The Journal of Rheumatology Volume 81, no.

Unresolved Issues in Identifying and Overcoming Inadequate Response in Rheumatoid Arthritis: Weighing the Evidence: CONTINUING MEDICAL EDUCATION (CME) INFORMATION

J Rheumatol 2008;81;1-3 http://www.jrheum.org/content/81/1

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The Journal of Rheumatology is a monthly international serial edited by Earl D. Silverman featuring research articles on clinical subjects from scientists working in rheumatology and related fields.

Downloaded from www.jrheum.org on September 23, 2021 - Published by The Journal of Rheumatology Introduction

Unresolved Issues in Identifying and Overcoming Inadequate Response in Rheumatoid Arthritis: Weighing the Evidence

CONTINUING MEDICAL EDUCATION (CME) INFORMATION

OVERVIEW Rheumatoid arthritis (RA) is a chronic, multisystem, Table of Contents inflammatory disorder of the joints that affects approxi- CME Information mately 1% of the world population. The ultimate goals of therapy include remission of disease and prevention of Unresolved Issues in Identifying and Overcoming joint damage. Reaching these goals has become a realistic Inadequate Response in Rheumatoid Arthritis: Weighing outcome for an increasing number of patients as treat- the Evidence ment options have expanded over the past 3 decades. In addition to older therapies, such as methotrexate (MTX), • Introduction other disease modifying antirheumatic drugs (DMARD), Stanley B. Cohen and tumor necrosis factor (TNF) inhibitors, newer bio- • Validated Outcome Measures/Tools logic treatments have become available. For the substan- John J. Cush tial number of patients who experience an inadequate response to standard , biological response • Predictors of Prognosis and Response modifiers (BRM) provide an important therapeutic alter- Michael H. Schiff native. The availability of multiple treatment options in • Overcoming Inadequate Response the absence of clear definitions or criteria for remission Primary and Secondary Response Failures and and inadequate response, however, makes clinical decisions Withdrawal Due to Toxicity Arthur L. Weaver about measuring outcomes, predicting response to treatment, Cycling and Dose Escalation Marc D. Cohen and prescribing pharmacologic therapies challenging. In Rituximab Philip J. Mease this program, distinguished rheumatologists weigh the Abatacept Lee S. Simon evolving body of clinical evidence to draw sound conclusions and resolve key issues in managing inadequate response to • Safety of Biologics treatment and in achieving optimal outcomes in RA. Roy M. Fleischmann • Conclusion Target Audience Stanley B. Cohen Unresolved Issues in Identifying and Overcoming Inadequate Response: Weighing the Evidence is intended CME Posttest for rheumatologists, rheumatology fellows, and other medical professionals interested in understanding the • Applicability, benefits, and limitations of various challenges of defining inadequate response to RA therapy outcome measures to identify and treat inadequate and developing effective evidence-based strategies to response to therapy attain treatment goals and achieve optimal outcomes. • Utility and reliability of predictors of response in aiding treatment decisions Educational Objectives • Safety and efficacy of currently available BRM This educational activity has been developed to improve Apply an appropriate, clinically rational, evidence- your ability to: based approach to altering BRM therapy to achieve Identify key unresolved issues in defining and over- adequate response and minimize disease progression coming inadequate response to therapy in RA Evaluate the clinical evidence to draw sound conclusions Release date: February 2008 about the Expiration date: February 2009

Personal non-commercial use only. The Journal of Rheumatology Copyright © 2008. All rights reserved. Introduction: CME information 1 Downloaded from www.jrheum.org on September 23, 2021 - Published by The Journal of Rheumatology Accreditation Faculty Disclosures The University of Texas Southwestern Medical Center is Dr. Stanley Cohen has disclosed that he has served as a accredited by the Accreditation Council for Continuing clinical investigator and research consultant for Medical Education to provide CME for . , Inc., Idec, Merck & Co., Inc., sanofi- aventis, Procter & Gamble, Inc., Centocor, Inc., Credit Designation Inc., Scios Inc., Bristol-Myers Squibb Company, The University of Texas Southwestern Medical Center and . designates this educational activity for a maximum of 4.0 AMA PRA Category 1 Credits™. Physicians should only Dr. Marc Cohen has disclosed that he has consulted for claim credit commensurate with the extent of their par- Genentech, Inc., , Wyeth, Amgen ticipation in the activity. Inc., and Centocor, Inc. He also has served on speakers’ bureaus for Genentech, Inc., Abbott Laboratories, and How to Receive CME Credit Amgen, Inc. To receive a maximum of 4.0 AMA PRA Category 1 Credits™, complete the posttest with a passing score Dr. John J. Cush has disclosed that he has worked as a (70% or better) and return the posttest and evaluation to: clinical investigator for Abbott Laboratories, Genentech, Inc., Biogen Idec, Pfizer Inc., Targeted Genetics UT Southwestern Medical Center, Corporation, and UCB. He also has served as an advisor, Continuing Medical Education/Enduring Materials, consultant, or lecturer for Centocor, Inc., Abbott 5323 Harry Hines Blvd., Laboratories, Pharmaceuticals Inc., sanofi-aventis, Dallas, TX 75390-9059 UCB, Pfizer Inc., Wyeth, and Pharmaceuticals Corporation. Or fax to (214) 648-2317 Dr. Roy M. Fleischmann has disclosed that he has served on speakers’ bureaus and advisory committees and as an Certificate will be mailed 4 to 6 weeks after receipt of independent contractor and consultant for Abbott requested items. Laboratories, Johnson & Johnson, Amgen Inc., Wyeth, and Genentech, Inc. Conflict of Interest It is the policy of The University of Texas Southwestern Dr. Philip J. Mease has disclosed that he has served on Medical Center that participants in CME activities be speakers’ bureaus and as an independent contractor and made aware of any affiliation or financial interest that consultant for Abbott Laboratories, Amgen Inc., Biogen may affect the speaker’s presentation. Each speaker has Idec, Centocor, Inc., and Genentech, Inc. He has also completed and signed a conflict of interest statement. served as an independent contractor for Roche The faculty members’ relationships are disclosed in the Laboratories and Wyeth and as a consultant for Roche course material. Laboratories and UCB. He is a stock owner of Amgen Inc.

Disclosure of Significant Relationships with Commercial Dr. Michael H. Schiff has disclosed that he has received Interests research support and served as a consultant and on It is the policy of the Office of Continuing Medical speakers’ bureaus for Abbott Laboratories, Amgen Inc., Education at The University of Texas Southwestern Bristol-Myers Squibb Company, Centocor, Inc., and Medical Center to ensure balance, independence, objec- Roche Laboratories. He has also consulted and spoken tivity, and scientific rigor in all of its directly sponsored for Wyeth, consulted for UCB, and received research or jointly sponsored educational activities. support from Genentech, Inc., UCB, and Targeted Program directors and speakers have completed and Genetics Corporation. signed a conflict of interest statement disclosing a finan- cial or other relationship with a commercial interest relat- Dr. Lee S. Simon has disclosed that he has consulted for ed directly or indirectly to the program. AAI Pharma Inc., Abbott Laboratories, Abraxis Bio- Information and opinions offered by the speakers rep- Science, Inc., Affinergy, Inc., Alder resent their viewpoints. Conclusions drawn by the audi- Inc., , AlphaRx, Altea Therapeutics ence should be derived from careful consideration of all Corporation, AstraZeneca Pharmaceuticals LP, Pfizer available scientific information. Products may be dis- Inc., Novartis Pharmaceuticals Corporation, Bayer cussed for treatment outside current approved labeling. HealthCare AG, Avanir Pharmaceuticals, Biosense

Personal non-commercial use only. The Journal of Rheumatology Copyright © 2008. All rights reserved. 2 The Journal of Rheumatology 2007; 35 Suppl 81 Downloaded from www.jrheum.org on September 23, 2021 - Published by The Journal of Rheumatology Webster, Inc., Cellegy Pharmaceuticals, Inc., Cell Dr. Arthur L. Weaver has disclosed that he served on Therapeutics, Inc., Cerimon Pharmaceuticals, Inc., speakers’ bureaus, advisory committees, and as a consultant Chelsea Therapeutics, Inc., ChemoCentryx, Inc., Coley for Abbott Laboratories, Amgen Inc., Astellas Pharma Pharmaceuticals Group, Inc., CombinatoRx, Inc., Cure, Inc., sanofi-aventis, Biogen Idec, Biovail Corporation, Cypress Pharmaceutical, Inc., DiObex, Inc., Dr Reddy’s Bristol-Myers Squibb Company, Centocor, Inc., Cypress Laboratories Ltd., Genelabs Technologies, Inc., Pharmaceutical, Inc., Fujisawa, Genentech, Inc., Helsinn Hisamitsu Pharmaceutical Co., Inc., Jazz Group, , Human Genome Sciences, Pharmaceuticals, Inc., Lab Pharma, Leerink Swann and Inc., , Medecisive Laboratories, Company, Luxor, Millennium Pharmaceuticals, Inc., Merck & Co., Inc., Merkel, Laboratories Inc., McKesson Corp., MedImmune Inc., Neopharm, Inc., Novartis, Ortho-McNeil, Inc., Pfizer Inc., Primus Neuromed Pharmaceuticals Ltd., Nitec Pharma AG, Pharmaceuticals, Inc., Prometheus, Proprius Pharmaceuticals, Nomura, Nuvo Research Inc., Omeros Corporation, Shwarz Pharma AG, TAP Pharmaceutical Products Inc., Parexel International, Pfizer Inc., PLX Pharma Inc., Takeda Pharmaceuticals North America, Inc., Polymerix Corporation, Procter & Gamble, ProEthic TheraQuest Biosciences, and Wyeth. Additionally, he is Pharmaceuticals, Proprius Pharmaceuticals, Purdue on the board of directors and owns stock in MGI Pharma L.P., Puretech Ventures, PureTech Development Pharma. LLC, Regeneron Pharmaceuticals, Inc., Rigel, Savient Pharmaceuticals, Inc., Sepracor Inc., Serono, Inc., Discussion of Off-Label Use Shwarz Pharma AG, SkyePharma PLC, SNBL, Solace Because this course is meant to educate physicians with Pharmaceuticals, TAP Pharmaceutical Products Inc., what is currently in use and what may be available in the Takeda Pharmaceuticals North America Inc., Talagen, future, “off-label” use may be discussed. Authors have Teva Neuroscience, Inc., TiGenix N.V., White Mountain been requested to inform the reader when off-label use is Pharma, and Zydus Pharmaceuticals, Inc. being discussed.

Personal non-commercial use only. The Journal of Rheumatology Copyright © 2008. All rights reserved. Introduction: CME information 3 Downloaded from www.jrheum.org on September 23, 2021 - Published by The Journal of Rheumatology