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

Ivan Foeldvari1, Ilona S Szer, Lawrence S Zemel

  • 1Hamburger Zentrum für Kinder- und Jugendrheumatologie, Am Klinikum Eilbek, Dehnhaide 120, 22081 Hamburg, Germany. sprechstunde@kinderrheumatologie.de

The Journal of Rheumatology
|November 18, 2008
PubMed

Insights

Celecoxib demonstrated comparable efficacy to naproxen in treating juvenile rheumatoid arthritis (JRA) over 12 weeks. Both medications were well-tolerated, with similar adverse event rates, though naproxen showed slightly more gastrointestinal events.

Area of Science:

  • Pediatric Rheumatology
  • Pharmacology
  • Clinical Trials

Background:

  • Juvenile rheumatoid arthritis (JRA) is a chronic autoimmune disease affecting children.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to manage JRA symptoms.
  • Evaluating the efficacy and safety of different NSAIDs in pediatric populations is crucial.

Purpose of the Study:

  • To compare the efficacy and safety of celecoxib versus naproxen in pediatric patients diagnosed with JRA.
  • To determine if celecoxib is non-inferior to naproxen in treating JRA symptoms.

Main Methods:

  • A multicenter, randomized, double-blind, noninferiority study was conducted.
  • Pediatric patients with JRA received either celecoxib (3 mg/kg bid or 6 mg/kg bid) or naproxen (7.5 mg/kg bid) for 12 weeks.
  • The primary efficacy endpoint was the proportion of patients achieving the American College of Rheumatology pediatric 30% improvement criterion (ACR Pediatric-30) at 12 weeks.

Main Results:

  • Both celecoxib dosages were found to be at least as effective as naproxen in achieving ACR Pediatric-30 response at 12 weeks.
  • The higher dose of celecoxib (6 mg/kg bid) showed numerically higher response rates compared to naproxen and the lower dose of celecoxib.
  • Adverse event profiles were similar across groups, with a non-significant trend towards more gastrointestinal events with naproxen.

Conclusions:

  • Celecoxib at both 3 mg/kg bid and 6 mg/kg bid demonstrated non-inferior efficacy to naproxen in managing JRA signs and symptoms over a 12-week treatment period.
  • All investigated treatments, including celecoxib and naproxen, were generally well-tolerated in the pediatric JRA population.
  • The findings support the use of celecoxib as an effective treatment option for children with JRA.
Abstract

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