High response rate in the phase I/II study of meloxicam in juvenile rheumatoid arthritis.
OBJECTIVE
Use of meloxicam as a selective COX-2 inhibitor for treatment of adult rheumatic diseases decreases the frequency of gastrointestinal (GI) side effects in comparison with nonselective COX inhibitors. Up to 50% of children with juvenile rheumatoid arthritis (JRA) also develop GI side effects through nonselective COX inhibitors. In this 12 week Phase I/II study, with an additional open extension lasting up to 52 weeks, the safety, efficacy, and pharmacokinetics of meloxicam in JRA were investigated.


METHODS
Meloxicam suspension 0.25 mg/kg once daily was given to 36 patients with JRA who required a nonsteroidal antiinflammatory drug. Safety evaluation and periodic measurement of efficacy were carried out using the Pediatric Rheumatology International Trials Organisation (PRINTO) criteria. Eighteen patients underwent pharmacokinetic (PK) evaluation.


RESULTS
Thirty-one patients completed the study. Four were dropped due to administrative reasons. One patient, who found the drug ineffective, discontinued participation. A response was seen according to PRINTO outcome criteria in 44% of the patients at Week 4, 62% at Week 12, and 74% at Week 52. Drug related adverse events were observed in 5 patients. PK evaluation showed that the maximum plasma concentration Cmax of -34% and AUC(0-infinity) of -28% tended to be lower in younger children (2-6 years) versus older children. Plasma elimination half-life (13 h) was similar in all patients.


CONCLUSIONS
Meloxicam suspension 0.25 mg/kg once daily seems to be effective and safe for treating active JRA over a period of 52 weeks.
Foeldvari
Ivan
I
Pediatric Rheumatology Clinic, Am Allgemeinen Krankenhaus Eilbek, Hamburg, Germany. sprechstunde@kinderrheumatologie.de
Burgos-Vargas
Ruben
R
Thon
Angelika
A
Tuerck
Dietrich
D
D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D051545:Cyclooxygenase 1; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007527:Isoenzymes / Q000037:antagonists & inhibitors; D008297:Male; D000077239:Meloxicam; D008565:Membrane Proteins; D017060:Patient Satisfaction; D011451:Prostaglandin-Endoperoxide Synthases; D013843:Thiazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D008565:Membrane Proteins; D013843:Thiazines; D013844:Thiazoles; D051545:Cyclooxygenase 1; D051546:Cyclooxygenase 2; C496511:PTGS1 protein, human; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; D000077239:Meloxicam