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ARTICLE

Etanercept Therapy in Rheumatoid Arthritis

A Randomized, Controlled Trial

right arrow Larry W. Moreland, MD; Michael H. Schiff, MD; Scott W. Baumgartner, MD; Elizabeth A. Tindall, MD; Roy M. Fleischmann, MD; Ken J. Bulpitt, MD; Arthur L. Weaver, MD; Edward C. Keystone, MD; Daniel E. Furst, MD; Philip J. Mease, MD; Eric M. Ruderman, MD; David A. Horwitz, MD; Daniel G. Arkfeld, MD; Leslie Garrison, MD, MPH; Daniel J. Burge, MD; Consuelo M. Blosch, MD; Mary L.M. Lange, MS; Neil D. McDonnell, PharmD; and Michael E. Weinblatt, MD

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
space

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.

 

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R. Noguera-Pons, J. Borras-Blasco, I. Romero-Crespo, R. Anton-Torres, A. Navarro-Ruiz, and J. A. Gonzalez-Ferrandez
Optic Neuritis with Concurrent Etanercept and Isoniazid Therapy
Ann. Pharmacother., December 1, 2005; 39(12): 2131 - 2134.
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Ann Rheum DisHome page
J C Davis, D M van der Heijde, J Braun, M Dougados, J Cush, D Clegg, R D Inman, A Kivitz, L Zhou, A Solinger, et al.
Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks
Ann Rheum Dis, November 1, 2005; 64(11): 1557 - 1562.
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Ann Rheum DisHome page
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, 2005
Ann Rheum Dis, November 1, 2005; 64(suppl_4): iv2 - iv14.
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Ann Rheum DisHome page
M G Ruocco and M Karin
IKK{beta} as a target for treatment of inflammation induced bone loss
Ann Rheum Dis, November 1, 2005; 64(suppl_4): iv81 - iv85.
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Br Med BullHome page
C. J. Edwards
Immunological therapies for rheumatoid arthritis
Br. Med. Bull., September 20, 2005; 73-74(1): 71 - 82.
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Ann Rheum DisHome page
A Zink, J Listing, S Kary, P Ramlau, M Stoyanova-Scholz, K Babinsky, U von Hinueber, E Gromnica-Ihle, S Wassenberg, C Antoni, et al.
Treatment continuation in patients receiving biological agents or conventional DMARD therapy
Ann Rheum Dis, September 1, 2005; 64(9): 1274 - 1279.
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ChestHome page
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.
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J Clin PharmacolHome page
T. Doan and E. Massarotti
Rheumatoid Arthritis: An Overview of New and Emerging Therapies
J. Clin. Pharmacol., July 1, 2005; 45(7): 751 - 762.
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Ann Rheum DisHome page
D P M Symmons
Anti-tumour necrosis factor {alpha} therapy: can we afford it?
Ann Rheum Dis, July 1, 2005; 64(7): 969 - 970.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Rheumatology (Oxford)Home page
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.
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Ann Rheum DisHome page
P J Mease and C E Antoni
Psoriatic arthritis treatment: biological response modifiers
Ann Rheum Dis, March 1, 2005; 64(suppl_2): ii78 - ii82.
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Rheumatology (Oxford)Home page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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J Intensive Care MedHome page
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.
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J. Immunol.Home page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
P Mease
TNF{alpha} therapy in psoriatic arthritis and psoriasis
Ann Rheum Dis, July 1, 2004; 63(7): 755 - 758.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
F C Breedveld and J R Kalden
Appropriate and effective management of rheumatoid arthritis
Ann Rheum Dis, June 1, 2004; 63(6): 627 - 633.
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NEJMHome page
N. J. Olsen and C. M. Stein
New Drugs for Rheumatoid Arthritis
N. Engl. J. Med., May 20, 2004; 350(21): 2167 - 2179.
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Ann Rheum DisHome page
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.
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Rheumatology (Oxford)Home page
A. Brennan and N. Bansback
Re: Wolfe et al. Do rheumatology cost-effectiveness analyses make sense?
Rheumatology, May 1, 2004; 43(5): 677 - 678.
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Rheumatology (Oxford)Home page
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.
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Rheumatology (Oxford)Home page
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.
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Arch DermatolHome page
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.
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Ann Rheum DisHome page
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.
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Rheumatology (Oxford)Home page
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.
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Rheumatology (Oxford)Home page
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.
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Ann Rheum DisHome page
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.
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Ann Rheum DisHome page
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.
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