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.