Clinical Issues in Rheumatoid Arthritis by Integritas Communications

Jointly provided by the Elsevier Office of Continuing Medical Education and Integritas Communications. This activity is supported by an independent educational grant from Gilead Sciences, Inc.

MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

RIEKE ALTEN, MD

Course Chair Professor of Medicine Department Head Internal Medicine, Rheumatology, Clinical Immunology, and Osteology Schlosspark-Klinik University Medicine Berlin Berlin, Germany Prof. Dr. Rieke Alten is Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology, and Osteology at Schlosspark-Klinik, University Medicine Berlin, where she also serves as the director of the Rheumatology Research Center. Prof. Dr. Alten received her medical degrees and training in internal medicine from the Free University Berlin. After graduating, she pursued training in rheumatology and immunology research at Institute of Immunology, University of Zürich (Switzerland). She received board certification in internal medicine in 1984, in rheumatology in 1985, in physical therapy and rehabilitation medicine in 1998, and in sports medicine in 2001. Since 1990 she has been Head of the Department of Internal Medicine, Rheumatology at Schlosspark-Klinik, University Medicine Berlin. Prof. Dr. Alten’s research focuses on the development and systematic evaluation of biological and immunomodulatory treatments for rheumatic diseases. She has been lead and principal investigator in clinical trials of novel therapies in rheumatic diseases and has contributed to several investigator-initiated trials. She has published more than 200 original papers, book chapters, and reviews. Prof. Dr. Alten is a member of the Steering Committee of the OMERACT Flare in Rheumatoid Arthritis Group. She has served as a board member of the German Medical Association, as a member of the Institute for Approval of drugs for the German Ministry of Health, as a board member of the “Kaiserin-Friedrich-Stiftung” for postgraduate education in Germany, and as a board member of the German Society of Rheumatology.

FACULTY

JOEL KREMER, MD, FACP, MACR FACULTY

Pfaff Family Professor of Medicine Albany Medical College Director of Research The Center for Rheumatology Albany, New York, USA

Dr. Joel M. Kremer is the Pfaff Family Professor of Medicine at Albany Medical College and Director of Research at The Center for Rheumatology, a private practice in Albany, New York. In 2000 he transitioned from full-time academic medicine and Head of the Division of Rheumatology at Albany Medical College to the position of Director of Research. He still trains fellows and residents on a weekly basis. He was also privileged to spend 13 years (1997-2010) at the VA (Veterans Affairs) Medical Center on a part-time basis as Director of their outpatient rheumatology clinic. He is a graduate of Temple University School of Medicine, where he was elected to Alpha Omega Alpha honorary medical society. Dr. Kremer has been involved with clinical research for 38 years starting with intensive study of methotrexate (MTX) in the early 1980s through the mid-late 1990s and has published approximately 50 manuscripts on MTX and given invited lectures at the annual meeting of the American College of Rheumatology (ACR). He is the recipient of the Virginia Engalitcheff Award of the Arthritis Foundation in 1998 for his work on MTX that has â&#x20AC;&#x153;contributed substantially to the welfare of patients with arthritis in the last decade.â&#x20AC;? Beginning in the late 1990s through the present he has participated in and led many studies on biologic agents and small molecules (Janus kinase [JAK] inhibitors). Dr. Kremer is founder and Chief Medical Officer of the Corrona registry. Corrona has become the only registry in the United States that collects real-world evidence on safety and effectiveness of drugs in patients with rheumatic diseases including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, and as of last year inflammatory bowel disease. The Corrona registry has contributed more than 100 peer-reviewed manuscripts to the scientific literature including comparative effectiveness, cardiovascular safety, and scrupulous profiles of the activity of many newer agents in the United States. Dr. Kremer has contributed more than 265 peer-reviewed manuscripts and more than 450 published abstracts, and has also edited 4 books and 12 chapters in texts. He serves as the President of the Corrona Research Foundation, a not-for-profit organization founded for the purpose of connecting academic researchers with the Corrona data. He is a master of the ACR and also an avid skier and swimmer. 4

JOSEF SMOLEN, MD FACULTY

Professor of Medicine Chair, Division of Rheumatology Department of Medicine III Medical University of Vienna Vienna, Austria

Dr. Josef Smolen is Professor of Medicine and Chair of the Division of Rheumatology and Department of Medicine III at the Medical University of Vienna, Austria. Professor Smolen earned his medical degree from the University of Vienna, where he undertook training in immunology, internal medicine, and rheumatology. He completed a research fellowship at the National Institutes of Health in 1980 and 1981 alongside Alfred Steinberg and John Decker. Professor Smolenâ&#x20AC;&#x2122;s research has centered on basic immunology and the pathogenesis of rheumatic diseases, with achievements including the elucidation of major T-cell functions, and the evolution of therapies including leflunomide, and tumor necrosis factor (TNF) and interleukin (IL)-6-inhibitors. He has published more than 500 original papers, reviews, and essays, is an editorial board member of several journals, is editor of the textbook Rheumatology, and is among the most highly cited authors in his field. Professor Smolen is involved in several scientific societies and has held the position of President for the European League Against Rheumatism (EULAR; 2003-2005), the Austrian Society of Rheumatology (2005-2007), and the Austrian Society of Immunology (2007-2009). He is a member of the Austrian Academy of Sciences and the German Academy of Sciences. Professor Smolen is also a Fellow of the Royal Society of Physicians, United Kingdom, and is an Honorary Doctor of the Universities of Lund, Sweden, Leiden, The Netherlands, and Budapest, Hungary.

PREAMBLE

PROGRAM DESCRIPTION Rheumatoid arthritis (RA) is a chronic inflammatory joint disease that can cause bone and cartilage damage and lead to disability.1 RA affects about 24.5 million people, with 5 and 50 per 100,000 people newly developing the condition each year.1,2 RA has resulted in increased mortality in recent years, creating a need for an understanding of treat-totarget recommendations and appropriate disease activity measures.3 Adopting treatto-target strategies in RA patients has shown great promise in improving RA outcomes.4 Treatments for RA continue to emerge along with advances in the understanding of its pathologic mechanisms and the development of drugs that target them.5 Many cytokines involved in controlling cell growth and the immune response in RA function by binding to and activating cytokine receptors, which in turn rely on the Janus kinase (JAK) family of enzymes for signal transduction. Disease-modifying antirheumatic drugs (DMARDs) inhibit the activity of these JAK enzymes and block cytokine signaling.6 Identifying the mechanistic profiles and clinical trial data for current and emerging targeted synthetic DMARDs can assist health care providers in optimizing RA patient outcomes.7 In this Clinical Issuesâ&#x201E;˘ program, an expert faculty panel will discuss and debate the latest insights into RA immunopathology with a focus on JAK enzyme activation, increase participantsâ&#x20AC;&#x2122; understanding of treat-to-target recommendations and appropriate disease activity measures, and describe the mechanistic profiles and clinical trial data for current and emerging targeted synthetic DMARDs. Attendees will leave this engaging program with new information and a fresh perspective on the evolving best practices for managing patients with RA.

REFERENCES

1. Smolen JS, et al. Lancet. 2016;388(10055):2023-2038. 2. GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388 (10053): 1545-1602. 3. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;385 (9963): 117-171. 4. Bykerk VP, et al. Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice. Ann Rheum Dis. 2012;71(12): 1950-1954. 5. Kahlenberg JM, Fox DA. Advances in the medical treatment of rheumatoid arthritis. Hand Clin. 2011;27(1):11-20. 6. Kontzias A, et al. Jakinibs: a new class of kinase inhibitors in cancer and autoimmune disease. Curr Opin Pharmacol. 2012;12(4):464-470. 7. Ramiro S, et al. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2017;76(6):1101-1136.

TARGET AUDIENCE This activity has been designed to meet the educational needs of health care professionals involved in the diagnosis, treatment, or management of patients with rheumatoid arthritis.

EDUCATIONAL OBJECTIVES Upon completion of this activity, participants will be better able to:

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•• Discuss the latest insights into RA immunopathology with a focus on JAK enzyme activation •• Evaluate patients with RA longitudinally based on an understanding of treat-to-target recommendations and appropriate disease activity measures •• Describe the mechanistic profiles and clinical trial data for current and emerging targeted synthetic DMARDs •• Integrate targeted synthetic DMARDs into treatment regimens for patients with RA based on current clinical practice guidelines and evidence for efficacy and safety

AGENDA 08:15–08:20

Welcome and Preactivity Questionnaire

08:20–08:35

RA Pathophysiology: A Focus on JAK Enzymes Josef Smolen, MD

08:35–08:55

L ong-term Assessment of Patients With RA: Understanding Treatment Targets as a Foundation for Therapeutic Tailoring Joel Kremer, MD, FACP, MACR

08:55–09:15

Clinical Trial Results With Current and Emerging JAK Inhibitors Rieke Alten, MD

09:15–09:30

The Evolving Roles of JAK Inhibitors in RA Josef Smolen, MD

09:30–09:45

Postactivity Questionnaire and Q&A Session

DISCLOSURE OF CONFLICTS OF INTEREST It is the policy of the Elsevier Office of Continuing Medical Education that all faculty, instructors, and planners disclose any real or apparent conflicts of interest relating to the topics of this educational activity.

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The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Rieke Alten, MD Grants/Research Support: Gilead Sciences, Inc., and Pfizer Inc.; Honoraria/Consultation Fees: Eli Lilly & Company, and Pfizer Inc.; Speakers Bureau: Eli Lilly & Company, and Pfizer Inc. Joel Kremer, MD, FACP, MACR Grants/Research Support: AbbVie Inc., Genentech, Inc., Eli Lilly & Company, and Novartis Pharmaceuticals Corporation; Stock Shareholder: Corrona Josef Smolen, MD Grants/Research Support: AbbVie Inc., AstraZeneca, Janssen Pharmaceuticals, Inc., Eli Lilly & Company, F. Hoffmann-La Roche Ltd, Merck Sharp Dohme Corp., and Pfizer Inc.; Honoraria/Consultation Fees: AbbVie Inc., Amgen Inc., AstraZeneca, Astro-Pharma GmbH, Bristol-Myers Squibb, Celgene Corporation, Celltrion Inc., Chugai Pharmaceutical Co., Ltd., Eli Lilly & Company, Gilead Sciences, Inc., GlaxoSmithKline, F. Hoffmann-La Roche Ltd, ILTOO Pharma, Janssen Pharmaceuticals, Inc., Medimmune, LLC, Merck Sharp Dohme Corp., Pfizer Inc., Sandoz International GmbH, Samsung Pharmaceutical Co., Ltd., Sanofi, and UCB S.A.

Non-faculty Jim Kappler, PhD; Sandy Breslow; Alison Kemp; and Bernard M. Abrams, MD, hereby state that neither they nor their spouses/life partners have any financial relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

CME CREDIT (PHYSICIANS) This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Elsevier Office of Continuing Medical Education and Integritas Communications. The Elsevier Office of Continuing Medical Education is accredited by the ACCME to provide continuing medical education for physicians.

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The Elsevier Office of Continuing Medical Education designates this enduring activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

European CME Credits The Clinical Issues in Rheumatoid Arthritis: Discussions and Debates on the Evolving Roles of Targeted Synthetic DMARDs, Amsterdam, Netherlands, 15/06/2018-15/06/2018 has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME®) with 1 European CME credit (ECMEC®s). Each medical specialist should claim only those hours of credit that he/she actually spent in the educational activity. Through an agreement between the Union Européenne des Médecins Spécialistes (UEMS) and the American Medical Association, physicians may convert EACCME credits to an equivalent number of AMA PRA Category 1 Credits™. Information on the process to convert EACCME® credit to AMA credit can be found at www.ama-assn.org/ education/earn-credit-participation-international-activities. Live educational activities, occurring outside of Canada, recognized by the UEMSEACCME® for ECMEC®s are deemed to be Accredited Group Learning Activities (Section 1) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada.

FEE INFORMATION There is no fee for this educational activity.

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DISCLOSURE OF UNLABELED USE This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The Elsevier Office of Continuing Medical Education, Integritas Communications, and Gilead Sciences, Inc., do not recommend the use of any agent outside of the labeled indications.

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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 or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

METHOD OF PARTICIPATION In order to claim credit, participants must complete the following: •• Read the educational objectives, accreditation information, and faculty disclosures before this live activity. •• Attend this live symposium. •• Complete and return the evaluation form at the end of the symposium or complete the online evaluation form at https://courses.elseviercme.com/771eval.

SLIDES

GUIDELINES »»2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Singh JA, et al. Arthritis Rheumatol. 2016;68(1):1-26. http://onlinelibrary.wiley.com/doi/10.1002/art.39480/epdf

»»Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions. Smolen JS, et al. Ann Rheum Dis. 2013;72(4):482-492. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3595138/pdf/annrheumdis-2012-202469.pdf

»»EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Smolen JS, et al. Ann Rheum Dis. 2017;76(6):960-977. http://ard.bmj.com/content/annrheumdis/early/2017/03/06/annrheumdis-2016-210715.full.pdf

»»Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Smolen JS, et al. Ann Rheum Dis. 2016;75(1):3-15. http://ard.bmj.com/content/early/2015/05/12/annrheumdis-2015-207524.full.pdf

PATIENT AND PROVIDER RESOURCES The American College of Rheumatology has published a concise overview to help patients and caregivers learn more about rheumatoid arthritis and to provide tips for living well with this rheumatic disease. http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis

»»American College of Rheumatology Patient Education Videos The American College of Rheumatology has produced a library of videos about the impact of rheumatic disease, what to do when diagnosed with rheumatic disease, when to see a rheumatologist, and what patients have to say about their experiences of living with rheumatic disease. http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Patient-Education-Videos

RESOURCE CENTER

»»American College of Rheumatology Disease Overview

»»Arthritis Foundation The Arthritis Foundation provides self-care tools and resources covering treatment options, pain management, diet and exercise, and common comorbidities associated with many different arthritic conditions. http://www.arthritis.org

»»EULAR ‘Don’t Delay, Connect Today’ Campaign This European League Against Rheumatism (EULAR) Campaign aims to raise awareness of the importance of early diagnosis in preventing further damage to those living with rheumatic and musculoskeletal diseases, and to encourage timely access to evidence-based treatment. https://www.eular.org/what_we_do_dont_delay _connect_today _2017.cfm

»»European League Against Rheumatism EULAR is an organization that represents people with arthritis/rheumatism, health professionals, and scientific societies of rheumatology of all the European nations. https://www.eular.org/eular_mission.cfm

»»Health Topics: Rheumatoid Arthritis A resource from the National Institute of Arthritis and Musculoskeletal and Skin Diseases for people who have rheumatoid arthritis, as well as for their family members, friends, and others who want to find out more about this disease. https://www.niams.nih.gov/health-topics/rheumatoid-arthritis

»»Rheumatoid Arthritis Support Network

RESOURCE CENTER

The Rheumatoid Arthritis Support Network provides up-to-date information for patients with rheumatoid arthritis, including links to patient support groups, blogs written by patients with rheumatoid arthritis, resources to help pay for medications, and smart device apps to help track symptoms over time. https://www.rheumatoidarthritis.org/

SUGGESTED READING »»Additional Abstracts From the 2017 American College of Rheumatology/ Association of Rheumatology Health Professionals Annual Meeting. November 2017; San Diego, California. http://acrabstracts.org/

»»Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Anderson J, et al. Arthritis Care Res (Hoboken). 2012;64(5):640-647. http://onlinelibrary.wiley.com/doi/10.1002/acr.21649/pdf 34

»»Methotrexate and rheumatoid arthritis: current evidence regarding subcutaneous versus oral routes of administration. Bianchi G, et al. Adv Ther. 2016;33(3):369-378. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4833794/

»»Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Cohen SB, et al. Ann Rheum Dis. 2017;76(7):1253-1262. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5530353/pdf/annrheumdis-2016-210457.pdf

»»Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Dougados M, et al. Ann Rheum Dis. 2017;76(1):88-95. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5264214/pdf/annrheumdis-2016-210094.pdf

»»Long term safety of filgotinib in the treatment of rheumatoid arthritis: week 84 data from a phase 2b open-label extension study. Genovese MC, et al. Arthritis Rheumatol. 2017;69 (suppl 10). Abstract 1909. http://acrabstracts.org/abstract/long-term-safety-of-filgotinib-in-the-treatment-of-rheumatoidarthritis-week-84-data-from-a-phase-2b-open-label-extension-study/

»»Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Fleischmann R, et al. Lancet. 2017;390(10093):457-468. https://www.ncbi.nlm.nih.gov/pubmed/28629665

»»Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group.

RESOURCE CENTER

Fleischmann R, et al. Clin Rheumatol. 2017;36(1):15-24. https://link.springer.com/article/10.1007/s10067-016-3436-1

»»Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. Fleischmann R, et al. RMD Open. 2017;3(2):e000491. http://rmdopen.bmj.com/content/3/2/e000491

»»Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Genovese MC, et al. Rheumatology. 2018;57(5):900-908. https://academic.oup.com/rheumatology/article/57/5/900/4837139

»»Upadacitinib (ABT-494) in patients with active rheumatoid arthritis and inadequate response or intolerance to biological DMARDs: a phase 3 randomized, placebo-controlled, double-blind study of a selective JAK-1 inhibitor. Genovese MC, et al. Arthritis Rheumatol. 2017;69(suppl 10). Abstract 10L. http://acrabstracts.org/abstract/upadacitinib-abt-494-in-patients-with-active-rheumatoidarthritis-and-inadequate-response-or-intolerance-to-biological-dmards-a-phase-3randomized-placebo-controlled-double-blind-study-of-a-selec/

»»Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: results from a randomised, dose-finding study (DARWIN 2). Kavanaugh A, et al. Ann Rheum Dis. 2017;76(6):1009-1019. http://ard.bmj.com/content/annrheumdis/76/6/1009.full.pdf

»»No effect of baseline serum CRP levels on clinical efficacy parameters in rheumatoid arthritis patients treated with filgotinib: post hoc analysis from two phase 2B studies. Kavanaugh A, et al. Arthritis Rheumatol. 2017;69 (suppl 10) Abstract 537. http://acrabstracts.org/abstract/no-effect-of-baseline-serum-crp-levels-on-clinical-efficacyparameters-in-rheumatoid-arthritis-patients-treated-with-filgotinib-post-hoc-analysis-fromtwo-phase-2b-studies/

RESOURCE CENTER

»»Time to achieve moderate/low disease activity and remission in RA patients on baricitinib compared to adalimumab, methotrexate, and placebo. Keystone EC, et al. Arthritis Rheumatol. 2017;69 (suppl 10). Abstract 513. http://acrabstracts.org/abstract/time-to-achieve-moderatelow-disease-activity-and-remissionin-ra-patients-on-baricitinib-compared-to-adalimumab-methotrexate-and-placebo/

»»Peficitinib, a JAK inhibitor, in the treatment of moderate-to-severe rheumatoid arthritis in patients with an inadequate response to methotrexate. Kivitz AJ, et al. Arthritis Rheumatol. 2017;69(4):709-719. https://www.ncbi.nlm.nih.gov/pubmed/27748083

»»Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Kremer JM, et al. Arthritis Rheum. 2011;63(3):609-621. http://onlinelibrary.wiley.com/doi/10.1002/art.30158/epdf

»»Cycling versus swapping in patients with rheumatoid arthritis with an inadequate response to at least one tumor necrosis factor alpha inhibitor: a systematic review and meta-analysis of observational study. Lopez-Olivo MA, et al. Arthritis Rheumatol. 2017;69(suppl 10):Abstract 2483. http://acrabstracts.org/abstract/cycling-versus-swapping-in-patients-with-rheumatoidarthritis-with-an-inadequate-response-to-at-least-one-tumor-necrosis-factor-alpha-inhibitora-systematic-review-and-meta-analysis-of-observational/

»»Pathogenetic insights from the treatment of rheumatoid arthritis. McInnes IB, Schett G. Lancet. 2017;389(10086):2328-2337. https://www.ncbi.nlm.nih.gov/pubmed/28612747

»»Thromboembolism with Janus kinase (JAK) inhibitors for rheumatoid arthritis: how real is the risk? Scott IC, et al. Drug Saf. 2018 Mar 2. [Epub ahead of print]. https://www.ncbi.nlm.nih.gov/pubmed/29500799

»»Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dosefinding study (DARWIN 1).

RESOURCE CENTER

Westhovens R, et al. Ann Rheum Dis. 2017;76(6):998-1008. http://ard.bmj.com/content/annrheumdis/76/6/998.full.pdf

NOTES 38

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