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Safety and efficacy of once weekly etanercept 0.8 mg/kg in a multicentre 12 week trial in active polyarticular course juvenile idiopathic arthritis
Rheumatology, 06/03/09
Horneff G et al. - Treatment with etanercept once weekly using a double dosage leads to a significant improvement of disease activity in patients with active polyarticular course juvenile idiopathic arthritis and is well tolerated.
Methods- Study was undertaken to evaluate the safety and efficacy of etanercept x1/wk 0.8 mg/kg up to 50 mg s.c. in a 3 mo open label trial
- 20 pts; age: 4-17 yrs old
- Active polyarticular disease defined by:
- presence of ≥5 active joints with swelling,
- alternatively with pain or tenderness combined with limitation of motion
- Safety: based on AEs reports
- Efficacy: assessed using the PedACR30/50/70 criteria
- At the start of treatment the pts showed high disease activity.
- A rapid reduction of all disease activity parameters was observed
- A PedACR30/50/70 response was reached by:
- 75%/35%/10% of pts after 4 wks
- 90%/75%/35% after 8 wks
- 95%/75%/75%
after 12 wks of treatment
- There were 37 AEs, none of them serious, with injection site reactions; minor infections being the most frequent; no drop outs
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