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Phase 3 psoriatic arthritis data for ENBREL (etanercept) announced at a national scientific meeting

n ACR20 response compared to 15 percent of 104 patients receiving placebo, after 12 weeks of treatment.
  • 72 percent of patients receiving ENBREL achieved a treatment response compared to 31 percent of patients receiving placebo after 12 weeks of treatment, using the PsARC measurement.
  • 54 percent of patients receiving ENBREL for 24 weeks were assessed as having clear or almost clear skin manifestations, as measured by the dermatologists global assessment, compared to 23 percent of patients receiving placebo. At baseline, 20 percent of patients in each group were clear or almost clear of skin disease.
    Also in this study, a subset (62 patients receiving ENBREL and 66 patients receiving placebo who had greater than 3 percent of their body covered by psoriatic plaque) were evaluated for psoriasis activity. Results showed that:
  • 23 percent of patients receiving ENBREL improved by 75 percent or better compared to 3 percent of patients receiving placebo, as measured by the psoriasis area and severity index (PASI) score.

    Adverse events were similar to those reported in previous trials of ENBREL in patients with rheumatoid arthritis. There was no increase in the number of serious adverse events occurring in patients receiving ENBREL as compared with those receiving placebo. Only the rate of injection site reactions (ISRs) in patients receiving ENBREL was statistically different compared to placebo (36 percent vs. 9 percent).

    These data are currently being reviewed by the U.S. Food & Drug Administration (FDA) for potential approval of ENBREL for the treatment of psoriatic arthritis. In September, the FDA granted priority review status requiring that the FDA act on the supplemental Biologics License Application (sBLA) within six months of submission date. Immunex submitted its sBLA for ENBREL on July 16, 2001. ENBREL is the first product to be reviewed by the FDA for the treatment of psoriatic arthritis.

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  • 12-Nov-2001


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