A Prospective Study Comparing Celecoxib with Naproxen in Children with Juvenile Rheumatoid Arthritis

<jats:sec><jats:title>Objective</jats:title><jats:p>To compare the efficacy and safety of celecoxib and naproxen in children with juvenile rheumatoid arthritis (JRA).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec>