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Tumor necrosis factor (TNF) plays a pathogenic role in juvenile rheumatoid arthritis (JRA). Adalimumab, a TNF antagonist that has benefit for adult rheumatoid arthritis, now has been evaluated for treatment of JRA in a manufacturer-funded study.
This study’s unusual protocol was designed to minimize exposure to placebo. During an open-label 16-week lead-in phase, 171 children with JRA (age range, 4–17 years) were stratified by methotrexate use (85 patients) or nonuse (86 patients). All received 24 mg/m2 of adalimumab subcutaneously every other week for 16 weeks. At week 16, 74% of methotrexate recipients and 94% of nonrecipients achieved American College of Rheumatology Pediatric 30% (ACR Pedi 30) responses; responders were enrolled in the d…