Title: Long-Term Efficacy and Safety of Infliximab plus Methotrexate for The Treatment of Polyarticular Course Juvenile Rheumatoid Arthritis: Findings from an Open-Label Treatment Extension
Authors: Ruperto, Nicolino ×
Lovell, Daniel J
Cuttica, Ruben
Woo, Patricia
Meiorin, Silvia
Wouters, Carine
Silverman, Earl D
Balogh, Zsolt
Henrickson, Michael
Davidson, Joyce
Foeldvari, Ivan
Imundo, Lisa
Simonini, Gabriele
Oppermann, Joachim
Xu, Stephen
Shen, Yaung-Kaung
Visvanathan, Sudha
Fasanmade, Adedigbo
Mendelsohn, Alan
Martini, Alberto
Giannini, Edward H #
Issue Date: Apr-2010
Publisher: H.K. Lewis
Series Title: Annals of the Rheumatic Diseases vol:69 issue:4 pages:718-722
Abstract: OBJECTIVE: /st> To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA). METHODS: /st> Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg every 8 weeks plus methotrexate. RESULTS: /st> Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively. CONCLUSIONS: /st> In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate. Clinical trials registration number NCT00036374.
ISSN: 0003-4967
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Pediatric Immunology
× corresponding author
# (joint) last author

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