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ACR: PEGylated Soluble Tumor Necrosis Factor Receptor Type I (PEG sTNF-RI) Shows Promise in Rheumatoid Arthritis SAN FRANCISCO, CA -- November 12, 2001 -- Amgen today announced data from as early trial of one investigational compound being studied in rheumatoid arthritis (RA). The results of this trial are being presented here this week at the 65th annual scientific meeting of the American College of Rheumatology (ACR). "We are pleased with these initial results that indicate our research is headed in the right direction,” said Dr. Roger M. Perlmutter, executive vice president, Amgen research and development. “Amgen will continue to explore new medicines in the area of rheumatology using cutting-edge technologies.” A Phase 2, multi-center, double blind, randomized extension study (n=502) conducted by Dr. Michael Schiff, medical director of the Denver Arthritis Clinic Research Unit, and colleagues evaluated long-term safety of PEGylated Soluble Tumor Necrosis Factor Receptor Type I, or PEG sTNF-RI, in the treatment of patients with active RA. Patients who completed previous randomized, placebo-controlled Phase 2 clinical studies (either every-other week or weekly) were eligible for this study. Patients in the every-other-week dosing study were randomized to receive PEG sTNF-RI (300 mg/kg or 600 mg/kg) every other week, and those who were previously enrolled in the weekly dosing study were randomized to receive either 400 mg/kg or 800 mg/kg every week. Patients were treated for an average of seven months and were allowed to continue most single or combination background disease-modifying RA treatments. Ten percent of patients reported a mild to moderate reaction at the site of injection, and 5 percent of these reports were determined to be related to the study treatment. No patients withdrew from the study for these reactions. There were no neutralizing antibodies (proteins that can lead to an attack by the immune system) detected and no treatment-related effects on laboratory variables or vital signs. There were 12 serious infectious episodes (2 percent), and three of these (0.6 percent) were determined to be related to study treatment. "We were pleased that no opportunistic infections, tuberculosis or neurological problems like multiple sclerosis were seen with PEG sTNF-RI in this trial,” said Dr. Schiff. “We look forward to conducting further studies to evaluate higher and more frequent dosing with this therapy." Though efficacy was not a primary endpoint for this study, efficacy measures were collected and analyzed. Researchers saw a continuation of clinical effect from the prior study as measured by American College of Rheumatology scoring. SOURCE: Amgen E-mail this page to a friend or colleague! To print, use this version