Etanercept in children with polyarticular juvenile rheumatoid arthritis.
Etanercept in children with polyarticular juvenile rheumatoid arthritis.
复制标题
DOI：
10.1056/nejm200003163421103
复制
发表时间：
2000-03-16
影响因子：
158.5
通讯作者：
Finck, BK
中科院分区：
文献类型：
--
作者：
Lovell, DJ;Giannini, EH;Finck, BK
背景资料：我们评估了依那西普，可溶性肿瘤坏死因子受体（p75）：Fc融合蛋白，在儿童多关节幼年型类风湿性关节炎谁不耐受或有一个不充分的反应，以methotrexate.Methods的安全性和有效性：患者4至17岁接受0.4毫克的依那西普每公斤体重皮下注射每周两次长达三个月的初始，开放标签的一部分，一项多中心试验。那些对治疗有反应的患者随后进入一项双盲研究，并被随机分配接受安慰剂或依那西普治疗4个月或直到疾病发作。反应被定义为疾病活动的六个指标中至少有三个指标改善30%或更多，不超过一个指标恶化超过30%.Results：在开放标签研究结束时，69名患者中有51名（74%）对依那西普治疗有反应。在双盲研究中，26名接受安慰剂的患者中有21名（81%）因疾病发作而退出，而25名接受依那西普的患者中有7名（28%）（P = 0.003）。安慰剂组至疾病发作的中位时间为28天，而依那西普组超过116天（P
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