NeurologyLive® Top Expert Interviews: December 2021

The NeurologyLive^® team has been as busy as always bringing you the latest clinical news and research updates in neurology over the last month, including conducting several interviews with experts across a number of different and varying topics.

Among these included conversations on the costs associated with Alzheimer disease drug development with Jeffrey Cummings, MD, ScD; the recent approval of a new agent for generalized myasthenia gravis with James F. Howard, MD; the treatment of migraine in the emergency department with Anne-Maree Kelly, MD; a recent study that assessed the effectiveness of educational sleep medicine “boot camps” with Anita Shelgikar, MD, MHPE; and the highlights from the American Epilepsy Society Annual Meeting with Imad Najm, MD.

Click through the slides to see and read more from each expert’s exclusive conversation with NeurologyLive^® in December 2021.

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WATCH TIME: 3 minutes

The Substantial Costs Affiliated With Alzheimer Drug Development: Jeffrey Cummings, MD, ScD

"They’re [enrolled patients] the people we’re trying to help, but they’re also our allies in terms of drug development. That number—the size of it—was breathtaking to me.”

To better understand the costs of AD drug development in the private sector, lead author Jeffrey Cummings, MD, ScD, and colleagues collected data on 1099 nonanimal AD clinical trials from the last quarter-century. At the end of the analysis, cumulative expenditures on the research and development stage were estimated at $42.5 billion, with the greatest costs ($24,064 million; 57%) incurred during phase 3.¹

Cummings, MD, ScD, professor of brain science, and director, Chambers-Grundy Center for Transformative Neuroscience, University of Nevada–Las Vegas, sat down with NeurologyLive^® to discuss the reasoning behind his analysis and the most notable takeaways from the data. He also briefly mentioned the staggering number of patients that have been in these trials and the role they play in drug development.

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The Effect of Efgartigimod’s Approval on the Myasthenia Gravis Landscape: James F. Howard, MD

"The approval of efgartigimod by the FDA is going to again transform our management of myasthenia gravis, without question. The ability of this drug to reduce levels of circulating antibody IgG will provide patients with a new option for therapy, a much safer option for therapy, and one that has been demonstrated in clinical trials to be of substantial durability in its duration of effect."

In mid-December, the FDA approved Argenx’s first-in-class investigational antibody fragment to target the neonatal Fc receptor for the treatment of generalized myasthenia gravis in adults who test positive for the anti-acetylcholine receptor antibody. The agent, efgartigimod, is being marketed as Vyvgart.²

Clinical trial investigator James F. Howard, MD, Distinguished Professor of Neuromuscular Disease, University of North Carolina School of Medicine, told NeurologyLive^® in this interview that he anticipates that the approval will have an impact on the use of both plasma exchange and intravenous—and perhaps subcutaneous—immunoglobulin in clinical practice because of efgartigimod’s efficacy.

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Understanding the Care for Headache in Emergency Departments: Anne-Maree Kelly, MD

"We found wildly varying rates of advancing imaging, particularly CT scanning, ranging from about 1 in 4 patients to about 3 in every 4 patients, and that variation appears to be geographical. Just as a sideline, we’ve done more analyses and it seems to not correlate well with positive findings."

Although headache is a common reason for presentation to emergency departments (ED), questions remain about the epidemiology, investigation, and treatment of those with nontraumatic headache as the main presenting complaint. To better describe this epidemiology, an international, multicenter, cross-sectional study led by Anne-Maree Kelly, MD, included 4536 patients across 67 hospitals and 10 countries and was conducted over 1 calendar month in 2019.³

Kelly, a senior emergency physician at Western Health and the director of the Joseph Epstein Center for Emergency Medicine Research, sat down with NeurologyLive^® to discuss the motivation behind the large analysis, as well as the top findings she observed. She also provided context on why previous research on dyspnea played a role in the reasoning for the study, and how studies like this are great self-assessments of our medical institutions.

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Discussing Sleep Medicine Education for Health Professional Trainees: Anita Shelgikar, MD, MHPE

“Sleep medicine education is important for anyone in any health profession because our patients with sleep disorders see our colleagues throughout their journey in health care. It’s really important that people at different points in our health care system—our colleagues, dentistry, nursing, medicine—that everyone has a recognition and awareness of sleep disorders so that we can best help our mutual patients when they present with sleep-related concerns.”

A recent study enrolled 21 health professions trainees, 14 of whom were sleep medicine fellows, in a 2-day introduction course to sleep medicine, asking participants to complete 2 validated sleep knowledge questionnaires—The Assessment of Sleep Knowledge in Medical Education and The Dartmouth Sleep Knowledge and Attitude Survey—at the conclusion of the course. Investigators found that, contrary to previously reported data, baseline sleep medicine knowledge is higher amongst this population, and the boot camp helped to improve knowledge and interest in sleep medicine in this specific group of trainees.⁴

Anita Shelgikar, MD, MHPE, clinical associate professor of neurology; and director, Sleep Medicine Fellowship Program, University of Michigan, had a conversation with NeurologyLive® noted that at the conclusion of the study, investigators identified a statistically significant difference in the assessments of sleep knowledge in the medical education survey when compared with baseline.

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WATCH TIME: 7 minutes

Takeaways From AES 2021: Imad Najm, MD

“The themes here, which I see in the next 3 to 5 years continuing to expand—hopefully in a way that will excite all of us to a point that we translate this into clinical practice—are the field of gene therapy and the field of machine learning and artificial intelligence.”

The 2021 American Epilepsy Society (AES) Annual Meeting, December 3-7, was held in Chicago and virtually, including presentations and updates across the field of epilepsy. Imad Najm, MD, director, Cleveland Clinic Epilepsy Center, Cleveland Clinic Neurological Institute, sat down with NeurologyLive^® to discuss presentations that he was a part of at AES 2021, as well as takeaways from the conference overall.

Najm was a part of several presentations, covering topics such as MR fingerprinting, specifically in patients with MRI-negative intractable focal epilepsy, its use in the characterization of subcortical nuclei in medically intractable focal epilepsy, as well its radiomics for characterization of focal cortical dysplasia. Speaking to AES 2021 in general, Najm commented on the potential of genetics and gene therapy in the field of epilepsy, as well as artificial intelligence.

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REFERENCES
1. Cummings JL, Goldman DP, Simmons-Stern NR, Ponton E. The costs of developing treatments for Alzheimer disease: a retrospective exploration. Alzheimer Dement. Published online September 28, 2021. doi:10.1002/alz.12450
2. FDA Approves New Treatment for Myasthenia Gravis. News release. FDA. December 17, 2021. Accessed January 13, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-myasthenia-gravis
3. Kelly AM, Kuan WS, Chu KH, et al. Epidemiology, investigation, management, and outcome of headache in emergency departments (HEAD study)–a multinational observational study. Headache. 2021;61(10):1539-1552. doi:10.1111/head.14230?
4. Wappel SR, Scharf SM, Cohen L, et al. Improving sleep medicine education among health professions trainees. J Clin Sleep Med. 2021;17(12):2461-2466. doi:10.5664/jcsm.9456