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

Daniel J. Lovell, Edward H. Giannini, Andreas Reiff, Olcay Y. Jones, Rayfel Schneider, Judyann C. Olson, Leonard D. Stein, Abraham Gedalia, Norman Todd Ilowite, Carol A. Wallace, Mary Lange, Barbara K. Finck, Daniel J. Burge

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)218-226
Number of pages9
JournalArthritis and Rheumatism
Volume48
Issue number1
DOIs
StatePublished - Jan 1 2003
Externally publishedYes

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Juvenile Arthritis
Safety
Therapeutics
Prednisone
Methotrexate
Etanercept
Infection

ASJC Scopus subject areas

  • Immunology
  • Rheumatology

Cite this

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. / Lovell, Daniel J.; Giannini, Edward H.; Reiff, Andreas; Jones, Olcay Y.; Schneider, Rayfel; Olson, Judyann C.; Stein, Leonard D.; Gedalia, Abraham; Ilowite, Norman Todd; Wallace, Carol A.; Lange, Mary; Finck, Barbara K.; Burge, Daniel J.

In: Arthritis and Rheumatism, Vol. 48, No. 1, 01.01.2003, p. 218-226.

Research output: Contribution to journalArticle

Lovell, DJ, Giannini, EH, Reiff, A, Jones, OY, Schneider, R, Olson, JC, Stein, LD, Gedalia, A, Ilowite, NT, Wallace, CA, Lange, M, Finck, BK & Burge, DJ 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 and Rheumatism, vol. 48, no. 1, pp. 218-226. https://doi.org/10.1002/art.10710
Lovell, Daniel J. ; Giannini, Edward H. ; Reiff, Andreas ; Jones, Olcay Y. ; Schneider, Rayfel ; Olson, Judyann C. ; Stein, Leonard D. ; Gedalia, Abraham ; Ilowite, Norman Todd ; Wallace, Carol A. ; Lange, Mary ; Finck, Barbara K. ; Burge, Daniel J. / 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. In: Arthritis and Rheumatism. 2003 ; Vol. 48, No. 1. pp. 218-226.
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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.",
author = "Lovell, {Daniel J.} and Giannini, {Edward H.} and Andreas Reiff and Jones, {Olcay Y.} and Rayfel Schneider and Olson, {Judyann C.} and Stein, {Leonard D.} and Abraham Gedalia and Ilowite, {Norman Todd} and Wallace, {Carol A.} and Mary Lange and Finck, {Barbara K.} and Burge, {Daniel J.}",
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T1 - Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis

T2 - Interim results from an ongoing multicenter, open-label, extended-treatment trial

AU - Lovell, Daniel J.

AU - Giannini, Edward H.

AU - Reiff, Andreas

AU - Jones, Olcay Y.

AU - Schneider, Rayfel

AU - Olson, Judyann C.

AU - Stein, Leonard D.

AU - Gedalia, Abraham

AU - Ilowite, Norman Todd

AU - Wallace, Carol A.

AU - Lange, Mary

AU - Finck, Barbara K.

AU - Burge, Daniel J.

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N2 - 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.

AB - 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.

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