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A phase II, multicenter, open-label study evaluating dosing and preliminary safety and efficacy of canakinumab in systemic juvenile idiopathic arthritis with active systemic features

机译：II期，多中心，开放标签的研究，评估canakinumab在具有活跃系统特征的系统性幼年特发性关节炎中的剂量，初步安全性和有效性

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Objective To assess dosing, preliminary safety, and efficacy of canakinumab, a fully human anti-interleukin-1β (anti-IL-1β) antibody, in children with systemic juvenile idiopathic arthritis (JIA) and active systemic features. Methods In this phase II, multicenter, open-label, dosage-escalation study, children with systemic JIA who were ≤4 years of age, had fever, and were receiving ≤0.4 mg/kg/day of corticosteroids were administered a single subcutaneous dose of canakinumab, 0.5-9 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. Results A total of 23 children ages 4-19 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 1-21). Therapy was generally well tolerated and few patients experienced injection-site reactions. Conclusion 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.
机译：目的评估具有完全人源性抗白细胞介素1β（抗IL-1β）抗体的canakinumab的剂量，初步安全性和疗效，用于系统性幼年特发性关节炎（JIA）和活动性系统特征的儿童。方法在第二阶段的多中心，开放标签，剂量递增研究中，对单次皮下给药剂量为≤4岁，发烧且每天接受≤0.4mg / kg皮质类固醇的系统性JIA儿童卡那基单抗的剂量为0.5-9毫克/千克体重，并在复发时重新服用。根据美国风湿病学会（ACR）儿科改善标准对治疗的反应进行了评估。结果共有23名4-19岁的儿童患有活动性疾病。在这些患者中，有1名患者被排除在分析之外，而3名重新入组的患者两次被纳入功效分析。到第一个治疗周期的第15天，25例患者中有15例（60％）达到了适应性ACR小儿50反应，其中4例达到了非活动性疾病状态。随着时间的流逝，反应得以持续，在整个研究过程中，13名患者中有11名能够维持其反应。在基线接受类固醇治疗的11名应答者中，有8名在最初的5个月中将类固醇剂量从平均0.38 mg / kg /天降低至0.13 mg / kg /天，其中4名能够停药类固醇。每4周皮下注射canakinumab剂量为4 mg / kg时，预计4周内复发的患者中位百分比估计为6％（95％置信区间1-21）。治疗通常耐受良好，很少有患者出现注射部位反应。结论Canakinumab在这一有限的队列研究中具有令人鼓舞的初步安全性和有效性。根据该试验的结果，有必要对更多的系统性JIA儿童进行进一步研究。

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