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A prospective study comparing celecoxib with naproxen in children with juvenile rheumatoid arthritis.

Author(s): Foeldvari I, Szer IS, Zemel LS, Lovell DJ, Giannini EH, Robbins JL, West CR, Steidle G, Krishnaswami S, Bloom BJ

Affiliation(s): Hamburger Zentrum fur Kinder- und Jugendrheumatologie, Am Klinikum Eilbek, Dehnhaide 120, 22081 Hamburg, Germany. sprechstunde@kinderrheumatologie.de

Publication date & source: 2009-01, J Rheumatol., 36(1):174-82.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

Page last updated: 2009-10-20

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