Richard Lipton, MD

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

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 

 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.

 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 

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

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The director of the Montefiore Headache Center will provide further insight into migraine care at the 1st Annual International Congress on the Future of Neurology, to be held September 27-28 in New York City.

Richard Lipton, MD: Interpreting Eptinezumab's Impact on HIT-6 Score

“The findings of this study are really good news both for patients and physicians because they say that, over the course of a month, the impact of migraine on patients’ lives, as measured by HIT-6, reduces very steeply and then stays reduced through the treatment period.”

, July 11-14, in Philadelphia, Pennsylvania, a number of presentations and posters revealed data regarding eptinezumab’s impact on patients with migraine. The anti-calcitonin gene-related peptide (CGRP) therapy has shown promise thus far in reducing the frequency of headache attacks in these patients, but these new data suggest that the Alder Biopharmaceuticals agent may also reduce the impact migraine has on these individuals’ lives.

Richard Lipton, MD, director, Montefiore Headache Center, and professor of neurology, Albert Einstein College of Medicine, was involved in a number of these studies, including one which focused specifically on the impact of migraine as measured by the 6-item Headache Impact Test (HIT-6) questionnaire.

 The HIT-6 questionnaire, while easy to implement in practice, has also had its usefulness in migraine clarified in recent works.

 Using this test, Lipton and colleagues explored eptinezumab’s effect on patients’ scores.

Ultimately, while conducting this subanalysis of the PROMISE-2 study, Lipton and colleagues found that the treatment not only drastically lowered the impact migraine was having on patients, it allowed them to maintain this reduction over the full 6-month treatment period, with some significant reductions seen as early as month 1. To find out more about these findings, 

1. 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

2. Houts C. Content validity of the HIT-6 in migraine patients: results of a systematic literature review. Presented at: 2019 American Headache Society Annual Meeting; July 11-14, 2019; Philadelphia, PA. Poster 213LB.

3.. Cady R. Chronic migraine: Establishing a responder definition for the HIT-6 total score. Presented at: 2019 American Headache Society Annual Meeting; July 11-14, 2019; Philadelphia, PA. 214LB.

The director of the Montefiore Headache Center and professor of neurology at Albert Einstein College of Medicine spoke about the results of an analysis of eptinezumab’s effect on the severity of migraine and its impact on patients’ lives.

Richard Lipton, MD

Articles

Richard Lipton, MD: Interpreting Eptinezumab's Impact on HIT-6 Score

Richard Lipton, MD: Eptinezumab Maintains Reductions in the Impact of Migraine