Richard B. Lipton, MD

"The rules for who needs preventive treatment may change when you have an acute treatment that also works as a preventive. One advantage of gepants as a class is that most acute treatments taken too often actually cause headaches to come more frequently and can lead to medication overuse headache.”

In recent years, migraine specialists and neurologists within the space have benefited from an influx of therapies and modalities to not only treat but to prevent migraine. Among the most notable is rimegepant (Nurtec ODT; Biohaven), an oral calcitonin gene-related peptide (CGRP) antagonist that became the first approved treatment for both acute and preventive therapy earlier this year.

Targeting the GCRP pathway discovered by Peter Goadsby, MD, PhD, DSc, has been a breakthrough way to directly impact and treat patients with both episodic and chronic migraine. Richard B. Lipton, MD, has served as an investigator on multiple trials that have evaluated rimegepant, and said that the recent approval has opened the door for new treatment regimen possibilities, as well as additional layered approaches.

At the 2021 American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6, Lipton, director of the 

, showcased several research endeavors in which he and his colleagues took part. In an interview with 

he discussed the greatest takeaways from the meeting, including thoughts on topline research, awards, and the direction that the space is moving toward.

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The director of the Montefiore Headache Center discussed the momentum within the migraine research community as well as some of the more notable presentations from AHS 2021. 

AHS 2021 Takeaways and the State of Migraine Research: Richard B. Lipton, MD

"When you gather real-world evidence, your mission is to know how these combinations will work in the real-world. In a way, this design is very pertinent to the question that we’re asking on 1 hand. On the other hand, we don’t have a contemporaneous placebo group and don’t have random allocation of patients to treatment arms.”

2021 American Headache Society (AHS) 63rd Scientific Annual Meeting

, June 3-6, the design and interim findings from the Combining UbRogepAnt and Preventives for MiGrainE (COURAGE) study were presented by Richard B. Lipton, MD. The prospective, observational study evaluates the real-world effectiveness of ubrogepant (50 mg or 100 mg) for the acute treatment of migraine when used with onabotulinumtoxinA (Botox; Allergan/AbbVie) with a monoclonal antibody (mAb) or with both using data collected on the Migraine Buddy app.

The study consists of 3 arms: ubrogepant and calcitonin gene-related peptide mAb, ubrogepant and onabotulinumtoxinA, and ubrogepant and both onabotulinumtoxinA and CGRP mAb. While the results for the latter 2 arms have yet to be finalized, Lipton said there are a number of combinations outside of this study that should seek further exploration.

Lipton, director of the Montefiore Headache Center, described the wide variety of layered treatment approaches investigators should consider examining, including the real-world effectiveness of multiple preventives and treatments that are fairly new to the market.

The director of the Montefiore Headache Center discussed future aspirations and potential combinations that should be researched to treat patients with migraine. 

Exploring New Therapy Combinations to Treat Migraine: Richard B. Lipton, MD

"My personal practice is to give gepants on top of monoclonal antibodies. There’s other evidence that suggest that this will work.”

The COmbining UbRogepAnt and Preventives for MiGrainE (COURAGE) study is a novel, application-based approach to assess the real-world effectiveness of ubrogepant (Ubrelvy; AbbVie) in reduction of pain, improvement of disability, and patient satisfaction when used concomitantly with calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs). Interim findings from the first arm of the study were presented at the 

2021 Virtual American Headache Society (AHS) 63rd Scientific Annual Meeting

Results showed that real-world use of ubrogepant in addition to preventive treatment with a CGRP mAb produced high rates of meaningful pain relief (64.2% at 2 hours and 84.5% at 4 hours). The full analysis, which has yet to be released, will include data from multiple attacks, attacks treated with a second dose of ubrogepant, additional daily and 30-day effectiveness measures for use of ubrogepant with onabotulinumtoxinA (Botox; Allergan/AbbVie), and use of ubrogepant with both onabotulinumtoxinA and CGRP mAbs.

Lipton, director for the Montefiore Headache Center, sat down with 

to discuss the background of the study and its purpose, the main outcomes observed, and whether clinicians can immediately incorporate the findings into their clinical care practice.

The director for the Montefiore Headache Center discussed the COURAGE study and how to effectively use a layered treatment approach with ubrogepant and CGRP monoclonal antibodies. 

Concomitant Use of Ubrogepant With CGRP Monoclonal Antibodies: Richard B. Lipton, MD

"I regard Migraine Buddy as providing a novel way of gathering real world evidence about migraine treatment.”

2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting

, June 3-6, research conducted by Richard B. Lipton, MD, evaluated the real-world effectiveness of ubrogepant (Ubrelvy; AbbVie) when used with onabotulinumtoxinA (Botox; Allergan/AbbVie), with a monoclonal antibody, or with both, using data collected on the Migraine Buddy app. The investigators concluded that the entirely remote design, made possible by the app, provides a unique opportunity to continue to understand more about patients with migraine, especially in a COVID-19-pandemic setting.

The app, which has over 1 million users, allows communication to doctors, insurance companies, and employers, while assisting patients in understanding their triggers and symptoms. Lipton, professor and vice chair of neurology, Albert Einstein College of Medicine, and director, 

, noted that studying medical claims, conducting surveys, and performing real-world clinical trials that do not interfere with a patient’s daily life are the traditional ways researchers have collected real-world data.

Lipton discussed how Migraine Buddy can help change the way clinical trials are conducted, with the potential to reach larger masses of patients with migraine.

The director of the Montefiore Headache Center detailed the ways the Migraine Buddy app can help simplify conducting migraine clinical trials while expanding the reach of patients. 

Richard B. Lipton, MD

Articles

AHS 2021 Takeaways and the State of Migraine Research: Richard B. Lipton, MD

Exploring New Therapy Combinations to Treat Migraine: Richard B. Lipton, MD

Concomitant Use of Ubrogepant With CGRP Monoclonal Antibodies: Richard B. Lipton, MD

Advantages of Migraine Buddy App: Richard B. Lipton, MD