Drs. Lovell and Giannini have served as ad hoc consultants to Immunex Corporation.
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
Article first published online: 10 JAN 2003
Copyright © 2003 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 48, Issue 1, pages 218–226, January 2003
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
- Issue published online: 10 JAN 2003
- Article first published online: 10 JAN 2003
- Manuscript Accepted: 11 SEP 2002
- Manuscript Received: 18 FEB 2002
- Immunex Corporation, Seattle, WA
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.
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%.
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.
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.