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Dosing Celecoxib in Pediatric Patients With Juvenile Rheumatoid Arthritis
The Journal of Clinical Pharmacology, 09/01/2011
Clinical Article
Krishnaswami S et al. – Doses and dosage forms not studied in the juvenile rheumatoid arthritis (JRA) trial were approved based on the results of this analysis.
Methods- Pharmacokinetic (PK) and efficacy data from a randomized, double–blind, 12–week study of celecoxib dosed at 3 and 6 mg/kg twice a day (bid) as an investigational suspension formulation in 152 JRA patients aged 2 to 17 years, PK data from 36 adult RA patients, and relative bioavailability data in healthy adults comparing suspension or capsule sprinkles with the commercial capsule were analyzed.
- Typical oral clearance (L/h) values were 40% and 24% lower in patients weighing 10 and 25 kg, respectively, compared with a 70–kg patient.
- Longitudinal, logistic pharmacodynamic models incorporating linear effects of dose/area under the plasma concentration–time curve (AUC) over 0 to 12 hours (AUC0–12) suggested that the percentage of responders increased with celecoxib exposure.
- Systemic exposures (AUC) were similar for the suspension, capsule sprinkles, and intact capsule.
- Administration of a 50–mg bid capsule (or sprinkles) for patients weighing 10 to 25 kg and 100 mg bid for patients >25 kg was predicted to yield similar exposures and response rates as those observed in the JRA trial.