency, and quality of life.

With a 2020 PDUFA date looming, Lipton sat down with NeurologyLive to provide some insight into the interpretation of the findings related to the HIT-6 metric, and what he and his coinvestigators observed from Alder Biopharmaceuticals’ investigational agent.

At the upcoming 1st Annual International Congress on the Future of Neurology, to be held September 27-28 in New York City, Lipton will provide additional insight into migraine alongside other top faculty discussing a range of neurological disorders. The professor of neurology at Albert Einstein College of Medicine will present on the current approach to migraine "chronification" alongside Michael J. Marmura, MD, and Stewart Tepper, MD. Use code Neuro19SI to register now and receive 25% off. 

For more coverage of AHS 2019, click here.
REFERENCE
Lipton R. Eptinezumab Demonstrated Early and Sustained Reductions in HIT-6 Total Score Over Time in Patients with Chronic Migraine in the PROMISE-2 Trial. Presented at: 2019 American Headache Society Annual Meeting; July 11-14, 2019; Philadelphia, PA. Poster 215LB