A randomized, placebo‐controlled trial of infliximab plus methotrexate for the treatment of polyarticular‐course juvenile rheumatoid arthritis
Nicolino Ruperto,Daniel J. Lovell,Ruben Cuttica,Nick Wilkinson,Patricia Woo,Graciela Espada,Carine Wouters,Earl D. Silverman,Zsolt Balogh,Michael Henrickson,Maria Teresa Apaz,Eileen Baildam,Anders Fasth,Valeria Gerloni,Pekka Lahdenne,AM Prieur,Angelo Ravelli,Rotraud K. Saurenmann,M.L. Gamir,Nico M Wulffraat,László Maródi,Ross E. Petty,Rik Joos,Francesco Zulian,Deborah McCurdy,Barry L. Myones,K. Nagy,Peter Reuman,Ilona S. Szer,Suzanne Travers,A. Beutler,Greg Keenan,Jason Clark,Sudha Visvanathan,Adedigbo A. Fasanmade,Aparna Raychaudhuri,Alan M. Mendelsohn,Alberto Martini,Edward H. Giannini +38 more
TLDR
Safety data indicated that the 6-mg/kg dose may provide a more favorable risk/benefit profile for infliximab in the treatment of juvenile rheumatoid arthritis, and achievement of the primary efficacy end point at 3 months did not differ significantly between inflIXimab-treated and placebo-treated patients.Abstract:
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, American College of Rheumatology.read more
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Juvenile idiopathic arthritis
Angelo Ravelli,Alberto Martini +1 more
TL;DR: In conclusion, juvenile idiopathic arthritis is a broad term that describes a clinically heterogeneous group of arthritides of unknown cause, which begin before 16 years of age, and drugs such as anticytokine agents constitute a valuable treatment option for patients who are resistant to conventional antirheumatic agents.
Journal ArticleDOI
Juvenile idiopathic arthritis: new insights into classification, measures of outcome, and pharmacotherapy.
TL;DR: This review focuses on recent advances in JIA, especially developments in its classification, validation of appropriate measures of holistic outcome, and the specific contribution of established and newer pharmacologic agents available for treating children and young people.
Journal ArticleDOI
Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2010
Daniel E. Furst,E.C. Keystone,J. Braun,F. C. Breedveld,G.-R. Burmester,F De Benedetti,Thomas Dörner,Paul Emery,Roy Fleischmann,Allan Gibofsky,Joachim R. Kalden,A. Kavanaugh,Bruce Kirkham,Philip J. Mease,J. Sieper,Nora G. Singer,Josef S Smolen,P.L.C.M. van Riel,Michael H. Weisman,Kevin L. Winthrop +19 more
TL;DR: The consensus statement is annotated to document the credibility of the data supporting it as much as possible and the number of possible references has become so large that reviews are sometimes included; if they contain category A references, they will be referred to as category A evidence.
Journal ArticleDOI
2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Initiation and Safety Monitoring of Therapeutic Agents for the Treatment of Arthritis and Systemic Features
Timothy Beukelman,Nivedita M. Patkar,Kenneth G. Saag,Sue Tolleson-Rinehart,Randy Q. Cron,Esi Morgan DeWitt,Norman T. Ilowite,Yukiko Kimura,Ronald M. Laxer,Daniel J. Lovell,Alberto Martini,C. Egla Rabinovich,Nicolino Ruperto +12 more
TL;DR: Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology are intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient.
Journal ArticleDOI
Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial
Nicolino Ruperto,Daniel J. Lovell,Pierre Quartier,Eliana Paz,Nadina Rubio-Pérez,Clovis A. Silva,Carlos Abud-Mendoza,Ruben Burgos-Vargas,Valeria Gerloni,José Melo-Gomes,Claudia Saad-Magalhães,Flavio Sztajnbok,Claudia Goldenstein-Schainberg,Morton Scheinberg,Immaculada Calvo Penades,Michael Fischbach,Javier Orozco,Philip J. Hashkes,Christine Hom,Lawrence Jung,Loredana Lepore,Sheila Knupp Feitosa de Oliveira,Carol A. Wallace,Leonard H. Sigal,Alan J. Block,A Covucci,Alberto Martini,Edward H. Giannini +27 more
TL;DR: The safety and efficacy of abatacept, a selective T-cell costimulation modulator, in children with juvenile idiopathic arthritis who had failed previous treatments was assessed.
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Etanercept in Children with Polyarticular Juvenile Rheumatoid Arthritis
Daniel J. Lovell,Edward H. Giannini,Andreas Reiff,Gail Cawkwell,Earl D. Silverman,James J. Nocton,Leonard D. Stein,Abraham Gedalia,Norman T. Ilowite,Carol A. Wallace,James B Whitmore,Barbara K. Finck +11 more
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