TY - JOUR T1 - A Prospective Study Comparing Celecoxib with Naproxen in Children with Juvenile Rheumatoid Arthritis JF - The Journal of Rheumatology JO - J Rheumatol SP - 174 LP - 182 DO - 10.3899/jrheum.080073 VL - 36 IS - 1 AU - IVAN FOELDVARI AU - ILONA S. SZER AU - LAWRENCE S. ZEMEL AU - DANIEL J. LOVELL AU - EDWARD H. GIANNINI AU - JEFFERY L. ROBBINS AU - CHRISTINE R. WEST AU - GINA STEIDLE AU - SRIRAM KRISHNASWAMI AU - BRADLEY J. BLOOM Y1 - 2009/01/01 UR - http://www.jrheum.org/content/36/1/174.abstract N2 - Objective To compare the efficacy and safety of celecoxib and naproxen in children with juvenile rheumatoid arthritis (JRA). Methods In this multicenter, randomized, double-blind, noninferiority study, subjects with JRA were randomized to receive a target dose of celecoxib 3 mg/kg bid or 6 mg/kg bid, or a target dose of naproxen 7.5 mg/kg bid for 12 weeks (maximum allowed dose = 600 mg total daily dose). The primary efficacy measure was the percentage of responders at Week 12 attaining the American College of Rheumatology pediatric 30% improvement criterion (ACR Pediatric-30). Results Both celecoxib doses were at least as effective as naproxen at Week 12 [ACR Pediatric-30 treatment differences: celecoxib 3 mg/kg bid – naproxen = 1.36% (95% CI –13.08 to 15.80); celecoxib 6 mg/kg bid – naproxen = 13.02% (95% CI –0.22 to 26.25)]. Celecoxib 6 mg/kg bid had a numerically higher response rate than celecoxib 3 mg/kg bid at all postrandomization visits and a numerically higher response rate than naproxen 7.5 mg/kg bid at Weeks 4, 8, and 12. Improvement in each ACR Pediatric-30 core set measure was comparable to or numerically higher for celecoxib 6 mg/kg bid than naproxen or celecoxib 3 mg/kg bid. Adverse event rates were similar for all treatment groups, except that gastrointestinal adverse events were more common in the naproxen group, although the difference was not statistically significant. Conclusion Celecoxib 3 mg/kg bid and 6 mg/kg bid were at least as effective as naproxen 7.5 mg/kg bid in treating the signs and symptoms of JRA over 12 weeks. All treatments were generally well tolerated. ER -