[HTML][HTML] Etanercept in children with polyarticular juvenile rheumatoid arthritis

DJ Lovell, EH Giannini, A Reiff… - … England Journal of …, 2000 - Mass Medical Soc
DJ Lovell, EH Giannini, A Reiff, GD Cawkwell, ED Silverman, JJ Nocton, LD Stein, A Gedalia…
New England Journal of Medicine, 2000Mass Medical Soc
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 …
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.
The New England Journal Of Medicine