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Methotrexate is established treatment for juvenile idiopathic arthritis (JIA) and more recently tumor necrosis factor (TNF) antagonists have been shown to be effective. Now the results of a trial of adalimumab, a fully human monoclonal antibody against TNF, have been reported (New England Journal of Medicine 2008;359:810–20). A total of 171 patients aged 4–17 years with polyarticular JIA entered a 16-week open-label, lead-in phase in two groups: 86 in a no-methotrexate group (either never had methotrexate or discontinued it at least 2 weeks previously) and 85 in a methotrexate group (stable dose for at least 3 months before the trial and continued during the open-label, 16-week phase). During the open-label phase all patients received subcutaneous adalimumab every 2 weeks and 144, 64 (74%) in the no-methotrexate group and 80 (94%) in the methotrexate group, had an American College of Rheumatology Pediatric 30% (ACR Pedi 30) response at 16 weeks. Of these, 133 (58 and 75) were randomised to adalimumab or placebo for the 32-week, double-blind, withdrawal phase. Disease flares during the withdrawal phase occurred in 71% (placebo, no-methotrexate), 41% (adalimumab, no methotrexate), 65% (placebo, methotrexate), and 37% (adalimumab, methotrexate). At the end of the double-blind withdrawal phase significantly more patients in the methotrexate group had ACR Pedi 30, 50, 70, or 90 responses with adalimumab than with placebo. In the no-methotrexate group this …
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