STOCKHOLM, SWEDEN — June 14, 2002 —
Immunex Corporation today announced that data supporting the efficacy, tolerability and science of Enbrel® (etanercept) will be discussed at the 3rd Annual European League Against Rheumatism Meeting this week in approximately 35 oral and poster presentations. Data on Enbrel, the only fully human, TNF soluble receptor, will include the longest study to date of patients on a continuous therapy to inhibit tumor necrosis factor (TNF) in rheumatoid arthritis (RA).
“What we have seen over time is a consistent and sustained response to this RA therapy, with more than 70% of patients responding,” said Daniel Burge, M.D., Immunex vice president of clinical development. “Consistent response, defined as having achieved an ACR 20 response, has been seen when Enbrel is used as monotherapy (without other disease modifying anti-rheumatic drugs), whether patients are young or old, whether patients have long-standing disease or are newly diagnosed with moderate to severe disease.” Data was presented from an ongoing study of 629 patients using Enbrel (etanercept) as monotherapy and who had failed other DMARDs (disease-modifying anti-rheumatic agents).
These patients were observed in an open-label follow up study. The following data were presented for 119 patients who have now completed five years of therapy with Enbrel: — 71% patients achieved the ACR 20 — 48% patients achieved the ACR 50 — 27% patients achieved the ACR 70 “In addition to seeing sustained efficacy through five years of follow up, Enbrel has demonstrated a consistent tolerability profile,” said Dr. Burge. “In short-term studies of people being treated with Enbrel, the serious infection rate was comparable to those receiving placebo, and did not change with long-term experience. In addition, post-marketing reports of serious infections including tuberculosis, occur at rates comparable to the expected U.S. background incidence.”
Enbrel was generally well tolerated over the five years of this study. In the study, no significant differences in the type or rate of adverse events were seen in patients treated with Enbrel over time. Serious adverse events occurred at a rate of 0.14 per patient-year in this long-term study compared to 0.13 in the patients treated with Enbrel and 0.20 in placebo patients in the previous controlled studies.
Likewise, serious infection (associated with hospitalization or IV antibiotics) occurred at a rate of 0.04 per patient year in the long-term study, compared to 0.04 per patient year in the patients treated with Enbrel and 0.05 in placebo patients in the controlled studies. The number of malignancies reported in patients treated with Enbrel was similar to the expected number calculated from the National Cancer Institute SEER database (30 observed vs. 31 predicted). No opportunistic infections have been observed in patients treated with Enbrel in the long-term study.
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