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Ibuprofen suspension in the treatment of juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study
E H Giannini1, E J Brewer, M L Miller
1Department of Pediatrics, Baylor College of Medicine, Houston, Texas.
Insights
Ibuprofen suspension and aspirin showed similar effectiveness in treating juvenile rheumatoid arthritis. Ibuprofen was better tolerated, with fewer children discontinuing treatment due to adverse reactions.
Area of Science:
- Pediatric Rheumatology
- Pharmacology
- Clinical Trials
Background:
- Juvenile rheumatoid arthritis (JRA) is a chronic inflammatory condition affecting children.
- Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used for JRA management.
- Comparing the efficacy and safety of different NSAIDs in pediatric populations is crucial.
Purpose of the Study:
- To compare the efficacy and safety of ibuprofen suspension versus aspirin in children with JRA.
- To evaluate the dose-response relationship of ibuprofen suspension in pediatric JRA patients.
Main Methods:
- A 12-week, multicenter, double-blind trial compared ibuprofen (30-40 mg/kg/day) with aspirin (60-80 mg/kg/day) in 92 children with JRA.
- An open-label, 24-week trial assessed ibuprofen suspension (30, 40, and 50 mg/kg/day) in 84 additional JRA patients.
Main Results:
- No significant differences in treatment response rates or improvement in disease activity indexes were observed between ibuprofen and aspirin.
- Fewer children receiving aspirin discontinued treatment due to adverse reactions compared to the ibuprofen group.
- Similar favorable response rates were noted across different ibuprofen doses, with sustained improvement over 24 weeks.
Conclusions:
- Ibuprofen suspension is an effective NSAID for treating juvenile rheumatoid arthritis in children.
- Ibuprofen suspension demonstrates acceptable tolerability in pediatric patients with JRA.
- A dose-response relationship was identified for upper gastrointestinal adverse reactions with ibuprofen.
Abstract:
Ninety-two children with juvenile rheumatoid arthritis were randomly assigned to treatment in a multicenter, double-blind, 12-week trial designed to compare the efficacy and safety of a liquid formulation of ibuprofen at a dosage of 30 to 40 mg/kg/day versus those of aspirin at a dosage of 60 to 80 mg/kg/day. No significant intergroup differences in response rates or in the amount of improvement in articular indexes of disease activity were observed. More children treated with aspirin discontinued treatment early because of adverse reactions. After this trial, 84 additional patients with juvenile rheumatoid arthritis entered a 24-week, multidose (30, 40, and 50 mg/kg/day), open trial of ibuprofen suspension. Favorable response rates for the three groups were similar, and continued improvement was observed throughout the 24-week period. A dose-response relationship was observed with respect to adverse reactions of the upper gastrointestinal tract. We conclude that ibuprofen suspension is an effective nonsteroidal antiinflammatory drug and that its tolerability in children is acceptable.