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Immunex Enbrel

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's Arthritis Advisory Committee votes April 11 that etanercept clinical data supports a claim of delaying radiographic progression in patients with early rheumatoid arthritis but votes against the claim for the overall RA population. Enbrel currently is approved for reduction in signs and symptoms of moderately to severely active RA in patients who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs). In the double-dummy, 632-patient Enbrel pivotal trial, patients with highly active disease were randomized to etanercept 10 mg or 25 mg twice-weekly injections, or optimized oral methotrexate (MTX) 20 mg per week. The study was designed to show that Enbrel 25 mg would "preserve at least 70% of the expected benefit of MTX" in preventing progression of disease, as assessed by the Total Sharp Score, a radiographic endpoint measuring erosion and joint space narrowing. The company reported that Enbrel 25 mg "is estimated to have 113% of the predicted MTX treatment effect and…preserves at least 96% of the predicted MTX treatment effect." The committee also endorsed Enbrel's efficacy in treating "signs and symptoms" in patients with early RA who have not received treatment with other DMARDs. The claim was supported by area under the curve measurements of the American College of Rheumatology numeric response (ACR-N) index, which demonstrated a benefit for Enbrel versus methotrexate

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