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| |  ACR: Long-Term Etanercept Monotherapy Effective in DMARD-Refractory Rheumatoid Arthritis By Bruce Sylvester Special to DG News NEW ORLEANS, LA -- OCTOBER 28, 2002 -- Patients with disease modifying anti-rheumatic drug (DMARD) - refractory rheumatoid arthritis who take etanercept (Enbrel) for more than five years show significant improvement while also decreasing, or discontinuing, use of corticosteroids, researchers report. These results were reported today at the annual meeting of the American College of Rheumatology. "These data indicate a consistent and sustained efficacy and long-term tolerability of Enbrel and continue to distinguish it as an important therapeutic option available for people suffering from the often debilitating effects of RA," said Dr. Mark Genovese, assistant professor of medicine at Stanford University School of Medicine, California, United States. Of the 629 subjects enrolled in the ongoing research, 562 were evaluable for efficacy. From this subset, 480 subjects received etanercept as monotherapy for more than 1 year, 431 for more than 2 years, 393 for more than 3 years, 319 for more than 4 years, and 68 patients for more than 5 years. All of the evaluable subjects showed a sustained response to etanercept therapy for the duration of therapy. At 4 years, the investigators found that 79 percent of patients had achieved the ACR 20, 53 percent the ACR 50, and 26 percent the ACR 70. Also, 26 percent of these subjects showed no tender joints, 21 percent had no swollen joints, and 17 percent had disability scores of zero. Of the 342 subjects were using corticosteroid therapy at baseline and following 4 years of etanercept treatment, 73 percent achieved decreased dosing or discontinuation of corticosteroids. The researchers reported a serious adverse events rate of 0.14 per patient-year with long-term therapy. This compares to a rate in shorter controlled studies of 0.13 in etanercept-treated patients and 0.20 in placebo patients. They also reported serious infections (associated with hospitalization or intravenous antibiotics) occurring at a rate of 0.05 per patient-year with long-term therapy compared with a rate of 0.04 in etanercept patients and 0.05 in placebo patients in other clinical trials. Malignancy rates were at the expected level calculated from the Surveillance, Epidemiology and End Results database (17 reported vs. 20 expected). The investigators reported no opportunistic infections. Subjects in the ongoing study have been followed for up to 68 months for a total of 1950 patient-years. Immunex Corporation provided support for this research.
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