Etanercept in children with polyarticular juvenile rheumatoid arthritis

Daniel J. Lovell, Edward H. Giannini, Andreas Reiff, Gail D. Cawkwell, Earl D. Silverman, James J. Nocton, Leonard D. Stein, Abraham Gedalia, Norman Todd Ilowite, Carol A. Wallace, James Whitmore, Barbara K. Finck

Research output: Contribution to journalArticle

999 Citations (Scopus)

Abstract

Background: We evaluated the safety and efficacy of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein, in children with polyarticular juvenile rheumatoid arthritis who did not tolerate or had an inadequate response to methotrexate. Methods: Patients 4 to 17 years old received 0.4 mg of etanercept per kilogram of body weight subcutaneously twice weekly for up to three months in the initial, open-label part of a multicenter trial. Those who responded to treatment then entered a double- blind study and were randomly assigned to receive either placebo or etanercept for four months or until a flare of the disease occurred. A response was defined as an improvement of 30 percent or more in at least three of six indicators of disease activity, with no more than one indicator worsening by more than 30 percent. Results: At the end of the open-label study, 51 of the 69 patients (74 percent) had had responses to etanercept treatment. In the double-blind study, 21 of the 26 patients who received placebo (81 percent) withdrew because of disease flare, as compared with 7 of the 25 patients who received etanercept (28 percent) (P=0.003). The median time to disease flare with placebo was 28 days, as compared with more than 116 days with etanercept (P<0.001). In the double-blind study, there were no significant differences between the two treatment groups in the frequency of adverse events. Conclusions: Treatment with etanercept leads to significant improvement in patients with active polyarticular juvenile rheumatoid arthritis. Etanercept is well tolerated by pediatric patients. (C) 2000, Massachusetts Medical Society.

Original languageEnglish (US)
Pages (from-to)763-769
Number of pages7
JournalNew England Journal of Medicine
Volume342
Issue number11
DOIs
StatePublished - Mar 16 2000
Externally publishedYes

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Juvenile Arthritis
Double-Blind Method
Placebos
Etanercept
Tumor Necrosis Factor Receptors
Medical Societies
Therapeutics
Methotrexate
Multicenter Studies
Body Weight
Pediatrics
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Lovell, D. J., Giannini, E. H., Reiff, A., Cawkwell, G. D., Silverman, E. D., Nocton, J. J., ... Finck, B. K. (2000). Etanercept in children with polyarticular juvenile rheumatoid arthritis. New England Journal of Medicine, 342(11), 763-769. https://doi.org/10.1056/NEJM200003163421103

Etanercept in children with polyarticular juvenile rheumatoid arthritis. / Lovell, Daniel J.; Giannini, Edward H.; Reiff, Andreas; Cawkwell, Gail D.; Silverman, Earl D.; Nocton, James J.; Stein, Leonard D.; Gedalia, Abraham; Ilowite, Norman Todd; Wallace, Carol A.; Whitmore, James; Finck, Barbara K.

In: New England Journal of Medicine, Vol. 342, No. 11, 16.03.2000, p. 763-769.

Research output: Contribution to journalArticle

Lovell, DJ, Giannini, EH, Reiff, A, Cawkwell, GD, Silverman, ED, Nocton, JJ, Stein, LD, Gedalia, A, Ilowite, NT, Wallace, CA, Whitmore, J & Finck, BK 2000, 'Etanercept in children with polyarticular juvenile rheumatoid arthritis', New England Journal of Medicine, vol. 342, no. 11, pp. 763-769. https://doi.org/10.1056/NEJM200003163421103
Lovell DJ, Giannini EH, Reiff A, Cawkwell GD, Silverman ED, Nocton JJ et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. New England Journal of Medicine. 2000 Mar 16;342(11):763-769. https://doi.org/10.1056/NEJM200003163421103
Lovell, Daniel J. ; Giannini, Edward H. ; Reiff, Andreas ; Cawkwell, Gail D. ; Silverman, Earl D. ; Nocton, James J. ; Stein, Leonard D. ; Gedalia, Abraham ; Ilowite, Norman Todd ; Wallace, Carol A. ; Whitmore, James ; Finck, Barbara K. / Etanercept in children with polyarticular juvenile rheumatoid arthritis. In: New England Journal of Medicine. 2000 ; Vol. 342, No. 11. pp. 763-769.
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abstract = "Background: We evaluated the safety and efficacy of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein, in children with polyarticular juvenile rheumatoid arthritis who did not tolerate or had an inadequate response to methotrexate. Methods: Patients 4 to 17 years old received 0.4 mg of etanercept per kilogram of body weight subcutaneously twice weekly for up to three months in the initial, open-label part of a multicenter trial. Those who responded to treatment then entered a double- blind study and were randomly assigned to receive either placebo or etanercept for four months or until a flare of the disease occurred. A response was defined as an improvement of 30 percent or more in at least three of six indicators of disease activity, with no more than one indicator worsening by more than 30 percent. Results: At the end of the open-label study, 51 of the 69 patients (74 percent) had had responses to etanercept treatment. In the double-blind study, 21 of the 26 patients who received placebo (81 percent) withdrew because of disease flare, as compared with 7 of the 25 patients who received etanercept (28 percent) (P=0.003). The median time to disease flare with placebo was 28 days, as compared with more than 116 days with etanercept (P<0.001). In the double-blind study, there were no significant differences between the two treatment groups in the frequency of adverse events. Conclusions: Treatment with etanercept leads to significant improvement in patients with active polyarticular juvenile rheumatoid arthritis. Etanercept is well tolerated by pediatric patients. (C) 2000, Massachusetts Medical Society.",
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T1 - Etanercept in children with polyarticular juvenile rheumatoid arthritis

AU - Lovell, Daniel J.

AU - Giannini, Edward H.

AU - Reiff, Andreas

AU - Cawkwell, Gail D.

AU - Silverman, Earl D.

AU - Nocton, James J.

AU - Stein, Leonard D.

AU - Gedalia, Abraham

AU - Ilowite, Norman Todd

AU - Wallace, Carol A.

AU - Whitmore, James

AU - Finck, Barbara K.

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N2 - Background: We evaluated the safety and efficacy of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein, in children with polyarticular juvenile rheumatoid arthritis who did not tolerate or had an inadequate response to methotrexate. Methods: Patients 4 to 17 years old received 0.4 mg of etanercept per kilogram of body weight subcutaneously twice weekly for up to three months in the initial, open-label part of a multicenter trial. Those who responded to treatment then entered a double- blind study and were randomly assigned to receive either placebo or etanercept for four months or until a flare of the disease occurred. A response was defined as an improvement of 30 percent or more in at least three of six indicators of disease activity, with no more than one indicator worsening by more than 30 percent. Results: At the end of the open-label study, 51 of the 69 patients (74 percent) had had responses to etanercept treatment. In the double-blind study, 21 of the 26 patients who received placebo (81 percent) withdrew because of disease flare, as compared with 7 of the 25 patients who received etanercept (28 percent) (P=0.003). The median time to disease flare with placebo was 28 days, as compared with more than 116 days with etanercept (P<0.001). In the double-blind study, there were no significant differences between the two treatment groups in the frequency of adverse events. Conclusions: Treatment with etanercept leads to significant improvement in patients with active polyarticular juvenile rheumatoid arthritis. Etanercept is well tolerated by pediatric patients. (C) 2000, Massachusetts Medical Society.

AB - Background: We evaluated the safety and efficacy of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein, in children with polyarticular juvenile rheumatoid arthritis who did not tolerate or had an inadequate response to methotrexate. Methods: Patients 4 to 17 years old received 0.4 mg of etanercept per kilogram of body weight subcutaneously twice weekly for up to three months in the initial, open-label part of a multicenter trial. Those who responded to treatment then entered a double- blind study and were randomly assigned to receive either placebo or etanercept for four months or until a flare of the disease occurred. A response was defined as an improvement of 30 percent or more in at least three of six indicators of disease activity, with no more than one indicator worsening by more than 30 percent. Results: At the end of the open-label study, 51 of the 69 patients (74 percent) had had responses to etanercept treatment. In the double-blind study, 21 of the 26 patients who received placebo (81 percent) withdrew because of disease flare, as compared with 7 of the 25 patients who received etanercept (28 percent) (P=0.003). The median time to disease flare with placebo was 28 days, as compared with more than 116 days with etanercept (P<0.001). In the double-blind study, there were no significant differences between the two treatment groups in the frequency of adverse events. Conclusions: Treatment with etanercept leads to significant improvement in patients with active polyarticular juvenile rheumatoid arthritis. Etanercept is well tolerated by pediatric patients. (C) 2000, Massachusetts Medical Society.

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