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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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