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Previous Volume 342:763-769 March 16, 2000 Number 11 Next

	Full Text PDF Editorial by Pisetsky, D. S. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

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.

Source Information

From Children's Hospital Medical Center, Cincinnati (D.J.L., E.H.G.); Children's Hospital of Los Angeles, Los Angeles (A.R.); All Children's Hospital, St. Petersburg, Fla. (G.D.C.); the Hospital for Sick Children, Toronto (E.D.S.); the Medical College of Wisconsin, Milwaukee (J.J.N.); the University of North Carolina, Chapel Hill (L.D.S.); Children's Hospital, New Orleans (A.G.); Schneider Children's Hospital, New Hyde Park, N.Y. (N.T.I.); Children's Hospital and Medical Center, Seattle (C.A.W.); and Immunex Corporation, Seattle (J.W., B.K.F.).

Address reprint requests to Dr. Lovell at Children's Hospital Medical Center, Pavilion Bldg. 2-129, 3333 Burnet Ave., Cincinnati, OH 45229-3039.

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