Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. Export

@article{citeulike:3021992, 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.}, address = {Children's Hospital Medical Center, Cincinnati, OH 45229-3039, USA.}, author = {Lovell, D. J. and Giannini, E. H. and Reiff, A. and Cawkwell, G. D. and Silverman, E. D. and Nocton, J. J. and Stein, L. D. and Gedalia, A. and Ilowite, N. T. and Wallace, C. A. and Whitmore, J. and Finck, B. K.}, citeulike-article-id = {3021992}, citeulike-linkout-0 = {http://view.ncbi.nlm.nih.gov/pubmed/10717011}, citeulike-linkout-1 = {http://www.hubmed.org/display.cgi?uids=10717011}, day = {16}, issn = {0028-4793}, journal = {The New England journal of medicine}, keywords = {anti-tnf, rheum}, month = {March}, number = {11}, pages = {763--769}, posted-at = {2008-07-20 04:47:52}, priority = {2}, title = {Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group.}, url = {http://view.ncbi.nlm.nih.gov/pubmed/10717011}, volume = {342}, year = {2000} }

TY - JOUR ID - citeulike:3021992 L3 - citeulike-article-id:3021992 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. IS - 11 JF - The New England journal of medicine SN - 0028-4793 AD - Children's Hospital Medical Center, Cincinnati, OH 45229-3039, USA. EP - 769 TI - Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. VL - 342 SP - 763 KW - anti-tnf KW - rheum AU - Lovell, DJ AU - Giannini, EH AU - Reiff, A AU - Cawkwell, GD AU - Silverman, ED AU - Nocton, JJ AU - Stein, LD AU - Gedalia, A AU - Ilowite, NT AU - Wallace, CA AU - Whitmore, J AU - Finck, BK PY - 2000/03/16/ UR - http://view.ncbi.nlm.nih.gov/pubmed/10717011 ER -