Cause for Alarm: New Avenues to the Management of Severe Asthma by Integritas Communications

REYNOLD A. PANETTIERI, JR, MD Moderator Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Translational Medicine and Science Director, Rutgers Institute for Translational Medicine and Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, New Jersey

MONICA KRAFT, MD Professor of Medicine Chair, Department of Medicine The Robert and Irene Flinn Endowed Chair in Medicine University of Arizona (UA) College of Medicine – Tucson Deputy Director UA Health Sciences Asthma and Airway Disease Research Center Tucson, Arizona

Dr. Reynold Panettieri is the inaugural Director of the Institute for Translational Medicine and Science and Vice Chancellor for Translational Medicine and Science at Rutgers University in New Brunswick, New Jersey. He previously served as the Director of the Airways Biology Initiative and the Deputy Director of the Center of Excellence in Environmental Toxicology at the University of Pennsylvania in Philadelphia, Pennsylvania. Dr. Panettieri’s interests include the cellular and molecular mechanisms that regulate airway smooth muscle cell growth and the immunobiology of airway smooth muscle. Consequences of increases in airway smooth muscle growth promote the development of irreversible airflow obstruction and airway remodeling seen in patients with chronic severe asthma. His lab also focuses on cytosolic signaling pathways that mediate gene expression and alter myocyte growth. In addition to his research and clinical interests, Dr. Panettieri served as chairperson of the National Institutes of Health (NIH) Lung Cellular, Molecular, and Immunobiology Study Section, is a member of the NIH Distinguished Editorial Panel, and is a member of the American Society for Clinical Investigation and Association of American Physicians. Dr. Panettieri earned his medical degree from the University of Pennsylvania. He also completed his residency and fellowship at the Hospital of the University of Pennsylvania.

Dr. Monica Kraft is a Professor of Medicine, Chair of the Department of Medicine, and The Robert and Irene Flinn Endowed Chair of Medicine at the University of Arizona (UA) College of Medicine in Tucson, Arizona. She also serves as Deputy Director of the UA Health Sciences Asthma and Airway Disease Research Center. Prior to joining UA in 2014, Dr. Kraft served as chief of the Division of Pulmonary, Allergy, and Critical Care, as the Charles C. Johnson, MD, Distinguished Professor of Medicine, and as director of the Duke Asthma, Allergy and Airway Center at Duke University in Durham, North Carolina. As vice chair for research in the Duke University Department of Medicine from 2009-2013, Dr. Kraft implemented several important initiatives to support the department’s research endeavors and was instrumental in the re-submission and renewal of Duke’s NIH-funded Clinical Translational Science Award (CTSA). Dr. Kraft has previously served as Director of the Carl and Hazel Felt Laboratory in Adult Asthma Research and as Medical Director of the pulmonology physiology unit at the National Jewish Medical and Research Center in Denver, Colorado. She received her undergraduate degree in chemistry from the University of California (UC) Davis and her medical degree from UC San Francisco. She served as chief resident at Harbor-UCLA Medical Center in Torrance, California, and completed her fellowship at the University of Colorado Health Sciences Center, Division of Pulmonary Sciences and Critical Care Medicine in Aurora, Colorado.

ANJU TRIPATHI PETERS, MD Professor of Medicine Department of Allergy and Immunology Department of Otolaryngology – Head and Neck Surgery Director of Clinical Research Division of Allergy and Immunology Northwestern University Feinberg School of Medicine Chicago, Illinois

Dr. Anju T. Peters is a Professor in the Department of Medicine and Department of Otolaryngology – Head and Neck Surgery at Northwestern University Feinberg School of Medicine in Chicago, Illinois. She graduated from University of Michigan Medical School in Ann Arbor, Michigan, and completed her residency and fellowship in the Division of Allergy and Immunology at Northwestern University Feinberg School of Medicine. She currently serves as the Director of Clinical Research in the Division of Allergy and Immunology at Northwestern University Feinberg School of Medicine. Dr. Peters has focused her research on the field of chronic rhinosinusitis and its associated comorbidities including allergic rhinitis, asthma, and immunodeficiencies. She has published extensively in these areas and is currently involved in clinical trials in asthma and chronic rhinosinusitis. She has served as the Chair for the practice parameters on chronic rhinosinusitis, which are leading guidelines on the treatment of chronic rhinosinusitis. In addition to her work on the national practice guidelines in the field of rhinosinusitis, Dr. Peters has been invited to present original clinical research and lectures at local, national, and international meetings. Dr. Peters is currently the Deputy Editor of the American Journal of Rhinology and Allergy, a leading journal targeting allergists and otolaryngologists Dr. Peters practices as an allergist in the Division of Allergy and Immunology and in the Sinus and Allergy Center of Northwestern University. Her specific interest is in taking care of patients with chronic rhinosinusitis with and without nasal polyps and associated conditions of asthma and immunodeficiencies.

DISCLOSURE OF CONFLICTS OF INTEREST

This activity is supported by AstraZeneca. The Non-CME Corporate Forum content and views expressed therein do not necessarily reflect the views, policies or position of the American College of Allergy, Asthma & Immunology. There is no registration fee for attending this Non-CME Corporate Forum; however, seating is limited. Preregistration does not guarantee seating. We recommend arriving at the meeting room early. Dinner will be provided.

TARGET AUDIENCE The design of this activity addresses the needs of clinical immunologists, pulmonologists, and other physicians involved in the management of patients with severe asthma.

PROGRAM DESCRIPTION Best practices within the management of severe asthma require the integration of evidence-based guidelines, the latest scientific information, and an accumulation of clinical experience—all of which inform individualized treatment selection and chronic care decisions. To better mirror real-world practice, this Case-in-Point™ severe asthma program will utilize a case-based format to actively engage learners while emphasizing knowledge consolidation and translation. Within the context of these representative, challenging case studies, a multidisciplinary panel of expert faculty will review and discuss key topics including newer insights into type 2 (T2)-high and T2-low asthma pathophysiology, the longitudinal assessment of severe disease, and the latest evidence and rationale for the implementation of available and emerging targeted therapies.

LEARNING OBJECTIVES After completing this activity, the participant should be better able to: • Describe clinically relevant pathophysiologic processes in severe asthma, including implications for new targeted treatment options • Comprehensively assess patients with asthma for disease severity, lung function, and treatment responses • Discuss the mechanisms of action and clinical profiles of new and emerging targeted therapies for severe asthma • Individualize treatment regimens for patients with severe asthma based on symptoms, phenotypes, and patient preferences

Integritas Communications (Integritas) adheres to the policies and guidelines, including the Standards for Integrity and Independence in Accredited CE, set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other professional organizations, as applicable, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous. All persons in a position to control the content of an accredited continuing education program provided by Integritas are required to disclose all financial relationships with any ineligible company within the past 24 months to Integritas. All financial relationships reported are identified as relevant and mitigated by Integritas in accordance with the Standards for Integrity and Independence in Accredited CE in advance of delivery of the activity to learners. The content of this activity was vetted by Integritas to assure objectivity and that the activity is free of commercial bias. All relevant financial relationships have been mitigated. The faculty have the following relevant financial relationships with ineligible companies: Reynold A. Panettieri, Jr, MD: Consulting Fee: AstraZeneca plc, Bayer AG, Genentech, Inc., Teva Pharmaceutical Industries Ltd.; Contracted Research: ACTIV-1, AstraZeneca plc, Genentech, Inc., Janssen Pharmaceuticals, Medimmune, LLC, Novartis International AG, Origo Biopharma, Research Institute for Fragrance Materials, Inc., Teva Pharmaceutical Industries Ltd., Vault Health, Inc.; Speakers Bureau: AstraZeneca plc, Genentech, Inc., Merck & Co., Inc., Sanofi S.A. Monica Kraft, MD: Consulting Fee: AstraZeneca plc, Sanofi S.A.; Contracted Research: ALA Pharma Ltd., AstraZeneca plc, Chiesi USA, Inc., National Institutes of Health, Sanofi S.A.; Royalty: RaeSedo, LLC (CMO) Anju T. Peters, MD: Consulting Fee: AstraZeneca plc, GlaxoSmithKline, Novartis International AG, Optinose US, Inc., Regeneron Pharmaceuticals, Inc., Sanofi S.A.; Contracted Research: AstraZeneca plc, Merck & Co., Inc., Optinose US, Inc., Regeneron Pharmaceuticals, Inc., Sanofi S.A. The following planners and managers have reported no relevant financial relationships with ineligible companies: Celeste Collazo, MD, Rose O’Connor, PhD, CHCP, Jim Kappler, PhD

DISCLOSURE OF UNLABELED USE This activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Integritas does not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

INTEGRITAS COMMUNICATIONS CONTACT INFORMATION For questions about this activity, please contact Integritas Communications at info@exchangecme.com.

PROGRAM AGENDA

8:15 pm-8:25 pm

Welcome and Preactivity Polling

8:25 pm-8:40 pm

Pathologic Insights Into Severe Asthma: The Dynamic Epithelium

8:40 pm-8:50 pm

Therapeutic Targets and Emerging Agents for Severe Asthma: An Era of Precision Medicine

8:50 pm-9:10 pm

Managing Patients With Severe Asthma: Case Study Discussion #1

9:10 pm-9:30 pm

Managing Patients With Severe Asthma: Case Study Discussion #2

9:30 pm-9:45 pm

Postactivity Polling and Final Q&A Session

CLINICAL RESOURCE CENTER www.ExchangeCME.com/SAManagement

Asthma Therapy Assessment Questionnaire (ATAQ) This 4-question test assesses asthma control over the past 4 weeks. Each question has a possible score of 0 or 1; if the sum of the 4 question scores is >1, the patient’s asthma may be uncontrolled. Vollmer WM, et al. Am J Respir Crit Care Med. 1999;160(5 Pt 1):1647-1652. http://getasthmahelp.org/documents/2007Guidelines_ValidatedQuestionnaires.pdf

Shared Decision-Making Tool The CHEST Foundation, Allergy and Asthma Network, and American College of Allergy, Asthma & Immunology (ACAAI) have developed a shared decision-making tool for adults with severe asthma so that they may work collaboratively with clinicians to improve self-management skills, choose the best treatment plan, and increase adherence. http://asthma.chestnet.org/sdm-tool/

CLINICAL PRACTICE GUIDELINES Global Strategy for Asthma Management and Prevention.

PATIENT ADVOCACY ORGANIZATIONS AND RESOURCES Asthma and Allergy Foundation of America (AAFA)

Global Initiative for Asthma, 2021.

AAFA is dedicated to improving the quality of life for people with asthma and allergic diseases through education, advocacy, and research.

https://ginasthma.org/wp-content/uploads/2021/04/GINA-2021-Main-Report_FINAL_21_04_28-WMS.pdf

http://www.aafa.org/page/asthma.aspx

CLINICAL PRACTICE TOOLS

American College of Allergy, Asthma & Immunology (ACAAI)

Centers for Disease Control and Prevention (CDC) Asthma Action Plans These tools for asthma control were created following the evidence-based guidance published by the National Institutes of Health.

The ACAAI fosters a culture of collaboration and congeniality in which members work toward the common goals of patient care, education, advocacy, and research. https://acaai.org/asthma

https://www.cdc.gov/asthma/actionplan.html

American Lung Association

Asthma Control Test (ACT)

The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease through education, advocacy, and research.

This 5-question test evaluates asthma control over the past 4 weeks on a 5-point Likert scale. A score of <20 on the ACT suggests asthma that is uncontrolled. Nathan RA, et al. J Allergy Clin Immunol. 2004;113(1):59-65. https://getasthmahelp.org/documents/ACT_AdultEng.pdf

Asthma Control Questionnaire (ACQ) This 7-question assessment tool measures asthma control over the past 7 days. Six questions are self-administered by the patient, and 1 question requires a clinician’s input. Scores range from 1 (totally controlled) to 6 (severely uncontrolled). Juniper EF, et al. Eur Respir J. 1999;14(4):902-907. https://erj.ersjournals.com/content/erj/14/4/902.full.pdf

http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/asthma/

American Thoracic Society (ATS) The mission of the ATS is to improve health worldwide by advancing research, clinical care, and public health in respiratory disease, critical illness, and sleep disorders. https://www.thoracic.org/patients/patient-resources/

Chest Foundation The CHEST Foundation creates trusted patient education resources and disease awareness campaigns that empower patients to engage in better managing their health. https://foundation.chestnet.org/lung-health-a-z/asthma/