RT Journal Article
SR Electronic
T1 A Prospective Study Comparing Celecoxib with Naproxen in Children with Juvenile Rheumatoid Arthritis
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 174
OP 182
DO 10.3899/jrheum.080073
VO 36
IS 1
A1 IVAN FOELDVARI
A1 ILONA S. SZER
A1 LAWRENCE S. ZEMEL
A1 DANIEL J. LOVELL
A1 EDWARD H. GIANNINI
A1 JEFFERY L. ROBBINS
A1 CHRISTINE R. WEST
A1 GINA STEIDLE
A1 SRIRAM KRISHNASWAMI
A1 BRADLEY J. BLOOM
YR 2009
UL http://www.jrheum.org/content/36/1/174.abstract
AB 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.