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A Prospective Study Comparing Celecoxib with Naproxen in Children with Juvenile Rheumatoid Arthritis IVAN FOELDVARI, ILONA S. SZER, LAWRENCE S. ZEMEL, DANIEL J. LOVELL, EDWARD H. GIANNINI, JEFFERY L. ROBBINS, CHRISTINE R. WEST, GINA STEIDLE, SRIRAM KRISHNASWAMI, and BRADLEY J. BLOOM
ABSTRACT. 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. (J Rheumatol First Release Nov 15 2008; doi:10-3899/jrheum.080073) Key Indexing Terms:
JUVENILE RHEUMATOID ARTHRITIS
From the Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany; Rady Children's Hospital, San Diego, California; Connecticut Children's Medical Center, Hartford, Connecticut; Cincinnati Children's Hospital Medical Center, William S. Rowe Division of Rheumatology, Cincinnati, Ohio; Pfizer Inc., New London, Connecticut; and Pfizer Inc., Ann Arbor, Michigan, USA. Sponsored by Pfizer Inc. I. Foeldvari, MD, Hamburger Zentrum für Kinder- und Jugendrheumatologie; I.S. Szer, MD, Rady Children's Hospital; L.S. Zemel, MD, Connecticut Children's Medical Center; D.J. Lovell, MD, MPH; E.H. Giannini, MSc, DrPH, Cincinnati Children's Hospital Medical Center, William S. Rowe Division of Rheumatology; B.J. Bloom, MD; J.L. Robbins, Pfizer Inc., New London, CT; C.R. West; G. Steidle; S Krishnaswami, Pfizer Inc., Ann Arbor, MI. Address reprint requests to Dr. I. Foeldvari, Kinder- und Jugendrheumatologe, Hamburger Zentrum für Kinder- und Jugendrheumatologie, Am Klinikum Eilbek, Dehnhaide 120, 22081 Hamburg, Germany. E-mail: sprechstunde@kinderrheumatologie.de Accepted for publication August 15, 2008.
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