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A number of studies have been performed demonstrating the efficacy of etanercept.
In 180 adults a dose dependent fall in the number of involved joints was demonstrated after 3 months of treament. At the highest dose - 16mg/m2 - 64% improved, compared to 28% in the placebo group. Benefits manifested within 2 weeks, but symptoms returned a few weeks after stopping the drug.
In a study of 234 adults on etanercept 25mg, 62% had acheived a 20% improvement (ACR20 response), and 41% had acheived a 50% improvement (ACR50) by 3 months compared to placebo (23%). These improvements persisited at 6 months.
A study of 632 patients with disease duration of less than 3 years compared etanercept with methotrexate (mean dose 19mg). This study showed greater improvements in the etanercept group at 6 months and a year (using ACR-N). When measured using standard ACR response criteria (ACR 20,50,70) however results for etanercept were better than methotrexate at 6 months but not at one year.
A study of 89 patients with active disease despite methotrexate has also been performed. This showed that the addition of etanercept increased the number of those acheiveing a 20% response at 6 months from 27% to 71%.
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