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Long-Term Treatment With Enbrel Well Tolerated By Rheumatoid Arthritis Patients MONTREAL, QC -- June 25, 1998 -- A study of Immunex Corp.'s Enbrel(TM) shows that the drug was generally well-tolerated by rheumatoid arthritis patients receiving long-term therapy with dosing up to 18 months. These new interim open label data were presented at the annual Pan American Congress of Rheumatology (PANLAR) meeting in Montreal, QC., by Dr. Larry Moreland, a rheumatologist and investigator at the University of Alabama at Birmingham. Rheumatoid arthritis disease activity was also measured in this on-going open-label safety study. Seventy-two patients completed 18 months. Ninety-three percent experienced 20 percent reduction in tender joints, and 88 percent experienced 20 percent reduction in swollen joints. Seventy-five percent of the patients experienced 50 percent reduction in tender joints and 74 percent experienced 50 percent reduction in swollen joints. Injection site reactions were mild and infrequent. Adverse events were not outside of those expected in this population, and are consistent with other Enbrel studies. This open-label study includes 105 patients, 72 of whom have now completed 18 months on Enbrel. There are 11 study sites in the United States. Designed to evaluate the long-term safety and activity of Enbrel for the treatment of RA, patients were treated with 25 mg of Enbrel twice weekly in this on-going study. Patients qualified for participation in this study had active RA and had failed at least one DMARD. In addition, patients had to have been previously treated with Enbrel in other trials of the drug. These results are based on investigational data as analysed by Immunex. These data have not been reviewed by the FDA as part of an application for regulatory approval. Rheumatoid arthritis is a devastating disease that affects 2.5 million people in the United States and five million people world-wide. It is a disease of the immune system that occurs more often in women than men and has no known cure. The economic impact of this disease is also significant, since patients may begin to develop the disease in their 30s or 40s. In a recent study, 50 percent of RA patients became disabled and were unable to work 10 years after diagnosis. Enbrel is thought to interfere specifically with the inflammatory process in RA. In RA, excess TNF combines with cell surface TNF receptors and produces a cascade of damaging inflammatory effects on joints. Enbrel is a protein-based drug comprising only human amino acid sequences. Enbrel is a recombinant version of the soluble human p75 TNF receptor, linked to the Fc portion of human IgG1. It competitively inhibits the binding of TNF to its cell surface receptors, and thereby inhibits TNF biologic activity. E-mail this page to a friend or colleague! To print, use this version