2022 June AANnews

VOLUME 34 · ISSUE 6 · JUNE 2022

Visit AAN.com/Covid19 for the latest pandemic information and resources to support you and your crucial work.

JUNE 23 IS LAST CHANCE TO SAVE ON REGISTRATION AND RESERVE HOTEL FOR NEW SUMMER CONFERENCE Autoimmune Neurology and Neurology Year in Review Save on registration and book your hotel at the discounted AAN nightly rate before June 23 for the new AAN Summer Conference: Autoimmune Neurology and Neurology Year in Review. The conference will be coming in person this July 15 through 16 to the San Francisco Marriott Marquis, as well as via a virtual livestream option. Both will present the latest updates in the science and education of autoimmune neurology, one of the most rapidly evolving fields in modern neurology.

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July 15–16, San Francisco and Virtual

COVID-19 and Safety

Because of our commitment to creating a safe and healthy environment for participants, all in-person attendees in San Francisco are required to be “up to date” with their COVID-19 vaccines (as defined by the CDC). The current CDC definition of “up to date” is: “A person is up to date with their COVID-19 vaccination if they have received all recommended doses in the primary series and one booster when eligible. Getting a second booster is not necessary to be considered up to date at this time.”

Apply by September 1 for 2023 AAN Research Program Grant Opportunities

Members Find Unique Solutions to Navigate Staffing Challenges The Great Resignation, the Great Reshuffle, staffing challenges: whatever you call it, it’s clear organizations are struggling to hire and retain staff. Limited staff has put pressure on neurologists, APPs, and administrators to fill in the gaps to ensure patients’ needs are met, making long days longer and exacerbating burnout symptoms. The AAN reached out to neurology business administrators from across the country to learn what unique solutions they are finding to manage this crisis. Make sure to check back each month and connect with the AAN on social media as we feature more solutions throughout the year.

Applications are now open for the AAN’s 2023 Research Program grants. If you need research funding—or know someone who does—apply, or encourage them to apply, by the September 1 deadline.

Multiple awards are available in five categories: Career Development, Clinical Research Training Scholarship, Neuroscience Research Training Scholarship, Practice Research Training Scholarship, and Clinician Scientist Development Award. Applicants may apply in only one Continued on page 12

15 Advocacy Efforts Produce Results, More to Come

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16 Continuum Delivers New Insights on Dementia

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17 AAN Takes Pride in LGBTQI+ Inclusion

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Give your patients with RMS

A CONFIDENT START Superior efficacy, including reduction in relapses of up to nearly 60% vs Aubagio® (teriflunomide)1,2*

*Primary end point: relative reduction in adjusted ARR vs teriflunomide of 51% (0.11 vs 0.22) in ASCLEPIOS I and 59% (0.10 vs 0.25) in ASCLEPIOS II.1,2

Favorable safety profile, comparable to Aubagio1 1 MINUTE A MONTH, when the patient is ready to administer3† 80% of commercial patients receive their first bridge dose within 5 days4‡

1 MINUTE A MONTH ADMINISTRATION† WITH KESIMPTA® Start your patients with confidence today Visit KesimptaHCP.com to learn more 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 teriflunomide (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.1 ARR=annualized relapse rate; CDP=confirmed disability progression; DMT=disease-modifying therapy; GdE=gadolinium-enhancing; MRI=magnetic resonance imaging; RMS=relapsing multiple sclerosis. †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.1,2 ‡Based on prescription data as of November 2021.

References: 1. Kesimpta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020. 2. 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. 3. Data on file. Injection time. Novartis Pharmaceuticals Corp; East Hanover, NJ. September 2020. 4. Data on file.

Program data. Novartis Pharmaceuticals Corp; East Hanover, NJ. July 2021.

INDICATION

serious bacterial, fungal, and new or reactivated viral infections; some have been fatal in patients treated with KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, other anti-CD20 antibodies. The overall rate of infections and relapsing-remitting disease, and active secondary progressive serious infections in KESIMPTA-treated patients was similar to teriflunomide-treated patients (51.6% vs 52.7%, and 2.5% disease, in adults. vs 1.8%, respectively). The most common infections reported IMPORTANT SAFETY INFORMATION

by KESIMPTA-treated patients in relapsing MS (RMS) trials Contraindication: KESIMPTA is contraindicated in patients included upper respiratory tract infection (39%) and urinary with active hepatitis B virus infection. tract infection (10%). Delay KESIMPTA administration in patients with an active infection until resolved.

WARNINGS AND PRECAUTIONS Infections: An increased risk of infections has been observed Consider the potential increased immunosuppressive effects with other anti-CD20 B-cell depleting therapies. KESIMPTA when initiating KESIMPTA after an immunosuppressive therapy has the potential for an increased risk of infections including or initiating an immunosuppressive therapy after KESIMPTA. Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.

I want a treatment that fits in with my busy routine.

Kristin: mother, real estate agent, KESIMPTA patient§

Kristin, actual KESIMPTA patient since 2020, with RMS. Individual results may vary. Kristin was compensated for her time.

§

IMPORTANT SAFETY INFORMATION (cont) WARNINGS AND PRECAUTIONS (cont) 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

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

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 full Prescribing Information, including Medication Guide, at KesimptaHCP.com.

© 2022 Novartis

1/22

169031

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 live-attenuated 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 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) Adverse Reactions

KESIMPTA 20 mg N = 946 %

Teriflunomide 14 mg N = 936 %

Upper respiratory tract infectionsa

39

38

Injection-related reactions (systemic)

21

15 12

Headache

13

Injection-site reactions (local)

11

6

Urinary tract infection

10

8

Back pain

8

6

Blood immunoglobulin M decreased

6

2

aIncludes 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). Injectionrelated 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/dL. 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 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).

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 of Reproductive Potential Contraception 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.

Manufactured by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 U.S. License No.: 1244 KESIMPTA and SENSOREADY is a [registered] trademark of Novartis AG. T2020-112

AANnews · June 2022

June Highlights 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 For advertising rates, contact: Michael J. O’Brien II Account/Relationship Manager Wolters Kluwer Phone: (978) 578-4514 Email:

Michael.Obrien @wolterskluwer.com

B:11.125" T:10.875" S:9.75"

AAN Chief Executive Officer: Mary E. Post, MBA, CAE

Editor-in-Chief: Melissa W. Ko, MD, FAAN, CPE

18

Pairing Resident Mentor with Diversity Scholar Shapes Vibrant Future

19

pcoming Virtual “Spotlight On” Sessions to Highlight U AAN Section Work, Timely Issues

21

Giesser Named 2022 Ted M. Burns Humanism in Neurology Award Recipient

As part of his Enhanced Resident Leadership Program curriculum, resident Franklyn Rocha-Cabrero, MD, was asked to serve as a mentor to a 2021 Medical Student Diversity Scholar. As part of her curriculum, fourth-year medical student Alexandra Rincones was asked to share her goals for a mentor-mentee relationship.

The pairing of Rocha-Cabero with Rincones couldn’t have been more serendipitous.

At the April Annual Meeting in Seattle, 15 AAN Sections introduced 12 new “Spotlight On” sessions designed to highlight the Academy’s 41 sections and provide a venue for attendees to reconnect via a variety of lively discussion- and debate-based sessions on timely issues like daylight saving time, changes to neurology education, and careers in global health.

Barbara S. Giesser, MD, FAAN, of the Pacific Neuroscience Institute has been named the recipient of the 2022 Ted M. Burns Humanism in Neurology Award. The award recognizes the influence of the most compassionate and innovative neurologists in the field who bring creativity, advocacy, and innovation to their work.

Managing Editor: Angela M. Babb, MS, CAE, APR Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com

News Briefs AAN in the News

AANnews® is published monthly by the American Academy of Neurology for its 38,000 members worldwide.

Access this magazine and other AAN publications online at AAN.com.

Research presented at the AAN Annual Meeting Top Science Press Conference was covered by ABC News, Pittsburgh Post-Gazette, MDedge, and HealthDay and an article quoting AAN Science Committee Chair Natalia S. Rost, MD, MPH, FAAN, FAHA, who moderated the press conference was featured in Healio.

The American Academy of Neurology ’s registered trademarks and service marks are registered in the United States and various other countries around the world.

A study that was featured in an AAN Annual Meeting press release about a new drug that may be safe for those with mild cognitive impairment and mild dementia was mentioned by HealthDay, Healio, and MedPage Today.

“American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.

And a Neurology ® study suggesting that older adults who take drugs to lower cholesterol are less likely to develop parkinsonism later was picked up by MSN, UPI, Daily Mail, and more. 

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PLEASE RECYCLE POLYBAG WHERE #5 PLASTIC IS ACCEPTED

PRESIDENT'S COLUMN Reclaiming Our AAN Community in This Post-COVID World Like many of you, my indoor social activities during the first year following the COVID-19 outbreak were limited to time with my family. Aside from regular walks with friends and outdoor picnics when the weather allowed, my contact with the external world shrunk tremendously, replaced by the two-dimensional realm of Zoom meetings, FaceTime, and my telehealth screen. My role as president elect and, later, president of this organization, meant that my meetings with committees, leadership program groups, staff, and AAN members were virtual. Although we met frequently—as editor-in-chief of Brain & Life®, I met with the editorial team weekly to discuss how to provide readers scientific and unbiased information on the SARS-CoV-2 virus; the publication editors brainstormed together often; committees met virtually with regularity; and the board of directors met monthly instead of quarterly to discuss how to support members through the crisis—it was not the same.

It was not until April of 2021, some 15 months after our last in-person board meeting, that AAN directors and officers were able to get together, freshly vaccinated, with our new CEO, Mary Post, MBA, CAE, for a do-it-ourselves retreat. We would not meet again face-to-face until January of this year as surges and pandemic concerns disrupted our plans. Finally, the AAN membership and staff were brought together this past April, after three long years, to the Great Neuro Reunion in Seattle.

I did not realize the full impact of my isolation until we came together. Like a movie which goes from black and white to color, sensations were heightened, conversations more impactful, laughter more joyous, and even mundane chores like food shopping, cooking, and cleaning up after ourselves— shared activities during that first BOD meeting designed to optimize safety—were positively glorious. What I discovered had been missing was the face-to-face camaraderie of my AAN community.

The 74th Annual Meeting provided a venue for colleagues and friends to reconnect. The Live Well Experiential Learning Area focused on well-being through wide-ranging activities such as yoga, Bollywood dancing, interactive fireside chats, workshops on poetry and visual-thinking strategies, and HeadTalks served to showcase a unique collection of informative conversations from expert panels and gaming sessions designed to engage and delight. There were sessions for specific communities of neurologists including educators, neuro-trainees, researchers, policy junkies, practicing neurologists, leadership program grads, and attendees who wished to connect through IDEAS. For those unable to join us in person, we held a virtual Annual Meeting on April 24–26. Over 4,500 people participated in the three-day event which offered a new slate of programming. All the virtual Annual Meeting programming, from plenary sessions to neurology case conferences, were well attended and clearly resonated with attendees based on the volume of questions that were answered during the live Q&A. Meanwhile, our AAN Sections have continued to grow. Now, more than 31 percent of all AAN members—11,000 of your colleagues—belong to one or more sections. During the in-person Annual Meeting, 15 sections introduced 12 new “Spotlight on” sessions crafted to highlight the AAN’s 41 sections and provide a forum for their members to reconnect through discussion and debate-based gatherings on topics

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AANnews • June 2022

Avitzur

as varied as daylight saving time, changes in neurologic education, and careers in global health. We were happy to see more younger members and students attend these Spotlight sessions! Due to the popularity of those sessions, the sections are planning to host more events virtually during the rest of this year to continue to highlight issues on members’ minds and the work in which sections are engaged. Visit Synapse.AAN.com/ new-item683 to view opportunities to attend these future Zoom talks. And because you asked for it, a new Synapse mobile app is now available through the Apple Store and Google Play as an alternative to the online platform.

By the time you read this, I will have joined with more than 160 of our members at Neurology on the Hill held on May 23 and 24 in Washington, DC, where we lobby on your behalf with lawmakers on key issues that affect how you care for your patients. I look forward to meeting many more of you at upcoming committee meetings over the next 12 months. I also hope you will attend (in person or virtually) the new conference focused on the rapidly evolving subspecialty of autoimmune neurology and a neurology year in review in San Francisco on July 15–16 for a smaller neuro reunion.

As I continue to search for answers after the devastation borne of the pandemic, one of the shiniest silver linings has been the gift of a renewed appreciation for all of you, my AAN community.

Contact with you during the worst of it gave me purpose and engendered awe and respect for your service to neurology in your communities. And it has left me with a profound appreciation for what I took for granted in the past: the privilege of speaking with you in person. Now embarking on the second half of my term, I hope that each and every one of you will also reclaim your place in the AAN community and find meaning in the cornucopia of opportunities this organization offers. 

Orly Avitzur, MD, MBA, FAAN President, AAN oavitzur@aan.com @OrlyA on Twitter

MEMBERSHIP Academy Sees Changes To Executive Team Two changes are taking place on the AAN’s executive team reporting to CEO Mary E. Post, MBA, CAE. Kelly Ricker joined the AAN on May 31 in the role of chief learning officer overseeing Education, Science, Conferences, Industry, and Leadership Programs. She comes to the Academy after 13 years with the Computing Technology Industry Ricker Association—which advocates for an estimated 75 million industry and tech professionals— where she most recently served as executive vice president of Events & Education. Ricker also has held positions with the Consumer Technology Association and American Sportfishing Association.

Bruce Levi, JD, retires from his position as chief governance and strategy officer on July 1. He has served the Academy since 2011, when he was hired as general counsel. In addition to his legal role, Levi has served leadership roles in health policy, human resources, Levi member insights, publishing, UCNS general counsel, interim UCNS executive director, and board strategic planning. His work in coordinating our strategic planning efforts leaves a lasting legacy on this organization. 

PRACTICE Use Updated Parkinson’s Disease Quality Measures In late 2021, the AAN released updates to the Parkinson’s disease measures to facilitate quality improvement in practice. The updated Parkinson’s measure set has 10 measures, some of which use patient reported outcome measure (PROM) tools and scales to measure the outcomes of patients.

Collecting PROM data occurs when the patient (or care partner) completes a questionnaire during a visit, or prior to the visit, to help the medical team with a treatment plan. Axon 27 Parkinson’s Disease: Cognitive Impairment or Dysfunction Assessment is one of the quality measures that uses PROM tools. Clinicians and neurology practices can track these tools over time to set internal benchmarks. These benchmarks can be used to establish goals to improve patient care going forward and can use PROM implementation to track patient data over time. Practices can also use the collected patient data to determine successes for individual clinicians. The opportunities to use PROM will continue to increase over time.

Collecting PROM data now will provide practices a better understanding of patient trends and provide the tools to treat patients more efficiently in the future.

Six of the 10 Parkinson’s disease measures in the measurement set have been implemented into the Axon Registry ®. To learn more about the Axon Registry and enrollment information visit AAN.com/axon or contact registry@aan.com with questions. 

AANnews • June 2022

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PRACTICE Stroke During Delivery Began Uphill Climb for Vonn’s Mother In the June/July issue of Brain & Life®, skier Lindsey Vonn talks about how her mother had a stroke while delivering Lindsey and what her mother’s recovery was like. The article provides additional information on risk factors for women and stroke, including pregnancy.

In another feature story, neurologists with epilepsy explain how they manage it, how having the condition informs their practice, and the tips they share for dealing with it.

As offices open around the country, people with neurologic conditions may be wary about returning. Brain & Life explores the pros and cons of working from home and helps workers stay healthy whether they’re going back to the office or working remotely.

Brain & Life magazine is free for AAN members in the United States to distribute to patients, who also can subscribe for free. If you would like to adjust the number of copies you receive for your patients or update your clinic

address, email BeGreen@ WasteFreeMail.com. All members have online access to the magazine articles and additional resources at BrainandLife.org and are encouraged to share the website with their patients.

AAN members, patients, and caregivers also can listen to the new Brain & Life podcast, an entertaining weekly podcast featuring neurology experts, celebrity advocates, and people whose lives are affected by brain conditions. Follow and subscribe wherever you get your podcasts. Learn more at BrainandLife.org/podcast. 

22 J U N E/J U LY 2 0 E .O R G B R A I N A N D LI F

My mom has a strength that’s not always outwardly visible, but she has done incredible things.”

Seizure Management Advice from Those In the Know: Neurologists with Epilepsy Back to the Officen A Healthy Transitio From Remote to In-Person Work Brain Wonders Experts Explain Confabulation

NN — L I N D S AY VO

Latest Neurology: Clinical Practice Covers Spectrum of Topics Volume 12, Number 3,

June 2022

Neurology.org/CP

A peer-reviewed clinical

neurology journal for

the practicing neurolo

gist

RESEARCH

The Neurology Access Clinic : A Model to Improve Access to Neurologic Care in an Academic Medical Center RESEARCH

Two-Year Profile of Preven table Errors in Hospital-Based Neurology COMMENTARY

Tackling Quality—It’s Never a Level Playing Field: Companion Piece to the Neurology Outcome Measure Set CLINICAL/SCIENTIFIC

NOTE

Intracranial Hypertension in a Transgender Man

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The new issue of Neurology ® Clinical Practice offers an informative collection of research and commentary articles, including “The Inclusion of Historically Oppressed Genders in Neurologic Practice Research,” by Mackenzie Lerario, MD, et al.; “The Neurology Access Clinic: A Model to Improve Access to Neurologic Care in an Academic Medical Center,” by Katharina Maria Busl, MD, MS, FAAN, et al.; “Triggers for Referral to Specialized Palliative Care in Advanced Neurologic and Neurosurgical Conditions: A Systematic Review,”

by Teneille Emma Gofton, MD, et al.; “Two-year Profile of Preventable Errors in Hospital-Based Neurology,” by K. H. Vincent Lau, MD, et al.; “Disparities in Telehealth Care in Multiple Sclerosis,” by Ruth Ann Marrie, MD, et al.; “Intracranial Hypertension in a Transgender Man,” by Aileen Antonio, MD, et al.; and “Neuroimaging for Pediatric Non-First-time Seizures in the Emergency Department,” by Emma Mazzio, MD, et al.

Published continuously online and in print six times a year, Neurology: Clinical Practice is free to AAN members via the website (and available in print for US members only) who have a current subscription to Neurology ®.

Visit Neurology.org/cp for more information. 

Members Find Unique Solutions to Navigate Staffing Challenges

continued from cover

Cross-train, Cross-train, Cross-train

Nearly one-third of administrators suggested crosstraining staff as a way to help manage staffing shortages.

Kim Golden, administrator at Neurology and Sleep Associates in Suffolk, VA, has found success in hiring medical assistants (MA) to work at the front desk. These employees are cross-trained and can contribute to any Evans Van Fossen Golden Soronson function across the practice including the front desk, back bonus system that will reward staff for both quality and desk, and clinic. The clinical benefits of cross-training may productivity benchmarks such as quality measures, pointbe obvious because it creates flexibility among staff, allowing many of-service collections, and authorizations obtained prior to people to fill a variety of roles to meet the needs of the day. But patient visits. “Our new system is designed to identify important cross-training can also be used as a recruitment and retention benchmarks to show employees where and how they are tool. Cross-training is a way of investing time into an employee’s adding value to the practice. When employees meet those future career. It demonstrates to the employee the organization benchmarks, the bonus is intended to be a sign of the practice’s values them enough to make that investment, feels the employee appreciation of their efforts. The bonus will help us offer a is proficient in their current role to learn new skills, and trusts the competitive compensation package while also incentivizing employee with additional responsibilities. the delivery of excellent quality care; a win for employees, the practice, and, most importantly, our patients.”

Flexible Work Offering flexible schedules can help optimize, recruit, and retain Other bonus incentives have included focusing on building staff, making it an essential tool for managing this staffing community and culture by ordering in lunches, investing in crisis. Both Bryan Soronson, MPA, FACMPE, CRA, retired corporate wear for employees, and recognizing employees senior administrator in the department of neurology at the during staff meetings. Several organizations stressed University of Maryland School of Medicine, and Amy Knighton, the importance of performing salary reviews and making CMPE, CPC, practice administrator at Savannah Neurology necessary adjustments to ensure offered salaries are Specialists, have offered remote work opportunities for noncompetitive and equitable within a market. clinical and administrative staff. Depending on an organization’s What unique solutions have worked for you? policies, activities such as prior authorizations can successfully Tell us by emailing practice@aan.com! be managed from home. This gives flexibility to staff who may be struggling with childcare or work-life balance. Wendy Van Fossen, CPA, CEO at The Neurology Center, P.A., in Savannah, Ways to Optimize Staff GA, offers this opportunity to providers as well. “We currently allow providers to do two tele days each month from home.

5% 11% One physician got creative and changed her schedule to all tele Automate Processes Incorporate APPs on Monday mornings and added slots to her Tuesday through Friday in-office schedule. She maintained the same number 22% of patients and achieved a free afternoon at home each week.”

Use Telemedicine 3% These opportunities to work in a hybrid environment are Centralize valuable benefits practices can promote to potential employees.

Retention Administrators across the country report unprecedented challenges in retaining employees. All practice settings report having to compete with other organizations for qualified candidates, and employees are being offered signon bonuses, higher salaries, and more to incentivize them moving to a new enterprise. In addition to allowing flexible schedules, many organizations have focused on bonuses and recognition to retain their employees. Besides a traditional annual performance bonus, practices have developed ways to incentivize loyalty such as one practice that offers quarterly bonuses and another that is incentivizing quality care. David A. Evans, MBA, CEO of Texas Neurology, is rolling out a new

28%

Flexible Schedules

31%

Cross-train

As staffing challenges persist, the AAN is committed to continuing to develop resources to help members. We will continue to feature opportunities to engage with other members on our social media platforms, highlight more staffing solutions in AANnews, and regularly update our website at AAN.com/PracticeResources. Check back often to hear how your colleagues are managing these challenging times. 

AANnews • June 2022

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RESEARCH Apply by September 1 for 2023 AAN Research Program Grant Opportunities continued from cover

category and will be considered for all applicable awards within that category. During the application process, applicants will have the opportunity to select their first and second award preferences within the single category.

Research funding is available in the areas of ALS and related disorders, cognitive aging and age-related memory loss, stroke, Parkinson’s disease, peripheral neuropathy, mal de debarquement syndrome, frontotemporal degeneration, epilepsy, neuromuscular disease, and neurodisparities. For a full listing of awards within each category, detailed application requirements, and to apply, visit AAN.com/ResearchProgram.

2023 grant categories include: Career Development Award This award category is designed for junior investigators interested in an academic career in clinical, basic, or translational neurologic research. Recipient must be a neurologist and an AAN member interested in an academic career in neurologic research who completed residency between five–10 years prior to the start date of the Career Development Award (July 1, 2023).

Clinical Research Training Scholarship This award category recognizes the importance of good clinical research and encourages young investigators in clinical studies. Recipient must be an AAN member interested in an academic career in neurologic research who has completed residency or a PhD no more than five years prior to the beginning of this award (July 1, 2023).

Neuroscience Research Training Scholarship This award category aims to recognize the importance of and encourage young investigators in good laboratory or preclinical research. Recipient must be an AAN member interested in an academic career in neurologic research who has completed residency or a PhD no more than five years prior to the beginning of this award (July 1, 2023).

Practice Research Training Scholarship This award category supports practice-based research, which is defined as “clinical research that evaluates translation of evidence into best clinical practice,” and encourages young investigators to use studies to

Apply for Education Grants and Fellowships

by June 30 The AAN is pleased to announce three $10,000 Education Research Grants and one $65,000 Medical Education Research Training Fellowship for year 2022–2023. The application deadline is June 30, 2022.

Learn more and apply at AAN.com/research/awardsscholarships. 

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AANnews • June 2022

improve health systems and services, quality of care, implementation of therapies, physician performance, or patient adherence. It is intended to create unique training opportunities previously difficult to access for neurologists.

Recipient must be an AAN member interested in an academic career in neurologic research who has completed residency or a PhD no more than five years prior to the beginning of this award (July 1, 2023).

Clinician Scientist Development Award This award recognizes the importance of good clinical research and encourages young investigators in clinical studies in ALS. Recipient must be an AAN member interested in an academic career in neurological research who has completed residency or a PhD no more than seven years prior to the beginning of this award (July 1, 2023).

The AAN is committed to supporting researchers because we know that when you make a profound difference in the lives of researchers you ultimately make a profound difference in the lives of patients with brain disease.

The AAN Research Program grants are funded by the AAN and American Brain Foundation in partnership with other associations and exemplify this commitment to promoting neurology and neuroscience research training across a wide range of career levels and discovery stages. In addition, 88 percent of AAN Research Program recipients go on to receive further longer-term research funding. 

EVENTS June 23 Is Last Chance to Save on Registration and Reserve Hotel for New Summer Conference continued from cover Expert faculty Anastasia Zekeridou, MD, of Mayo Clinic in Rochester, “This is going to be the first autoimmune neurology MN, and Stacey Clardy, MD, PhD, conference of its kind, covering emerging science, FAAN, of the University of Utah, will the latest clinical and diagnostic developments, and direct the two-day program which everything in between. Join us July 15–16 to do what we will feature a variety of learning do best as neurologists—collaboratively developing better styles including didactic lectures, treatment plans for our patients—all while having fun.” hands-on experiences, case-based presentations, panel Q&A sessions, —Stacey Clardy, MD, PhD, FAAN posters, an Exhibit Hall, and more.

Co-director, AAN Summer Conference Autoimmune Neurology A year in review session will be led by Nicole Beaton Sur, MD, of the University of Miami. Upon completion, participants should Paraneoplastic Neurological Syndromes and Neurologic be able to recognize and diagnose neurologic autoimmunity; Complications of Immune Checkpoint Inhibitor Cancer interpret diagnostic testing for neurologic autoimmunity; Immunotherapy avoid neurologic autoimmunity misdiagnosis and recognize

Genetics in Autoinflammatory Diseases the pitfalls; and manage and treat neurologic autoimmune Approach to Autoimmune Encephalitis/Epilepsy Sessions disorders.

Registrants can attend in person in San Francisco with the Full Registration option or attend online with the Virtual Registration option. Full Registration includes in-person attendance in San Francisco with access to poster sessions, a networking reception, and meals in the Exhibit Hall. Both registration options include access to livestreamed sessions and session recordings within the virtual platform through August 15, 2022. Those seeking longer access to session recordings can upgrade their registration to Gold to add Summer Conference On Demand with the ability to rewatch sessions and claim CME until May 30, 2023.

The program includes:

Autoimmune Movement Disorders Neuromyelitis Optica and MOG-IgG Associated Autoimmunity Autoimmune and Inflammatory Myelopathies Unusual Presentations of Neurologic Autoimmunity Closing Keynote from Vanda A. Lennon, MD, PhD, of Mayo Clinic San Francisco only: Poster Hall and Exhibit Hall Visit AAN.com/SummerConference to learn more and to secure your registration and hotel by June 23. 

Friday, July 15 Autoimmune Neurology General Session including topics such as NMDA receptor encephalitis, neuromyelitis optica spectrum disorders, neural antibodies, and more Autoimmune Neurology Case Studies Neurology Year in Review featuring headache, multiple sclerosis, epilepsy, dementia, movement disorders, and stroke San Francisco only: Poster Hall, Exhibit Hall, Networking Reception

Saturday, July 16 Neurologic Manifestations of Rheumatologic Disease Inflammatory Myopathies and Autoimmune Neuromuscular Junction Disorders Immunotherapy Considerations in Special Populations with Autoimmune Neurological Conditions

July 15–16, San Francisco and Virtual

Immune-mediated Neuropathies AANnews • June 2022

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Follow and subscribe to our new podcast!

ADVOCACY

Capitol Hill Report Capitol Hill Report presents regular updates on legislative 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

An entertaining weekly podcast featuring conversations with neurology experts, celebrity advocates, and people whose lives are affected by brain conditions.

Listen wherever you get your podcasts!

Daniel J. Correa, MD, MSc, FAAN, podcast editor and co-host

Audrey R. Nath, MD, PhD, podcast assistant editor and co-host

Share with your patients.

BrainandLife.org/Podcast

AAN member Kavita V. Nair, PhD, published an op-ed in a local Colorado outlet advocating for letting patients benefit from prescription drug reform. Nair also recently testified before the Colorado House Health & Insurance Committee to advocate in favor of step therapy reform.

The Centers for Medicare & Medicaid Services has published the CY 2023 Medicare Advantage and Part D Final Rule, which will implement changes impacting Medicare Advantage and Part D plans aimed at reducing out-of-pocket drug costs by requiring that discounts be passed through directly to consumers as well as protections for dual-eligible beneficiaries. These policies were strongly supported by the AAN in the comments we submitted during the rulemaking process.

The AAN recently welcomed Hallie Koch, our new Government Relations Program Manager, to its ever-growing Washington, DC, office. Hallie will contribute to both the AAN’s state and federal advocacy efforts, including strengthening the AAN’s digital tools and empowering AAN members on the Academy’s top issues.

On May 24—after this issue of AANnews went to press—180 AAN members gathered in Washington, DC, for the 20th annual Neurology on the Hill to ask Congress to address overly burdensome barriers to care, extend telehealth flexibilities, and support the neurology workforce. Watch for a full report in the July AANnews. 

ADVOCACY EFFORTS PRODUCE RESULTS, MORE TO COME Advocacy for neurology is a primary activity of the AAN, and volunteer members and staff have made significant strides recently to improve the working environment for neurologists and care for their patients. Below are some of the major accomplishments for the first half of 2022.

TELEHEALTH Extended Medicare flexibilities by 151 days following the Public Health Emergency Secured $65 billion investment into fast, reliable, and affordable broadband infrastructure Majority of US Senate on record supporting permanent telehealth coverage

ADUCANUMAB

REGULATORY RELIEF Delayed penalty phase for the Medicare Appropriate Use Criteria program until at least January 1, 2023 Majority of the US House to cosponsor bill reforming prior authorization in Medicare Advantage Nearly 2,000 MN members urged Congress to support this legislation

MEDICAL RESEARCH

Academy successfully advocated for the FDA to narrow the label of aducanumab

$45 billion for NIH, an increase of $2 billion, marking the seventh consecutive year of strong increases

Provided significant comments to the National Coverage Determination

$1 billion for new agency focused on conducting high-risk, high-reward research

COST OF RX DRUGS Supported key provisions in the Build Back Better Act, which is pending in the Senate Published op-ed in national publication highlighting MN’s support for lowering drug costs

VETERANS Congress urged the Veterans Administration to increase its investment in the VA Neurology Centers of Excellence Congress commissioned report on ways to improve care for veterans with neurologic conditions

$620 million for the BRAIN Initiative, an increase of $60 million Supported new legislation in Congress to establish FDA Neuroscience Center of Excellence

WORKFORCE 1,000 new federally funded GME slots for the first time in decades Created a coalition to advocate for expanding and improving the Conrad 30 program, and secured a hearing on the legislation Enacted the Dr. Lorna Breen Health Care Provider Protection Act, which provides funding to improve mental and behavioral health among health care providers

REIMBURSEMENT Implemented increased reimbursements for evaluation and management codes, resulting in seven-percent increase in Medicare reimbursements for neurology overall Averted the “Medicare Cliff,” which would have reduced Medicare reimbursement by nearly 10 percent Advocated on many policy issues, including telehealth, as part of the Medicare Physician Fee Schedule

IDEAS Supported legislation specifically aimed at improving inclusivity in clinical trials, including the ENACT Act which recently received a hearing in Congress Supported legislation to improve affordability and accessibility of health care insurance for vulnerable populations Provided health equity feedback to the Centers for Medicare & Medicaid Services

COVID-19 Requested and supported rule requiring vaccination status for health care workers

AANnews • June 2022

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EDUCATION Continuum Delivers New Insights on Dementia Dementia is examined in the new issue of Continuum: Lifelong Learning in Neurology®.

Guest Editor John C. Morris, MD, FAAN, highlighted some of the new information shared in this issue.

“The recent availability of blood-based biomarkers for Alzheimer disease, when fully accessible, promises to improve the detection of this illness in all patients and thus reduce current disparities in access to accurate diagnosis. Cognitive impairment and behavioral features complicate most movement disorders, and their recognition and treatment are important for optimal patient management.”

Content for this issue includes: Alzheimer Disease / Eric M. McDade, DO Atypical Alzheimer Disease Variants / Angelina J. Polsinelli, PhD; Liana G. Apostolova, MD, MSc, FAAN Behavioral Variant Frontotemporal Dementia / Bradley F. Boeve, MD, FAAN

Health Disparities in Dementia / Joyce (Joy) E. Balls-Berry, PhD, MPE; Ganesh M. Babulal, PhD, OTD, MSCI, MOT

Morris

Management of Dementia / Cynthia M. Carlsson, MD, MS Rapidly Progressive Dementia / Gregory S. Day, MD, MSc, MSCI, FAAN

Cognitive Syndromes Associated with Movement Disorders / Jennifer G. Goldman, MD, MS, FAAN; Samantha K. Holden, MD, MS

The issue includes a postreading self-assessment and test with the opportunity to earn up to 20 AMA PRA Category 1 Credits™ toward Self-assessment CME.

Vascular Cognitive Impairment and Dementia / Ellen Chang Wong, MD; Helena Chang Chui, MD

Until June 30, 2022, subscriptions and renewals to Continuum® are 15-percent off the already low AAN member rate. AAN members pay just $339 per year for a subscription to Continuum and Continuum® Audio. Subscribe now by contacting Wolters Kluwer at (800) 361-0633 or (301) 223-2300 (international) or visit shop.lww.com/continuum and enter code WMQ074AA at checkout to receive the discounted price. AAN junior members who are transitioning to neurologist memberships are eligible to receive a 60-percent discount on the already low member rate for the Continuum and Continuum Audio subscription. 

Neuropsychological Assessment in Dementia Diagnosis / Sandra Weintraub, PhD, ABCN/ABPP, FAAN The Value of Neuroimaging in Dementia Diagnosis / Cyrus A. Raji, MD, PhD; Tammie L. S. Benzinger, MD, PhD Fluid Biomarkers in Dementia Diagnosis / Suzanne E. Schindler, MD, PhD Neuropathology of Dementia Disorders / Julie A. Schneider, MD, MS Genetics of Alzheimer Disease / Suman Jayadev, MD

Neurology Journal’s Resident & Fellow Section Offers Opportunities The Neurology ® Resident & Fellow editors seek neurology residents to serve a three-year term as editorial

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AANnews • June 2022

team members for the Neurology Resident & Fellow Section beginning September 2022.

and leadership potential. Those with an interest in medical education and teaching are particularly welcome.

Responsibilities will include manuscript review, assistance in writing manuscripts, recruiting others to write manuscripts, generating ideas for the section, and participation in monthly conference calls. New members are expected to dedicate an estimated three hours per month to the section. Residents should have excellent communication and interpersonal skills, including having demonstrated strong writing ability

Residents from accredited neurology training programs anywhere in the world are invited to apply.

Of the three-year term, trainees should be residents for the first two years and fellowship eligible for the final year.

Applications are due July 15, 2022.

To learn more about eligibility and application requirements, visit Neurology.org/rf/recruitment. 

MEMBERSHIP

AAN Takes Pride in LGBTQI+ Inclusion Inclusion is the reason the AAN was founded. To be an organization that is the home for all neurologists. It is what makes us stronger.

To support our goal of being a fully inclusive, deliberately diverse, and anti-racist organization and our core values of Inclusion, Diversity, Equity, Anti-racism, and Social Justice (IDEAS), we are excited to share progress and updates with you.

June is Pride Month for the LGBTQI+ community and its supporters, marking the month of the infamous Stonewall Uprising that took place in New York City’s Greenwich Village in 1969. Two Academy members—Wissam Deeb, MD, and Nicole Rosendale, MD—share their thoughts about why Pride is important and the AAN’s initiatives for neurologists and their LGBTQI patients. Deeb is assistant professor in the Department of Neurology at UMass Memorial Health & UMass Chan Medical School and member of the AAN’s Leadership Engagement Subcommittee. Rosendale is assistant professor of neurology, Neurohospitalist Division, at UCSF San Francisco General Hospital and Trauma Center, and member of the AAN’s IDEAS Subcommittee and past editor of the Neurology ® journal’s “Voices: Lived Experiences” feature. Both are leaders of the AAN’s LGBTQI Section.

Deeb: From my perspective, change and diversity typify the world. These forces shape human life and interactions and can be a source of both growth and strife.

Unfortunately, the LGBTQI+ communities (Lesbian, Gay, Bisexual, Transgender, Queer/Questioning, and Intersex) have been historically marginalized and medically pathologized.

Deeb

Rosendale: I think it's essential to remember that Pride started as a protest against the violence and discrimination LGBTQI+ people faced on a daily basis. While there have been significant advances for many in our community, hatred and violence remain a daily reality for many others. In the face of a record number of anti-LGBTQI+ laws across the country, recognizing the importance of Pride―both as a celebration of our uniqueness and resilience and as an ongoing protest against bigotry―is essential.

Deeb: Despite notable progress in the last few years, violence, discrimination, othering, and continued pathologizing of members of the LGBTQI+ communities continue. Indeed, Dr. Rosendale’s work shows this concern even among AAN members. The LGBTQI+ communities come together to celebrate Pride, among other celebrations for marginalized groups, for equity, dignity, self-affirmation, and visibility. In addition to the role of Pride in advocacy, it provides a sense of community and synergy.

Rosendale: Looking ahead―I would love to see more collaboration between the LGBTQI Section and other sections to bring a broader audience to essential IDEAS-related work.

I also hope to continue to build educational materials to empower our members to provide the kind of inclusive care I know we all strive to provide, bring a sense of belonging to our trainees, who are increasingly identifying as members of the LGBTQI+ community, and encourage our leadership to continue on the path towards intentional inclusion and equity in the organization.

Deeb: In the same spirit, the LGBTQI Section at the AAN aims to improve the careers of LGBTQI+ neurology professionals’ careers, and the lived experiences of LGBTQI+ persons with neurological disorders and diseases. Last year, we started developing educational materials to promote inclusive Rosendale care in neurology clinics. One such example was a NeuroBytes addressing gender-affirming care in a headache clinic. We also created a mentorship program for our members. So far, five members have been connected to mentors to help them develop their careers in neurology.

The AAN is continuing these and other conversations around serving minoritized and underserved populations now and into the future and encourages members to take part in IDEASrelated programming, education, research, and training to better understand and support not only your patients and families, but your colleagues as well. For more information, visit AAN.com/IDEAS. 

We Need Your Feedback!

Please complete a brief member survey regarding our efforts in Inclusion, Diversity, Equity, Anti-racism, Social Justice (IDEAS). To take the survey online, visit AAN.com/IDEAS. 

AANnews • June 2022

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MEMBERSHIP Pairing Resident Mentor with Diversity Scholar Shapes Vibrant Future The AAN’s prestigious Enhanced Resident Leadership Program (ERLP) identifies, trains, and nurtures a highly select group of 15 residents who have the motivation, drive, and potential to be future Academy leaders. The AAN’s Medical Student Diversity Scholarship offers up to 10 US medical students from underrepresented racial and ethnic backgrounds in medicine an unparalleled opportunity to explore career options in the field of neurology through access to the best and brightest minds in the field. It also offers budding young neurologists unique access to inspiring mentors.

Put the two together and you have a recipe for success—especially when the ingredients are resident Franklyn Rocha-Cabrero, MD, and fourth-year medical student Alexandra Rincones.

As part of his ERLP curriculum, Rocha-Cabrero was asked to serve as a mentor to a 2021 Medical Student Diversity Scholar.

As part of her curriculum, Rincones was asked to share her goals for a mentor-mentee relationship. The pairing of RochaCabero with Rincones couldn’t have been more serendipitous.

Both already had strong backgrounds in and were deeply passionate about increasing diversity within the neurology community—a long-held goal of the AAN’s, as well.

As a trailblazer millennial neurologist, Rocha-Cabrero entered the ERLP program with a long history in leadership that trails back to his undergraduate experiences, his intramural research and health equity/disparities training at the National Institutes of Health through a 2009 NIH Academy Intramural Research Training Award, and his numerous leaderships endeavors at minority-serving medical organizations, hospital committees, and medical education programs as a medical student, resident, and fellow. More recently, Rocha-Cabrero’s roles at his home institution at University of California-Irvine (UCI) served him especially well in ensuring alignment and success in his mentorship role with Rincones. As a member of the UCI Neurology Department’s Inclusion, Diversity, Equity, Activities (IDEAS) Committee, Rocha-Cabrero leads the Community Outreach Subcommittee, where his role is to expose underrepresented minorities to careers in neurology

Rocha-Cabrero

Rincones

and neuroscience with outreach activities that target K-12, undergraduate, and medical students. Additionally, he is part of the UCI Resident and Fellows Scholars Academy, which aims to retain underrepresented trainees into careers of service within academic institutions, especially to uplift and increase the number of underrepresented minorities in neurology.

“When I realized Alexandra was from the San Juan Bautista School of Medicine in Puerto Rico, I immediately requested to be her mentor,” said Rocha-Cabrero. “As we are both from Puerto Rico, we developed an effortless professional relationship.”

For her part, in addition to being a 2021 Medical Student Diversity Recipient, Rincones, an aspiring neurologist, had already been focusing her studies on health equity, medical education, women’s health, and clinical research. She also served as president of the Student Interest Group in Neurology, and a tutor, a member of the American Medical Women’s Association, and the Latino Medical Student Association.

“As an [Medical Student Diversity Scholarship] awardee, I had the opportunity to attend the AAN’s virtual 2021 Annual Meeting, explore career options in the field of neurology, learn about novel research topics in neurology, participate in empowering workshops with a wellness coach, and gain access to mentors,” said Rincones. “As my mentor, Dr. RochaCabrero guided me in an immense manner during the many stages of applying to adult neurology residency. He introduced me to many of his colleagues so that I could make connections

MENTORING GOALS

COACHING

GUIDEANCE

TRAINING

MOTIVATION

KNOWLEDGE

SUPPORT

with other people in my field and my future colleagues.

He introduced me to associations, such as the National Hispanic Medical Association and Student National Medical Association Inc. And he brought opportunities to my attention, including scholarship opportunities, which may expand my interests and further develop my medical career.”

The hard work paid off. “I could not contain my excitement that Alexandra matched into her #1 program at the University of South Florida Morsani School of Medicine,” said RochaCabrero. “It was definitely an emotional moment for me and for Alexandra. And I told her this was only the beginning.”

In fact, Rocha-Cabrero has renewed his commitment to mentoring Rincones throughout her residency/fellowship “until she becomes a successful Latina woman in neurology,” he said. “I have been very emotional for Alexandra’s success and happy for what the future holds for her. Her leadership potential is ripe!” “[Dr. Rocha-Cabrero] shaped and overall supported my core values and has inspired me to keep believing in myself,” said Rincones. “Thanks to the AAN’s Medical Student Diversity Scholarship, I have met a mentor with similar goals as myself which reaffirms my aspirations of becoming a voice for other underrepresented individuals in medicine. I am overjoyed to continue having Dr. Rocha-Cabrero guide me as his mentee through residency/fellowship and promise to pass the torch to my future mentees.”

“This experience has been very rewarding for me, to help diversity our neurology specialties that are in such high need for women Latinas in our community,” said Rocha-Cabrero.

“There is still a lot of work to increase minority representation within neurology departments and community practices and address the US patient population needs. We should continue supporting Alexandra and women like her. I hope we can continue highlighting these successes so that continued funding is allocated in the AAN for pipeline/diversity programs starting from K-12 all the way to fellowship.”

Visit AAN.com/education/enhanced-residentleadership to learn more about the AAN’s Enhanced Resident Leadership Program and AAN.com/education/medical-student-diversity to learn more about the Medical Student Diversity Scholarship. Applications for the 2023 programs will open this fall.

The Enhanced Resident Leadership Program is supported in part by HCA Healthcare; Impel NeuroPharma, Inc.; and LivaNova PLC. The Medical Student Diversity Scholarship is supported by AbbVie Foundation. 

Upcoming Virtual “Spotlight On” Sessions to Highlight AAN Section Work, Timely Issues At the April Annual Meeting in Seattle, 15 AAN Sections introduced 12 new “Spotlight On” sessions designed to highlight the Academy’s 41 sections and provide a venue for attendees to reconnect via a variety of lively discussionand debate-based sessions on timely issues like daylight saving time, changes to neurology education, and careers in global health.

Due to the popularity of the in-person sessions, AAN Sections are planning to host future sessions—virtually—throughout 2022 to continue to engage members and highlight the important work of section members.

Visit Synapse.AAN.com/new-item683 to see the schedule of upcoming sessions and be sure to check back often as sessions are added to the calendar. 

AAN Member Communities

Not a Section Member?

JOIN US!

If you’re not already an AAN Section member, consider joining one or more of the 41 sections representing a broad range of subspecialties.

Section membership is free to AAN members and allows you to take part in rich and timely discussions with other AAN members from more than 140 countries to share ideas and concerns and help shape the future of neurology. Membership in one or more AAN Sections also includes access to our associated online SynapseSM Member Communities and the new Synapse mobile app, where a growing number of participants are discussing the latest health care topics. Visit AAN.com/Sections to learn more and to join. 

SUCCESS AANnews • June 2022

19

— David Dodick, MD, FAAN Board Chair

“

“

The American Brain Foundation gives me hope that there is an organization whose sole focus is to fund research across the full spectrum of brain diseases. It gives me hope that a discovery in one area will have a profound ripple effect on our understanding and treatment of other diseases. And that is the benefit of studying brain diseases across the spectrum.

How is the American Brain Foundation working to create a world without brain disease?

Investing in research across all brain diseases and disorders knowing they are all connected Bringing donors and researchers together to find better treatments, prevention, and the cures of tomorrow Advocating for all those impacted by brain disease

A cure for one brain disease will lead to cures for many.

Learn more about our mission and research initiatives at AmericanBrainFoundation.org/About

AMERICAN BRAIN FOUNDATION Giesser Named 2022 Ted M. Burns Humanism in Neurology Award Recipient Barbara S. Giesser, MD, FAAN, of the Pacific Neuroscience Institute has been named the recipient of the 2022 Ted M. Burns Humanism in Neurology Award. The award recognizes the influence of the most compassionate and innovative neurologists in the field who bring creativity, advocacy, and innovation to their work. The award strives to inspire others to improve health care delivery and the lives of their colleagues and patients.

For the past 40 years, Giesser has specialized in diagnosis and personalized treatment for people with multiple sclerosis.

Her approach emphasizes integrating lifestyle and wellness strategies into the neurologic treatment plan. She has also conducted peer-reviewed research on exercise as a therapeutic method. In addition, she has served as a consultant for the National Multiple Sclerosis Society.

According to the award selection committee, “Dr. Giesser displays a humanism that is unparalleled and captures the essence of what it means to be a caring mentor, educator, and health care provider. She epitomizes the aims of the Ted M. Burns Award to celebrate neurologists whose work embodies humanism in patient care, education, advocacy, and everyday encounters.”

Giesser is a nationally recognized advocate for MS education and awareness, and is lauded by colleagues, patients, and students for her patient-centered approach. Since 1982 she has been a leader in patient advocacy and education, with more than 100 publications, including peer-reviewed research, reviews, and textbooks. She received numerous accolades and awards, including the Ronald Reagan UCLA Medical Center “Exceptional

Physician Award,” as well as joining the National Multiple Sclerosis Society’s Volunteer Hall of Fame in 2018. She also received recognition as one of the “Best Doctors in America” since 2005.

Giesser

“I am thrilled and honored to be recognized for doing what I love,” said Giesser. “I accept this award on behalf of the wonderful mentors and role models whom I have been fortunate to encounter in my life, most importantly my parents and my patients. When one is faced with the technological advances and administrative labyrinths inherent in modern health care that may strip individual patients of their humanity, it is very reassuring that the American Academy of Neurology and American Brain Foundation are facilitating formal recognition of humanism in the practice of medicine at this time.”

Visit AmericanBrainFoundation.org/tedburns to learn more about the Ted M. Burns Humanism in Neurology Fund and other ways you can support the Foundation’s efforts in creating more opportunities for researchers to help lead the way to cures. 

Spring Special Only $339 for AAN Members!

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2-PM054

FOR PATIENTS WITH RELAPSING FORMS OF MS

PLAYING WITH FEWER RELAPSES • The efficacy of VUMERITY® (diroximel fumarate) is based upon bioavailability studies in patients with relapsing forms of multiple sclerosis and healthy subjects comparing dimethyl fumarate to VUMERITY1 • Study 1: A 2-year, randomized, double-blind, placebo-controlled study in 1234 patients with RRMS. Primary endpoint: PPR1 • Study 2: A 2-year, multicenter, randomized, double-blind, placebo-controlled study in 1417 patients with RRMS. Primary endpoint: ARR1

VUMERITY offers the efficacy demonstrated by dimethyl fumarate across 2 pivotal trials1

of treated patients were relapse-free at 2 years1

• Dimethyl fumarate demonstrated a 49% and 34% relative risk reduction in PPR vs placebo, respectively (27% vs 46%; P<0.0001), (29% vs 41%; P=0.0020)

Based on ARR, treated patients experienced

RELAPSE every 2 years1

• Dimethyl fumarate demonstrated a 53% and 44% relative reduction in ARR vs placebo, respectively (0.172 vs 0.364; P<0.0001), (0.224 vs 0.401; P<0.0001)

Visit www.vumerityhcp.com

Indication VUMERITY® (diroximel fumarate) 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 CONTRAINDICATIONS

VUMERITY is contraindicated in patients • With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema • Taking dimethyl fumarate

WARNINGS AND PRECAUTIONS

Anaphylaxis and Angioedema • VUMERITY can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (which has the same active metabolite as VUMERITY) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue VUMERITY and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema

Progressive Multifocal Leukoencephalopathy • Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (which has the same active metabolite as VUMERITY). PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial • PML has occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9 × 109/L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8×109/L persisting for more than 6 months • At the first sign or symptom suggestive of PML, withhold VUMERITY and perform an appropriate diagnostic evaluation.

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

Important Safety Information (cont'd) WARNINGS AND PRECAUTIONS (CONT'D)

Progressive Multifocal Leukoencephalopathy (cont'd) • Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present Herpes Zoster and Other Serious Opportunistic Infections • Serious cases of herpes zoster have occurred in patients treated with dimethyl fumarate (which has the same active metabolite as VUMERITY), including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on VUMERITY for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered • Other serious opportunistic infections have occurred with dimethyl fumarate, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment • Consider withholding VUMERITY treatment in patients with herpes zoster or other serious infections until the infection has resolved Lymphopenia • VUMERITY may decrease lymphocyte counts. In the MS placebo-controlled trials with dimethyl fumarate (which has the same active metabolite as VUMERITY), mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable.

Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased but did not return to baseline. The incidence of infections and serious infections was similar in patients treated with dimethyl fumarate or placebo. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8 x 109/L or ≤0.5 x 109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5 x 109/L for 3.5 years) • In controlled and uncontrolled clinical trials with dimethyl fumarate, 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy. Neither VUMERITY nor dimethyl fumarate have been studied in patients with preexisting low lymphocyte counts • Obtain a complete blood count (CBC), including lymphocyte count, before initiating treatment with VUMERITY, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of VUMERITY in patients with lymphocyte counts less than 0.5 x 109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if VUMERITY is discontinued or interrupted because of lymphopenia. Consider withholding treatment from patients with serious infections until resolution Liver Injury • Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate (which has the same active metabolite as VUMERITY) in the postmarketing setting.

The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities © 2021 Biogen. All rights reserved. 07/21 VUM-US-0458 v4

resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients • Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials with dimethyl fumarate • Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with VUMERITY and during treatment as clinically indicated. Discontinue VUMERITY if clinically significant liver injury induced by VUMERITY is suspected Flushing • VUMERITY may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials of dimethyl fumarate (which has the same active metabolite as VUMERITY), 40% of dimethyl fumarate-treated patients experienced flushing. Flushing symptoms generally began soon after initiating dimethyl fumarate and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued dimethyl fumarate for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization

ADVERSE REACTIONS • The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate (which has the same active metabolite as VUMERITY) were flushing, abdominal pain, diarrhea, and nausea • Gastrointestinal adverse reactions: Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with dimethyl fumarate • Hepatic transaminases: An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate was seen primarily during the first six months of treatment and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with dimethyl fumarate or placebo • Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy

USE IN SPECIFIC POPULATIONS

Renal Impairment • No dosage adjustment is necessary in patients with mild renal impairment. Because of an increase in the exposure of a major metabolite, use of VUMERITY is not recommended in patients with moderate or severe renal impairment Please see following pages for Brief Summary of full Prescribing Information.

PPR=proportion of patients relapsed; ARR=annualized relapse rate.

Reference: 1. VUMERITY Prescribing Information, Biogen, Cambridge, MA.

VUMERITY® (diroximel fumarate) delayed-release capsules, for oral use Brief Summary of full Prescribing Information 1. INDICATIONS AND USAGE VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults.

2. DOSAGE AND ADMINISTRATION 2.1 Blood Tests Prior to Initiation of VUMERITY Obtain the following prior to treatment with VUMERITY: • A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions (5.4)] • Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions (5.5)] 2.2 Dosing Information The starting dosage for VUMERITY is 231 mg twice a day orally. After 7 days, the dosage should be increased to the maintenance dosage of 462 mg (administered as two 231 mg capsules) twice a day orally.

Temporary dosage reductions to 231 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the recommended dosage of 462 mg twice a day should be resumed. Discontinuation of VUMERITY should be considered for patients unable to tolerate return to the maintenance dosage.

Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to VUMERITY dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3)].

2.3 Administration Instructions Swallow VUMERITY capsules whole and intact. Do not crush or chew, or sprinkle the capsule contents on food.

If taken with food, avoid a high-fat, high-calorie meal/snack; the meal/snack should contain no more than 700 calories and no more than 30 g fat [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

Avoid co-administration of VUMERITY with alcohol [see Clinical Pharmacology (12.3)].

of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial.

During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5 × 109/L for 3.5 years) while taking dimethyl fumarate [see Warnings and Precautions (5.4)]. The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly.

PML has also occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9 × 109/L).

While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8×109/L persisting for more than 6 months.

At the first sign or symptom suggestive of PML, withhold VUMERITY and perform an appropriate diagnostic evaluation. 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.

Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Cases of PML diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with other MS medications associated with PML. Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present.

Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis. It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients.

2.4 Blood Tests to Assess Safety After Initiation of VUMERITY Obtain a complete blood cell count (CBC), including lymphocyte count, 6 months after initiation of VUMERITY and then every 6 to 12 months 5.3 Herpes Zoster and Other Serious Opportunistic Infections thereafter, as clinically indicated [see Warnings and Precautions (5.4)].

Serious cases of herpes zoster have occurred in patients treated Obtain serum aminotransferase, alkaline phosphatase, and total with dimethyl fumarate (which has the same active metabolite as bilirubin levels during treatment with VUMERITY, as clinically indicated VUMERITY) including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster [see Warnings and Precautions (5.5)]. meningomyelitis. These events may occur at any time during treatment.

2.5 Patients With Renal Impairment Monitor patients on VUMERITY for signs and symptoms of herpes No dosing adjustment is recommended in patients with mild renal zoster. If herpes zoster occurs, appropriate treatment for herpes zoster impairment. should be administered.

VUMERITY is not recommended in patients with moderate or severe Other serious opportunistic infections have occurred with dimethyl renal impairment [see Use in Specific Populations (8.6) and Clinical fumarate, including cases of serious viral (herpes simplex virus, Pharmacology (12.3)].

West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium 3. DOSAGE FORMS AND STRENGTHS These infections have been reported in VUMERITY is available as hard, delayed-release capsules containing tuberculosis) infections.

231 mg of diroximel fumarate. The capsules have a white cap and a patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, white body, printed with “DRF 231 mg” in black ink on the body. meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and 4. CONTRAINDICATIONS ear. Patients with symptoms and signs consistent with any of these VUMERITY is contraindicated in patients infections should undergo prompt diagnostic evaluation and receive • With known hypersensitivity to diroximel fumarate, dimethyl appropriate treatment. fumarate, or to any of the excipients of VUMERITY. Reactions Consider withholding VUMERITY treatment in patients with herpes may include anaphylaxis and angioedema [see Warnings and zoster or other serious infections until the infection has resolved [see Precautions (5.1)].

Adverse Reactions (6.2)].

• Taking dimethyl fumarate [see Drug Interactions (7.1)].

5.4 Lymphopenia 5. WARNINGS AND PRECAUTIONS VUMERITY may decrease lymphocyte counts. In the MS placebo5.1 Anaphylaxis and Angioedema controlled trials with dimethyl fumarate (which has the same active VUMERITY can cause anaphylaxis and angioedema after the first metabolite as VUMERITY), mean lymphocyte counts decreased by dose or at any time during treatment. Signs and symptoms in patients approximately 30% during the first year of treatment with dimethyl taking dimethyl fumarate (which has the same active metabolite as fumarate and then remained stable. Four weeks after stopping dimethyl VUMERITY) have included difficulty breathing, urticaria, and swelling fumarate, mean lymphocyte counts increased but did not return to of the throat and tongue. Patients should be instructed to discontinue baseline. Six percent (6%) of dimethyl fumarate patients and <1% of VUMERITY and seek immediate medical care should they experience placebo patients experienced lymphocyte counts <0.5 × 109/L (lower signs and symptoms of anaphylaxis or angioedema. limit of normal 0.91 × 109/L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with 5.2 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in dimethyl fumarate or placebo, respectively. There was no increased infections observed in patients with lymphocyte patients with MS treated with dimethyl fumarate (which has the same incidence of serious 9 9 active metabolite as VUMERITY). PML is an opportunistic viral infection counts <0.8 × 10 /L or ≤0.5 × 10 /L in controlled trials, although one

patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5 × 109/L for 3.5 years) [see Warnings and Precautions (5.2)].

In controlled and uncontrolled clinical trials with dimethyl fumarate, 2% of patients experienced lymphocyte counts <0.5 × 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 × 109/L with continued therapy. Neither VUMERITY® (diroximel fumarate) nor dimethyl fumarate have been studied in patients with preexisting low lymphocyte counts.

Obtain a complete blood count (CBC), including lymphocyte count, before initiating treatment with VUMERITY, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of VUMERITY in patients with lymphocyte counts less than 0.5 × 109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if VUMERITY is discontinued or interrupted because of lymphopenia.

Consider withholding treatment from patients with serious infections until resolution. Decisions about whether or not to restart VUMERITY should be individualized based on clinical circumstances.

The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules, which has the same active metabolite as VUMERITY. Adverse Reactions in Placebo-Controlled Trials with Dimethyl Fumarate In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [see Clinical Studies (14)].

The adverse reactions presented in Table 1 below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea.

Table 1: Adverse Reactions in Study 1 and 2 Reported for Dimethyl Fumarate at ≥2% Higher Incidence than Placebo

Adverse Reactions

Dimethyl Fumarate 240 mg Twice Daily (N=769) %

Placebo (N=771)%

5.5 Liver Injury Clinically significant cases of liver injury have been reported in patients 40 6 treated with dimethyl fumarate (which has the same active metabolite Flushing as VUMERITY) in the postmarketing setting. The onset has ranged Abdominal pain 18 10 from a few days to several months after initiation of treatment with 14 11 dimethyl fumarate. Signs and symptoms of liver injury, including Diarrhea elevation of serum aminotransferases to greater than 5-fold the upper Nausea 12 9 limit of normal and elevation of total bilirubin to greater than 2-fold Vomiting 9 5 the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required Pruritus 8 4 hospitalization. None of the reported cases resulted in liver failure, Rash 8 3 liver transplant, or death. However, the combination of new serum 6 4 aminotransferase elevations with increased levels of bilirubin caused Albumin urine present by drug-induced hepatocellular injury is an important predictor of Erythema 5 1 serious liver injury that may lead to acute liver failure, liver transplant, Dyspepsia 5 3 or death in some patients.

Elevations of hepatic transaminases (most no greater than 3 times Aspartate aminotransferase 4 2 the upper limit of normal) were observed during controlled trials with increased dimethyl fumarate [see Adverse Reactions (6.1)].

Lymphopenia 2 <1 Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with VUMERITY and during Gastrointestinal treatment, as clinically indicated. Discontinue VUMERITY if clinically Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, significant liver injury induced by VUMERITY is suspected. abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and 5.6 Flushing VUMERITY may cause flushing (e.g., warmth, redness, itching, and/ usually decreased over time in patients treated with dimethyl fumarate or burning sensation). In clinical trials of dimethyl fumarate (which has compared with placebo. Four percent (4%) of patients treated with the same active metabolite as VUMERITY), 40% of dimethyl fumarate- dimethyl fumarate and less than 1% of placebo patients discontinued treated patients experienced flushing. Flushing symptoms generally due to gastrointestinal events. The incidence of serious GI events was began soon after initiating dimethyl fumarate and usually improved 1% in patients treated with dimethyl fumarate. or resolved over time. In the majority of patients who experienced Hepatic Transaminases flushing, it was mild or moderate in severity. Three percent (3%) of An increased incidence of elevations of hepatic transaminases in patients discontinued dimethyl fumarate for flushing and <1% had patients treated with dimethyl fumarate was seen primarily during serious flushing symptoms that were not life-threatening but led the first six months of treatment, and most patients with elevations to hospitalization. had levels <3 times the upper limit of normal (ULN) during controlled Administration of VUMERITY with food may reduce the incidence of trials. Elevations of alanine aminotransferase and aspartate flushing [see Dosage and Administration (2.3)]. Studies with dimethyl aminotransferase to ≥3 times the ULN occurred in a small number of fumarate show that administration of non-enteric coated aspirin (up to patients treated with both dimethyl fumarate and placebo and were a dose of 325 mg) 30 minutes prior to dosing may reduce the incidence balanced between groups. There were no elevations in transaminases or severity of flushing [see Clinical Pharmacology (12.3)]. ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases 6. ADVERSE REACTIONS The following important adverse reactions are described elsewhere were <1% and were similar in patients treated with dimethyl fumarate or placebo. in labeling: • Anaphylaxis and Angioedema [see Warnings and Precautions (5.1)] • Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions Section (5.2)] • Herpes Zoster and Other Serious Opportunistic Infections [see Warnings and Precautions (5.3)] • Lymphopenia [see Warnings and Precautions (5.4)] • Liver Injury [see Warnings and Precautions (5.5)] • Flushing [see Warnings and Precautions (5.6)]

Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.

Adverse Reactions in Clinical Studies with VUMERITY

In clinical studies assessing safety in patients with RRMS, approximately 700 patients were treated with VUMERITY and approximately 490 patients received more than 1 year of treatment with VUMERITY. The adverse reaction profile of VUMERITY was consistent 6.1 Clinical Trials Experience with the experience in the placebo-controlled clinical trials with Because clinical trials are conducted under widely varying conditions, dimethyl fumarate. adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may 6.2 Postmarketing Experience The following adverse reaction has been identified during post approval use not reflect the rates observed in clinical practice.

of dimethyl fumarate. 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.

Hepatobiliary Disorders: Liver function abnormalities (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN) [see Warnings and Precautions (5.5)].

Infections and Infestations: Herpes zoster infection and other serious opportunistic infections [see Warnings and Precautions (5.3)].

Respiratory, Thoracic, and Mediastinal Disorders: Rhinorrhea Skin and Subcutaneous: Alopecia.

8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of VUMERITY® (diroximel fumarate) or dimethyl fumarate (which has the same active metabolite as VUMERITY) in pregnant women. In animal studies, administration of diroximel fumarate during pregnancy or throughout pregnancy and lactation resulted in adverse effects on embryofetal and offspring development (increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment) at clinically relevant drug exposures [see Data].

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data Animal Data Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/ day) to pregnant rats throughout organogenesis resulted in a decrease in fetal body weight and an increase in fetal skeletal variations at the highest dose tested, which was associated with maternal toxicity.

Plasma exposures (AUC) for MMF and HES (the major circulating drugrelated compound in humans) at the no-effect dose (100 mg/kg/day) for adverse effects on embryofetal development were approximately 2 times those in humans at the recommended human dose (RHD) of 924 mg/day.

Oral administration of diroximel fumarate (0, 50, 150, or 350 mg/kg/ day) to pregnant rabbits throughout organogenesis resulted in an increase in fetal skeletal malformations at the mid and high doses and reduced fetal body weight and increases in embryofetal death and fetal skeletal variations at the highest dose tested. The high dose was associated with maternal toxicity. Plasma exposures (AUC) for MMF and HES at the no-effect dose (50 mg/kg/day) for adverse effects on embryofetal development were similar to (MMF) or less than (HES) those in humans at the RHD. Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/day) to rats throughout gestation and lactation resulted in reduced weight, which persisted into adulthood, and adverse effects on neurobehavioral function in offspring at the highest dose tested. Plasma exposures (AUC) for MMF and HES at the no-effect dose for adverse effects on postnatal development (100 mg/kg/day) were approximately 3 times (MMF) or similar to (HES) those in humans at the RHD. 8.2 Lactation Risk Summary There are no data on the presence of diroximel fumarate or metabolites (MMF, HES) in human milk. The effects on the breastfed infant and on milk production are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VUMERITY and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

8.4 Pediatric Use Safety and effectiveness established.

17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).

Dosage and Administration Inform patients that they will be provided a starter dose bottle: one capsule twice a day for the first 7 days and then two capsules twice a day thereafter. Advise patients to take VUMERITY as instructed.

Inform patients to swallow VUMERITY capsules whole and intact.

Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that they should avoid a high-fat, high-calorie meal/snack at the time they take VUMERITY. If taken with food, the meal/snack should contain no more than 700 calories and no more than 30 g fat. Advise patients to avoid co-administration of VUMERITY with alcohol [see Dosage and Administration (2.2)].

Anaphylaxis and Angioedema Advise patients to discontinue VUMERITY and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.1)].

Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received dimethyl fumarate, and therefore may occur with VUMERITY. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Inform the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that 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 [see Warnings and Precautions (5.2)].

Herpes Zoster and Other Serious Opportunistic Infections Inform patients that herpes zoster and other serious opportunistic infections have occurred in patients who received dimethyl fumarate and therefore may occur with VUMERITY. Instruct the patient of the importance of contacting their doctor if they develop any signs or symptoms associated with herpes zoster or other serious opportunistic infections [see Warnings and Precautions (5.3)].

Lymphocyte Counts Inform patients that VUMERITY may decrease lymphocyte counts. A blood test should be obtained before they start therapy. Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

Liver Injury Inform patients that VUMERITY may cause liver injury. Instruct patients treated with VUMERITY to report promptly to their healthcare provider any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions (5.5)].

Flushing and Gastrointestinal (GI) Reactions Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI reactions. Advise patients experiencing flushing that taking VUMERITY with food (avoid high-fat, high-calorie meal or snack) or taking a nonenteric coated aspirin prior to taking VUMERITY may help [see Dosage and Administration (2.2) and Adverse Reactions (6.1)].

Pregnancy been Instruct patients that if they are pregnant or plan to become pregnant while taking VUMERITY they should inform their healthcare provider [see Use in Specific Populations (8.1)].

8.5 Geriatric Use Clinical studies of dimethyl fumarate and VUMERITY did not include sufficient numbers of patients aged 65 years and over to determine Manufactured for: Biogen Inc. whether they respond differently from younger patients.

Cambridge, MA 02142 8.6 Renal Impairment No dosage adjustment is necessary in patients with mild renal impairment. Because of an increase in the exposure of a major VUMERITY is a registered trademark of Biogen. metabolite [2-hydroxyethyl succinimide (HES)], use of VUMERITY is © Biogen 2022 not recommended in patients with moderate or severe renal impairment [see Clinical Pharmacology (12.3)]. in

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Careers.AAN.com

Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added.

Neurologist—Comprehensive Neurology Services PA— Frederick, Maryland Comprehensive Neurology Services (CNS) is a premier sub-speciality oriented Neurology group of 7 Neurologists and 4 APPs in central Maryland near Washington DC. We are seeking a Board-certified/Board Eligible Neurologist, with or without specialty, to be a part of our large and established practice. CNS has been involved in patient care for over 15 years and has grown to 4 offices in three counties over this time period. With offices in Frederick, Hagerstown, Germantown and Silver Spring, we cover a wide geographical area and cover all major Neurology sub-specialties. In addition, our providers cover hospitals in the area including: MERITUS Medical Center—Hagerstown, MD—Frederick Health Hospital—Frederick, MD—Holy Cross Germantown Hospital.

Holy Cross Hospital Silver Spring Providers at CNS enjoy the following: Enjoy the picturesque towns of Frederick and Hagerstown conveniently located near large cities such as DC and Baltimore, Large multi-specialty Neurology Group, Competitive Salary, Sign-on Bonus, Partnership Opportunity, Research opportunities with our providers, Benefits package retirement plan, medical, dental, vision, CME, Multitude of EMR systems—EPIC, Meditech and eClinicalworks, For more information, please contact: Info@thecns.com Practice Outpatient Neurology In The Most Popular Tourist Destination In The US—Synapse Neurology—Clermont, Florida Enjoy practicing in one of the MOST POPULAR travel destinations in the United States. From science programs to music festivals, bowl games and of course home to Mickey and Minnie Mouse, this Beautiful City attracts people from all over world where you can work and play. Synapse Neurology, located in Clermont, 26 miles west of Orlando is actively recruiting a Board-Certified General Neurologist or a fellowship trained neurologist to join the well-respected, established, and busy practice. This is a rapidly growing practice. Opportunities exist to develop subspecialty practices in a variety of areas, including, but not limited to, movement disorders, neuromuscular, headache, Cognitive neurology, MS and epilepsy. Practice Details And Features Include: General Neurologist, Nurse Practitioner, 5200 square foot modern office with electronic EMR, Clinical Neurophysiology Lab with EMG and EEG, In office Infusion Center, Botox Therapy, Outpatient Practice. Compensation and Benefits: 300K + Full benefits package. Email administrator@synapseneurology. com with interest or questions.

Coastal Virginia has a New General Neurology Opportunity!

—Bon Secours Medical Group—Hampton, Virginia Job Opportunity: Bon Secours Mercy Health a physician-led multi-specialty group in Hampton Roads, Virginia is currently recruiting for a BE/BC General Neurologist to join their existing practice Bon Secours Neuroscience Institute. Ideal candidate must have 3-5 years’ experience and be willing to help grow the developing program. Desired interest should be in EEG, EMG, Stroke and Neurophysiology. Job Details: Clinic Hours—Monday–Friday (8-5pm), Average patient volumes 15-20 per day, New Consults average 6 per day, Call coverage is 1 in 4 with Tele-Neurology Coverage. Hospital Affiliation: Maryview Medical Center/Primary Care Stroke Center, Outpatient: Harbour View Medical Center, A.P.C. support in clinic, EMR: EPIC inpatient and outpatient, Joint Commission Advanced Primary Stroke Center since 2010, Stroke Gold Plus Award from American Heart Association. Compensation & Benefits: Full Comprehensive Benefit Package to include; Medical Plans, Vision, Dental, Prescription Drugs, A.P.C support with collaboration earnings, Life Insurance Options, Disability Insurance, Short and Long Term, Wellness Plan, Flex Spending and HSA, Allowed Time Off plus holidays, Competitive Compensation, Sign-On Bonus, Relocation Expense, CME Annual $10,000, Participate in 457b Plan.

Region: The Hampton Roads area of Coastal Virginia offers a beautiful city of over one million that most would consider a cultural hot spot with a bustling, artsy urban downtown and affordable upscale suburbs with top public schools and safe neighborhoods. Known as “One of the Nation’s Top 20 places to educate your child”—Forbes magazine. Hampton Roads is 45 minutes south of historical Williamsburg, 4 hours south of D.C. and 1 hour north of the Outer Banks of North Carolina. Overall, a great opportunity to live in the

affluent suburbs of a lively, affordable city in Virginia while also caring for high-need patient population and earning a top income among physicians in your specialty nationwide.

Email Elizabeth Poplawsky at Elizabeth_Poplawsky@bshsi.org with interest or for more information.

Director of Dementia Research—Cleveland Clinic— Las Vegas, Nevada Cleveland Clinic Neurological Institute announces its search for a Director of Research to lead and expand the robust research programs at Cleveland Clinic Lou Ruvo Center in Las Vegas, Nevada. To be considered, candidates must have an MD or equivalent degree, be Board Certified and have a record of proven success and a passion for research in Alzheimer’s disease and related dementias. The successful applicant will develop a purpose-driven mission that builds on abundant expertise and resources at the Lou Ruvo Center for Brain Health. The successful candidate will lead and mentor the research team in Las Vegas while collaborating with investigators at the Cleveland and Florida locations. This includes major roles in our two NIH-funded Centers (Exploratory Alzheimer’s Disease Research Center and COBRE Center for Neurodegeneration and Translational Neuroscience), as well as research programs in movement disorders and multiple sclerosis. You will be fully supported in your own investigational pursuit of clinically relevant knowledge and improved therapeutics for Alzheimer’s disease and related dementias. Direct observation and understanding of cognitive disorders through clinical service is a required component of the position. The successful candidate will have academic accomplishments suitable for appointment as an associate or full professor at Cleveland Clinic Lerner College of Medicine. This position will be supported by a $2M endowed chair. Responsibilities will include: Strategic planning and leadership for growth of the research program—Directing, supporting, mentoring and developing investigator-initiated research studies—Outpatient clinical service and patient care (no call or weekends). This important position commands a competitive salary enhanced by an attractive benefits package including but not limited to: Excellent medical, dental, vision coverage—Comprehensive disability and life insurance benefits —Medical malpractice & tail coverage provided—Generous allowances for vacation, sick time, holidays and professional meetings—Reimbursement for society memberships and journal subscriptions—Highly competitive retirement plans with generous employer contribution. Interested candidates, please be sure to include your current CV and cover letter with application to Nathan Elting at eltingn@ccf.org.

University of Florida General Neurologists—UF Jacksonville Physicians, Inc—Saint Johns County, Florida The Department of Neurology at the University of Florida College of Medicine -Jacksonville, seeks full time faculty at the non-tenure accruing level of Clinical Assistant/ Associate/Full Professor. The successful candidates will be MD/DO and BC/BE adult neurologists with or without specialty training and will have the opportunity to join the newly created UF-COM Jacksonville Neurology practices located in Saint Johns County, Florida. This position will report to the Chairman of the Department of Neurology at the University of Florida College of Medicine-Jacksonville.

The successful candidates will enjoy a blended inpatient and outpatient schedule with responsibility for the delivery of high quality health care. Opportunities also exist to develop subspecialty interests, and to engage in both research and teaching. Collaboration and relationship building will be essential for successfully working alongside teams from UF-COM Jacksonville and Flagler Health. The following is a description of general duties and responsibilities: Provide and maintain a high level of quality and compassionate acute and chronic to both inpatients and outpatients from a wide variety of cases. Provide clinical teaching of trainees in Neurology and participate in the educational program.

Responsible for excellent communication with primary care physicians. Assist in marketing of the Neurology program to community physicians and managed care organizations.

Responsible for building relationship and communicating with primary care physicians, specialist and other stakeholders to enhance patient care and grow patient volume. Participate in monthly division meetings, administrative functions and

institutional committees. The University of Florida College of Medicine-Jacksonville is the largest of the three UF colleges—medicine, nursing and pharmacy—located on the approximately 110-acre UF Health Jacksonville campus. The college's 16 clinical science departments house more than 400 faculty members and 300 residents and fellows. The college offers 32 accredited graduate medical education programs. In addition to graduate medical education, clinical rotations in all the major disciplines are provided for students from the UF College of Medicine in Gainesville. For practicing physicians, the college offers a continuing medical education program that recruits national and international speakers who are well known and respected in their fields.

The campus' faculty, residents and fellows are active in clinical research. Residents and fellows regularly present their findings at locations across the country and publish their projects in well-known publications. Residents in Northeast Florida and Southeast Georgia are offered all the benefits of an academic health center by combining our strengths with that of the UF Health Jacksonville. Together, the University of Florida Health Science Center–Jacksonville and UF Health Jacksonville form the region’s premier academic health center–UF Health, a leader in the education of health professionals, a hub for clinical research and a unique provider of high-quality patient care. With more than 5,000 faculty and staff, the academic health center in Jacksonville is the largest UF campus outside of Gainesville, offering nearly 100 specialty services, including: Cancer services; Cardiovascular; Neuroscience; Orthopaedic; Pediatrics; Poison Center; Trauma and Critical Care; and Women and Families services. At 37 clinical sites throughout Northeast Florida, UF physicians tally more than 600,000 outpatient visits and more than 34,000 inpatient admissions annually.

About Saint Johns County, Florida Vibrant seaside region of cultural diversity including dining, art galleries, theatres, orchestras, ballets, festivals, live entertainment, living history interpretations and re-enactments, and celebratory parades.

St. Augustine population is 14,280 (2016); St. Johns County population is 254,261 (2018), U.S. Census Bureau indicates that the population increased 4.2 percent between 2017 and 2018, making St. Johns County the eighth-fastest growing county in the country. St. Johns County ranked Florida’s Healthiest County for the 8th consecutive year. The median income for a household in the county was $50,099, and the median income for a family was $59,153. St. Johns County School District ranked #1 in Florida for 10 consecutive years.

Home of the Florida School for the Deaf and Blind. Flagler College is recognized by US News and World Report as a “Best Value College.” As the oldest continuously occupied city established by Europeans in the continental United States, St. Augustine has a rich history. There are 53 properties and districts listed on the National Register in the county, including 6 National Historic Landmarks. Florida does not impose a state income tax. For additional information regarding our region, please visit: https://www.sjcchamber.com/ https://www.sjcchamber.com/st-augustine https://www. citystaug.com/ University of Florida—Recent Jobs (ufl.edu)  AANnews® Classified Advertising

he AAN offers a complete package of print, T online, and in-person recruitment advertising opportunities. Visit careers.AAN.com for all AAN options, rates, and deadlines. d copy for the August 2022 print edition of AANnews A must be submitted by July 1, 2022. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the T right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.

AANnews • June 2022

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AAN Summer Conference: Autoimmune Neurology and Neurology Year in Review AAN.com/SummerConference

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Deadline: UCNS Neuroimaging Certification UCNS.org/NIcertification

Free Webinar: Clinical Case Study: Telehealth for Neurology https://bit.ly/3E07lYW

JUNE 13

Free Webinar: NeuroPanels: Cervical Spine Complications in Sports Neurology and Headache Case Discussion AAN.com/NeuroPanels

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Research Funding Available

Boost Your Crucial Research This AAN funding boosters my work and career in frontotemporal dementia research.

Indira Garcia Cordero, PhD University Health Network Clinical Research Training Scholarship in FTD

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