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| |  ACR MEETING: Data Show Continued Response To Enbrel After Two Years Of Treatment SAN DIEGO, CA – Nov. 12, 1998 -- Immunex and Wyeth-Ayerst Laboratories’ Enbrel (etanercept), a new treatment for moderately to severely active rheumatoid arthritis (RA), has been shown to maintain its tolerability and side effect profile for as long as two years of continuous use. Rheumatoid arthritis activity was also measured in this open-label safety study. The clinical trial results were presented today (Nov. 12) at the 62nd national scientific meeting of the American College of Rheumatology (ACR). "Enbrel continues to show good tolerability for up to two years with a side effect profile similar to that of previously reported studies," said Dr. Scott Baumgartner of Spokane, WA., a lead Enbrel clinical investigator and practising rheumatologist. "Enbrel provides an important new treatment option for patients with moderate to severe rheumatoid arthritis." Enbrel is indicated for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Eighty-three of 105 patients continue on ENBREL in this open-trial, 51 of whom have now completed 24 months of treatment. Activity was measured by a composite score called a Paulus response. The Paulus response requires a 20 percent improvement in four of the following six parameters: tender joint count; swollen joint count; patient global assessment; physician global assessment; morning stiffness; and acute phase reactants. In this study, 88 percent of those reaching two years experienced a Paulus response of 20 percent; 65 percent experienced a Paulus response of 50 percent (meaning patients had at least a 50 percent improvement in the clinical parameters) and 39 percent experienced a Paulus response of 70 percent. Adverse events occurred at rates consistent with other Enbrel studies and did not increase with more prolonged use of the drug. The most frequently reported adverse events in controlled clinical trials with Enbrel were mild to moderate injection site reactions. The long-term effects of Enbrel treatment on the development or course of serious infection, malignancy and autoimmune disease are unknown. Patients with a serious infection, including sepsis, or who are allergic to Enbrel or any of its components should not take Enbrel. If patients develop a serious or unusual infection while on Enbrel, they should talk with their doctor immediately. Study participants were treated with 25 mg of Enbrel twice weekly in this ongoing study being conducted at 11 study sites in the United States. People who qualified for participation in this study had moderately to severely active RA and had failed at least one DMARD. In addition, participants had to have been previously treated with Enbrel in other clinical trials. RA is a devastating disease that affects more than two million people in the United States. It is a disease of the immune system that occurs more often in women than in men and has no known cure. The economic impact of the disease is also significant, since patients may begin to develop the disease at any age, but onset is highest among women in their 30s and 40s. Enbrel acts by binding tumour necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in the cascade of reactions that cause the inflammatory process of RA. Enbrel competitively inhibits the binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
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