Leflunomide or methotrexate for juvenile rheumatoid arthritis.

Détails

ID Serval
serval:BIB_37162
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Leflunomide or methotrexate for juvenile rheumatoid arthritis.
Périodique
New England Journal of Medicine
Auteur⸱e⸱s
Silverman E., Mouy R., Spiegel L., Jung L.K., Saurenmann R.K., Lahdenne P., Horneff G., Calvo I., Szer I.S., Simpson K., Stewart J.A., Strand V.
Collaborateur⸱rice⸱s
Leflunomide in Juvenile Rheumatoid Arthritis (JRA) Investigator Group
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Statut éditorial
Publié
Date de publication
2005
Volume
352
Numéro
16
Pages
1655-1666
Langue
anglais
Notes
Publication types: Clinical Trial ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
BACKGROUND: We compared the safety and efficacy of leflunomide with that of methotrexate in the treatment of polyarticular juvenile rheumatoid arthritis in a multinational, randomized, controlled trial.
METHODS: Patients 3 to 17 years of age received leflunomide or methotrexate for 16 weeks in a double-dummy, blinded fashion, followed by a 32-week blinded extension. The rates of American College of Rheumatology Pediatric 30 percent responses (ACR Pedi 30) and the Percent Improvement Index were assessed at baseline and every 4 weeks for 16 weeks and every 8 weeks during the 32-week extension study.
RESULTS: Of 94 patients randomized, 86 completed 16 weeks of treatment, 70 of whom entered the extension study. At week 16, more patients in the methotrexate group than in the leflunomide group had an ACR Pedi 30 response (89 percent vs. 68 percent, P=0.02), whereas the values for the Percent Improvement Index did not differ significantly (-52.87 percent vs. -44.41 percent, P=0.18). In both groups, the improvements achieved at week 16 were maintained at week 48. The most common adverse events in both groups included gastrointestinal symptoms, headache, and nasopharyngeal symptoms. Aminotransferase elevations were more frequent with methotrexate than with leflunomide during the initial study and the extension study.
CONCLUSIONS: In patients with polyarticular juvenile rheumatoid arthritis, methotrexate and leflunomide both resulted in high rates of clinical improvement, but the rate was slightly greater for methotrexate. At the doses used in this study, methotrexate was more effective than leflunomide.
Mots-clé
Administration, Oral, Adolescent, Alanine Transaminase/blood, Analysis of Variance, Antirheumatic Agents/adverse effects, Antirheumatic Agents/pharmacokinetics, Arthritis, Juvenile/drug therapy, Child, Child, Preschool, Female, Humans, Isoxazoles/adverse effects, Isoxazoles/pharmacokinetics, Logistic Models, Male, Methotrexate/adverse effects, Methotrexate/pharmacokinetics, Severity of Illness Index
Pubmed
Web of science
Création de la notice
19/11/2007 13:35
Dernière modification de la notice
20/08/2019 14:25
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