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.
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Funding This study (C0168T32) was sponsored by Centocor Ortho Biotech, Inc (formerly Centocor, Inc).
Competing interests EHG, DJL, AM, NR and PW served as members of the Steering Committee, as well as consultants for Centocor Ortho Biotech, Inc. The members of the Steering Committee had full access to analysis reports from Centocor Ortho Biotech, Inc. SX, Y-KS, SV, AF and AM are employees of Centocor Ortho Biotech, Inc.
Ethics approval This study was conducted with the approval of the independent ethics committee at each centre, which approved the protocol.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.