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16 March 1999 | Volume 130 Issue 6 | Pages 478-486
Background: In a phase II study, etanercept (recombinant human tumor necrosis factor receptor [p75]:Fc fusion protein) safely produced rapid, dose-dependent improvement in rheumatoid arthritis over 3 months.
Objective: To confirm the benefit of etanercept therapy of longer duration and simplified dosing in patients with rheumatoid arthritis.
Design: Randomized, double-blind, placebo-controlled trial with blinded joint assessors.
Setting: 13 North American centers.
Patients: 234 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs.
Intervention: Twice-weekly subcutaneous injections of etanercept, 10 or 25 mg, or placebo for 6 months.
Measurements: The primary end points were 20% and 50% improvement in disease activity according to American College of Rheumatology (ACR) responses at 3 and 6 months. Other end points were 70% ACR responses at 3 and 6 months and other measures of disease activity at 3 and 6 months.
Results: Etanercept significantly reduced disease activity in a dose-related fashion. At 3 months, 62% of the patients receiving 25 mg of etanercept and 23% of the placebo recipients achieved 20% ACR response (P < 0.001). At 6 months, 59% of the 25-mg group and 11% of the placebo group achieved a 20% ACR response (P < 0.001); 40% and 5%, respectively, achieved a 50% ACR response (P < 0.01). The respective mean percentage reduction in the number of tender and swollen joints at 6 months was 56% and 47% in the 25-mg group and 6% and –7% in the placebo group (P < 0.05). Significantly more etanercept recipients achieved a 70% ACR response, minimal disease status (0 to 5 affected joints), and improved quality of life. Etanercept was well tolerated, with no dose-limiting toxic effects.
Conclusions: Etanercept can safely provide rapid, significant, and sustained benefit in patients with active rheumatoid arthritis.
Author and Article Information
From University of Alabama at Birmingham, Birmingham, Alabama; Denver Arthritis Clinic, Denver, Colorado; Physician's Clinic of Spokane, Spokane, Washington; Portland Medical Associates, Portland, Oregon; Metroplex Clinical Research Center, Dallas, Texas; University of California, Los Angeles, and University of Southern California, Los Angeles, California; Arthritis Center of Nebraska, Lincoln, Nebraska; The Wellesley Central Hospital, Toronto, Ontario, Canada; Virginia Mason Medical Center, Minor and James Medical, and Immunex Corp., Seattle, Washington; Rush Medical College, Chicago, Illinois; and Brigham and Women's Hospital, Boston, Massachusetts.
Acknowledgments: The authors thank Bonnie Bermas, MD, and Agnes Maier (Brigham and Women's Hospital, Boston, Massachusetts); Lisa Cave and Traci Telander (Denver Arthritis Clinic, Denver, Colorado); Rick Chatwell, MD, and Lisa Kastanek, RN (Arthritis Center of Nebraska, Lincoln, Nebraska); Nancy Daly, RN, BSN, and Peri Todd (Rush Medical College, Chicago, Illinois); Ann Dugan (Immunex Corp., Seattle, Washington); Meredith Heick, MD, and Denise Wentling (Physician's Clinic of Spokane, Spokane, Washington); Judy Jancelwicz and Debbie Weber, RN (The Wellesley Central Hospital, Toronto, Ontario, Canada); Rita Jepson and Millie Sterz (University of California, Los Angeles, Los Angeles, California); Dorothy Johnson, RN, and Elena Spektor, MD (University of Southern California School of Medicine, Los Angeles, California); Xiomara Madera and Kristin Neeley (Virginia Mason Medical Center, Seattle, Washington); Philip Mon-Pere, MD, and Shiralynn Moore (Portland Medical Associates, Portland, Oregon); Steven Overman, MD, and Kevin Port (Minor and James Medical, Seattle, Washington); Tina Parkhill and Melinda Robertson, RN (University of Alabama at Birmingham, Birmingham, Alabama); Paula Walker and Kay Whitehead (Metroplex Clinical Research Center, Dallas, Texas).
Grant Support: By Immunex Corp., Seattle, Washington.
Requests for Reprints: Larry W. Moreland, MD, Arthritis Clinical Intervention Program, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 1717 6th Avenue, SRC 068, Birmingham, AL 35294-7201.
Current Author Addresses: Dr. Moreland: Arthritis Clinical Intervention Program, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 1717 6th Avenue, SRC 068, Birmingham, AL 35294-7201.
Dr. Schiff: Denver Arthritis Clinic, 4545 East Ninth Avenue, Suite 510, Denver, CO 80220-3981.
Dr. Baumgartner: Physician's Clinic of Spokane, 820 South McClellan #200, Spokane, WA 99204.
Dr. Tindall: Portland Medical Associates, 10201 SE Main Street, Suite 29, Portland, OR 97216.
Dr. Fleischmann: Metroplex Clinical Research Center, 5939 Harry Hines Boulevard, Suite 441, Dallas, TX 75235.
Dr. Bulpitt: Division of Rheumatology, Department of Medicine, University of California, Los Angeles, Room 3265, Box 951670, 1000 Veteran Avenue, Los Angeles, CA 90095-1670.
Dr. Weaver: Arthritis Center of Nebraska, 2121 South 56th, Lincoln, NE 68506.
Dr. Keystone: The Centre for Advanced Therapeutics, Mount Sinai Hospital, 600 University Avenue, Room 1005, Toronto, Ontario M5G 1X5, Canada.
Dr. Furst: Virginia Mason Medical Center, 1100 Ninth Avenue, Seattle, WA 98101.
Dr. Mease: Minor and James Medical, First Hill Medical Building, 515 Minor Avenue, #300, Seattle, WA 98104.
Dr. Ruderman: Rheumatology Associates, SC, Rush-Presbyterian-St. Luke's, Professional Building, 1725 West Harrison Street, Suite 1039, Chicago, IL 60612.
Drs. Horwitz and Arkfield: University of Southern California School of Medicine, 2011 Zonal Avenue, HMR 711, Los Angeles, CA 90033.
Drs. Garrison, Burge, Blosch, and McDonnell and Ms. Lange: Immunex Corp., 51 University Street, Seattle, WA 98101.
Dr. Weinblatt: Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115. ARTICLE
Etanercept Therapy in Rheumatoid Arthritis
A Randomized, Controlled Trial
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R. P. Baughman, E. E. Lower, D. A. Bradley, L. A. Raymond, and A. Kaufman Etanercept for Refractory Ocular Sarcoidosis: Results of a Double-Blind Randomized Trial Chest, August 1, 2005; 128(2): 1062 - 1047. [Abstract] [Full Text] [PDF]
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 T. Doan and E. Massarotti Rheumatoid Arthritis: An Overview of New and Emerging Therapies J. Clin. Pharmacol., July 1, 2005; 45(7): 751 - 762. [Abstract] [Full Text] [PDF]
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D P M Symmons Anti-tumour necrosis factor {alpha} therapy: can we afford it? Ann Rheum Dis, July 1, 2005; 64(7): 969 - 970. [Full Text] [PDF]
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A Familian, A E Voskuyl, G J van Mierlo, H A Heijst, J W R Twisk, B A C Dijkmans, and C E Hack Infliximab treatment reduces complement activation in patients with rheumatoid arthritis Ann Rheum Dis, July 1, 2005; 64(7): 1003 - 1008. [Abstract] [Full Text] [PDF]
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N J Bansback, A Brennan, and O Ghatnekar Cost effectiveness of adalimumab in the treatment of patients with moderate to severe rheumatoid arthritis in Sweden Ann Rheum Dis, July 1, 2005; 64(7): 995 - 1002. [Abstract] [Full Text] [PDF]
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M Ostensen, F Forger, J L Nelson, A Schuhmacher, G Hebisch, and P M Villiger Pregnancy in patients with rheumatic disease: anti-inflammatory cytokines increase in pregnancy and decrease post partum Ann Rheum Dis, June 1, 2005; 64(6): 839 - 844. [Abstract] [Full Text] [PDF]
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M van Oosterhout, E W N Levarht, J K Sont, T W J Huizinga, R E M Toes, and J M van Laar Clinical efficacy of infliximab plus methotrexate in DMARD naive and DMARD refractory rheumatoid arthritis is associated with decreased synovial expression of TNF{alpha} and IL18 but not CXCL12 Ann Rheum Dis, April 1, 2005; 64(4): 537 - 543. [Abstract] [Full Text] [PDF]
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C Eriksson, S Engstrand, K-G Sundqvist, and S Rantapaa-Dahlqvist Autoantibody formation in patients with rheumatoid arthritis treated with anti-TNF{alpha} Ann Rheum Dis, March 1, 2005; 64(3): 403 - 407. [Abstract] [Full Text] [PDF]
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M. Jit, B. Henderson, M. Stevens, and R. M. Seymour TNF-{alpha} neutralization in cytokine-driven diseases: a mathematical model to account for therapeutic success in rheumatoid arthritis but therapeutic failure in systemic inflammatory response syndrome Rheumatology, March 1, 2005; 44(3): 323 - 331. [Abstract] [Full Text] [PDF]
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P J Mease and C E Antoni Psoriatic arthritis treatment: biological response modifiers Ann Rheum Dis, March 1, 2005; 64(suppl_2): ii78 - ii82. [Abstract] [Full Text] [PDF]
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J. Ledingham, C. Deighton, and on behalf of the British Society for Rheumatology Update on the British Society for Rheumatology guidelines for prescribing TNF{alpha} blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001) Rheumatology, February 1, 2005; 44(2): 157 - 163. [Full Text] [PDF]
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J van Holten, K Pavelka, J Vencovsky, H Stahl, B Rozman, M Genovese, A J Kivitz, J Alvaro, G Nuki, D E Furst, et al. A multicentre, randomised, double blind, placebo controlled phase II study of subcutaneous interferon beta-1a in the treatment of patients with active rheumatoid arthritis Ann Rheum Dis, January 1, 2005; 64(1): 64 - 69. [Abstract] [Full Text] [PDF]
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K L Hyrich, A J Silman, K D Watson, and D P M Symmons Anti-tumour necrosis factor {alpha} therapy in rheumatoid arthritis: an update on safety Ann Rheum Dis, December 1, 2004; 63(12): 1538 - 1543. [Abstract] [Full Text] [PDF]
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A Calin, B A C Dijkmans, P Emery, M Hakala, J Kalden, M Leirisalo-Repo, E M Mola, C Salvarani, R Sanmarti, J Sany, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis Ann Rheum Dis, December 1, 2004; 63(12): 1594 - 1600. [Abstract] [Full Text] [PDF]
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 J. T. Giles and J. M. Bathon Serious Infections Associated with Anticytokine Therapies in the Rheumatic Diseases J Intensive Care Med, November 1, 2004; 19(6): 320 - 334. [Abstract] [PDF]
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 S. Ferrari-Lacraz, E. Zanelli, M. Neuberg, E. Donskoy, Y. S. Kim, X. X. Zheng, W. W. Hancock, W. Maslinski, X. C. Li, T. B. Strom, et al. Targeting IL-15 Receptor-Bearing Cells with an Antagonist Mutant IL-15/Fc Protein Prevents Disease Development and Progression in Murine Collagen-Induced Arthritis J. Immunol., November 1, 2004; 173(9): 5818 - 5826. [Abstract] [Full Text] [PDF]
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D E Furst, F C Breedveld, J R Kalden, J S Smolen, G R Burmester, J W J Bijlsma, M Dougados, P Emery, E C Keystone, L Klareskog, et al. Updated consensus statement on biological agents, specifically tumour necrosis factor {alpha} (TNF{alpha}) blocking agents and interleukin-1 receptor antagonist (IL-1ra), for the treatment of rheumatic diseases, 2004 Ann Rheum Dis, November 1, 2004; 63(suppl_2): ii2 - ii12. [Full Text] [PDF]
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F Wolfe, K Michaud, and E M DeWitt Why results of clinical trials and observational studies of antitumour necrosis factor (anti-TNF) therapy differ: methodological and interpretive issues Ann Rheum Dis, November 1, 2004; 63(suppl_2): ii13 - ii17. [Abstract] [Full Text] [PDF]
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A K Tausche, K Richter, A Grassler, S Hansel, B Roch, and H E Schroder Severe gouty arthritis refractory to anti-inflammatory drugs: treatment with anti-tumour necrosis factor {alpha} as a new therapeutic option Ann Rheum Dis, October 1, 2004; 63(10): 1351 - 1352. [Full Text] [PDF]
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T Jonsdottir, J Forslid, A van Vollenhoven, A Harju, S Brannemark, L Klareskog, and R F van Vollenhoven Treatment with tumour necrosis factor {alpha} antagonists in patients with rheumatoid arthritis induces anticardiolipin antibodies Ann Rheum Dis, September 1, 2004; 63(9): 1075 - 1078. [Abstract] [Full Text] [PDF]
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P Mease TNF{alpha} therapy in psoriatic arthritis and psoriasis Ann Rheum Dis, July 1, 2004; 63(7): 755 - 758. [Full Text] [PDF]
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A Y Goedkoop, M C Kraan, M B M Teunissen, D I Picavet, M A de Rie, J D Bos, and P P Tak Early effects of tumour necrosis factor {alpha} blockade on skin and synovial tissue in patients with active psoriasis and psoriatic arthritis Ann Rheum Dis, July 1, 2004; 63(7): 769 - 773. [Abstract] [Full Text] [PDF]
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F C Breedveld and J R Kalden Appropriate and effective management of rheumatoid arthritis Ann Rheum Dis, June 1, 2004; 63(6): 627 - 633. [Abstract] [Full Text]
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N. J. Olsen and C. M. Stein New Drugs for Rheumatoid Arthritis N. Engl. J. Med., May 20, 2004; 350(21): 2167 - 2179. [Full Text] [PDF]
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L B A van de Putte, C Atkins, M Malaise, J Sany, A S Russell, P L C M van Riel, L Settas, J W Bijlsma, S Todesco, M Dougados, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed Ann Rheum Dis, May 1, 2004; 63(5): 508 - 516. [Abstract] [Full Text] [PDF]
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A. Brennan and N. Bansback Re: Wolfe et al. Do rheumatology cost-effectiveness analyses make sense? Rheumatology, May 1, 2004; 43(5): 677 - 678. [Full Text] [PDF]
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N. Sultan, J. E. Pope, and P. J. Clements The health assessment questionnaire (HAQ) is strongly predictive of good outcome in early diffuse scleroderma: results from an analysis of two randomized controlled trials in early diffuse scleroderma Rheumatology, April 1, 2004; 43(4): 472 - 478. [Abstract] [Full Text] [PDF]
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D. James, A. Young, E. Kulinskaya, E. Knight, W. Thompson, W. Ollier, and J. Dixey Orthopaedic intervention in early rheumatoid arthritis. Occurrence and predictive factors in an inception cohort of 1064 patients followed for 5 years Rheumatology, March 1, 2004; 43(3): 369 - 376. [Abstract] [Full Text] [PDF]
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G. Krueger and K. Callis Potential of Tumor Necrosis Factor Inhibitors in Psoriasis and Psoriatic Arthritis Arch Dermatol, February 1, 2004; 140(2): 218 - 225. [Abstract] [Full Text] [PDF]
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J D Cohen, S Zaltni, M J Kaiser, M C Bozonnat, C Jorgensen, J P Daures, and J Sany Secondary addition of methotrexate to partial responders to etanercept alone is effective in severe rheumatoid arthritis Ann Rheum Dis, February 1, 2004; 63(2): 209 - 210. [Full Text] [PDF]
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C. Estrach, V. E. Abernethy, and J. K. Dawson Infections and anti-TNF therapy: strategies for screening based on clinical experience Rheumatology, January 1, 2004; 43(1): 115 - 116. [Full Text] [PDF]
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A. Brennan, N. Bansback, A. Reynolds, and P. Conway Modelling the cost-effectiveness of etanercept in adults with rheumatoid arthritis in the UK Rheumatology, January 1, 2004; 43(1): 62 - 72. [Abstract] [Full Text] [PDF]
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C Keller, A Webb, and J Davis Cytokines in the seronegative spondyloarthropathies and their modification by TNF blockade: a brief report and literature review Ann Rheum Dis, December 1, 2003; 62(12): 1128 - 1132. [Abstract] [Full Text] [PDF]
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L B A van de Putte, R Rau, F C Breedveld, J R Kalden, M G Malaise, P L C M van Riel, M Schattenkirchner, P Emery, G R Burmester, H Zeidler, et al. Efficacy and safety of the fully human anti-tumour necrosis factor {alpha} monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study Ann Rheum Dis, December 1, 2003; 62(12): 1168 - 1177. [Abstract] [Full Text] [PDF]
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