OPPORTUNITIES, ENCOURAGEMENT, AND KNOWING ONE’S SELF
Carlayne E. Jackson, MD, FAAN, 38th President of the American Academy of Neurology
It is a distinct honor to have this opportunity to address you as president of the American Academy of Neurology. It’s also humbling to have been chosen by my colleagues to follow such talented and dedicated individuals like Dr. Orly Avitzur, Dr. Jim Stevens, the late Dr. Ralph Sacco, and all the others who stretch back to A.B. Baker who created this home for us 75 years ago. They have made our Academy strong and responsive to our needs, and I shall strive every day to do the same.
I started working with the AAN in 2002 as an abstract reviewer for the Annual Meeting. In 2005, a colleague on the Science Committee was rotating off and there was a need for a member with research experience in neuromuscular diseases. The Academy was very intentional about wanting to include more women on committees since at the time women made up only 20 percent of appointments. In 2011, I was nominated for the Board of Directors. There were four women on the board at that time and I was the youngest member. In 2017, I was encouraged to apply for an officer position and became the secretary of the Board. Outside of my role on the Board, I also served on the Meeting Management Committee and became chair in 2019.
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Summer Conference Early Registration Discounts End June 1
May 11 Is Compensation and Productivity Survey Deadline
Minneapolis and Online
July 28–29, 2023
Don’t wait to secure your spot. June 1 is the last chance for early registration discounts for the 2023 AAN Summer Conference: Emergency and Hospital Neurology, set to take
Continued on page 5 ›
AAN members are encouraged to complete the 2023 Neurology Compensation and Productivity Survey by May 11 to receive access to a wealth of data for free—a $500 value. The Neurology Compensation and Productivity Survey is the largest neurology compensation and productivity survey in the United States, with more than 4,000 AAN members participating in 2021. For the first time, this year’s survey will capture additional information for those practicing in the full-time telehealth model and for those delivering care in the inpatient setting.
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VOLUME 35 ISSUE 5 MAY 2023 7 Re-energize Yourself, Your Career with These Leadership Development Opportunities 6 New Diversity, Equity, and Inclusion Committee Established 8 AAN Awards Recognize Achievements, Help Winners Realize Potential
Jackson
The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction.
The Vision of the AAN is to be indispensable to our members.
Contact Information
American Academy of Neurology
201 Chicago Avenue Minneapolis, MN 55415
Phone: (800) 879-1960 (toll free) (612) 928-6000 (international)
Email: memberservices@ aan.com
Website: AAN.com
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Account/Relationship Manager
Wolters Kluwer
Phone: (978) 578-4514
Email: Michael.Obrien @ wolterskluwer.com
EDUCATION
AAN CME Programs Receive Accreditation
The AAN has been reviewed by the Accreditation Council for Continuing Medical Education (ACCME) and awarded full accreditation for four years as a provider of continuing medical education for physicians. Accreditation in the ACCME System seeks to assure the medical community and the public that the AAN delivers education that is relevant to clinicians’ needs, evidence-based, evaluated for its effectiveness, and independent of commercial influence. The ACCME System employs a rigorous process for evaluating institutions' CME programs according to standards that reflect the values of the educator community and aim to accelerate learning, inspire change, and champion improvement in health care. Through participation in accredited CME, clinicians and teams drive improvement in their practice and optimize the care, health, and wellness of their patients.
AAN Chief Executive Officer: Mary E. Post, MBA, CAE
News Briefs
Workforce Shortage
Editor-in-Chief: Melissa W. Ko, MD, MBA, CPE, FAAN
Managing Editor: Angela M. Babb, MS, CAE, APR
Editor: Tim Streeter
Writers: Ryan Knoke and Sarah Parsons
Designer: Siu Lee
Email: aannews@ aan.com
AANnews® is published monthly by the American Academy of Neurology for its 40,000 members worldwide. Access this magazine and other AAN publications online at AAN.com.
The American Academy of Neurology ’s registered trademarks and service marks are registered in the United States and various other countries around the world.
“American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
The inclusion of advertisements and/or promotions of Sponsors and other Internet sites or resources that offer content, goods, or services on the Website does not imply endorsement of the advertised/promoted products or services by AAN.
The Senate Health, Education, Labor, and Pensions Committee put out a request for information on the national health care workforce shortage in early March. The AAN replied with recommendations that addressed administrative burden, reimbursement, physician burnout, loan forgiveness, and international medical graduate visas, among others.
Race/Ethnicity Information
The AAN published “Measuring Ambulatory Racial and Ethnic Neurologic Disparities with the Axon Registry” on March 1, 2023, online in Neurology ® Clinical Practice. The article examines the potential racial and ethnic disparities in ambulatory neurology quality measures within the Axon Registry ®. This analysis highlights the critical need for education and tools supporting the accurate capture of race and ethnicity data in the EHR. The analysis also highlights the feasibility of using the Axon Registry to assess neurologic disparities in outpatient care.
AANnews · May 2023
Opportunities, Encouragement, and Knowing One’s Self
I also joined the Leadership Development Committee upon its inauguration in 2015 and became very involved in mentorship. When Dr. Ralph Sacco began his presidency, he asked me to chair the Board Planning Committee, which is charged with strategic planning for the organization. This gave me an opportunity to work with AAN staff and committee chairs and get to really know the Academy and how it functions. I feel the reason I was selected as president elect is due to the encouragement of people within the organization and the opportunities that they gave me.
The increased visibility of women leading in the AAN and neurology sends the message to the pipeline that we are welcoming of women and will invest in their success. Currently, women consist of 48 percent of our committees, have equal representation on our Board, and the presidential line is all women. Women bring different perspectives with different solutions. They may have different approaches to negotiations. Diversity overall, including gender, drives greater organizational effectiveness. Women are increasingly represented at grant review committees for NIH and NINDS and this brings a different lens for research.
My being in this place at this time is rather ironic given that I never felt compelled to go to medical school. I grew up in San Antonio and I was encouraged to go into engineering because I was good in science. I attended Texas A&M as a chemical engineering major and when I went on a school trip to a chemical plant my junior year I was repelled by the noxious smell. That turned me off engineering! My boyfriend at the time, who remains my husband of 38 years, was going to dental school and I figured I might as well go to medical school and that way we could stay together in San Antonio. To be honest, I didn’t really enjoy my neuroscience course, but I had several inspiring mentors. One was Dr. Chuck Tegler, now chair at Wake Forest University School of Medicine, with whom I did my clerkship. The other is Dr. Rick Barohn, a lifelong mentor who is now executive vice chancellor for health affairs at the University of Missouri. Dr. Barohn urged me to shadow him for a year and be an instructor to experience the academic world, because my original intention was to go into private practice. I was given the opportunity to stay in San Antonio to join the University of Texas Health Science Center faculty and everything just clicked for me! I got involved in ALS clinical research and have just absolutely loved academic medicine.
By then I had three children, one of whom was handicapped. I had all my children during my residency and fellowship, and our entire extended family lived in San Antonio. And so, it was just natural that I would put my roots down here and continue here. The family support network is as vital as one’s professional network. By my mid-40s I had become a professor and I began wondering, what's next? Dr. Robin Brey, the chair of my department, recommended me to the dean for a role on the “clinical development team” that was centralizing all of our outpatient clinics in an eight-story building. We were tasked to introduce electronic health records to help ensure that everyone was using
the same policies and procedures. The goal was to change UT Health from an indigent patient practice to the preferred health care provider in San Antonio. I was then asked to serve as the chief medical officer and assistant dean for ambulatory services for the next 10 years and enjoyed it immensely.
When Dr. Brey retired, she asked me to be the interim chair of neurology. I was a bit hesitant as I knew my commitment to the presidency of the AAN would entail a lot of work and travel. But she convinced me I would be good at it and sometimes it’s the faith that others have in us that gives us the courage to take on something new. I quickly fell in love with the role and the chance to mentor my department and to do a lot of faculty development work. I was named the permanent chair in September and have been “drinking from the fire hose” ever since!
In our AAN leadership programs, we often say that the first thing you must do to be an effective leader is to know yourself and your strengths. You need to understand your leadership style. If you don't know how to lead yourself, you can't be successful leading a group. It is also essential to have a personal strategic plan. Set short-term and long-term goals every year and at least once a year sit down and really evaluate where you are and where you want to go. Don’t be swept up in the “whirlwind” of life and not have a clear direction of what you want to do.
So, I wear a lot of hats right now. President of the AAN, neurology chair at a major academic institution, wife, mother, sister, daughter, and recent grandmother! I manage it by putting in time on my calendar for the things I enjoy, like exercise and date nights with my husband and developing a strong support network of family, friends, and colleagues. I have learned to only do what I feel passionate about and to say “no” to the things that I’m not. I also reconnect with my mentors frequently— relationships will always be the key to success.
Opportunities come unexpectedly, and you need to be open to them. Don’t forget that you can be an advocate for yourself. I applied three times to be president elect of the AAN and when it wasn’t yet time for me to be chosen I simply doubled down on stretching myself, my knowledge, and skills. You must be a good listener and ask questions and learn as much as you can, so you are prepared for what might come your way. Have confidence in yourself to embrace new experiences and challenges and remember that you are a lifelong student.
Carlayne E. Jackson, MD, FAAN President, AAN cjackson@aan.com @CarlayneJackson on Twitter
4 A ANnews • May 2023 PRESIDENT'S COLUMN
from cover
continued
Early Registration Discounts End June 1
place July 28 and 29 at the Hyatt Regency in Minneapolis, MN, the hometown of the Academy. Registrants can also choose to attend live online. June 1 is the last chance to take advantage of the deepest registration discounts—up to $260 depending on AAN member type! Visit AAN.com/Summer today to learn more and to secure your savings.
Conference Directors Casey S.W. Albin, MD; S. Andrew Josephson, MD, FAAN; and Mark Milstein, MD, FAAN, will lead a lively two-day program dedicated to the critically important topic of emergency and hospital neurology, covering the most up-to-date information for neurologists and advanced practice providers. Tailored to the needs of the consultant neurologists at both tertiary and community practices, the curriculum will highlight the latest in clinically relevant scientific advances and case-based updates in all important neurohospitalist and neurocritical care topics, as well as offer sessions that will optimize practice, teaching, and quality improvement.
Programming includes:
Case-based updates in several areas including status epilepticus, intracerebral hemorrhage, arterial ischemic stroke, and more
Skills building sessions on topics such as brain death and device programming.
Global talks on health disparities, inpatient neurology, neurology resident training, and wellness among physicians and trainees
Three case-based programming tracks in neurocritical care; hospital neurology topics; and business, training, education, wellness, and diversity, equity, and inclusion
continued from cover
Exhibit Hall offers the opportunity to network with organizations that are at the forefront of advancing patient care
AAN.com/Summer
May 11 Is Compensation and Productivity Survey Deadline continued from cover
Past data has been used by members to help improve practice efficiency, develop business models, analyze gender-related pay disparities in neurology, segment productivity and compensation data, drive innovation and better business decision-making, and much more. Access the data via a user-friendly dashboard that allows you to filter by subspecialty, geographic region, gender, and more. The dashboard will be available by July 2023.
While access to the data is free for survey participants, the cost for US members who do not participate in the survey is $500, and $1,500 for nonmembers in the US.
Visit AAN.com/benchmark by May 11 to complete the survey and ensure access to a wealth of data that can help you in your work.
A ANnews • May 2023 5 EVENTS
and Online
Albin Josephson Milstein
Minneapolis
July 28–29, 2023 MAY 11
New Diversity, Equity, and Inclusion Committee Established
Inclusion is the reason the AAN was founded. The AAN is firmly committed to embracing the diversity of our members, staff, and the communities they serve, and affirms the need for equity and inclusiveness in our organization, our profession, and the care we provide for our patients. In this column, we share the wide spectrum of diversity, equity, and inclusion (DEI) work being done across the AAN.
The AAN Board of Directors voted to elevate the IDEAS Subcommittee to a new Diversity, Equity, and Inclusion (DEI) Committee.
As stated in the new committee’s charter, “The American Academy of Neurology and American Academy of Neurology Institute (AAN) is firmly committed to embracing the diversity of our members, staff, and the communities they serve and affirms the need for equity and inclusiveness in our organization, our profession, and the care we provide to our patients. Reporting to the Board of Directors, the DEI Committee’s primary role is to communicate to membership and leadership, the importance of DEI in practice, education, and research and to provide evidence for the AAN’s progress in DEI with a goal of being a fully inclusive, deliberately diverse, and anti-racist organization.”
The committee will be chaired by Nimish A. Mohile, MD, FAAN.
Reporting to the DEI Committee is the Health Care Equity Work Group, which oversees the yearlong multifaceted Health Care Equity Scholarship Program, the webinar series for members, and the halfday health care equity symposium at the Annual Meeting. The objective of this work group is to help members recognize disparities in care and move toward health equity in neurology.
Brain & Life Podcast: Educating the public on neurology and brain health. Follow and subscribe wherever you get your podcasts. BrainandLife.org/Podcast 6 A ANnews • May 2023 MEMBERSHIP
Mohile
Re-energize Yourself, Your Career with These Leadership Development Opportunities
Apply by June 6
It’s spring and there’s no better time to reinvigorate yourself and your career! Applications are open for three of the AAN’s leadership development programs that are sure to refresh and enhance your leadership and problem-solving skills, and boost your career satisfaction and trajectory. Only AAN Leadership Development Program opportunities combine the kind of high-caliber executive leadership education, important peer collaboration, and invaluable 1:1 coaching and mentoring to create a once-in-a-lifetime experience. The value of great leadership is more important than ever in today’s challenging health care environment and the AAN is committed to investing in members now to develop tomorrow’s leaders.
Diversity Leadership
The AAN is committed to building leadership reflective of our diverse member and patient demographics. This empowering and inspirational program provides a meaningful developmental experience that fully engages members from underrepresented neurology groups.
Emerging Leaders
This program is designed to identify, engage, and mentor talented early-career members less than seven years out of residency who have the disposition to lead and are interested in future roles within the AAN and the field of neurology.
Practice Leadership
A unique opportunity designed specifically to identify and engage US neurologists in a solo or small practice who are interested in helping to shape the future of neurology with the AAN and their communities. The program’s convenient format provides high-quality development training while accommodating the demanding schedules of busy practitioners.
Visit AAN.com/LEAD to browse the programs, application qualifications, and participant expectations and apply before the June 6 application deadline—and be sure and share these opportunities with colleagues who you think would be a good fit for this extraordinary leadership development opportunity.
AAN LEADERSHIP DEVELOPMENT
See What Graduates Are Saying About Their Leadership Program Experiences
The Emerging Leaders Program far exceeded my expectations for leadership development. I not only learned valuable skills for my growth in medical leadership, but also how I uniquely show up as a leader in any area of life. The community (including the coach, physician liaison, advisors, and fellow group members) is also such an invaluable support system. This is an amazing opportunity that I am incredibly grateful to have been a part of!
Jemima Akinsanya, DO 2021–2022 Emerging Leaders Program Graduate
The Diversity Leadership Program was a transformative career experience. I gained a stronger understanding of the AAN opportunities, a network of peers that have become friends, and a clearer plan of how to build a career that serves my priorities and society at large.
Gerson Suarez Cedeño, MD 2022 Diversity Leadership Program Graduate
The Practice Leadership Program was a very unique opportunity for me to collaborate with young physicians around the country all coming together for a common goal: to grow personally and professionally. There were physicians from large clinics, hospitals, and solo practices, all of whom brought a different perspective and new skills to the table when discussing common issues we all face. We learned a lot about ourselves and our emotional intelligence, which continues to help me in my day-to-day interactions with patients and my staff. I'm very grateful to the AAN.
Michael J. Soileau, MD 2020 Practice Leadership Program Graduate
A ANnews • May 2023 7
AAN Awards Recognize Achievements, Help Winners Realize Potential
Since the 1950s, the Academy has recognized the achievements of gifted researchers and clinicians dedicated to solving neurology’s greatest mysteries. The AAN’s first designated honor, “Junior Award of the Woman’s Auxiliary to the American Academy of Neurology,” was presented to John Logothetis, MD, who made headlines when he drove overnight from Minneapolis to the 1955 Annual Meeting in Houston to accept it. Logothetis was selected for his research, “A Study of Free Amino Acids in the Human Cerebrospinal Fluid.” A protégé of AAN founder A.B. Baker at the University of Minnesota, Logothetis went on to lead the department of neurology at the University of Salonica in Greece.
With time, the name of the Junior Award was changed to the S. Weir Mitchell Award, and in 1969 it was first presented to a woman, Margaret M. Waddington, MD, for “Angiographic Changes in Focal Motor Epilepsy.” Previously, Rebecca Hanson, MD, FAAN, who became an AAN member in 1967, won the Medical Student Essay Award in 1963.
The S. Weir Mitchell Award has appeared on the resumes of many illustrious AAN leaders and distinguished researchers, such as Robert W. Katzman, MD, (1960) who went on to receive the Potamkin Prize for Research in Pick’s, Alzheimer’s, and Related Diseases in 1992, and John C. Mazziotta, MD, PhD, FAAN, a recipient in 1981 and past chair of the American Brain Foundation.
EDUCATION AWARDS
A.B. Baker Award for Lifetime Achievement in Neurologic Education
Funded by an endowment created by matching funds from the A.B. Baker Family Trust and Novartis Pharmaceuticals.
Zachary London, MD, FAAN / University of Michigan, Ann Arbor, MI
A.B. Baker Teacher Recognition Award
Jayant Acharya, MD, FAAN / UCSD, La Jolla, CA
Aileen Antonio, MD / Trinity Health
Saint Mary’s Hauenstein Neurosciences, Grand Rapids, MI
Sanaz Attaripour, MD, PhD, FAAN / University of California-Irvine, Orange, CA
Nancy Baker, MD / Loma Linda University, Loma Linda, CA
Throughout the decades, the AAN’s awards have recognized young, enterprising talent in research who went forth to become leaders in their fields, make new discoveries, and break scientific barriers.
Before he was awarded the Nobel Prize in Psychology or Medicine, Stanley B. Prusiner, MD, gave the Cotzias Lecture in Basic Neuroscience at the 1987 Annual Meeting. At the time, his discovery of prions was beginning to gain recognition within the medical and scientific communities. Prusiner also received the 1991 Potamkin Prize as well as numerous other awards on his way to win the Nobel in 1997, and his work on prions had ostensibly become the biggest breakthrough during the “Decade of the Brain.”
Another noted neuroscientist, Eric R. Kandel, MD, was the Cotzias Lecturer in 1984, 16 years before he won the Nobel Prize.
Along with scientific research, AAN awards have grown to encompass recognition for achievements in neurology education and service to the specialty and to patients. Scholarship awards, too, have recognized the dreams of medical students who seek to learn more about neurology and opportunities in the profession by attending the Annual Meeting.
Today, the AAN recognizes the 2023 AAN award recipients and their contributions to the art and science of neurology.
Lauren Beslow, MD / Children’s Hospital of Philadelphia, Philadelphia, PA
Muhammad Fawad Bilal, MD / Owensboro Health, Owensboro, KY
Ania Busza, MD, FAAN / University of Rochester, Rochester, NY
Joseph Carrera, MD, PhD, FAAN / University of Michigan, Ann Arbor, MI
Madeline Chadehumbe, MD, FAAN / Neurabilities, Voorhees, NJ
Marissa Dean, MD / University of Alabama at Birmingham, Birmingham, AL
Wissam Deeb, MD, FAAN / UMass Memorial Medical Center, Worcester, MA
Stephen English, MD / Mayo Clinic, Jacksonville, FL
Prasanna Venkatesan Eswaradass, MD / University of Kansas Health System, Kansas City, KS
Jorge Ortiz Garcia, MD / University of Miami, Miami, FL
Justin Hoskin, BA, C-TAGME / Barrow
Neurological Institute, Phoenix, AZ
Maryam Hosseini, MD, MPH, FAAN / University of New Mexico, Albuquerque, NM
Spencer Hutto, MD / Florida State University, Jacksonville, FL
Humaira Khan, MD / CAVHS, Little Rock, AR
Inna Keselman, MD / UCLA, Los Angeles, CA
Neil Masangkay, MD / University of Arkansas for the Medical Sciences, Little Rock, AR
8 A ANnews • May 2023 MEMBERSHIP
Logothetis’s journey made Houston headlines.
Alina Masters-Israilov, MD, FAAN / Weill Medical College of Cornell University, New York, NY
Sally Mathias, MD / University of Kentucky, Lexington, KY
Prachi Mehndiratta, MD, PhD, FAAN / University of Maryland School of Medicine, Baltimore, MD
Anza Memon, MD / Henry Ford Health System, Bloomfield Hills, MI
Mostafa Mahmoud Hassan Meshref, MD / Al-Azhar University, Cairo, Mokkattam City, Cairo, Egypt
Nicholas Milano, MD / Medical University of South Carolina, Charleston, SC
Setareh Salehi Omran, MD / University of Colorado, Aurora, CO
Anna Pace, MD / Mount Sinai School of Medicine, New York, NY
Addie Patterson, MD, FAAN / University of Florida, Gainesville, FL
David C. Preston, MD, FAAN / University Hospitals-Cleveland Medical Center, Cleveland, OH
Divisha Raheja, MD / St Luke’s University, Lansdale, PA
Necrisha Roach, MD, PhD, FAAN / University of Virginia, Charlottesville, VA
Liana Rosenthal, MD / Johns Hopkins, Baltimore, MD
Vishwanath Sagi, MD / University of Louisville, Louisville, KY
Sita Jayalakshmi Sattaluri, MD / Krishna Institute of Medical Sciences, Secunderabad, India
Nicholas Silvestri, MD, FAAN / University at Buffalo, SUNY, Buffalo, NY
Shitiz Sriwastawa, MD, FAAN / West Virginia University, Morgantown, WV
Derek Stitt, MD, FAAN / Mayo Clinic, Rochester, MN
Adnan Subei, DO, FAAN / Memorial Healthcare System, Hollywood, FL
Anishee Undavia, MD / Einstein Medical Center Philadelphia, Philadelphia, PA
Mauricio Villamar, MD / Brown Neurology, Providence, RI
Association of Indian Neurologists in America Lifetime Achievement Award
Sponsored by the Association of Indian Neurologists in America Fund of the American Brain Foundation.
Sanjay P. Singh, MD, FAAN, FANA / Creighton University School of Medicine, Omaha, NE
Clerkship Director Innovation Award
Jamie LaBuzetta, MD / University of California San Diego, San Diego, CA
Clerkship Director Teaching Award
Norika Malhado-Chang, MD / University of California Davis, Davis, CA
Clerkship Education Coordinator Recognition Award
Alex Gough / McGaw Medical Center of Northwestern University, Chicago, IL
Brigitte H. Nettles / University of Oklahoma Health Sciences Center, Oklahoma City, OK
Consortium of Neurology Residents and Fellows Essay Contest
Yasmin Aghajan, MD / Harvard Medical School, Mass General Hospital, Cambridge, MA
Creative Expression of Human Values in Neurology Award
Sponsored by the Ethics, Law, and Humanities, a joint committee of the AAN, ANA, and CNS.
Lealani Mae Acosta / Vanderbilt University Medical Center, Nashville, TN
Director Mentorship Leadership Program
Aileen Antonio, MD / Trinity Health
Saint Mary’s Hauenstein Neurosciences, Grand Rapids, MI
Kapil Arya, MD / UAMS-Pediatric Neurology, Little Rock, AR
Rae E. Bacharach, DO / Penn State University, Milton S. Hershey Medical Center, Hershey, PA
Laxman Bahroo, DO, FAAN / Medstar Georgetown University Hospital, McLean, VA
Mark D. Baker, MD / GWU Neurology, Washington, DC
Danny Bega, MD / Northwestern University, Chicago, IL
Annapoorna Bhat, MD / University of New Mexico School of Medicine, Albuquerque, NM
A. Blake Buletko, MD / Cleveland Clinic, Cleveland, OH
Elizabeth A. Coon, MD, FAAN / Mayo Clinic, Rochester, MN
Suzanne Crandall, DO / Charleston Area Medical Center, Charleston, WV
William Alexander Dalrymple, MD / University of Virginia Health System, Charlottesville, VA
Zain Guduru, MD / University of Kentucky, Lexington, KY
Jafar Kafaie, MD, PhD / Saint Louis University, Saint Louis, MO
Adrienne M. Keener, MD / UCLA Neurology, Los Angeles, CA
Thomas Vincent Kodankandath, MD / Carilion Clinic Neurology, Roanoke, VA
Pearce Korb, MD, FAAN / VCU Health, Richmond, VA
Arielle Marisa Kurzweil, MD, FAAN / NYU, New York, NY
Max R. Lowden, MD, FAAN / Penn State University, Milton S. Hershey Medical Center, Hershey, PA
Soe Mar, MD, FAAN / Washington University School of Medicine, Saint Louis, MO
Tara K. Mangum, DO / Phoenix Children’s Hospital, Phoenix, AZ
Neil Masangkay, MD / University of Arkansas for the Medical Sciences, Little Rock, AR
Maryann Mays, MD, FAAN / Cleveland Clinic, Cleveland, OH
Lisa R. Merlin, MD, FAAN / SUNY Downstate Medical Center, Brooklyn, NY
Aaron Lane Nelson, MD, FAAN / NYU Langone Health, New York, NY
Ajitesh Ojha, MD / UPMC, Pittsburgh, PA
Michael L. Palm, MD, FAAN / UT Health San Antonio, San Antonio, TX
Sonja Potrebic, MD, PhD, FAAN / Southern California Permanente Medical Group, Los Angeles, CA
David Preston, MD, FAAN / University Hospitals-Cleveland Medical Center, Cleveland, OH
Joel Isaac Shenker, MD, PhD / University of Missouri, Columbia, MO
Jacqueline Stone, MD / Memorial SloanKettering Cancer Center, New York, NY
Kavitha Tirumalasetti, MD / Phoenix Children’s Hospital, Phoenix, AZ
Diego Torres-Russotto, MD, FAAN / Miami Neuroscience Institute-Baptist Health South Florida, Miami, FL
Melanie Truong-Le, DO / UT Southwestern Medical Center, Dallas, TX
Alan Wang, MD / Banner University Medical Center-Phoenix, Phoenix, AZ
Christina Wilson, MD, FAAN / University of Florida, Gainesville, FL
Edward Yu, MD / Northwell Health, Staten Island, NY
A ANnews • May 2023 9 Continued on page 10 ›
AAN Awards Recognize Achievements, Help Winners Realize Potential
Enhanced Resident Leadership Program
Shane Arsenault, MD / Memorial University of Newfoundland St. John’s, Newfoundland and Labrador, Canada
Alexis Ariel Clay, MD / Boston Medical Center, Boston, MA
Catherine R. Garcia, MD / Baylor College of Medicine, Houston, TX
Joshua Luster, MD / San Antonio Uniformed Services Health Education Consortium, San Antonio, TX
Thien Nguyen, MD / University of Kentucky, Lexington, KY
Meghna Rajaprakash, MD / Johns Hopkins Hospital and Kennedy Krieger Institute, Neurodevelopmental Disabilities/Child Neurology, Baltimore, MD
Brigitte Reina, MD / Dartmouth-Hitchcock Medical Center, Lebanon, NH
Avni Sanghi, DO / Emory University, Atlanta, GA
Carol Swetlik, MD / Cleveland Clinic, Wickliffe, OH
Vaishnavi Lakshmi Vaidyanathan, MD / Phoenix Children’s Hospital, Tempe, AZ
Miranda Wan, MD / Foothills Medical Center, Calgary, Alberta, Canada
Alexandra Mae Wood, MD / Medical College of Wisconsin Affiliated Hospitals, Milwaukee, WI
Shea Wright, MD / University of Utah, Salt Lake City, UT
SERVICE AWARDS
AAN President's Award
Elaine C. Jones, MD, FAAN / Access TeleCare, Sarasota, FL
Ambassador Award
Sponsored by the American Brain Foundation. Peter Frampton
Board Chair Award
Sponsored by the American Brain Foundation. Jane Ransom / American Brain Foundation, Minneapolis, MN
General Neurology Award
Sponsored by the American Academy of Neurology.
continued from page 9
Rachel Zolno, MD / Washington University in St. Louis, St. Louis, MO
Fellowship Director Recognition Award
Anita V. Shelgikar, MD, MHPE / University of Michigan, Ann Arbor, MI Christina Wilson, MD, FAAN / University of Florida, Gainesville, FL
Fellowship Education Coordinator Recognition Award
Sara Nagel / University of Wisconsin, Madison, WI
Michael Lilley, MHA / St. Luke’s University, Bethlehem, PA
Frank A. Rubino Award for Excellence in Clinical Neurology Teaching
Funded by Mayo Clinic Frank A. Rubino, MD Development Fund.
Douglas J. Gelb, MD, PhD, FAAN / University of Michigan, Ann Arbor, MI
Neurology ® Resident & Fellow Section Writing Award
Sponsored by Neurology Resident & Fellow Section.
Jodie I. Roberts, MD, MSc; Kristine Woodward, MD, MSc; Adam Kirton, MD, MSc; and Michael J. Esser, MD, PhD / for “Pearls & Oy-sters: Cerebral Abscess Secondary to Pulmonary Arteriovenous Malformation in Hereditary Hemorrhagic Telangiectasia”
Neuroscience Course Director Excellence
Balaji Krishnaiah, MD / University of Tennessee Health Sciences Center, Memphis, TN
Residency Education Coordinator Recognition Award
Jennifer Shipley / University of Florida, College of Medicine, Gainesville, FL
Jillian Iffland, MEd / University of Maryland School of Medicine, Baltimore, MD
Michael Weintraub, MD, FACP, FAAN, FAHA / New York Medical College, Tarrytown, NY
Kenneth M. Viste Jr., MD Patient Advocate of the Year Award
Sponsored by the American Academy of Neurology and endowed by gifts from Dr. Viste’s colleagues, friends, and patients.
Geetanjali S. Rathore, MD, FAAN / Children's Hospital and Medical Center, Omaha, NE
Mridha Spirit of Neurology
Humanitarian Award
Sponsored by the American Brain Foundation and funded through the philanthropy of Dr. and Mrs. Mridha.
Residency Director Recognition Award
Margie A. Ream, MD, PhD / Nationwide Children’s Hospital/The Ohio State University, Columbus, OH
Leticia Tornes, MD, FAAN / University of Miami, Miami, FL
Gretchen Birbeck, MD, MPH, DTMH, FAAN / University of Rochester, Rochester, NY
Bhim Sen Singhal, MD, FAAN / Bombay Hospital Institute of Medical Sciences, Mumbai, Maharashtra, India
Olha Tychkivska, MD / St. Nicholas Lviv City Children's Clinical Hospital, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine
Neurology Practice Award
Sponsored by the American Academy of Neurology.
NeurAbilities Healthcare, Voorhees, NJ
10 A ANnews • May 2023 MEMBERSHIP
S. Weir Mitchell Award: Rose Baker; Howard D. Fabing, MD, FAAN; unknown; John Logothetis, MD, FAAN; Francis M. Forster, MD, FAAN, 1955 Annual Meeting
Public Leadership in Neurology Award
Sponsored by the American Brain Foundation.
Arianna Huffington
QI Innovation Award
Sponsored by the American Academy of Neurology.
Fazila Aseem, MD, MPH / University of North Carolina School of Medicine, Chapel Hill, NC
SCIENTIFIC AWARDS
AAN Neuro-infectious Disease Award
Sponsored by the American Academy of Neurology.
Mashina Chomba, MBChB, MMed / University Teaching Hospital, Lusaka, Zambia
Alliance Awards: Founders
Sponsored by the American Academy of Neurology and endowed by the former American Academy of Neurology Alliance.
Alexander Sandweiss, MD, PhD / Baylor College of Medicine and Texas Children's Hospital, Houston, TX
Alliance Awards: S. Weir Mitchell
Sponsored by the American Academy of Neurology and endowed by the former American Academy of Neurology Alliance.
John Pluvinage, MD, PhD / University of California, San Francisco, San Francisco, CA
Bruce S. Schoenberg International Award in Neuroepidemiology
Sponsored by the American Academy of Neurology and endowed by GlaxoSmithKline, Inc.
Jitendra Sahu, DM / Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India
Career Development Award
Funded by the American Academy of Neurology.
Jonathan Brent, MD, PhD / Feinberg School of Medicine, Northwestern University, Chicago, IL
Nathan Cohen, MD / Children's National Medical Center, Washington, DC
Clinical Research Training Scholarship
Funded by the American Academy of Neurology.
Andrew Dhawan, MD, PhD / Cleveland Clinic, Cleveland, OH
Anthony Linares, MD, PhD / University of California, Los Angeles, Los Angeles, CA
Martineau Louine, MD / University of California, San Francisco, San Francisco, CA
Pravin Khemani, MD, FAAN / Swedish Neuroscience Institute, Seattle, WA Ted Burns Humanism in Neurology Award
Sponsored by the American Brain Foundation.
Deanna Saylor, MD, MHS / Johns Hopkins University School of Medicine, Baltimore, MD
Volunteer Service Award
Sponsored by the American Academy of Neurology.
Praveen Kumar Yadav, MBBS, MD, DM, FAAN, MRCP, FRCP, FEBN, MNAMS / Aarogyam Neuroclinic, Durgapur, West Bengal, India
Evan Madill, MD / Brigham and Women's Hospital, Boston, MA
Clinical Research Training
Scholarship in ALS
Funded by The ALS Association and American Brain Foundation in collaboration with the American Academy of Neurology.
Marina Avetisyan, MD, PhD / Massachusetts General Hospital, Boston, MA
Clinical Research Training
Scholarship in FTD
Funded by Holloway Family Fund of The Association for Frontotemporal Degeneration and American Brain Foundation in collaboration with the American Academy
Daniel Ohm, PhD / University of Pennsylvania, Philadelphia, PA
Clinical Research Training
Scholarship in Migraine
Funded by Amgen, Inc. and American Brain Foundation in collaboration with the American Academy of Neurology.
Patricia Olson, MD, PhD / Brigham and Women's Hospital, Boston, MA
Clinical Research Training Scholarship in Neurodisparities
Funded by the Edgar J. Kenton III, MD Foundation; Eisai; and American Brain Foundation in collaboration with the American Academy of Neurology.
Dominique Popescu, PhD / Massachusetts General Hospital, Boston, MA
Clinical Research Training Scholarship in Neuromuscular Disease
Funded by the Neuromuscular Study Group and American Brain Foundation in collaboration with the American Academy of Neurology.
Natalie Katz, MD, PhD / Duke University, Durham, NC
Clinical Research Training Scholarship in Parkinson's Disease
Funded by the Parkinson's Foundation and American Brain Foundation in collaboration with the American Academy of Neurology.
Robert Heuermann, MD, PhD / Washington University, St. Louis, MO
Clinical Research Training Scholarship in Peripheral Neuropathy
Funded by the Foundation for Peripheral Neuropathy through the American Brain Foundation in collaboration with the American Academy of Neurology.
Paula Barreras, MD / Cedars-Sinai Medical Center, Los Angeles, CA
Erika Williams, MD, PhD / Brigham and Women's Hospital, Boston, MA
Dreifuss-Penry Epilepsy Award
Sponsored by the American Academy of Neurology and endowed by members of the American Academy of Neurology Epilepsy Section; Abbott Laboratories, Inc.; Cephalon, Inc.; Cyberonics, Inc.; Elan Corporation; GlaxoSmithKline, Inc.; Novartis; OrthoMcNeil Pharmaceutical, Inc.; Pfizer Inc; Shire Pharmaceuticals Group; and UCB Pharma.
Jonathan Kleen, MD, PhD / University of California, San Francisco, Medical Center San Francisco, CA
Continued on page 12 ›
S. Weir Mitchell Award: Madge DeJong; Adolph L. Sahs, MD, FAAN; Florence Hauser; W. King Engel, MD, FAAN; Joseph M. Foley, MD, FAAN, 1962 Annual Meeting
AAN Awards Recognize Achievements, Help Winners Realize Potential
H. Richard Tyler Award
Sponsored by the American Academy of Neurology and the American Academy of Neurology History Section.
Alison Christy, MD, PhD / Providence Health and Services, Northern Oregon Region, Portland, OR
Health Care Equity Research Award
Sponsored by the American Academy of Neurology.
Jordan J. Cole, MD / Washington University, St. Louis, MO
Bruce Ovbiagele, MD, MSc, MAS, MBA, MLS, FAAN / San Francisco VA, San Francisco, CA
Nicole Rosendale, MD / University of California, San Francisco, San Francisco, CA
Irwin Schatz Award for Autonomic Disorders
Sponsored by the American Academy of Neurology and endowed by Lundbeck, Inc.
Paola Sandroni, MD, PhD, FAAN / Mayo Clinic, Rochester, MN
John Dystel Prize for Multiple Sclerosis Research
Sponsored by the American Academy of Neurology and National Multiple Sclerosis Society and made possible through a special contribution from the John Dystel Multiple Sclerosis Research Fund at the National Multiple Sclerosis Society.
Roland Martin, MD / University of Zurich, Zurich, Switzerland
Jon Stolk Award in Movement Disorders for Young Investigators
Sponsored by the American Academy of Neurology and endowed by Kyowa Pharmaceutical, Inc., Lineberry Research, Quintiles, Dr. Dennis Gillings, and VelaPharma. Farwa Ali, MBBS / Mayo Clinic, Rochester, MN
Lawrence C. McHenry: An Award for the History of Neurology
Sponsored by the American Academy of Neurology.
Kelsey Smith, MD / Mayo Clinic, Rochester, MN
Lawrence M. Brass Stroke Research Award
Funded by the American Heart Association and the American Brain Foundation, in collaboration with the American Academy of Neurology.
Margy McCullough-Hicks, MD / University of Minnesota, Minneapolis, MN
continued from page 11
McKnight Clinical Translational Research Scholarship in Cognitive Aging and Age-Related Memory Loss
Funded by the McKnight Brain Research Foundation through the American Brain Foundation, and the American Academy of Neurology.
Eva Klinman, MD, PhD / Washington University, St. Louis, MO
Sheena Baratono, MD, PhD / Brigham and Women's Hospital, Boston, MA
Medical Student Essay Awards: G. Milton Shy
Sponsored by the American Academy of Neurology.
Trenley Anderson, BA, MM / Case Western Reserve University, Cleveland Heights, OH
Medical Student Essay Awards: Lewis P. Rowland
Sponsored by the American Academy of Neurology.
Sumita Strander, BA / Harvard Medical School, Brookline, MA
Medical Student Essay Awards: Roland P. Mackay
Sponsored by the American Academy of Neurology.
Zabrina Reyes, BS / Tulane University School of Medicine, New Orleans, LA
Medical Student Essay Awards: Saul R. Korey
Sponsored by the American Academy of Neurology.
Alexandra Miner, BA, MS / Virginia Tech Carilion School of Medicine, New York, NY
Michael S. Pessin Stroke Leadership Prize
Sponsored by the American Academy of Neurology and endowed by Dr. Pessin’s family, friends, and colleagues.
Neal Parikh, MD, MS / CTNU-Weill Cornell Medicine, New York, NY
Movement Disorders Research Award
Sponsored by the American Academy of Neurology, the Parkinson’s Foundation, and the American Academy of Neurology Movement Disorders Section and endowed by the Parkinson’s Foundation.
Jill Ostrem, MD, FAAN / University of California, San Francisco, San Francisco, CA
Neuro-oncology Investigator Award
Sponsored by the American Academy of Neurology and supported by friends of Dr. Jerome Posner.
Karisa Schreck, MD, PhD / Johns Hopkins University, Baltimore, MD
Neuro-oncology Scientific Award
Sponsored by the American Academy of Neurology and supported by friends of Dr. WK Alfred Yung.
Ingo Mellinghoff, MD, FACP / Memorial Sloan Kettering Cancer Center, New York, NY
Neuroscience Research Prize
Sponsored by the American Academy of Neurology.
Pulkith Paruchuri / Heritage High School, Frisco, TX
Samantha Schaevitz / Byram Hills High School, Bedford, NY
Maxx Yung / Roslyn High School, Roslyn, NY
Neuroscience Research Prize in Child Neurology
Sponsored by the American Academy of Neurology and the Child Neurology Society.
Rania Lateef / Charles J. Colgan High School, Manassas, VA
Neuroscience Research Training Scholarship
Funded by the American Academy of Neurology.
Vishnu Cuddapah, MD, PhD / Children's Hospital of Philadelphia, Philadelphia, PA
Sharan Srinivasan, MD, PhD / University of Michigan, Ann Arbor, MI
12 A ANnews • May 2023 MEMBERSHIP 12 A ANnews • May 2023
Victor Potamkin and the first recipient of the Potamkin Prize, Robert D. Terry, MD, 1988
Norman Geschwind Prize in Behavioral Neurology
Sponsored by the American Academy of Neurology and endowed through Dr. Geschwind’s family, friends, and colleagues; Pfizer Inc; and the Society for Behavioral and Cognitive Neurology.
Liliana Ramirez-Gomez, MD / Wang Ambulatory Care Center, Boston, MA
Potamkin Prize for Research in Pick's, Alzheimer's, and Related Diseases
Sponsored by the American Academy of Neurology and the American Brain Foundation and funded through the philanthropy of the Potamkin family.
Maria Gorno Tempini, MD, PhD / University of California, San Francisco, San Francisco, CA
Practice Research Training Scholarship
Funded by the American Academy of Neurology.
Nirupama Yechoor, MD, MSc / Massachusetts General Hospital, Boston, MA
SCHOLARSHIPS
Education Research Grant
Catherine Albin, MD / Emory University School of Medicine, Atlanta, GA
Jonathan Attwood, MA (Oxon), BMBCh / University of Oxford, Oxford, United Kingdom
Futures in Neurological Research Scholarship to the Annual Meeting
Sponsored by the AAN Clinical Research Subcommittee
Maya Ayoub, MD, EdM / University of California, Los Angeles, Los Angeles, CA
Negin Badihian, MD / Mayo Clinic, Rochester, MN
Bryce A. Bagley / Stanford University, Stanford, CA
Mara Bahri / The Ohio State University College of Medicine, Columbus, OH
Shawn Barton, MD, PhD / Emory University School of Medicine, Atlanta, GA
Aaron Eduardo Rodriguez Calienes, MD / University of Iowa Hospitals & Clinics, Iowa City, IA
Kate Dembny / University of Minnesota, Minneapolis, MN
Richard Olney Clinician Scientist Development Award in ALS
Funded by The ALS Association and American Brain Foundation in collaboration with the American Academy of Neurology.
Maurizio Grassano, MD / University of Turin, Turin, Italy
Scientific Breakthrough Award
Sponsored by the American Brain Foundation
Josep O. Dalmau, MD, PhD, FAAN / University of Barcelona, University of Pennsylvania, Barcelona, Catalonia, Spain
Vanda Lennon, MD, PhD / Mayo Clinic, Rochester, MN
Sheila Essey Award: An Award for ALS Research
Presented by the AAN and the ALS Association and supported through the philanthropy of the Essey family through the American Brain Foundation and the ALS Association.
Virginia Lee, PhD, MBA / University of Pennsylvania, Philadelphia, PA
Sleep Science Award
Sponsored by the American Academy of Neurology and the Sleep Section and endowed by Cephalon, Inc.
Tiffany Braley, MD, MS / University of Michigan Medical Center, Ann Arbor, MI
Susan S. Spencer, MD, Clinical Research Training Scholarship in Epilepsy
Funded by the American Epilepsy Society, Epilepsy Foundation, and American Brain Foundation in collaboration with the American Academy of Neurology.
Wesley Kerr, MD, PhD / University of Pittsburgh, Philadelphia, PA
Wayne A. Hening Sleep Medicine Investigator Award
Sponsored by the American Academy of Neurology and endowed by UCB, Inc., Lilly USA, Elite Home Medical & Respiratory, Inc., Raleigh Neurology Associates, and friends of Dr. Wayne A. Hening.
Joseph Cheung, MD, MS / Mayo Clinic, Jacksonville, FL
Alyssa Edwards / Case Western Reserve School of Medicine, Cleveland, OH
Karam Gagi, MD / Michigan State University, Lansing, MI
Maria Garcia-Dominguez, MD / UMass Chan Medical School, Worcester, MA
Yung-Tian Gau, MD, PhD / SUNY Upstate Medical University, Syracuse, NY
Joseph Geraghty / University of Illinois College of Medicine, Chicago, IL
Laura Gilbert, DO, MBA / Washington University in St. Louis, St. Louis, MO
Mirna Hennawy, MD / University of British Columbia, Vancouver, BC, Canada
Billie Hsieh / The University of Texas Health Science Center at Houston, Houston, TX
Nimansha Jain / Washington University in St. Louis School of Medicine, St. Louis, MO
Dominic Julian / University of Arizona College of MedicinePhoenix, Phoenix, AZ
Manpreet Kaur / Yale University, New Haven, CT
Angela Kwan / University of Ottawa, Ottawa, ON, Canada
Emile Lemoine, MD, MSc / University of Montreal, Montreal, Quebec, Canada
Continued on page 19
A ANnews • May 2023 13
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2018 Advocate of the Year Glynnis Zieman, MD, FAHS, with David B. Watson, MD, FAAN.
KESIMPTA® IS DIFFERENT FOR A REASON
The Only SC delivered B-cell RMS treatment1,2
Powerful efficacy.* Early and continued relapse reduction over the study period3,4
EFFICACY
Established safety profile in pivotal trials which included treatmentnaïve patients3,5
1 Minute a Month, † when the patient is ready to administer3,6
• Primary end point: relative reduction in adjusted ARR vs Aubagio® (teriflunomide) of 51% (0.11 vs 0.22) in ASCLEPIOS I and 58% (0.10 vs 0.25) in ASCLEPIOS II3
• Post hoc analysis of pooled data from ASCLEPIOS I and II: cumulative ARR by time interval (KESIMPTA N=946, Aubagio N=936). Reduction in ARR seen in the first 3 months and time intervals over 2 years 4,7:
– Month 0 to 3: 0.236 vs 0.373
– Month 0 to 27: 0.123 vs 0.258
– No conclusions can be drawn
SAFETY
• Adverse events with an incidence of ≥5% with KESIMPTA and a greater incidence than Aubagio were: upper respiratory tract infections (39% vs 38%), injection-related reactions (systemic) (21% vs 15%), headache (13% vs 12%), injection-site reactions (local) (11% vs 6%), urinary tract infection (10% vs 8%), back pain (8% vs 6%), and blood immunoglobulin M decrease (6% vs 2%)3
• The overall rate of infections and serious infections in patients treated with KESIMPTA was similar to patients who were treated with Aubagio (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively)3
INDICATION
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.
WARNINGS AND PRECAUTIONS
Infections: An increased risk of infections has been observed with other anti-CD20 B-cell depleting therapies. KESIMPTA has the potential for an increased risk of infections including serious bacterial, fungal, and new or reactivated viral infections; some have been fatal in patients treated with other anti-CD20 antibodies. The overall rate of infections and serious infections in KESIMPTAtreated patients was similar to teriflunomide-treated patients (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively). The most common infections reported by KESIMPTA-treated patients in relapsing MS (RMS) trials included upper respiratory tract infection (39%) and urinary tract infection (10%). Delay KESIMPTA administration in patients with an active infection until resolved.
Consider the potential increased immunosuppressive effects when initiating KESIMPTA after an immunosuppressive therapy or initiating an immunosuppressive therapy after KESIMPTA.
Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.
Make KESIMPTA® your 1st choice
KesimptaHCP.com
ARR=annualized relapse rate; CDP=confirmed disability progression; CI=confidence interval; DMT=disease-modifying therapy; GdE=gadolinium-enhancing; MRI=magnetic resonance imaging; RMS=relapsing multiple sclerosis; SC=subcutaneous.
*Study Design: ASCLEPIOS I and II were 2 identical randomized, active-controlled, double-blind Phase 3 studies in patients with RMS, approximately 40% of whom were DMT treatment-naïve. Patients were randomized to double-dummy subcutaneous KESIMPTA (20 mg every 4 weeks) or oral Aubagio (14 mg daily) for up to 30 months. Primary end point was ARR. Key MRI end points were number of GdE T1 lesions, and annualized rate of new or enlarging T2 lesions. A key clinical end point was reduction in risk of 3-month CDP. Treatment duration was variable based on end-of-study criteria. Maximum duration 120 weeks, median duration 85 weeks.3
Post hoc Study Design: ARR by time intervals was analyzed from the pooled pivotal trials. The ARR (95% CI) was estimated separately for each time interval by fitting a negative binomial regression model adjusted for treatment as factor.4,7
†As per stability technical specification data, when the patient is ready to inject, it typically takes less than 1 minute a month to administer. Once-monthly dosing begins after the initial dosing period, which consists of 20 mg subcutaneous doses at weeks 0, 1, and 2. Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.3,6
Hepatitis B Virus: Reactivation: No reports of hepatitis B virus (HBV) reactivation in patients with MS treated with KESIMPTA. However, HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with ofatumumab at higher intravenous doses for chronic lymphocytic leukemia (CLL) than the recommended dose in MS and in patients treated with other anti-CD20 antibodies.
Infection: KESIMPTA is contraindicated in patients with active hepatitis B disease. Fatal infections caused by HBV in patients who have not been previously infected have occurred in patients treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. Perform HBV screening in all patients before initiation of KESIMPTA. Patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], should consult liver disease experts before starting and during KESIMPTA treatment.
Progressive Multifocal Leukoencephalopathy: No cases of progressive multifocal leukoencephalopathy (PML) have been reported for KESIMPTA in RMS clinical studies; however, PML resulting in death has occurred in patients being treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. In addition, JC virus infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
If PML is suspected, withhold KESIMPTA and perform an appropriate diagnostic evaluation. If PML is confirmed, KESIMPTA should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to starting KESIMPTA for inactivated vaccines. The safety of immunization with live or live-attenuated vaccines following KESIMPTA therapy has not been studied. Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with KESIMPTA During Pregnancy. For infants whose mother was treated with KESIMPTA during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines. If the B-cell count has not recovered in the infant, do not administer the vaccine as having depleted B-cells may pose an increased risk in these infants.
Injection-Related Reactions: Injection-related reactions with systemic symptoms occurred most commonly within 24 hours of the first injection, but were also observed with later injections. There were no life-threatening injection reactions in RMS clinical studies.
The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. If injection-related reactions occur, symptomatic treatment is recommended.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections and after discontinuation of therapy until B-cell repletion. Consider discontinuing KESIMPTA therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
Fetal Risk: Based on animal data, KESIMPTA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to KESIMPTA in utero. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving KESIMPTA and for at least 6 months after the last dose. Most common adverse reactions (>10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection-site reactions.
Please see additional Important Safety Information on the previous page and Brief Summary of full Prescribing Information on the following pages.
References: 1. National Multiple Sclerosis Society. Medications. Accessed February 10, 2022. https://www.nationalmssociety.org/Treating-MS/Medications 2. Torres JB, Roodselaar J, Sealey M, et al. Distribution and e icacy of ofatumumab and ocrelizumab in humanized-CD20 mice following subcutaneous or intravenous administration. P2.2-052. Poster presented at: 71st American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. 3. Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 4. Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab vs teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. LB62. Poster presented at: 6th Congress of the European Academy of Neurology; May 23-26, 2020; Virtual. 5. Hauser SL, Bar-Or A, Cohen JA, et al; for the ASCLEPIOS I and ASCLEPIOS II trial groups. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med. 2020;383(6):546-557. 6. Data on file. Injection time. Novartis Pharmaceuticals Corp; East Hanover, NJ. June 2020. 7. Data on file. OMB157G (ofatumumab). Summary of clinical e icacy in relapsing multiple sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.
INFORMATION (cont)
(cont) Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 © 2022 Novartis 10/22 246578
IMPORTANT SAFETY
WARNINGS AND PRECAUTIONS
KESIMPTA, the KESIMPTA logo, and SENSOREADY are registered trademarks of Novartis AG.
KESIMPTA® (ofatumumab) injection, for subcutaneous use
Initial U.S. Approval: 2009
BRIEF SUMMARY: Please see package insert for full prescribing information.
1 INDICATIONS AND USAGE
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
4 CONTRAINDICATIONS
KESIMPTA is contraindicated in patients with:
•Active HBV infection [see Warnings and Precautions (5.1)]
5 WARNINGS AND PRECAUTIONS
5.1 Infections
An increased risk of infections has been observed with other anti-CD20 B-cell depleting therapies.
KESIMPTA has the potential for an increased risk of infections, including serious bacterial, fungal, and new or reactivated viral infections; some of these infections have been fatal in patients treated with other anti-CD20 antibodies. In Study 1 and Study 2 [see Clinical Studies (14) in the full prescribing information], the overall rate of infections and serious infections in patients treated with KESIMPTA was similar to patients who were treated with teriflunomide (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively). The most common infections reported by KESIMPTA-treated patients in the randomized clinical relapsing MS (RMS) trials included upper respiratory tract infection (39%) and urinary tract infection (10%). Delay KESIMPTA administration in patients with an active infection until the infection is resolved.
Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants
When initiating KESIMPTA after an immunosuppressive therapy or initiating an immunosuppressive therapy after KESIMPTA, consider the potential for increased immunosuppressive effects [see Drug Interactions (7.1) and Clinical Pharmacology (12.2) in the full prescribing information]. KESIMPTA has not been studied in combination with other MS therapies.
Hepatitis B Virus
Reactivation
There were no reports of HBV reactivation in patients with MS treated with KESIMPTA. However, HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients being treated with ofatumumab for chronic lymphocytic leukemia (CLL) (at higher intravenous doses than the recommended dose in MS but for a shorter duration of treatment) and in patients treated with other anti-CD20 antibodies.
Infection
KESIMPTA is contraindicated in patients with active hepatitis B disease. Fatal infections caused by HBV in patients who have not been previously infected have occurred in patients being treated with ofatumumab for CLL (at higher intravenous doses than the recommended dose in MS but for a shorter duration of treatment). HBV screening should be performed in all patients before initiation of treatment with KESIMPTA. At a minimum, screening should include Hepatitis B surface antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb) testing. These can be complemented with other appropriate markers as per local guidelines. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with KESIMPTA. These patients should be monitored and managed following local medical standards to prevent HBV infection or reactivation.
Progressive Multifocal Leukoencephalopathy
Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability.
Although no cases of PML have been reported for KESIMPTA in the RMS clinical studies, PML resulting in death has occurred in patients being treated with ofatumumab for CLL (at substantially higher intravenous doses than the recommended dose in MS but for a shorter duration of treatment). In addition, JCV infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies. At the first sign or symptom suggestive of PML, withhold KESIMPTA and perform an appropriate diagnostic evaluation. Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
If PML is confirmed, treatment with KESIMPTA should be discontinued.
Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of KESIMPTA for live or live-attenuated vaccines,
and whenever possible, at least 2 weeks prior to initiation of KESIMPTA for inactivated vaccines.
KESIMPTA may interfere with the effectiveness of inactivated vaccines. The safety of immunization with live or live-attenuated vaccines following KESIMPTA therapy has not been studied. Vaccination with live or liveattenuated vaccines is not recommended during treatment and after discontinuation until B-cell repletion [see Clinical Pharmacology (12.2) in the full prescribing information]
Vaccination of Infants Born to Mothers Treated with KESIMPTA During Pregnancy
In infants of mothers treated with KESIMPTA during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines.
Inactivated vaccines may be administered, as indicated, prior to recovery from B-cell depletion, but an assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
5.2 Injection-Related Reactions
In Study 1 and Study 2, systemic and local injection reactions were reported in 21% and 11% of patients treated with KESIMPTA compared to 15% and 6% of patients treated with teriflunomide who received matching placebo injections, respectively [see Adverse Reactions (6.1) and Clinical Studies (14) in the full prescribing information]
Injection-related reactions with systemic symptoms observed in clinical studies occurred most commonly within 24 hours of the first injection, but were also observed with later injections. Symptoms observed included fever, headache, myalgia, chills, and fatigue, and were predominantly (99.8%) mild to moderate in severity. There were no life-threatening injection reactions in the RMS clinical studies.
Local injection-site reaction symptoms observed in clinical studies included erythema, swelling, itching, and pain.
Only limited benefit of premedication with corticosteroids, antihistamines, or acetaminophen was observed in RMS clinical studies. The first injection of KESIMPTA should be performed under the guidance of an appropriately trained healthcare professional. If injection-related reactions occur, symptomatic treatment is recommended.
5.3 Reduction in Immunoglobulins
As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 7.7% of patients treated with KESIMPTA compared to 3.1% of patients treated with teriflunomide in RMS clinical trials [see Adverse Reactions (6.1)]. Treatment was discontinued because of decreased immunoglobulins in 3.4% of patients treated with KESIMPTA and in 0.8% of patients treated with teriflunomide. No decline in immunoglobulin G (IgG) was observed at the end of the study. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing KESIMPTA therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
5.4 Fetal Risk
Based on animal data, KESIMPTA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to KESIMPTA in utero. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving KESIMPTA and for at least 6 months after the last dose [see Use in Specific Populations (8.1)]
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail elsewhere in the labeling:
•Infections [see Warnings and Precautions (5.1)]
•Injection-Related Reactions [see Warnings and Precautions (5.2)]
•Reduction in Immunoglobulins [see Warnings and Precautions (5.3)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Approximately 1500 patients with RMS received KESIMPTA in clinical studies. In Study 1 and Study 2, 1882 patients with RMS were randomized, 946 of whom were treated with KESIMPTA for a median duration of 85 weeks; 33% of patients receiving KESIMPTA were treated for up to 120 weeks [see Clinical Studies (14.1) in the full prescribing information]. The most common adverse reactions occurring in greater than 10% of patients treated with KESIMPTA and more frequently than in patients treated with
teriflunomide were upper respiratory tract infections, injection-related reactions (systemic), headache, and injection-site reactions (local). The most common cause of discontinuation in patients treated with KESIMPTA was low immunoglobulin M (3.3%), defined in trial protocols as IgM at 10% below the lower limit of normal (LLN).
Table 1 summarizes the adverse drug reactions that occurred in Study 1 and Study 2.
Table 1: Adverse Reactions in Patients With RMS With an Incidence of at Least 5% With KESIMPTA and a Greater Incidence Than Teriflunomide (Pooled Study 1 and Study 2)
because of potential additive immunosuppressive effects when initiating KESIMPTA.
8 USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
Risk Summary
There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women. Ofatumumab may cross the placenta and cause fetal B-cell depletion based on findings from animal studies (see Data)
Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to KESIMPTA have not been studied in clinical trials. The potential duration of B-cell depletion in infants exposed to ofatumumab in utero, and the impact of B-cell depletion on the safety and effectiveness of vaccines, are unknown. Avoid administering live vaccines to neonates and infants exposed to KESIMPTA in utero until B-cell recovery occurs [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2) in the full prescribing information].
Following administration of ofatumumab to pregnant monkeys, increased mortality, depletion of B-cell populations, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels substantially higher than that in humans (see Data)
the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis.
Injection-Related Reactions and Injection-Site Reactions
The incidence of injection-related reactions (systemic) was highest with the first injection (14.4%), decreasing with subsequent injections (4.4% with second, less than 3% with third injection). Injection-related reactions were mostly (99.8%) mild to moderate in severity. Two (0.2%) patients treated with KESIMPTA reported serious injection-related reactions. There were no life-threatening injection-related reactions. Most frequently reported symptoms (2% or greater) included fever, headache, myalgia, chills, and fatigue.
In addition to systemic injection-related reactions, local reactions at the administration site were very common. Local injection-site reactions were all mild to moderate in severity. The most frequently reported symptoms (2% or greater) included erythema, pain, itching, and swelling [see Warnings and Precautions (5.2)]
Laboratory Abnormalities
Immunoglobulins
In Study 1 and Study 2, a decrease in the mean level of IgM was observed in KESIMPTA-treated patients but was not associated with an increased risk of infections [see Warnings and Precautions (5.3)]. In 14.3% of patients in Study 1 and Study 2, treatment with KESIMPTA resulted in a decrease in a serum IgM that reached a value below 0.34 g/L. KESIMPTA was associated with a decrease of 4.3% in mean IgG levels after 48 weeks of treatment and an increase of 2.2% after 96 weeks.
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medication, and the underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other ofatumumab products may be misleading.
Treatment-induced anti-drug antibodies (ADAs) were detected in 2 of 914 (0.2%) KESIMPTA-treated patients; no patients with treatment-enhancing or neutralizing ADAs were identified. There was no impact of positive ADA titers on PK, safety profile or B-cell kinetics in any patient; however, these data are not adequate to assess the impact of ADAs on the safety and efficacy of KESIMPTA.
7 DRUG INTERACTIONS
7.1 Immunosuppressive or Immune-Modulating Therapies
Concomitant usage of KESIMPTA with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with KESIMPTA.
When switching from therapies with immune effects, the duration and mechanism of action of these therapies should be taken into account
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data
Animal Data
Intravenous administration of ofatumumab (weekly doses of 0, 20, or 100 mg/kg) to pregnant monkeys during the period of organogenesis (gestations days 20 to 50) resulted in no adverse effects on embryofetal development; however, B-cell depletion was observed in fetuses at both doses when assessed on gestation day 100. Plasma exposure (Cave) at the no-effect dose (100 mg/kg) for adverse effects on embryofetal development was greater than 5000 times that in humans at the recommended human maintenance dose of 20 mg. A no-effect dose for effects on B-cells was not identified; plasma exposure (Cave) at the low-effect dose (20 mg/kg) was approximately 780 times that in humans at the recommended human maintenance dose (RHMD) of 20 mg/month.
Intravenous administration of ofatumumab (5 weekly doses of 0, 10, and 100 mg/kg, followed by biweekly doses of 0, 3, and 20 mg/kg) to pregnant monkeys throughout pregnancy resulted in no adverse effects on the development of the offspring. However, postnatal death, B-cell depletion, and impaired immune function were observed in the offspring at the high dose. The deaths at the high dose were considered secondary to B-cell depletion. Plasma exposure (Cave) in dams at the no-effect dose (100/20 mg/kg) for adverse developmental effects was approximately 500 times that in humans at RHMD. A no-effect level for mortality and immune effects in offspring was not established because of the limited number of evaluable offspring at the low dose.
8.2 Lactation
Risk Summary
There are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Human IgG is excreted in human milk, and the potential for absorption of ofatumumab to lead to B-cell depletion in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KESIMPTA and any potential adverse effects on the breastfed infant from KESIMPTA or from the underlying maternal condition.
8.3 Females and Males
Contraception
of Reproductive Potential
Females of childbearing potential should use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) in the full prescribing information]
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of KESIMPTA did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects.
NJ 07936
Pharmaceuticals Corporation
Hanover,
and SENSOREADY
[registered] trademarks of Novartis AG. T2022-52
Manufactured by: Novartis
East
U.S. License No.: 1244 KESIMPTA
are
Adverse Reactions KESIMPTA 20 mg N = 946 % Teriflunomide 14 mg N = 936 % Upper respiratory tract infectionsa 39 38 Injection-related reactions (systemic) 21 15 Headache 13 12 Injection-site reactions (local) 11 6 Urinary tract infection 10 8 Back pain 8 6 Blood immunoglobulin M decreased 62
aIncludes
AAN Awards Recognize Achievements, Help Winners Realize Potential
Yasamin Mahjoub, MD / University of Calgary, Calgary, AB, Canada
Gabriel Marx / Albert Einstein College of Medicine, Bronx, NY
Takahisa Mikami, MD / Tufts Medical Center, Boston, MA
Nicholas Mannix, MD / The Ohio State University Wexner Medical Center, Columbus, OH
Kelli Money, MD, PhD / University of Colorado Anschutz Medical Campus, Aurora, CO
Tanziyah Muqeem, MD, PhD / Duke University Hospital, Durham, NC
George Naratadam / University of Texas Health San Antonio, San Antonio, TX
Ai Ohno / California University of Science and Medicine, St. San Bernardino, CA
Nikolai Gil Reyes, MD, FPNA / University Health Network-Toronto Western Hospital, University of Toronto, Toronto, ON, Canada
Cyprien Rivier, MD, MSc / Yale University, New Haven, CT
Nihal Satyadev, MPH / University of Medicine and Health Sciences, Los Angeles, CA
Zachary Weinstock / Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, NY
Hannah Zhao-Fleming, MD, PhD / Mayo Clinic, Rochester, MN
continued from page 13
Daniel Zhou, MD, MSE / University of Nebraska Medical Center, Omaha, NE
Zahra Zhu / Penn State College of Medicine, Hershey, PA
International Scholarship Award
Sponsored by the American Academy of Neurology International Subcommittee.
Gianmarco Abbadessa, MD / Naples, Italy
Jeremias Ayerbe, MD / Buenos Aires, Argentina
Solomiia Bandrivska, MD / Kyiv, Ukraine
Benjamin Beland, MD / Calgary, Alberta, Canada
Juliette Brenner, MD / Rotterdam, Netherlands
Gavin Brittain, MBBS, MRCP / Stockport, Great Britain
Nargiza Chekeeva, MD / Bishkek, Chui, Kyrgystan
Mashina Chomba, MBChB, MMed / Lusaka, Zambia
Aline Dias, MD / Campinas, Sau Paulo, Brazil
Adrian Espiritu, MD, FPNA / Toronto, Ontario, Canada
Milagros Galecio-Castillo, MD / Lima, Peru
Tinatin Giuashvili, MD / Tbilisi, Georgia
Enrique Gomez, MD, MSc / Guadalajara, Jalisco, Mexico
Mar Guasp, MD / Barcelona, Catalunya, Spain
Rauan Kaiyrzhanov, MD / Shymkent, Kazakhstan
Eva Kesenheimer, MD, PhD / Basel, Basel Stadt, Switzerland
Nicholas Koluba, MD / Mbarara, Uganda
Aleksandre Kotetishvili, MD / Tbilisi, Georgia
Oreoluwa Lagunju, MD / Ibadan, Oyo, Nigeria
Jimmy Li, MD / Sherbrooke, Quebec, Canada
Salvatore Mazzeo, MD / Florence, Tuscany, Italy
Frighton Mutete, MBChB / Lusaka, Zambia
Amina Nasri, MD / Manouba, Tunis, Tunisia
Christelle Nilles, MD / Paris, France
Mundih Njohjam, MD / Bameda, Cameroon
Maria Agustina Piedrabuena, MD / Caba, Argentina
Gabriel Pinella, MD, MSc / Cali, Colombia
Valentina Quintana, MD / Cali, Colombia
Saskia Raeuber, MD, FPNA / Dusseldorf, Germany
Lokesh Saini, MD, DM / Jodhpur, India
Kamalesh Tayade, MD / Jalgon, Maharashtra, India
Taras Voloshyn, MD, PhD / Truskavets, Lviv, Ukraine
Maria Janina Wendebourg, MD / Basel, Basel Stadt, Switzerland
Maria Agustina Ruiz Yanzi, MD / Buenos Aires, Argentina
Ramdinal Zairinal, MD / Depok, West Java, Indonesia
Medical Education Research Training Fellowship
Ashley Paul, MD / Johns Hopkins University, Baltimore, MD
Medical Student Diversity Annual Meeting Scholarship
Freda Biyaa Assuah / Nova Southeastern University
Connor Bluntson / University of Mississippi Medical Center School of Medicine
Jasmine Shareen Coles / Wayne State University School of Medicine
Continued on page 20
A ANnews • May 2023 19
MEMBERSHIP
›
2015 Neuroscience Research Prize recipients Yinge Zhao, Lauren Houle, and Monica Lee with American Brain Foundation President John C. Mazziotta, MD, PhD, FAAN.
AAN Awards Recognize Achievements, Help Winners Realize Potential
Hayden Alexander Moses Hatch / Albert Einstein College of Medicine
Jairo Stuart Hernandez / University of Florida College of Medicine
Joy C. Josephs Njiribeako / Texas Tech University Health Sciences Lubbock
Christine Petit-Frere / Morehouse School of Medicine
continued from page 19
Sierra Cowan / Tilman J. Fertitta Family College of Medicine
JuleLayne Curry / University of Tennessee Health Science Center College of Medicine
Gregory Devine / Creighton University
Phoenix Health Sciences
Sarah Doebley / Lewis Katz School of Medicine at Temple University
Rebecca Merrill / Wake Forest School of Medicine
Cassie Morgan / UNT Health Science Center-TCOM
Daphne Nguyen / UT Health San Antonio, Long School of Medicine
Alexis Notarianni / Geisinger Commonwealth School of Medicine
Riya Parikh / Chicago Medical School at Rosalind Franklin University
Johann Park / California Northstate University College of Medicine
Ihika Rampalli / Baylor College of Medicine
Rui Tang / TTUHSC El Paso
Vani Thirumala / University of Texas Medical Branch
Jaclyn Thoma / Rush Medical College
Allison Valerius / University of North Dakota
Pooja Venkatesh / University of Texas Southwestern Medical Center
Ashley Vincenty-Acosta / Ponce Health Sciences University
Jeremiah Wayne / University of Kentucky
Yunting Yu / Penn State College of Medicine
Andrea Zhang / University of Miami Miller School of Medicine
Medical Student Research Scholarship
John Austin / University of Texas Health Science Center San Antonio Long School of Medicine, San Antonio, TX
Miguel Rodriguez / University of Tennessee Health Science Center-College of Medicine
Jude Tunyi / The Ohio State College of Medicine
Jasmin Williams / University of Connecticut School of Medicine
Medical Student Experience at the Annual Meeting Scholarship
Abrar Ahmed / University of Western Ontario
Kaitlyn Alleman / Chicago Medical School
Seema Arshed / Noorda College of Osteopathic Medicine
Nadia Azad / Emory University School of Medicine
Alexis Ballew / Medical College of Wisconsin
Robert Cascella / Washington University School of Medicine in St. Louis
Abigail Connor / Long School of Medicine at UTHSCSA
Lauren Dugan / California University of Science and Medicine
Mahalya Gogerly-Moragoda / Icahn School of Medicine at Mount Sinai
Madison Grindstaff / Lincoln Memorial University
Elijah Hale / University of Colorado School of Medicine
Natasha Hamilton / Rocky Vista University
Mouhamad Hammami / Oakland University
Gregory Heinonen / Columbia University
Vagelos College of Physicians and Surgeons
Seungrok Hong / University of Cincinnati College of Medicine
James Johnson / University of Louisville School of Medicine
Jason Li / Indiana University School of Medicine
Moriah Mabry / University of Colorado
School of Medicine
Liam Cooper-Brown / McGill University, Montreal, Quebec, Canada
Nishtha Gupta / Drexel University College of Medicine, Philadelphia, PA
Hunter Hazelwood / University of Kentucky, Lexington, KY
Andrea He / Virginia Commonwealth University, Richmond, VA
Seungrok Hong / University of Cincinnati College of Medicine, Cincinnati, OH
Guldamla Kalender / University of Minnesota, Minneapolis, MN
Christina Kargol / University of Cincinnati College of Medicine, Cincinnati, OH
Liliana Ladner / Virginia Tech Carilion School of Medicine, Roanoke, VA
Khashayar Mozaffari / George Washington University, Washington, DC
Tiffany Ong / Wake Forest School of Medicine, Winston-Salem, NC
Casey Orozco-Poore / Harvard Medical School, Boston, MA
20 A ANnews • May 2023 MEMBERSHIP
Gladys E. Maestre, MD, PhD, 2000 Bruce Schoenberg International Award and Lecture in Neuroepidemiology, and Walter A. Rocca, MD, MPH
Soo Hwan Park / Geisel School of Medicine at Dartmouth, Hanover, NH
Madeline Ross / University of Pittsburgh School of Medicine, Pittsburgh, PA
Ella Sahlas / McGill University, Montreal, Quebec, Canada
Cassandra Seifert / University of Maryland School of Medicine, Baltimore, MD
Natalie Smith / University of Washington School of Medicine, Seattle, WA
Jessica Tang / University of California Davis, Davis, CA
Meesha Trivedi / Texas Tech University Health Science Center El Paso Paul L. Foster School of Medicine, El Paso, TX
Ethan Zerpa-Blanco, MS, NRP / Rowan University School of Osteopathic Medicine, Stratford, NJ
Medical Student Scholarship to the Annual Meeting
Nancy Eudalia Abarca, MPH / Michigan State University, East Lansing, MI
Kristen Lynn Adams / Liberty University College of Osteopathic Medicine, Lynchburg, VA
Bakhtawar Amad, MBBS / University of Florida, Gainesville, FL
Nyle Almeida / University of Oklahoma Health Sciences Center, Oklahoma City, OK
Aisha Bosula / Drexel University College of Medicine, Philadelphia, PA
Valerie Braddick / Larner College of Medicine at the University of Vermont, Burlington, VT
Bobby Bradley / University of Tennessee, Knoxville, TN
Sydney Chatfield / Larner College of Medicine at the University of Vermont, Burlington, VT
Margaret Codispoti / Edward Via College of Osteopathic Medicine, Blacksburg, VA
Alecca Como / Oakland University
William Beaumont School of Medicine, Rochester, MI
Elita Rose Delbruck / California University of Science and Medicine, Colton, CA
Victor Ekuta / Xavier University School of Medicine, San Diego, CA
Dafni F.T. Frohman / Renaissance School of Medicine at Stony Brook University, Stony Brook, NY
Mimi Tra Giang / Washington University in St. Louis School of Medicine, St. Louis, MO
Nupur N. Goel / Northeast Ohio Medical University, Rootstown, OH
Brittany Guidos, MS / University of Miami Miller School of Medicine, Miami, FL
Samantha Hao / Johns Hopkins University, Baltimore, MD
Paige Harmon / Emory School of Medicine, Atlanta, GA
Annie Ziyi He / UT Southwestern Medical Center, Dallas, TX
Jeremiah Hyslip / University of Massachusetts Chan Medical School, Worcester, MA
Akansha Jain / University of Iowa, Iowa City, IA
Nora Rano Jandhyala / NYU Grossman School of Medicine, New York City, NY
Hannah Marie Kelly / Case Western Reserve University School of Medicine, Cleveland, OH
Stella Knowlton / California Northstate University College of Medicine, Elk Grove, CA
Nancy Le / California Northstate University College of Medicine, Elk Grove, CA
Nzita Merdi Lutete / Brody School of Medicine, Greenville, NC
Ana Poulette Negron-Garcia / San Juan Bautista School of Medicine, Caguas, PR
Wendy Osei-Bonsu / Penn State College of Medicine, Hershey, PA
Elena Penhos / The Ohio State University, Columbus, OH
Elelia Phillips / University of Mississippi Medical Center, Jackson, MS
Lauren Danielle Pomerantz / Penn State College of Medicine, Hershey, PA
Andres Thomas Pope / University of the Incarnate Word, San Antonio, TX
Padmapriya Radhakrishnan / Edward Via College of Osteopathic Medicine-Auburn, Auburn, AL
Maya Mounir Ramy / Texas A&M College of Medicine, College Station, TX
Muslima Sonia Razaqyar / University of Texas Health Science Center at San Antonio, San Antonio, TX
Morgan Nicole Rolon-Newton / Texas Tech Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX
Rishi Sharma / University of Minnesota Medical School, Minneapolis, MN
Katherine May Sheu, PhD / University of California, Los Angeles, Los Angeles, CA
Alex David Waldman / Emory University, Atlanta, GA
Emma Wetmore / Medical University of South Carolina, Columbia, SC
Emily Ling Xu / Icahn School of Medicine at Mount Sinai, New York City, NY
Ruiyi Yuan / University of Rochester, Rochester, NY
Chris Zajner / University of Western Ontario, London, ON, Canada Continued
A ANnews • May 2023 21
on page 22 ›
2007 sanofi-aventis Minority Scholar Anthony Owusu (left) with Annapurni Jayam-Trouth, MD, FAAN, and Patrick A. Griffith, MD, FAAN.
AAN Awards Recognize Achievements, Help Winners Realize Potential continued
Resident Research Scholarship
Sponsored by the Clinical Research Subcommittee.
Ho Wing Andy Chan, MD / Mount Sinai Hospital, New York, NY
Tanziyah Muqeem, MD, PhD / Duke University Medical Center, Durham, NC
Alexander Sandweiss, MD, PhD / Baylor College of Medicine, Houston, TX
Resident Scholarship to the Annual Meeting
Albert Aboseif, DO / Cleveland Clinic Foundation
Muhammad Khurram Afzal, MD / Saint Louis University School of Medicine
Julia Aigbogun, MD / Tulane University School of Medicine
Mustafa Al-Chalabi, DO / University of Toledo
Pooneh Memar Ardestani, MD, PhD / Einstein Healthcare Network
Benjamin Becker, MD / University of Michigan
Shivkumar Bhadola, MD / Boston Medical Center
John Daniel Bireley, MD / Cleveland Clinic
Alexander Buslov, MD / Thomas Jefferson University, Department of Neurology
Kiley Cameron, MD / University of Nebraska Medical Center
Jordan Carrier, MD / University of Rochester Medical Center
Papul Chalia, MD / Penn State Health
Milton S. Hershey Medical Center
Midori Eckenstein, MD / University of Utah Medical Center
Aimalohi Esechie, MD, PhD / University of Texas Medical Branch
Alexander Seth Fein, MD / NYU
Falen Fernandes, MD / Memorial University of Newfoundland and Labrador
Mark Phillips Figgie, Jr., MD / University Hospitals/CWRU
Claudia Gambrah-Lyles, MD / Children's Hospital of Philadelphia
Mekka Garcia, MD / NYU
Himanshu Gupta, MD / Hamilton General Hospital
from page 21
Patrick Hartnett, MD / University of Vermont College of Medicine
Alice Hawkins, MD / Mount Sinai Health System
Katy Anne Helms, MD / Wake Forest Baptist
Allyson Heng, MD / UAB Neurology
Lucas Horta, MD / BMC
Allison Courtney Hyland, MD / UCSF
Department of Child Neurology
James Im, MD / University of Toronto
Dan Tong Jia, MD / Northwestern University
Naila Kausar, MD / Texas Tech University Health Sciences Center El Paso
Nadia Khalil, MD / University of South Florida Morsani College of Medicine
Arham Khan, DO / Stony Brook Medicine
Nooshin Kiani Nia, MD / University of Missouri Kansas City
Ryan Alexander Kollar, DO / Hartford Hospital
Sanjith Prahas Krishnam, DO / The University of Alabama Hospital
Brianne Kuns, DO / Sparrow Hospital
Barbara Kwiecinska, MD / University of Louisville Physicians Neurology
Alexus Ludwig, DO / University at Buffalo
Daniel Mandel, MD / Brown University
Erin McCoy, MD / University of Louisville Child Neurology
Brooke McNeilly, DO / UMass Memorial Medical Center-University Campus
Amit Mehta, MD / Medstar Georgetown University Hospital
Nara Michaelson, MD / New York
Presbyterian Hospital/Weill Cornell Hunter Mitchell, MD / University of Tennessee
Shalane Alexa Morales-Nunez, MD / Augusta University
Jorge Eduardo Patino Murillas, MD / The University of Texas Health Science Center at Houston McGovern Medical School
Ganapathiram Nambi, MD / Medical University of South Carolina
George Plummer, MD / University of Washington
Kevin Porras, MD / University of Miami
Casey Potts, DO / Ohio State University
Min Qiao, MD / Barnes Jewish Hospital
Mathura Ravishankar, MD / UPMC
Graham Kiyoshi Reid, DO / Wright State University Boonshoft School of Medicine
Elsa Cassandra Rodriguez, MD / University of Florida-Neurology
Deborah Kathleen Rose, MD / Duke
Julien Rousseau, MD, CM / University of Montreal
Lekshmi Perringassery Sateesh, MD / SUNY Downstate Medical Center
Benjamin Simpson, MD / Cedars-Sinai
Sandeep Singh, MD / Harbor UCLA Medical Center
Alyssa Smith, MD / Geisinger Medical Center
Jonathan Solomonow, MD / University of Maryland
M. Nelson Starkey, MD / Loma Linda University
Harry William Sutherland, MD / Yale University School of Medicine
Stephanie Syc-Mazurek, MD, PhD / Mayo Clinic
Angel Cadena Tejada, MD / Medical University of South Carolina
Panayiotis Tjionas, MD / BSWH-Temple
Megan Trenz, DO / NYU Langone Hospitals
Rani Priyanka Vasireddy, MBBS / University of Kentucky
Joaquin Augusto Vizcarra, MD / Emory University
Jeremy Wells, MD / University of North Carolina
Connor David Welsh, DO / Barrow Neurological Institute
Anudeep Yelam, MD / University of Missouri
Angela Young, MD / University of Manitoba
Musab Zorlu, MD / UConn Health
22 A ANnews • May 2023
MEMBERSHIP
Congratulations New Fellows of the American Academy of Neurology!
The AAN congratulates the following members who were named prestigious Fellows of the American Academy of Neurology (FAAN) between December 2022 and March 2023.
Vinita J. Acharya, MD, FAAN
Norman Ajiboye, MD, FAAN
Gishlaine Alfonso, MD, FAAN
Muhammad M. Alvi, MD, FAAN
Ganesh Asaithambi, MD, FAAN
Christina Azevedo, MD, FAAN
Poonam Bhatia, MD, FAAN
Susana M. Bowling, MD, FAAN
Yefim Cavalier, DO, FAAN
Gregory E. Cooper, MD, PhD, FAAN
Vincent Scott DeOrchis, MD, FAAN
Mariel Deutsch, MD, FAAN
Jason B. Diamond, MD, MPH, FAAN
Adam Damon Drobnis, MD, FAAN
Brian Droker, MD, FAAN
Debra J. Ehrlich, MD, FAAN
Xuesheng Feng, MD, PhD, FAAN
Alessandro Filla, MD, FAAN
Bikram Prasad Gajurel, MD, DM, FAAN
Rocio Carolina Garcia Santibanez, MD, FAAN
Rajeev Garg, MD, FAAN
Madeleine C. Geraghty, MD, FAAN
Ashley P. Ghiaseddin, MD, FAAN
Candelaria Gomez Manzano, MD, FAAN
Robert H. Gross, MD, FAAN
Zain Guduru, MD, FAAN
Khatuna Gurgenashvili, MD, FAAN
Dietrich Haubenberger, MD, FAAN
Diane Hesselbrock, MD, FAAN
Camilla Kilbane, MD, FAAN
Michele Longo, MD, FAAN
Zabeen Kaizar Mahuwala, MD, FAAN
Seraj Omar Makkawi, MBBS, FRCPC, FAAN
Justin P. Martello, MD, FAAN
Miriam Mattoscio, MD, PhD, FAAN
Carine W. Maurer, MD, PhD, FAAN
Michelle Monje, MD, PhD, FAAN
Chandra Sekhar Reddy Muddireddy, MD, FAAN
Richard Ronan Murphy, MD, MBChB, FAAN
Jiwon Oh, MD, FAAN
James H. Park, MD, FAAN
Chilvana V. Patel, MBBS, FAAN
Jonathan Perk, MD, PhD, FAAN
Emily Poole Pharr, MD, FAAN
Amanda Lee Piquet, MD, FAAN
Scott R. Plotkin, MD, FAAN
Srinivasa Potluri, MD, FAAN
Matiur Rahman, MD, FAAN
Kumar Rajamani, MD, FAAN
Jordan D. Raynor, MD, FAAN
Joel Armando Salinas, MD, FAAN
Friedhelm Sandbrink, MD, FAAN
Julie B. Schwartzbard, MD, FAAN
Meredith Spindler, MD, FAAN
Kara Stavros, MD, FAAN
Fernando Gustavo Stelzer, MD, PhD, FAAN
Prasanna Kumar Reddy Tadi, MD, FAAN
Dinah Thyerlei, MD, FAAN
W. Oliver Tobin, MB BCh, BAO, PhD, FAAN
Joshua Tobin, MD, FAAN
Sudhakar Tummala, MD, FAAN
Eduardo Boiteux Uchoa Cavalcanti, MD, FAAN
Umesh Verma, MD, FAAN
Linda C. Wendell, MD, FAAN
Barbara Willekens, MD, PhD, FAAN
Wen-Ying Wu-Chen, MD, FAAN
Praveen Kumar Yadav, MD, FAAN
Interested in Elevating Your Membership Status to FAAN?
Visit AAN.com/FAAN to see if you’re eligible to apply for the FAAN designation—or encourage a qualifying colleague to apply. Applying for FAAN status is free, acknowledges exemplary work and achievements in the neurosciences, the clinical practice of neurology, or academic/ administrative neurology; helps set you apart both within the Academy and throughout your professional career; and offers eligibility to serve on the AAN Board of Directors.
A ANnews • May 2023 23
Capitol Hill Report
Capitol Hill Report presents regular updates on legislative and regulatory actions and how the Academy ensures that the voice of neurology is heard on Capitol Hill. It is emailed to US members twice monthly and is posted at AAN.com/view/HillReport Below are some recent highlights.
Latest Advocacy News
On March 22, the AAN submitted comments in response to a proposed rule from the Drug Enforcement Administration (DEA) impacting prescribing of controlled substances via telemedicine following the termination of the public health emergency. The proposed rules affect telemedicine consultations by a medical practitioner who has never conducted an in-person evaluation of a patient, and who has not received a referral from a medical practitioner who conducted an in-person examination. The AAN’s comments primarily addressed alignment with other telehealth flexibilities and ways in which the proposed rule could be implemented to minimize burden on providers.
The AAN has been active during the 2024 appropriations cycle, working tirelessly with members of Congress to secure federal funding for our many advocacy priorities. As Congress weighs in on what appropriators should allocate, we need them to hear from you!
On March 30, Kavita Nair, PhD, FAAN, vice-chair of the AAN’s Coding and Payment Policy Subcommittee, testified in support of banning the use of “copay accumulator” programs in Colorado. In support of this effort, Nair also published a joint editorial with state Sen. Faith Winter calling on Colorado legislators to support SB23-195. On March 31, the bill passed out of committee. Nair’s success is a powerful reminder of how AAN members can gain valuable tools through their engagement with AAN advocacy.
Issue in Focus
The AAN has long advocated for boosting the neurology workforce. In early March, Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA) of the Senate Committee
on Health, Education, Labor, and Pensions (HELP) put out a request for information on the national health care workforce shortage. The AAN’s response to this request discussed multiple hurdles, both more recent and long-standing, that neurologists are facing.
The letter addresses specific solutions to bolster the current neurology workforce, including reducing overly burdensome administrative requirements, appropriately valuing neurologic care, understanding the importance of the physician-led care team, and addressing mental health and burnout among physicians. The letter mentions several legislative priorities the AAN supports that seek to address these issues: the Improving Seniors’ Timely Access to Care Act, the Gold Card Act, the Safe Step Act, and potential legislation that aligns with the Dr. Lorna Breen Health Care Provider Protection Act passed into law in 2022.
The letter also highlights solutions that aim to build the future of the neurology workforce. These include supporting training and residency through Medicare-funded GME slots and student loan relief and supporting the international medical graduate workforce. AAN priorities in these areas include the Resident Physician Shortage Reduction Act, Resident Education Deferred Interest (REDI) Act, the Healthcare Workforce Resilience Act, and the Conrad State 30 and Physician Access Reauthorization Act. Last year, Congress approved 200 new federally funded GME slots, building on the 1,000 new slots approved a few years ago for the first time in decades.
The AAN recognizes this request for information as only the start to necessary conversations surrounding legislative solutions to the health care workforce shortage. The AAN is committed to working closely with Congress and the Senate HELP Committee to ensure that the neurology workforce is supported and that patients have access to neurologic care.
24 A ANnews • May 2023 ADVOCACY
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Vascular Neurologist—Ascension Saint Agnes—Saint Agnes Hospital—Baltimore, MD, United States
Seeking Fellowship trained Vascular neurologist to direct our dual certified Primary Stroke Program by The Joint Commission (TJC) and Maryland Institute for Emergency Medical Services System (MIEMSS). Working with 4 other multi sub-specialty trained neurologists for inpatient consultations and outpatient clinical activities. Program includes our well-established cerebrovascular service with gold and elite plus status. The program infrastructure includes our dedicated Nurse Practitioner and Stroke coordinators. Current director planning retirement. For more information reach out to Kelly Morin, Director, Operations at Ascension at kmorin@ascension.org
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Brief Summary: for full Prescribing Information and Patient Information, refer to package insert.
INDICATION AND USAGE
INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.
CONTRAINDICATIONS
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.
WARNINGS AND PRECAUTIONS
Somnolence
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. In patients taking a strong CYP2D6 or CYP3A4 inhibitor, or who are CYP2D6 poor metabolizers, INGREZZA concentrations may be higher and QT prolongation clinically significant. For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary. For patients taking a strong CYP3A4 inhibitor, reduce the dose of INGREZZA to 40 mg once daily. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
Parkinsonism
INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. In the 3 placebo-controlled clinical studies in patients with tardive dyskinesia, the incidence of parkinson-like adverse events was 3% of patients treated with INGREZZA and <1% of placebo-treated patients. Postmarketing safety reports have described parkinson-like symptoms, some of which were severe and required hospitalization. In most cases, severe parkinsonism occurred within the first 2 weeks after starting or increasing the dose of INGREZZA. Associated symptoms have included falls, gait disturbances, tremor, drooling, and hypokinesia. In cases in which follow-up clinical information was available, parkinson-like symptoms were reported to resolve following discontinuation of INGREZZA therapy. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.
ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
• Hypersensitivity
• Somnolence
• QT Prolongation
• Parkinsonism
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Variable and Fixed Dose Placebo-Controlled Trial Experience
The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose, dose escalation, dose reduction), including 445 patients. Patients were 26 to 84 years of age with moderate to severe tardive dyskinesia and had concurrent diagnoses of mood disorder (27%) or schizophrenia/ schizoaffective disorder (72%). The mean age was 56 years. Patients were 57% Caucasian, 39% AfricanAmerican, and 4% other. With respect to ethnicity, 28% were Hispanic or Latino. All subjects continued previous stable regimens of antipsychotics; 85% and 27% of subjects, respectively, were taking atypical and typical antipsychotic medications at study entry.
Adverse Reactions Leading to Discontinuation of Treatment
A total of 3% of INGREZZA treated patients and 2% of placebo-treated patients discontinued because of adverse reactions.
Common Adverse Reactions
Adverse reactions that occurred in the 3 placebo-controlled studies at an incidence of ≥2% and greater than placebo are presented in Table 1.
Table 1: Adverse Reactions in 3 Placebo-Controlled Studies of 6-week Treatment Duration Reported at ≥2% and >Placebo
Other Adverse Reactions Observed During the Premarketing Evaluation of INGREZZA
Other adverse reactions of ≥1% incidence and greater than placebo are shown below. The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
Endocrine Disorders: blood glucose increased
General Disorders: weight increased
Infectious Disorders: respiratory infections
Neurologic Disorders: drooling, dyskinesia, extrapyramidal symptoms (non-akathisia)
Psychiatric Disorders: anxiety, insomnia
During controlled trials, there was a dose-related increase in prolactin. Additionally, there was a dose-related increase in alkaline phosphatase and bilirubin, suggesting a potential risk for cholestasis.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of INGREZZA that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity reactions (including allergic dermatitis, angioedema, pruritis, and urticaria)
Skin and Subcutaneous Tissue Disorders: rash
DRUG INTERACTIONS
Drugs Having Clinically Important Interactions with INGREZZA
Table 2: Clinically Significant Drug Interactions with INGREZZA
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Implication: Concomitant use of INGREZZA with MAOIs may increase the concentration of monoamine neurotransmitters in synapses, potentially leading to increased risk of adverse reactions such as serotonin syndrome, or attenuated treatment effect of INGREZZA.
Prevention or Management: Avoid concomitant use of INGREZZA with MAOIs.
Examples: isocarboxazid, phenelzine, selegiline
Strong CYP3A4 Inhibitors
Clinical Implication: Concomitant use of INGREZZA with strong CYP3A4 inhibitors increased the exposure (Cmax and AUC) to valbenazine and its active metabolite compared with the use of INGREZZA alone. Increased exposure of valbenazine and its active metabolite may increase the risk of exposure-related adverse reactions.
Prevention or Management: Reduce INGREZZA dose when INGREZZA is coadministered with a strong CYP3A4 inhibitor.
Examples: itraconazole, ketoconazole, clarithromycin
Strong CYP2D6 Inhibitors
Clinical Implication: Concomitant use of INGREZZA with strong CYP2D6 inhibitors increased the exposure (Cmax and AUC) to valbenazine’s active metabolite compared with the use of INGREZZA alone. Increased exposure of active metabolite may increase the risk of exposure-related adverse reactions.
Prevention or Management: Reduce INGREZZA dose when INGREZZA is coadministered with a strong CYP2D6 inhibitor.
Examples: paroxetine, fluoxetine, quinidine
Strong CYP3A4 Inducers
Clinical Implication: Concomitant use of INGREZZA with a strong CYP3A4 inducer decreased the exposure of valbenazine and its active metabolite compared to the use of INGREZZA alone. Reduced exposure of valbenazine and its active metabolite may reduce efficacy.
Prevention or Management: Concomitant use of strong CYP3A4 inducers with INGREZZA is not recommended.
Examples: rifampin, carbamazepine, phenytoin, St. John’s wort1
Digoxin
Clinical Implication: Concomitant use of INGREZZA with digoxin increased digoxin levels because of inhibition of intestinal P-glycoprotein (P-gp).
Prevention or Management: Digoxin concentrations should be monitored when coadministering INGREZZA with digoxin. Increased digoxin exposure may increase the risk of exposure-related adverse reactions. Dosage adjustment of digoxin may be necessary.
1 The induction potency of St. John’s wort may vary widely based on preparation.
Drugs Having No Clinically Important Interactions with INGREZZA
Dosage adjustment for INGREZZA is not necessary when used in combination with substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4/5 based on in vitro study results.
OVERDOSAGE
Human Experience
The pre-marketing clinical trials involving INGREZZA in approximately 850 subjects do not provide information regarding symptoms with overdose.
Management of Overdosage
No specific antidotes for INGREZZA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. If an overdose occurs, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org). For further information on INGREZZA, call 84-INGREZZA (844-647-3992).
Distributed by: Neurocrine Biosciences, Inc. San Diego, CA 92130
INGREZZA is a registered trademark of Neurocrine Biosciences, Inc.
CP-VBZ-US-0203v6 03/2022
Adverse Reaction1 INGREZZA (n=262) (%) Placebo (n=183) (%) General Disorders Somnolence (somnolence, fatigue, sedation) 10.9% 4.2% Nervous System Disorders Anticholinergic effects (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention) 5.4% 4.9% Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder) 4.1% 2.2% Headache 3.4% 2.7% Akathisia (akathisia, restlessness) 2.7% 0.5% Gastrointestinal Disorders Vomiting 2.6% 0.6% Nausea 2.3% 2.1% Musculoskeletal Disorders Arthralgia 2.3% 0.5% 1 Within each adverse reaction category, the observed adverse reactions are listed in order of decreasing frequency.
for oral use
YOUR ADULT PATIENTS WITH TARDIVE DYSKINESIA (TD)
Take. Control.
INGREZZA is the simple, once-daily choice to reduce TD severity1
UNIQUELY SELECTIVE
Only INGREZZA exclusively delivers one primary metabolite (+ α) for potent and selective inhibition of VMAT21-3,*
PROVEN EFFICACY
INGREZZA 80 mg reduced uncontrolled movements in 7 of 10 patients at 6 weeks (post hoc analysis)1,4,†
THE SIMPLE CHOICE
The only VMAT2 inhibitor that offers an effective starting dosage you can adjust based on response and tolerability1
SAVINGS & SUPPORT
$10 or less out-of-pocket is what most patients pay for INGREZZA 5
*Based on in vitro VMAT2 binding affinity of dihydrotetrabenazine (HTBZ) metabolites and INGREZZA’s primary active metabolite, + α HTBZ. The clinical significance of in vitro data is unknown and is not meant to imply clinical outcomes. † Post hoc analysis included patients who had a baseline and a Week 6 AIMS total score. Reduction in uncontrolled movements as assessed by ≥1-point decrease in AIMS total score.
MOST PRESCRIBED TREATMENT FOR TARDIVE DYSKINESIA5
Important Information INDICATION & USAGE
INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.
WARNINGS & PRECAUTIONS
Somnolence
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
WARNINGS & PRECAUTIONS (continued)
Parkinsonism
INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.
ADVERSE REACTIONS
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >Placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088
Please see the adjacent page for Brief Summary of Prescribing Information and visit Neurocrine.com/INGREZZAPI for full Prescribing Information.
Visit INGREZZAHCP.com/Results to see how you can help your TD patients take control ADVERTISEMENT
HELP
Not actual size Actor portrayal
©2023 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US-1760v2 05/2023
REFERENCES: 1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc. 2. Harriott ND, Williams JP, Smith EB, Bozigian HP, Grigoriadis DE. VMAT2 inhibitors and the path to INGREZZA (valbenazine). Prog Med Chem. 2018;57(1):87-111. 3. Grigoriadis DE, Smith E, Hoare SRJ, Madan A, Bozigian H. Pharmacologic characterization of valbenazine (NBI-98854) and its metabolites. J Pharmacol Exp Ther 2017;361(3):454-461. 4. Data on file. Neurocrine Biosciences, Inc. 5. Data on file as of Q4 2022. Neurocrine Biosciences, Inc.