Leflunomide or methotrexate for juvenile rheumatoid arthritis.

Details

Serval ID
serval:BIB_37162
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Leflunomide or methotrexate for juvenile rheumatoid arthritis.
Journal
New England Journal of Medicine
Author(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.
Working group(s)
Leflunomide in Juvenile Rheumatoid Arthritis (JRA) Investigator Group
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
2005
Volume
352
Number
16
Pages
1655-1666
Language
english
Notes
Publication types: Clinical Trial ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
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.
Keywords
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
Create date
19/11/2007 12:35
Last modification date
20/08/2019 13:25
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