Research Article

You have full text access to this OnlineOpen article

Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: Interim results from an ongoing multicenter, open-label, extended-treatment trial

  1. Daniel J. Lovell1,‡,*,
  2. Edward H. Giannini1,‡,
  3. Andreas Reiff2,
  4. Olcay Y. Jones3,
  5. Rayfel Schneider4,
  6. Judyann C. Olson5,
  7. Leonard D. Stein6,
  8. Abraham Gedalia7,
  9. Norman T. Ilowite8,
  10. Carol A. Wallace9,
  11. Mary Lange10,†,
  12. Barbara K. Finck10,†,
  13. Daniel J. Burge10,
  14. for the Pediatric Rheumatology Collaborative Study Group§

Article first published online: 10 JAN 2003

DOI: 10.1002/art.10710

Issue

Arthritis & Rheumatism

Arthritis & Rheumatism

Volume 48, Issue 1, pages 218–226, January 2003

Additional Information

How to Cite

Lovell, D. J., Giannini, E. H., Reiff, A., Jones, O. Y., Schneider, R., Olson, J. C., Stein, L. D., Gedalia, A., Ilowite, N. T., Wallace, C. A., Lange, M., Finck, B. K., Burge, D. J. and for the Pediatric Rheumatology Collaborative Study Group (2003), Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: Interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis & Rheumatism, 48: 218–226. doi: 10.1002/art.10710

Author Information

  1. 1

    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

  2. 2

    Children's Hospital of Los Angeles, Los Angeles, California

  3. 3

    All Children's Hospital, St. Petersburg, Florida

  4. 4

    The Hospital for Sick Children, Toronto, Ontario, Canada

  5. 5

    Medical College of Wisconsin, Milwaukee

  6. 6

    University of North Carolina at Chapel Hill

  7. 7

    Children's Hospital, New Orleans, Louisiana

  8. 8

    The Schneider Children's Hospital, New Hyde Park, New York

  9. 9

    Children's Regional Hospital and Medical Center, Seattle, Washington

  10. 10

    Immunex Corporation, Seattle, Washington

  1. †

    EOS Biotechnology, South San Francisco, California

  1. ‡

    Drs. Lovell and Giannini have served as ad hoc consultants to Immunex Corporation.

  2. §

    In addition, the following investigators of the Pediatric Rheumatology Collaborative Study Group participated in the trial: Murray Passo, MD: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Bracha Shaham, MD, Bram Bernstein, MD: Children's Hospital of Los Angeles, Los Angeles, California; Gail D. Cawkwell, MD, CM, PhD: All Children's Hospital, St. Petersburg, Florida; Earl D. Silverman, MD, FRCPC: The Hospital for Sick Children, Toronto, Ontario, Canada; James J. Nocton, MD: Medical College of Wisconsin, Milwaukee; Ann Reed, MD: University of North Carolina at Chapel Hill (current address: Mayo Clinic, Rochester, Minnesota); and David Sherry, MD: Children's Hospital and Medical Center, Seattle, Washington (current address: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania).

*Cincinnati Children's Hospital Medical Center, Building E, Room 2-129, 3333 Burnet Avenue, Cincinnati, OH 45229-3039

  1. ‡

    Drs. Lovell and Giannini have served as ad hoc consultants to Immunex Corporation.

  2. §

    In addition, the following investigators of the Pediatric Rheumatology Collaborative Study Group participated in the trial: Murray Passo, MD: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Bracha Shaham, MD, Bram Bernstein, MD: Children's Hospital of Los Angeles, Los Angeles, California; Gail D. Cawkwell, MD, CM, PhD: All Children's Hospital, St. Petersburg, Florida; Earl D. Silverman, MD, FRCPC: The Hospital for Sick Children, Toronto, Ontario, Canada; James J. Nocton, MD: Medical College of Wisconsin, Milwaukee; Ann Reed, MD: University of North Carolina at Chapel Hill (current address: Mayo Clinic, Rochester, Minnesota); and David Sherry, MD: Children's Hospital and Medical Center, Seattle, Washington (current address: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania).

Publication History

  1. Issue published online: 10 JAN 2003
  2. Article first published online: 10 JAN 2003
  3. Manuscript Accepted: 11 SEP 2002
  4. Manuscript Received: 18 FEB 2002

Funded by

  • Immunex Corporation, Seattle, WA

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (83K)

Abstract

Objective

To evaluate the long-term efficacy and safety of etanercept in children with juvenile rheumatoid arthritis (JRA) participating in an ongoing multicenter, open-label, extended-treatment trial. All patients had been participants in an initial randomized efficacy and safety trial of etanercept.

Methods

Etanercept was administered at a dosage of 0.4 mg/kg (maximum 25 mg) subcutaneously twice each week. Safety and efficacy evaluations were performed every 3–4 months. The JRA 30% definition of improvement (DOI) was defined as improvement of ≥30% in at least 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 30%.

Results

At the time of analysis, 48 of the 58 patients (83%) were still enrolled in the study; 43 of them (74%) had completed 2 years of treatment. Of these 43 patients, 81% met the JRA 30% DOI, 79% met the JRA 50% DOI, and 67% met the JRA 70% DOI. Ten children started low-dose methotrexate after year 1. Of the 32 children taking prednisone, the dosage was decreased to <5 mg/day in 26 (81%). Two children had serious infections (varicella with aseptic meningitis in one and complicated sepsis in the other). In general, adverse events were of the types seen in a general pediatric patient population.

Conclusion

Children with severe, longstanding, methotrexate-resistant polyarticular JRA demonstrated sustained clinical improvement with >2 years of continuous etanercept treatment. Etanercept was generally well-tolerated. There were no increases in the rates of adverse events over time. However, children taking etanercept should be monitored closely for infections.

View Full Article (HTML) Get PDF (83K)