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Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis
Arthritis & Rheumatism, 08/31/09
Giannini EH et al. – Etanercept or etanercept plus MTX has an acceptable safety and effectiveness profile in children with selected categories of JIA. Improvement was maintained for 3 y in those continuing to receive medication.
Methods- 2-18 y old RF+ or RF- patients with polyarthritis, systemic JIA, or extended oligoarthritis were enrolled
- Patients received MTX (≥ 10 mg/m2/w), etanercept (0.8 mg/kg/w), or etanercept + MTX for 3 y in an open-label, non-randomized study
- 197, 103, and 294 patients were enrolled in the MTX, etanercept, and etanercept + MTX groups, respectively
- The rates of AEs were 4.6, 7.1, and 6.0 per 100 patient-years, respectively
- Medically important infections were similar (1.3, 1.8, and 2.8 per 100 patient-years, respectively)
- Scores for physician's global assessment and total active joints improved from baseline, and improvement was maintained for the duration of the study
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