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IVAN FOELDVARI, RUBEN BURGOS-VARGAS, ANGELIKA THON, and DIETRICH TUERCK

ABSTRACT.

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 C_max 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.

Conclusion. Meloxicam suspension 0.25 mg/kg once daily seems to be effective and safe for treating active JRA over a period of 52 weeks. (J Rheumatol 2002;29:1079-83)

Key Indexing Terms:

COX-2 INHIBITOR
COX-1 INHIBITOR
CHILDREN
NONSTEROIDAL ANTIINFLAMMATORY DRUG

From the Pediatric Rheumatology Clinic, Am Allgemeinen Krankenhaus Eilbek, Hamburg, Germany; Department of Rheumatology, Hospital General de Mexico, Mexico City, Mexico; Department of Pediatric Rheumatology, University Children's Hospital, Hannover, Germany; and Department of Pharmacokinetics and Drug Metabolism, Boehringer Ingelheim Pharma KG, Biberach, Germany.

Supported by Boehringer Ingelheim Pharma KG, Biberach, Germany.

I. Foeldvari, MD, Pediatric Rheumatology Clinic, Am Allgemeinen Krankenhaus Eilbek; R. Burgos-Vargas, MD, Department of Rheumatology, Hospital General de Mexico; A. Thon, MD, Department of Pediatric Rheumatology, University Children's Hospital, Hannover; D. Tuerck, PhD, Boehringer Ingelheim Pharma KG.

Address reprint requests to Dr. I. Foeldvari, Kinder und Jugendrheumatologische Sprechstunde, Am Allgemeinen Krankenhaus Eilbek, Friedrichsberger Str. 60, 22081 Hamburg, Germany. E-mail: sprechstunde@kinderrheumatologie.de

Submitted July 5, 2001; revision accepted November 8, 2001.