title: Leflunomide or methotrexate for juvenile rheumatoid arthritis.
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.
authors.affiliation: Department of Pediatrics, University of Toronto, Toronto. esilverman@sickkids.ca
authors.forename: Earl
authors.initials: E
authors.lastname: Silverman
authors.forename: Richard
authors.initials: R
authors.lastname: Mouy
authors.forename: Lynn
authors.initials: L
authors.lastname: Spiegel
authors.forename: Lawrence K
authors.initials: LK
authors.lastname: Jung
authors.forename: Rotraud K
authors.initials: RK
authors.lastname: Saurenmann
authors.forename: Pekka
authors.initials: P
authors.lastname: Lahdenne
authors.forename: Gerd
authors.initials: G
authors.lastname: Horneff
authors.forename: Immaculada
authors.initials: I
authors.lastname: Calvo
authors.forename: Ilona S
authors.initials: IS
authors.lastname: Szer
authors.forename: Karen
authors.initials: K
authors.lastname: Simpson
authors.forename: John A
authors.initials: JA
authors.lastname: Stewart
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D000704:Analysis of Variance; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000077339:Leflunomide; D016015:Logistic Models; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012720:Severity of Illness Index
chemical_list: D018501:Antirheumatic Agents; D007555:Isoxazoles; D000410:Alanine Transaminase; D000077339:Leflunomide; D008727:Methotrexate