PT  - JOURNAL ARTICLE
AU  - Nicolino Ruperto
AU  - Daniel J Lovell
AU  - Ruben Cuttica
AU  - Patricia Woo
AU  - Silvia Meiorin
AU  - Carine Wouters
AU  - Earl D Silverman
AU  - Zsolt Balogh
AU  - Michael Henrickson
AU  - Joyce Davidson
AU  - Ivan Foeldvari
AU  - Lisa Imundo
AU  - Gabriele Simonini
AU  - Joachim Oppermann
AU  - Stephen Xu
AU  - Yaung-Kaung Shen
AU  - Sudha Visvanathan
AU  - Adedigbo Fasanmade
AU  - Alan Mendelsohn
AU  - Alberto Martini
AU  - Edward H Giannini
TI  - 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
AID  - 10.1136/ard.2009.100354
DP  - 2010 Apr 01
TA  - Annals of the Rheumatic Diseases
PG  - 718--722
VI  - 69
IP  - 4
4099  - http://ard.bmj.com/content/69/4/718.short
4100  - http://ard.bmj.com/content/69/4/718.full
SO  - Ann Rheum Dis2010 Apr 01; 69
AB  - Objective To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA). Methods Patients eligible for the open-label extension (OLE, weeks 52–204) received infliximab 3–6 mg/kg every 8 weeks plus methotrexate. Results 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 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.