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Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis.

Publication ,  Journal Article
Giannini, EH; Ilowite, NT; Lovell, DJ; Wallace, CA; Rabinovich, CE; Reiff, A; Higgins, G; Gottlieb, B; Singer, NG; Chon, Y; Lin, S-L ...
Published in: Arthritis Rheum
September 2009

OBJECTIVE: This study was undertaken to evaluate the long-term safety and effectiveness of etanercept alone or in combination with methotrexate (MTX) in children with selected categories of juvenile idiopathic arthritis (JIA). METHODS: Patients ages 2-18 years with rheumatoid factor (RF)-positive or RF-negative polyarthritis, systemic JIA, or extended oligoarthritis were eligible for the study. Patients received MTX alone (> or =10 mg/m(2)/week [ approximately 0.3 mg/kg/week], maximum dosage 1 mg/kg/week), etanercept alone (0.8 mg/kg/week, maximum dose 50 mg), or etanercept plus MTX for 3 years in an open-label, nonrandomized study. Safety was assessed by measuring rates of adverse events, and effectiveness was assessed using the physician's global assessment of disease activity and the pediatric total joint assessment. RESULTS: A total of 197, 103, and 294 patients were enrolled in the MTX, etanercept, and etanercept plus MTX groups, respectively. Exposure-adjusted rates of adverse events were similar among the 3 treatment groups (18.3, 18.7, and 21.6 per 100 patient-years in the MTX, etanercept, and etanercept plus MTX groups, respectively). Respective rates per 100 patient-years of serious adverse events (4.6, 7.1, and 6.0) and medically important infections (1.3, 1.8, and 2.1) were also similar among the 3 treatment groups. Scores for physician's global assessment and total active joints improved from baseline, and improvement was maintained for the duration of the study. CONCLUSION: These data confirm the findings of other long-term studies and suggest that etanercept or etanercept plus MTX has an acceptable safety and effectiveness profile in children with selected categories of JIA. Improvement was maintained for 3 years in those continuing to receive medication.

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Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

September 2009

Volume

60

Issue

9

Start / End Page

2794 / 2804

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Rheumatoid Factor
  • Registries
  • Receptors, Tumor Necrosis Factor
  • Methotrexate
  • Male
  • Longitudinal Studies
  • Injections, Subcutaneous
  • Immunoglobulin G
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Giannini, E. H., Ilowite, N. T., Lovell, D. J., Wallace, C. A., Rabinovich, C. E., Reiff, A., … Pediatric Rheumatology Collaborative Study Group, . (2009). Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum, 60(9), 2794–2804. https://doi.org/10.1002/art.24777
Giannini, E. H., N. T. Ilowite, D. J. Lovell, C. A. Wallace, C. E. Rabinovich, A. Reiff, G. Higgins, et al. “Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis.Arthritis Rheum 60, no. 9 (September 2009): 2794–2804. https://doi.org/10.1002/art.24777.
Giannini EH, Ilowite NT, Lovell DJ, Wallace CA, Rabinovich CE, Reiff A, et al. Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2009 Sep;60(9):2794–804.
Giannini, E. H., et al. “Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis.Arthritis Rheum, vol. 60, no. 9, Sept. 2009, pp. 2794–804. Pubmed, doi:10.1002/art.24777.
Giannini EH, Ilowite NT, Lovell DJ, Wallace CA, Rabinovich CE, Reiff A, Higgins G, Gottlieb B, Singer NG, Chon Y, Lin S-L, Baumgartner SW, Pediatric Rheumatology Collaborative Study Group. Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2009 Sep;60(9):2794–2804.
Journal cover image

Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

September 2009

Volume

60

Issue

9

Start / End Page

2794 / 2804

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Rheumatoid Factor
  • Registries
  • Receptors, Tumor Necrosis Factor
  • Methotrexate
  • Male
  • Longitudinal Studies
  • Injections, Subcutaneous
  • Immunoglobulin G
  • Humans