{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T01:09:32Z","timestamp":1790730572438,"version":"4.1.0"},"reference-count":50,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2012,1,27]],"date-time":"2012-01-27T00:00:00Z","timestamp":1327622400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatism"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess dosing, preliminary safety, and efficacy of canakinumab, a fully human anti\u2013interleukin\u20101\u03b2 (anti\u2013IL\u20101\u03b2) antibody, in children with systemic juvenile idiopathic arthritis (JIA) and active systemic features.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this phase II, multicenter, open\u2010label, dosage\u2010escalation study, children with systemic JIA who were \u22654 years of age, had fever, and were receiving \u22640.4 mg\/kg\/day of corticosteroids were administered a single subcutaneous dose of canakinumab, 0.5\u20139 mg\/kg of body weight, and were redosed upon relapse. Response to treatment was assessed according to an adaptation of the American College of Rheumatology (ACR) pediatric criteria for improvement.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 23 children ages 4\u201319 years with active disease were enrolled. Of these, 1 patient was excluded from analysis, and 3 of the reenrolled patients were included twice in the efficacy analysis. By day 15 of the first treatment cycle, 15 of 25 patients (60%) had achieved an adapted ACR Pediatric 50 response, with 4 of them achieving inactive disease status. Response was sustained over time, with 11 of 13 patients able to maintain their response throughout the study. In 8 of the 11 responders who had been receiving steroids at baseline, the steroid dosage was decreased from a mean of 0.38 mg\/kg\/day to 0.13 mg\/kg\/day over the first 5 months, and 4 of them were able to discontinue steroids. At a dose of 4 mg\/kg of canakinumab given subcutaneously every 4 weeks, the median percentage of patients predicted to relapse within 4 weeks was estimated to be 6% (95% confidence interval 1\u201321). Therapy was generally well tolerated and few patients experienced injection\u2010site reactions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Canakinumab has a promising preliminary safety and efficacy profile in this limited cohort. Based on the findings of this trial, further studies in a larger population of children with systemic JIA are warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.33342","type":"journal-article","created":{"date-parts":[[2011,9,27]],"date-time":"2011-09-27T22:34:51Z","timestamp":1317162891000},"page":"557-567","source":"Crossref","is-referenced-by-count":168,"title":["A phase II, multicenter, open\u2010label study evaluating dosing and preliminary safety and efficacy of canakinumab in systemic juvenile idiopathic arthritis with active systemic 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