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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.
Source Information
From the Departments of Pediatrics and Immunology, University of Toronto, Toronto (E.S.); the Division of Rheumatology, Hospital for Sick Children, Toronto (E.S., L.S.); Hôpital des Enfants Malades, Paris (R.M.); the Department of Pediatrics, Creighton University Medical Center, Omaha, Nebr. (L.K.J.); University Children's Hospital, Zürich, Switzerland (R.K.S.); the Hospital for Children and Adolescents, University of Helsinki, Helsinki (P.L.); Martin Luther Uniklinik Halle, Halle, Germany (G.H.); Hospital Universitario Infantil, Valencia, Spain (I.C.); the Pediatric Rheumatology Division, Children's Hospital San Diego, San Diego, Calif. (I.S.S.); Sanofi–Aventis, Bridgewater, N.J. (K.S.); Sanofi–Aventis Pharma Canada, Laval, Que. (J.A.S.); and the Division of Immunology, Stanford University, Palo Alto, Calif. (V.S.).
Address reprint requests to Dr. Silverman at the Hospital for Sick Children, 555 University Ave., Rm. 8248, Division of Rheumatology, Toronto, ON M5G 1X8, Canada, or at esilverman{at}sickkids.ca.
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