Biologic Therapies VII Summit: Precision Medicine in the Biologic Era

Transcription

1 R.J. Fasenmyer Center for Clinical Immunology and Cleveland Society of Rheumatology Biologic Therapies VII Summit: Precision Medicine in the Biologic Era and 26th Annual Cleveland Review of Rheumatic Diseases April 6 8, 2017 InterContinental Hotel and Bank of America Conference Center Cleveland, OH This program has been endorsed by Association of Women in Rheumatology, Cleveland Society of Rheumatology, Ohio Association of Rheumatology, Pennsylvania Rheumatology Society, and United Rheumatology. Cleveland Society of Rheumatology

2 Biologic Therapies VII Summit: Precision Medicine in the Biologic Era Overview Biologic Therapies VII Summit is an advanced course that brings together world leaders in immune-based therapies and addresses cutting-edge translational immunology and the latest data on biologic therapeutics. This year s Summit focuses on precision medicine and kicks off with a fundamental immunologic plenary session, reviewing recent basic laboratory breakthroughs in terms of their potential clinical implications. The Biologic Crossfire session provides critical insights into new pathways and shared challenges for multiple disciplines engaged in the use of biologic therapies. Target Audience The Summit is directed towards rheumatologists, allergists/immunologists, dermatologists, internal medicine physicians, nurse practitioners, nurses, and physician assistants interested in or using biologic therapeutics for autoimmune and autoinflammatory disorders. Learning Objectives Critically assess clinical data on biologic use in immune-related diseases in the areas of pulmonary disease, dermatology, metabolic bone diseases, and systemic lupus erythematosus (SLE). Describe recent advances in biologic drug development, regulations, and indications in immune-mediated inflammatory diseases (IMIDs). Critically appraise data on genetics and personalized medicine as applied to rheumatic diseases and IMIDs. Analyze recent investigations on efficacy and toxicity of biologic agents across IMIDS. Detail current knowledge related to predicting outcomes in patients with rheumatoid arthritis (RA). Summarize updates in diagnosis, classification, therapies, and immune-system targets in both psoriatic arthritis (PsA) and spondyloarthopathies (SpA) and describe their clinical implications. Develop strategies to predict, prevent, and treat comorbid complications of biologic therapy including cardiovascular disease and serious infections. Accreditation The Cleveland Clinic Foundation Center for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Cleveland Clinic Foundation Center for Continuing Education designates this live activity for a maximum of AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Participants claiming CME credit from this activity may submit the credit hours to the American Osteopathic Association for Category 2 credit. Other Health Care Professionals A certificate of attendance will be provided to other health care professionals for requesting credits in accordance with state nursing boards, specialty societies, or other professional associations. Disclaimer The information in this educational activity is provided for general medical education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient s medical condition. The viewpoints expressed in this CME activity are those of the faculty. They do not represent an endorsement by The Cleveland Clinic Foundation. In no event will The Cleveland Clinic Foundation be liable for any decision made or action taken in reliance upon the information provided through this CME activity. Recording or reproducing this summit in any format is prohibited.

3 How to Obtain AMA PRA Category 1 Credits or Certificate of Participation For your convenience, an online evaluation is available for you to receive AMA PRA Category 1 Credit TM or Certificate of Participation for this activity. Following the conclusion of the activity, you will be notified by within 5 days that the system is open to claim credit. You have 60 days to claim credit. To claim credit or obtain a certificate of participation in mycme: 1. Go to New Users: (By attending this activity, an account has been created for you in our credit claiming system (MyCME). Please follow these steps.) Click on Reset Password. Enter address used for registration. You will receive an to reset your password. Existing Users: Enter address used for registration. Enter password. 2. Click here to Claim Credit/Complete Evaluation for the activity you attended. 3. Complete all fields and select the number of credits you are claiming by either using (a) the drop-down or (b) checking the box marked maximum available. 4. Click Save and View Certificate. 5. Your official certificate will be displayed. Please print and keep with your permanent files. Please note: If you need assistance, contact the CME office at or mycme@ccf.org. Acknowledgement The Cleveland Clinic Foundation Center for Continuing Education acknowledges educational grants for partial support of this activity from: AbbVie, Inc. Amgen, Inc. Bristol-Myers Squibb Co. Celgene Corporation Crescendo Bioscience, Inc. Genentech Janssen Scientific Affairs, LLC Novartis Pharmaceuticals Corporation UCB, Inc.

4 Biologic Therapies VII Summit: Precision Medicine in the Biologic Era Faculty Presentations and Mobile App The faculty presentations are available via a complimentary mobile app available for tablets, mobile devices, and laptops with note-taking and highlighting capability. instructions with your personalized password were sent 1 week prior to the Summit. If you did not pre-register for the Summit or have misplaced your , please follow the instructions below: Step 1 Download the Cleveland Clinic CME app from the Apple App Store or Google Play Store. Once the app opens on your device, select Biologic Therapies VII Summit. Once on your device, press login and enter your username (your ) and the password ed to you. If you do not have access to the , click Login and then click Forgot Password in the upper right corner to have your account information ed to you again. If you are an onsite registrant or did not receive an with instructions, please click Create Account and enter the event code BIO17 to create an account and log in. Once you have logged in, you will move through several pages of settings and terms and conditions until you get to the main screen of the app. From there, please download the presentations within the app by clicking the Get Slides button at the bottom of the main screen. Please note that you must be connected to a strong Internet connection to do this. Step 2 Find the presentation you want and interact with the presentation slides by drawing on slides and highlighting text. Use the notetaking mode to type your notes next to each slide. Final presentations will be available after the activity. If you took notes on a presentation, both the original and updated presentations will be available for download to your device. Step 3 Notes are saved online in the Online Personal Summary in addition to being saved inside the app. To access your notes for printing while in the app, select Personal Summary on the main screen to launch your personal summary web page (Internet is required) or yourself the link by selecting the Link to My Summary. Within your Personal Summary, select Presentation Notes to see the titles of presentations you have taken notes on. To print either all of the presentation slides or just the slides for which you have taken notes, select the title to view your notes and annotations for that title and Print. To access faculty presentations via your laptop: Visit If you pre-registered, an account was created for you and instructions sent via . If you have created an app account already, login using the login information that was ed to you. If you have not created an app account, click Create Account, enter the event code BIO17, and follow the prompts to create an account. Once logged in, select Menu in the left-hand corner and select Education Sessions. Select a Browse by option, then click the name of the presentation you want to view. Click the View Slides button at the top of the screen to begin viewing the slides and taking notes. Use the tool bar at the bottom of the slides window to bookmark the slide, view session information, or take notes on the slides. To download all presentations or access your Personal Summary, return to the home screen and select MENU at the top of the screen and select SUMMARY. Select ALL PRESENTATIONS then click the SELECT ALL checkbox. At the bottom of the screen select PRINT SELECTED SLIDES. Right click on the new screen and select PRINT. In the print window change the printer destination to Adobe PDF and select print. Save your PDF to the folder of your choosing (this step may take up to 60 seconds). Internet Explorer is NOT recommended. Users must have Adobe Acrobat Pro installed in order to save to PDF. For technical support, contact Cadmium at

5 Activity Co-Directors Leonard H. Calabrese, DO Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University R.J. Fasenmyer Chair of Clinical Immunology Department of Rheumatic and Immunologic Diseases Orthopaedic and Rheumatologic Institute Cleveland Clinic Cleveland, OH M. Elaine Husni, MD, MPH Director, Arthritis and Musculoskeletal Treatment Center Vice Chair, Department of Rheumatic and Immunologic Diseases Orthopaedic and Rheumatologic Institute Cleveland Clinic Cleveland, OH Planning Committee Jonathan Kay, MD Professor of Medicine University of Massachusetts Medical School Director of Clinical Research Division of Rheumatology UMass Memorial Medical Center Worcester, MA Edward Keystone, MD Professor of Medicine University of Toronto Director The Rebecca MacDonald Centre For Arthritis Mount Sinai Hospital Toronto, Canada Elizabeth Kirchner, MSN, CNP Director of Patient Care R.J. Fasenmyer Center for Clinical Immunology Nurse Practitioner Department of Rheumatic and Immunologic Diseases Orthopaedic and Rheumatologic Institute Cleveland Clinic Cleveland, OH Christopher Ritchlin, MD, MPH Professor of Medicine Allergy, Immunology and Rheumatology Division University of Rochester Medical Center Rochester, NY Nizar Zein, MD Associate Professor of Medicine Cleveland Clinic Lerner College of Medicine of Case Western Reserve University Chief, Section of Hepatobiliary Diseases Medical Director of Liver Transplantation Mikati Foundation Endowed Chair in Liver Diseases Department of Gastroenterology and Hepatology Digestive Disease and Surgery Institute Cleveland Clinic Cleveland, OH

6 Biologic Therapies VII Summit: Precision Medicine in the Biologic Era Guest Faculty Laura Cappelli, MD, MHS Instructor of Medicine Division of Rheumatology Johns Hopkins School of Medicine Baltimore, MD John J. Cush, MD Director of Clinical Rheumatology Baylor Research Institute Executive Editor, RheumNow.com Dallas, TX Dafna D. Gladman, MD, FRCPC Senior Scientist Toronto Western Research Institute University of Toronto Toronto, Canada V. Michael Holers, MD Scoville Professor and Head, Division of Rheumatology Departments of Medicine and Immunology University of Colorado Anschutz Medical Campus Aurora, CO Arthur Kavanaugh, MD Professor of Medicine Director, Center for Innovative Therapy Division of Rheumatology, Allergy, and Immunology University of California, San Diego San Diego, CA Iain McInnes, FRCP, PhD, FRSE, FMedSci Muirhead Professor of Medicine ARUK Professor of Rheumatology Director of Institute of Infection Immunity and Inflammation College of Medical, Veterinary and Life Sciences University of Glasgow Glasgow, Scotland Philip Mease, MD Director, Rheumatology Research Swedish Medical Center Clinical Professor, University of Washington School of Medicine Seattle, WA William Rigby, MD Professor of Medicine and Microbiology Vice-Chair, Department of Medicine The Geisel School of Medicine at Dartmouth Lebanon, NH Gregg J. Silverman, MD Associate Director, Division of Rheumatology Professor of Medicine and Pathology NYU School of Medicine New York, NY Vibeke Strand, MD Adjunct Clinical Professor Division of Immunology/Rheumatology Stanford University Biopharmaceutical Consultant Palo Alto, CA Troy R. Torgerson, MD, PhD Associate Professor, Department of Pediatrics University of Washington Principal Investigator Seattle Children s Research Institute Seattle, WA Michael H. Weisman, MD Cedars-Sinai Chair in Rheumatology Director, Division of Rheumatology Professor of Medicine Cedars-Sinai Medical Center Distinguished Professor of Medicine David Geffen School of Medicine at UCLA Los Angeles, CA Kevin Winthrop, MD, MPH Assistant Professor Divisions of Infectious Diseases, Public Health, and Preventive Medicine Oregon Health & Science University Portland, OR Cleveland Clinic Faculty Cassandra Calabrese, DO Department of Rheumatic and Immunologic Diseases Department of Infectious Diseases Orthopaedic and Rheumatologic Institute Chad Deal, MD Head, Center for Osteoporosis and Metabolic Bone Disease Vice Chair Quality and Outcomes Department of Rheumatic and Immunologic Diseases Orthopaedic and Rheumatologic Institute Anthony Fernandez, MD, PhD Director of Medical Dermatology Department of Dermatology Department of Anatomic Pathology Dermatology and Plastic Surgery Institute Joseph Parambil, MD Department of Pulmonary and Critical Care Medicine Respiratory Institute

7 Faculty Disclosure In accordance with the Standards for Commercial Support issued by the Accreditation Council for Continuing Medical Education (ACCME), The Cleveland Clinic Foundation Center for Continuing Education requires resolution of all faculty conflicts of interest to ensure CME activities are free of commercial bias. The following faculty have indicated that they may have a relationship, which in the context of their presentation(s), could be perceived as a potential conflict of interest: Leonard H. Calabrese, DO Chad Deal, MD Anthony Fernandez, MD, PhD Dafna D. Gladman, MD AbbVie Pharmaceuticals, Bristol Myers Squibb Co., Genentech/ Roche, Janssen GlaxoSmithKline, Pfizer, Inc., UCB Crescendo Amgen, Lilly AbbVie Pharmaceuticals Celgene Corporation Mallinckrodt Inc. Novartis Roche Pharmaceuticals AbbVie Pharmaceuticals, Bristol-Myers Squibb Co., Celgene Corporation, Janssen, Lilly, Novartis Pharmaceuticals, Pfizer, Inc., UCB Principal Investigator for a Phase III Clinical Trial Grant support V. Michael Holers, MD Janssen M. Elaine Husni, MD, MPH Arthur Kavanaugh, MD Jonathan Kay, MD AbbVie Pharmaceuticals, Amgen, Genentech, Janssen Amgen, Bristol-Myers Squibb Co., Genzyme/Sanofi, Lilly, Regeneron Novartis Pharmaceuticals Pfizer, Inc. Pfizer, Inc. Abbott Laboratories, Amgen, Bristol-Myers Squibb Co., Centocor, UCB AbbVie Pharmaceuticals, Genentech, Lilly, Pfizer, Inc., UCB Alexion Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb Co., Epirus Biopharmaceuticals, Inc., GlaxoSmithKline, Hospira, Janssen, Merck Sharp & Dohme Limited, Myriad Genetics, Inc., Novartis Pharmaceuticals Ardea Roche Pharmaceuticals Fast Forward Pharmaceuticals, B.V., Samsung Bioepis

8 Edward Keystone, MD Iain McInnes, FRCP, PhD, FRSE, FmedSci Merck AstraZeneca Pharmaceuticals, Janssen, Pfizer, Inc. Lilly Crescendo AbbVie Pharmaceuticals, Janssen, MSD, Novartis Bristol-Myers Squibb Co., Pfizer, Inc., UCB Board Membership Philip Mease, MD Roche Pharmaceuticals AbbVie Pharmaceuticals, Amgen, Bristol-Myers Squibb Co., Celgene Corporation, Crescendo, Genentech, Janssen, Lilly, Pfizer, Inc., UCB William Rigby, MD Christopher Ritchlin, MD, MPH Vibeke Strand, MD Troy R. Torgerson, MD, PhD Kevin Winthrop, MD, MPH Corrona, LLC, Demira, Sun Pharmaceutical Industries Ltd., Zynerba Merck, Novartis Abbott Laboratories Bristol-Myers Squibb Co. Lilly Genentech/Roche Pfizer, Inc. AbbVie Pharmaceuticals, Bristol-Myers Squibb Co., Janssen, Novartis Pharmaceuticals Amgen UCB AbbVie Pharmaceuticals, Amgen, Bristol-Myers Squibb Co., Bayer, Celltrion, Crescendo, Genentech, GlaxoSmithKline, Lilly, Merck & Co, Inc., Novartis Pharmaceuticals, Pfizer, Inc., Roche Pharmaceuticals, Samsung Bioepis, Sandoz, UCB Anthera, AstraZeneca, Boehringer Ingelheim, EMD Serono, Inc., Janssen, Regeneron, Sanofi Aventis CSL Behring, Shire ADMA Biologics, Inc., atyr Pharma Bristol-Myers Squibb Co. AbbVie Pharmaceuticals, Galapagos, Genentech/Roche, Lilly, Pfizer, Inc., UCB Research support Research grant The following faculty have indicated they have no relationship which, in the context of their presentation(s), could be perceived as a potential conflict of interest: Cassandra Calabrese, DO Laura Cappelli, MD John J. Cush, MD Elizabeth Kirchner, MSN, CNP Joseph Parambil, MD Gregg J. Silverman, MD Michael H. Weisman, MD Nizar Zein, MD

9 Agenda Thursday, April 6, :30 am Registration, Continental Breakfast, and Visit Exhibits 8:00 am Welcoming Remarks and History of Cleveland Clinic Leonard H. Calabrese, DO, and M. Elaine Husni, MD, MPH IMMUNOLOGIC PLENARY SESSION Moderator: Leonard H. Calabrese, DO 8:30 am RJ Fasenmyer Annual Lectureship Cytokine Profiles in Health and Disease What Can They Inform Us? Iain McInnes, FRCP, PhD, FRSE, FMedSci 9:25 am Pre-Rheumatoid Arthritis: Can We Define It and Prevent Its Progression? V. Michael Holers, MD 10:20 am Refreshment Break and Visit Exhibits 10:50 am Lessons in Autoimmunity from the World of Primary Immunodeficiency Diseases Troy R. Torgerson, MD, PhD 2:00 pm Tailoring Therapy Based on Disease Duration: Is There a Window of Opportunity? Edward Keystone, MD 2:30 pm Predicting Outcomes in RA The Role of Biomarkers Jonathan Kay, MD 3:00 pm Predicting the Outcome of Treatment De- Escalation or Discontinuation: What Do We Know? Arthur Kavanaugh, MD 3:30 pm Refreshment Break and Visit Exhibits 4:00 pm Cases with the Masters: Clinical Challenges in Rheumatoid Arthritis Moderator: Leonard H. Calabrese, DO Panel: John J. Cush, MD; Arthur Kavanaugh, MD; Jonathan Kay, MD; Edward Keystone, MD; and Iain McInnes, PhD 4:45 pm Adjourn 11:45 am Lunch Break Optional Non-CME Luncheon Satellite Symposia Presentations start at 12:00 pm Moving From Volume to Value Based Care and the MACRA Quality Payment Program InterContinental Ballroom C The Role of IL-6 in Rheumatoid Arthritis InterContinental Ballroom AB PERSONALIZED APPROACH TO RHEUMATOID ARTHRITIS SESSION Moderator: Jonathan Kay, MD 5:30 pm Optional Non-CME Satellite Dinner Symposia Treatment For Adult Patients with Active Ankylosing Spondylitis, Psoriatic Arthritis, and Moderate to Severe Plaque Psoriasis Holiday Inn Cleveland Clinic 8650 Euclid Ave Cleveland, OH Clinical Assessment of RA Fellowship Educational Program InterContinental Room 204 1:00 pm Biologics Across Immune-Mediated Inflammatory Diseases from the Rheumatology Perspective The Year in Review Arthur Kavanaugh, MD, and John J. Cush, MD

10 Agenda Friday, April 7, :30 am Registration, Continental Breakfast, and Visit Exhibits PSA AND SPA: ADVANCES IN PATHOGENESIS CLASSIFICATION AND MANAGEMENT SESSION Moderator: M. Elaine Husni, MD, MPH 8:00 am Keeping Your Eye on the Target: Immune Targets in PsA and SpA Christopher Ritchlin, MD, MPH 8:45 am PsA Guidelines Dafna D. Gladman, MD 9:10 am Emerging Treatment and Management Paradigms In PsA Philip Mease, MD 9:35 am Question and Answer Panel Moderator: M. Elaine Husni, MD, MPH 9:45 am Refreshment Break and Visit Exhibits 10:15 am SpA 2017: Natural History Informing Classification and Diagnosis Michael H. Weisman, MD 10:40 am Emerging Treatment and Management Paradigms in SpA Philip Mease, MD 11:05 am Question and Answer Panel Moderator: M. Elaine Husni, MD, MPH 11:15 am Cases with the Masters: Clinical Challenges in PsA and SpA Moderators: M. Elaine Husni, MD, MPH, and Christopher Ritchlin, MD, MPH Panel: Dafna D. Gladman, MD; Philip Mease, MD; and Michael H. Weisman, MD 12:00 pm Lunch Break Optional Non-CME Luncheon Satellite Symposia Presentations start at 12:15 pm Non-Infectious Uveitis the Importance of Prompt Recognition and Treatment InterContinental Ballroom C BIOLOGIC CROSSFIRE LESSONS ACROSS DISCIPLINES SESSION Moderators: Leonard H. Calabrese, DO, and M. Elaine Husni, MD, MPH 1:15 pm Autoimmune Complications from Cancer Chemotherapy: An Emerging Field Laura Cappelli, MD, MHS 1:40 pm Kinase Inhibitors: New Agents, New Indications William Rigby, MD 2:05 pm SLE IFN Based Therapies Rationale and Data Gregg J. Silverman, MD 2:30 pm Question and Answer Panel Moderators: Leonard H. Calabrese, DO, and M. Elaine Husni, MD, MPH 2:45 pm Refreshment Break and Visit Exhibits 3:15 pm Novel Immunotherapeutics in the Pipeline Vibeke Strand, MD 3:40 pm Advances in Biologics for Metabolic Bone Disease Chad Deal, MD 4:05 pm Novel and Boutique Biologics: Advances in Dermatology Anthony Fernandez, MD, PhD 4:30 pm Idiopathic Pulmonary Fibrosis and Autoimmune Disease: Emerging Joseph Parambil, MD 4:45 pm Question and Answer Panel Moderators: Leonard H. Calabrese, DO, and M. Elaine Husni, MD, MPH 5:00 pm Adjourn 6:30 pm Optional Non-CME Satellite Dinner Symposium Integrating Wellness Into Immunology Disease Management InterContinental Room 207 Evolving Topics in Rheumatology: Spondyloarthritis InterContinental Ballroom AB

11 Agenda Saturday, April 8, 2017 PREDICTING AND PREVENTING CO-MORBIDITIES SESSION Moderator: Leonard H. Calabrese, DO 8:30 am Cardiovascular Disease Across IMIDs: Controversies and Best Practices M. Elaine Husni, MD, MPH 9:00 am Vaccinations: Best Practices in IMIDs Populations Kevin Winthrop, MD, MPH 9:30 am Preventing Serious Infections in IMIDs Patients Leonard H. Calabrese, DO 10:00 am Refreshment Break and Visit Exhibits 10:30 am Cases with the Masters Moderator: Leonard H. Calabrese, DO Panel: Cassandra Calabrese, DO; M. Elaine Husni, MD, MPH; and Kevin Winthrop, MD, MPH 11:30 am Adjourn Coming Soon! Wish you could go back and listen to a lecture again? We have the solution! Biologic Therapies VII Summit: Precision Medicine in the Biologic Era Online Series 26 webcasts Online monograph Primary Vasculitides: Best Practices and Future Advances Online Series 8 webcasts Online monograph These activities have been approved for AMA PRA Category 1 Credit. Visit

12 February 18, Basic and Clinical Immunology Save the17 Date! Mandalay Bay, Las Vegas, NVBusy Clinician Symposium for the March 2018, Florida Day 1: Boot Camp! The fundamentals of the immune response NEW New data on the mechanisms of action of existing biologics and biologics in clinical development Day 2: Focus on How to Train and Maintain the Immune System Diet, exercise, mindfulness How stress contributes to immunologic aging R educing inflammation and extending telomeric age through meditation D iet and the microbiome and how they influence immunologic development and inflammation T he role of meditation in quelling the inflammatory response and as adjunctive therapy for IMIDs Morning yoga and meditation sessions! Flipped classrooms and more! Give us your testimonial! endorsed by Arizona United Rheumatology Alliance, Association of Women in Rheumatology, California gy Alliance, Cleveland Society of Rheumatology, and Rheumatology Association of Nevada. Tell us... Why you keep coming back What makes this meeting different Why your colleagues should attend too Visit us on Thursday in the Boardroom, just off the Exhibitor Area Organizer: Copyright 2017 The Cleveland Clinic Foundation. All Rights Reserved.