Etanercept in Children with Polyarticular Juvenile Rheumatoid Arthritis

doi:10.1056/NEJM200003163421103

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

Etanercept in Children with Polyarticular Juvenile Rheumatoid Arthritis

Daniel J. Lovell, M.D., M.P.H., Edward H. Giannini, M.Sc., Dr.P.H., Andreas Reiff, M.D., Gail D. Cawkwell, M.D., Ph.D., Earl D. Silverman, M.D., James J. Nocton, M.D., Leonard D. Stein, M.D., Abraham Gedalia, M.D., Norman T. Ilowite, M.D., Carol A. Wallace, M.D., James Whitmore, Ph.D., Barbara K. Finck, M.D., for The Pediatric Rheumatology Collaborative Study Group

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by Pisetsky, D. S.

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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 arthritiswho did not tolerate or had an inadequate response to methotrexate.

Methods Patients 4 to 17 years old received 0.4 mg of etanerceptper kilogram of body weight subcutaneously twice weekly forup to three months in the initial, open-label part of a multicentertrial. Those who responded to treatment then entered a double-blindstudy and were randomly assigned to receive either placebo oretanercept for four months or until a flare of the disease occurred.A response was defined as an improvement of 30 percent or morein at least three of six indicators of disease activity, withno 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 thedouble-blind study, 21 of the 26 patients who received placebo(81 percent) withdrew because of disease flare, as comparedwith 7 of the 25 patients who received etanercept (28 percent)(P=0.003). The median time to disease flare with placebo was28 days, as compared with more than 116 days with etanercept(P<0.001). In the double-blind study, there were no significantdifferences between the two treatment groups in the frequencyof adverse events.

Conclusions Treatment with etanercept leads to significant improvementin 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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