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ACR: Kineret (Anakinra)/Enbrel (Etanercept) Combo Appears to be Well-Tolerated in Rheumatoid Arthritis SAN FRANCISCO, CA -- November 12, 2001 -- An early clinical study shows that combination treatment with Kineret (anakinra) and Enbrel (etanercept) appears to be well-tolerated in rheumatoid arthritis (RA) patients. The findings will be presented this week at the 65th annual scientific meeting of the American College of Rheumatology (ACR), by lead investigator Dr. Michael Schiff, medical director, Denver Arthritis Clinic Research Unit. "This study represents an important first step in determining the potential risk-benefit ratio of combination biologic therapy," said Dr. Schiff. In this single-arm, multi-center, open-label study, 58 RA patients with active disease already taking a usual dose of etanercept (25 mg twice weekly) were then administered anakinra (1 mg/kg/day) for 24 weeks. The most common side effect was a mild to moderate reaction at the site of injection (83 percent), followed by respiratory complaints (53 percent). Four patients acquired serious infections, but there were no reports of tuberculosis or opportunistic infections (infections caused by normally harmless microorganisms in a person whose resistance has been lowered by disease). Although there was no control group, patients exhibited improvements in signs and symptoms of the disease and health-related quality of life. "It appears that it is safe to proceed with larger trials to assess the overall safety and efficacy of combination therapy for rheumatoid arthritis patients," said Dr. Schiff. Rheumatoid arthritis affects more than two million Americans. It is the most serious and disabling type of arthritis that is characterized by chronic joint inflammation, pain, stiffness and fatigue. SOURCE: Denver Arthritis Clinic E-mail this page to a friend or colleague! To print, use this version