title: A prospective study comparing celecoxib with naproxen in children with juvenile rheumatoid arthritis.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Hamburger Zentrum für Kinder- und Jugendrheumatologie, Am Klinikum Eilbek, Dehnhaide 120, 22081 Hamburg, Germany. sprechstunde@kinderrheumatologie.de
authors.forename: Ivan
authors.initials: I
authors.lastname: Foeldvari
authors.forename: Ilona S
authors.initials: IS
authors.lastname: Szer
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Zemel
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lovell
authors.forename: Edward H
authors.initials: EH
authors.lastname: Giannini
authors.forename: Jeffery L
authors.initials: JL
authors.lastname: Robbins
authors.forename: Christine R
authors.initials: CR
authors.lastname: West
authors.forename: Gina
authors.initials: G
authors.lastname: Steidle
authors.forename: Sriram
authors.initials: S
authors.lastname: Krishnaswami
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Bloom
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D000068579:Celecoxib; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009288:Naproxen / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011720:Pyrazoles; D013449:Sulfonamides; D009288:Naproxen; D000068579:Celecoxib