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Etanercept in Combination with Sulfasalazine, Hydroxychloroquine, or Gold in the Treatment of Rheumatoid Arthritis
JAMES R. O'DELL, KARA PETERSEN, ROBERT LEFF, WILLIAM PALMER, ERIC SCHNED, KENT BLAKELY, CLAIRE HAIRE, and ANA FERNANDEZ
ABSTRACT. Methods. A prospective open-label study enrolled 119 patients with RA who had active disease despite stable therapy with SSZ (n = 50), HCQ (n = 50), or intramuscular gold (n = 19). Primary efficacy endpoints consisted of American College of Rheumatology responses at 24 and 48 weeks. Safety was established at regularly scheduled visits. Results. Patients in each etanercept combination showed significant improvement at both 24 and 48 weeks. Toxicity withdrawals by 48 weeks included gold (n = 1): proteinuria; HCQ (n = 5): septic wrist and bilateral pneumonia, rash, optic neuritis, breast cancer, squamous cancer of the tongue; and SSZ (n = 5): otitis media, elevated liver function indicators, pericarditis, rash, and gastroenteritis. The most common adverse events not requiring discontinuation from the study were injection site reactions (43% of patients) and upper respiratory type infections (34%). Conclusion. This study is the first to prospectively evaluate the safety of etanercept in combination with SSZ, HCQ, and gold in patients with RA. Etanercept in combination with SSZ, HCQ, or gold was efficacious and well tolerated, with a discontinuation rate of 9% (11/119) for adverse events at 48 weeks. (J Rheumatol 2006;33:213-8) Key Indexing Terms:
RHEUMATOID ARTHRITIS
From the Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA. J.R. O'Dell, MD, University of Nebraska Medical Center (UNMC); K. Petersen, MD, University of Iowa Medical Center, Iowa City, Iowa; R. Leff, MD; A. Fernandez, MD, St. Mary's/Duluth Clinic Health System, Duluth, Minnesota; W. Palmer, MD, Westroads Medical Group, Omaha, Nebraska; E. Schned, MD, Park Nicollet Clinic, St. Louis Park, Minnesota; K. Blakely, MD, Platte Valley Medical Group, Kearney, Nebraska; C. Haire, RN, MSN, UNMC. Address reprint requests to Dr. J.R. O'Dell, Department of Internal Medicine, University of Nebraska Medical Center, 983025 Nebraska Medical Center, Omaha, NE 68198-3025. E-mail: jrodell@unmc.edu Accepted for publication August 15, 2005. |