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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
  1. Nicolino Ruperto (nicolaruperto{at}
  1. IRCCS G. Gaslini, Italy
    1. Daniel J Lovell (daniel.lovell{at}
    1. Children's Hospital Medical Center, United States
      1. Ruben Cuttica (elizalde_reumato{at}
      1. Hospital General de Ninos Pedro de Elizalde, Argentina
        1. Patricia Woo (patricia.woo{at}
        1. University College London, United Kingdom
          1. Silvia Meiorin (smeiorin{at}
          1. Hospital de Ninos Ricardo Gutierrez, Argentina
            1. Carine Wouters (carine.wouters{at}
            1. University Hospital Gasthuisberg, Belgium
              1. Earl D Silverman (earl.silverman{at}
              1. Hospital for Sick Children, Canada
                1. Zsolt Balogh (bazsoand{at}
                1. National Institute of Rheumatology and Physiotherapy, Hungary
                  1. Michael Henrickson (michael-henrickson{at}
                  1. Children's Hospital at OUMC, University of Oklahoma, United States
                    1. Joyce Davidson (joyce.davidson{at}
                    1. Royal Hospital for Sick Children, United Kingdom
                      1. Ivan Foeldvari (foeldvari{at}
                      1. Hamburger Zentrum für Kinder- und Jugendrheumatologie, Germany
                        1. Lisa Imundo (lfi1{at}
                        1. Columbia Presbyterian Med Center - Babies Hospital, United States
                          1. Gabriele Simonini (gabriele.simonini{at}
                          1. Ospedale A. Meyer, Italy
                            1. Joachim Oppermann (j_oppermann{at}
                            1. Carl-Thiem-Klinikum Cottbus, Germany
                              1. Yaung-Kaung Shen (yshen5{at}
                              1. Centocor, United States
                                1. Sudha Visvanathan (svisvana{at}
                                1. Centocor, United States
                                  1. Adedigbo Fasanmade (afasanma{at}
                                  1. Centocor, United States
                                    1. Alan Mendelsohn (amendel2{at}
                                    1. Centocor, United States
                                      1. Alberto Martini (albertomartini{at}
                                      1. University of Genoa, Italy
                                        1. Edward H Giannini (edward.giannini{at}
                                        1. Cincinnati Children's Hospital Medical Center, United States


                                          Objective: Assess long-term efficacy and safety of infliximab plus methotrexate (MTX) in juvenile rheumatoid arthritis (JRA).

                                          Methods: Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg q8wks plus MTX.

                                          Results: Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (8 patients) or patient/physician/sponsor requirement (8 patients). Infliximab (mean dose=4.4 mg/kg/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 through 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate.

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