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2.3 Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular course juvenile rheumatoid arthritis (JRA): Findings from an open-label treatment extension

We report long-term safety & efficacy of infliximab (IFX)+ methotrexate (MTX) treatment in JRA patients. In an international, multicenter, randomized, double-blind study, 122 children w/active polyarticular JRA despite prior MTX therapy received MTX plus a 3-dose induction (wks 0, 2, 6) of IFX 3 mg/kg through wk 44, or placebo (PBO) for 14 wks followed by IFX 6 mg/kg (wks 14, 16, 20, & then q8 wks) through wk 44. Patients completing treatment through wk 44 were eligible to enter an open-label extension (OLE) of IFX 3 mg/kg, beginning at wk 52 & continuing q8 wks through wk 196. All patients continued with concomitant MTX. Physicians could increase or decrease the IFX dose by ≤1.5 mg/kg/infusion q8 wks, up to 6 mg/kg or down to 3 mg/kg, based on clinical response. Primary endpoint was the proportion of patients meeting ACR-Pedi-30, defined as improvement of ≥30% in ≥3 of 6 core variables, & ≤1 of the remaining variables worsened by >30%. Remission was defined as 0 joints with active arthritis, normal ESR, & physician's global assessment ≤10 mm on a 10-cm visual analog scale. 78/122(63.9%) children entered the OLE. The mean(SD) IFX dose at wk 196 was 4.4(1.6)mg/kg. IFX was well-tolerated;14.1% of patients discontinued due to adverse events (AE) from wks 52–204. The distribution/types of AE were similar to those in the first 52 wks & no new safety issues were reported. Among the 36 study patients by wk 204, ACR-Pedi-30/50/70/90 responses were 91.7%(33/36), 83.3%(30/36), 69.4%(25/36), & 50%(18/36), respectively. 39%(14/36) of patients achieved remission. From wk 52 through wk 216, 36.6%(26/71) of patients were positive for IFXantibodies; 57.7%(15/26) of these had an infusion reaction. Continuous IFX+MTX administered up to 4 yrs was safe & effective in JRA patients, although accompanied by a high rate of patient discontinuation, which included subjects in remission.

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Correspondence to N Ruperto.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Keywords

  • Methotrexate
  • Infliximab
  • Juvenile Rheumatoid Arthritis
  • Core Variable
  • Active Arthritis