American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis
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Arthritis & Rheumatism (Arthritis Care & Research) Vol. 59, No. 6, June 15, 2008, pp 762–784 DOI 10.1002/art.23721 © 2008, American College of Rheumatology SPECIAL ARTICLE American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis KENNETH G. SAAG,1 GIM GEE TENG,1 NIVEDITA M. PATKAR,1 JEREMY ANUNTIYO,2 CATHERINE FINNEY,2 JEFFREY R. CURTIS,1 HAROLD E. PAULUS,2 AMY MUDANO,1 MARIA PISU,1 MARY ELKINS-MELTON,1 RYAN OUTMAN,1 JEROAN J. ALLISON,1 MARIA SUAREZ ALMAZOR,3 S. LOUIS BRIDGES, JR.,1 W. WINN CHATHAM,1 MARC HOCHBERG,4 CATHERINE MACLEAN,5 6 7 5 1 TED MIKULS, LARRY W. MORELAND, JAMES O’DELL, ANTHONY M. TURKIEWICZ, AND DANIEL E. FURST2 Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to these guidelines and recommendations to be voluntary, with the ultimate determination regarding their application to be made by the physician in light of each patient’s individual circumstances. Guidelines and recommendations are intended to promote beneficial or desirable outcomes but cannot guarantee any specific outcome. Guidelines and recommendations developed or endorsed by the ACR are subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice. Introduction ing antirheumatic drugs (DMARDs) and the rate of biologic DMARD use is rising rapidly (1,2). The American College The majority of patients with a confirmed diagnosis of of Rheumatology (ACR) has not updated its recommenda- rheumatoid arthritis (RA) use nonbiologic disease-modify- University of Nebraska, Omaha; 7Larry W. Moreland, MD: Dr. Saag’s work was supported by the Agency for Health- University of Pittsburgh, Pittsburgh, Pennsylvania. care Research and Quality (grant U18-H510389), the Uni- Dr. Saag has received consultant fees (less than $10,000 versity of Alabama, Birmingham Center for Education and each) from Roche, UCB, Nitec, and Amgen and research Research on Therapeutics of Musculoskeletal Diseases, and support from Abbott, Amgen, Centecor, Roche, and Wyeth. a grant from the American College of Rheumatology. Drs. Dr. Curtis has received consultant fees, speaking fees, Pisu, Allison, and Moreland’s work was supported by a and/or honoraria (less than $10,000 each) from Roche, grant from the American College of Rheumatology. Dr. Merck, Procter and Gamble, Eli Lilly, UCB, and Novartis Furst’s work was supported by a grant from the American and research support from Amgen, Eli Lilly, Merck, Novar- College of Rheumatology and the NIH. tis, Procter and Gamble, and Roche. Dr. Paulus has received 1Kenneth G. Saag, MD, MSc, Gim Gee Teng, MD, Nivedita consultant fees (less than $10,000 each) from Amgen, Roche M. Patkar, MD, MSPH, Jeffrey R. Curtis, MD, MPH, Amy and Mathematica. Dr. Chatham has received speaking fees Mudano, MPH (current address: Blue Cross and Blue Shield and honoraria (less than $10,000 each) from Bristol-Myers of Alabama, Birmingham), Maria Pisu, PhD, Mary Elkins- Squibb and Amgen. Dr. Hochberg has received consultant Melton, BA, Ryan Outman, MS, Jeroan J. Allison, MD, MS, fees (less than $10,000 each) from Amgen and Bristol-Myers S. Louis Bridges, Jr., MD, PhD, W. Winn Chatham, MD, Squibb. Dr. MacLean owns stock and/or holds stock options Anthony M. Turkiewicz, MD: University of Alabama, Bir- in WellPoint. Dr. Mikuls has received speaking fees (less mingham; 2Jeremy Anuntiyo, MD, Catherine Finney, MD, than $10,000 each) from Genentech and Amgen and unre- Harold E. Paulus, MD, Daniel E. Furst, MD: University of stricted grants from Abbott, Amgen, and Bristol-Myers California, Los Angeles; 3Maria Suarez Almazor, MD, MPH: Squibb. Dr. Moreland has received consultant fees, speaking University of Texas, MD Anderson, Houston; 4Marc Hoch- fees, and/or honoraria (less than $10,000 each) from Roche, berg, MD, MPH: University of Maryland, Baltimore; 5Cathe- Bristol-Myers Squibb, Centocor, Pfizer, Amgen, Incyte, and rine MacLean, MD, PhD, James O’Dell, MD: University of Genentech. Dr. O’Dell has received consultant fees and speak- California, Los Angeles, RAND Corporation, Santa Monica, ing fees (less than $10,000) from Abbott. Dr. Turkiewicz has and West Los Angeles VAMC; 6Ted Mikuls, MD, MSPH: received consultant fees and speaking fees (less than $10,000) 762 Recommendations for the Use of Nonbiologic and Biologic DMARDs in RA 763 tions for nonbiologic DMARDs since 2002 (3) and has not previously developed recommendations for biologic agents. Although past guidelines have been derived from an informal consensus approach, we used a formal group process to develop recommendations that were as evi- dence-based as possible. To develop these new recommendations on behalf of the ACR, following the principles delineated by the Appraisal of Guidelines for Research and Evaluation (AGREE) Col- from Pfizer, honoraria (less than $10,000 each) from Amgen, Wyeth, and Hoffman-LaRoche, and consultant fees, speak- ing fees, and honoraria (more than $10,000) from Abbott. Dr. Furst has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Actelion, Amgen, Array, Biogenidec, Bristol-Myers Squibb, Centocor, Genentech, Gilead, GlaxoSmith-Kline, Encysive, Nitec, No- vartis, Roche, TAP, UCB, Wyeth, and Xoma and research Figure 1. Methodologic process for the American College of support from Actelion, Bristol-Myers Squibb, Celgene, Ge- Rheumatology recommendations for the use of biologic and non- nentech, Gilead, Novartis, Roche, and UCB. biologic disease-modifying antirheumatic drug therapies. RAND/ Members of the Core Expert Panel: Kenneth G. Saag, MD, UCLA ϭ Research and Development/University of California at MSc, Jeffrey R. Curtis, MD, MPH, Harold E. Paulus, MD, Los Angeles. Jeroan J. Allison, MD, MS, Maria Suarez Almazor, MD, MPH, S. Louis Bridges, Jr., MD, PhD, W. Winn Chatham, MD, Marc Hochberg, MD, MPH, Catherine MacLean, MD, PhD, Ted Mikuls, MD, MSPH, Larry W. Moreland, MD, laboration (4), we first conducted a systematic review of James O’Dell, MD, Anthony M. Turkiewicz, MD, Daniel E. scientific evidence to create an evidence report and draft Furst, MD. guidelines. We addressed each of the 5 domains prespeci- Members of the Task Force Panel: Claire Bombardier, MD, fied by the ACR, namely: 1) indications for use; 2) screen- MSc (University of Toronto, Toronto, Ontario, Canada), ing for tuberculosis (TB; biologic DMARDs only); 3) mon- Robin K. Dore, MD (University of California, Los Angeles), Linda F. Golodner, BA (National Consumers League, Wash- itoring for side effects; 4) assessing the clinical response; ington, DC), Sean Hennessy, PharmD, PhD (University of and 5) the roles of cost and patient preferences in decision- Pennsylvania School of Medicine, Philadelphia), Arthur F. making (biologic DMARDs only). A Working Group and a Kavanaugh, MD (University of California, San Diego), Core Expert Panel (CEP) of clinicians and methodologists Dinesh Khanna, MD, MSC (University of Cincinnati, Cincin- nati, Ohio, current address: University of California, Los guided the development of these recommendations. We Angeles), Joel M. Kremer, MD (Albany Medical Center, Al- next convened a Task Force Panel (TFP) of internationally- bany, NY), Amye L. Leong, MBA (US Bone and Joint Decade, recognized clinicians, methodologists, and patient repre- North Wales, PA), Eric L. Matteson, MD, MPH (Mayo Clinic, sentatives with broad expertise in the use of nonbiologic Rochester, MN), John T. Schousboe, MD, MS (Park Nicollet and biologic DMARD therapies, evidence-based medicine, Clinic, St. Louis Park, MN, and University of Minnesota, Minneapolis), Anna N. A. Tosteson, ScD (Dartmouth Medi- patient preference, and health care economics. They were cal School, Lebanon, NH), Peter Tugwell, MD (University of to critique and rate proposed recommendations using a Ottawa, Ottawa, Ontario, Canada), Yusuf Yazici, MD (New well-accepted group process, the modified Research and York University Hospital for Joint Diseases, New York). Development/University of California at Los Angeles Additional members of the University of Alabama, Bir- mingham (UAB) and University of California, Los Angeles (RAND/UCLA) Appropriateness Method (5) (Figure 1). Al- (UCLA) Working Groups: Timothy Beukelman, MD, Maria though the TFP and CEP considered drug-specific indica- I. Danila, MD, MS, Jeffrey Faggard, MD, Angelo Gaffo, MD, tions from the US Food and Drug Administration (FDA) Allyson McDonough, MD, Raj Nair, MD, Bita Shakoory, MD, and other regulatory authorities, in some cases the TFP Martha Verchot, MS, MLS (UAB), Paul Maranian, MS, extrapolated recommendations outside the present bounds Shruti Scott, MPH (UCLA). Content Specific Expert Advisors: Kevin L. Winthrop, MD, of approved labeling. Although terminology used by reg- MPH (tuberculosis; Oregon Health and Science University, ulatory agencies varies, in this article we refer to biologic Portland), Gregory J. Gores, MD (hepatology; Mayo Clinic, agents as drugs. Rochester, MN), Michael Saag, MD (human immunodefi- Disseminated under the aegis of the ACR, we recognize ciency virus; University of Alabama, Birmingham), Paul Shekelle, MD, PhD (RAND/UCLA Appropriateness Method; that recommendations surrounding certain issues (e.g., University of California, Los Angeles). cost considerations and TB testing approaches) may