A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis

Objective. To evaluate the safety and efficacy of infliximab in the treatment of juvenile rheumatoid arthritis (JRA). Methods. This was an international, multicenter, randomized, placebo-controlled, double-blind study. One hundred twenty-two children with persistent polyarticular JRA despite prior m...

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Autores principales: Ruperto, Nicolino, Lovell, Daniel J., Cuttica, Ruben, Wilkinson, Nick, Woo, Patricia, Espada, Graciela, Wouters, Carina, Silverman, Earl D., Balogh, Zsolt, Henrickson, Michael, Apaz, María Teresa, Baildam, Eileen
Formato: Artículo
Lenguaje:Español
Publicado: 2007
Materias:
R Medicina (General)
Acceso en línea:http://pa.bibdigital.ucc.edu.ar/4019/1/A_Ruperto_Lovell_Cuttica_Wilkinson_Woo_Wouters_Silverman_Balogh_Henrickson_Apaz_Baildam.pdf
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Producción Académica Universidad Católica de Córdoba (UCCor) de Universidad Católica de Córdoba
id I38-R144-4019
record_format dspace
spelling I38-R144-40192025-04-11T22:20:33Z http://pa.bibdigital.ucc.edu.ar/4019/ A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis Ruperto, Nicolino Lovell, Daniel J. Cuttica, Ruben Wilkinson, Nick Woo, Patricia Espada, Graciela Wouters, Carina Silverman, Earl D. Balogh, Zsolt Henrickson, Michael Apaz, María Teresa Baildam, Eileen R Medicina (General) Objective. To evaluate the safety and efficacy of infliximab in the treatment of juvenile rheumatoid arthritis (JRA). Methods. This was an international, multicenter, randomized, placebo-controlled, double-blind study. One hundred twenty-two children with persistent polyarticular JRA despite prior methotrexate (MTX) therapy were randomized to receive infliximab or placebo for 14 weeks, after which all children received infliximab through week 44. Patients received MTX plus infliximab 3 mg/kg through week 44, or MTX plus placebo for 14 weeks followed by MTX plus infliximab 6 mg/kg through week 44. Results. Although a higher proportion of patients in the 3 mg/kg infliximab group than in the placebo group had achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) criteria for improvement at week 14 (63.8% and 49.2%, respectively), the between-group difference in this primary efficacy end point was not statistically significant (P = 0.12). By week 16, after the crossover from placebo to infliximab 6 mg/kg when all patients were receiving infliximab, an ACR Pedi 30 response was achieved in 73.2% of all patients. By week 52, ACR Pedi 50 and ACR Pedi 70 responses had been reached in 69.6% and 51.8%, respectively, of patients. Infliximab was generally well tolerated, but the safety profile of infliximab 3 mg/kg appeared less favorable than that of infliximab 6 mg/kg, with more frequent occurrences of serious adverse events, infusion reactions, antibodies to infliximab, and newly induced antinuclear antibodies and antibodies to double-stranded DNA observed with the 3 mg/kg dose. Conclusion. While infliximab at 3 mg/kg and 6 mg/kg showed durable efficacy at 1 year, achievement of the primary efficacy end point at 3 months did not differ significantly between infliximab-treated and placebo-treated patients. Safety data indicated that the 6-mg/kg dose may provide a more favorable risk/benefit profile. These results warrant further investigation in children with JRA. 2007-09-30 info:eu-repo/semantics/article info:eu-repo/semantics/closedAccess application/pdf spa http://pa.bibdigital.ucc.edu.ar/4019/1/A_Ruperto_Lovell_Cuttica_Wilkinson_Woo_Wouters_Silverman_Balogh_Henrickson_Apaz_Baildam.pdf Ruperto, Nicolino, Lovell, Daniel J., Cuttica, Ruben, Wilkinson, Nick, Woo, Patricia, Espada, Graciela, Wouters, Carina, Silverman, Earl D., Balogh, Zsolt, Henrickson, Michael, Apaz, María Teresa and Baildam, Eileen (2007) A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis and Rheumatism, 56 (9). pp. 3096-3106. ISSN 0004-3591 info:eu-repo/semantics/altIdentifier/doi/10.1002/art.22838
institution Universidad Católica de Córdoba
institution_str I-38
repository_str R-144
collection Producción Académica Universidad Católica de Córdoba (UCCor)
language Español
orig_language_str_mv spa
topic R Medicina (General)
spellingShingle R Medicina (General)
Ruperto, Nicolino
Lovell, Daniel J.
Cuttica, Ruben
Wilkinson, Nick
Woo, Patricia
Espada, Graciela
Wouters, Carina
Silverman, Earl D.
Balogh, Zsolt
Henrickson, Michael
Apaz, María Teresa
Baildam, Eileen
A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis
topic_facet R Medicina (General)
description Objective. To evaluate the safety and efficacy of infliximab in the treatment of juvenile rheumatoid arthritis (JRA). Methods. This was an international, multicenter, randomized, placebo-controlled, double-blind study. One hundred twenty-two children with persistent polyarticular JRA despite prior methotrexate (MTX) therapy were randomized to receive infliximab or placebo for 14 weeks, after which all children received infliximab through week 44. Patients received MTX plus infliximab 3 mg/kg through week 44, or MTX plus placebo for 14 weeks followed by MTX plus infliximab 6 mg/kg through week 44. Results. Although a higher proportion of patients in the 3 mg/kg infliximab group than in the placebo group had achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) criteria for improvement at week 14 (63.8% and 49.2%, respectively), the between-group difference in this primary efficacy end point was not statistically significant (P = 0.12). By week 16, after the crossover from placebo to infliximab 6 mg/kg when all patients were receiving infliximab, an ACR Pedi 30 response was achieved in 73.2% of all patients. By week 52, ACR Pedi 50 and ACR Pedi 70 responses had been reached in 69.6% and 51.8%, respectively, of patients. Infliximab was generally well tolerated, but the safety profile of infliximab 3 mg/kg appeared less favorable than that of infliximab 6 mg/kg, with more frequent occurrences of serious adverse events, infusion reactions, antibodies to infliximab, and newly induced antinuclear antibodies and antibodies to double-stranded DNA observed with the 3 mg/kg dose. Conclusion. While infliximab at 3 mg/kg and 6 mg/kg showed durable efficacy at 1 year, achievement of the primary efficacy end point at 3 months did not differ significantly between infliximab-treated and placebo-treated patients. Safety data indicated that the 6-mg/kg dose may provide a more favorable risk/benefit profile. These results warrant further investigation in children with JRA.
format Artículo
author Ruperto, Nicolino
Lovell, Daniel J.
Cuttica, Ruben
Wilkinson, Nick
Woo, Patricia
Espada, Graciela
Wouters, Carina
Silverman, Earl D.
Balogh, Zsolt
Henrickson, Michael
Apaz, María Teresa
Baildam, Eileen
author_facet Ruperto, Nicolino
Lovell, Daniel J.
Cuttica, Ruben
Wilkinson, Nick
Woo, Patricia
Espada, Graciela
Wouters, Carina
Silverman, Earl D.
Balogh, Zsolt
Henrickson, Michael
Apaz, María Teresa
Baildam, Eileen
author_sort Ruperto, Nicolino
title A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis
title_short A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis
title_full A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis
title_fullStr A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis
title_full_unstemmed A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis
title_sort randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis
publishDate 2007
url http://pa.bibdigital.ucc.edu.ar/4019/1/A_Ruperto_Lovell_Cuttica_Wilkinson_Woo_Wouters_Silverman_Balogh_Henrickson_Apaz_Baildam.pdf
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