Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis - Interim results from an ongoing multicenter, open-label, extended-treatment trial
Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis - Interim results from an ongoing multicenter, open-label, extended-treatment trial
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DOI：
10.1002/art.10710
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发表时间：
2003-01-01
影响因子：
--
通讯作者：
Burge, DJ
中科院分区：
文献类型：
--
作者：
Lovell, DJ;Giannini, EH;Burge, DJ
客观的。旨在评估依那西普对幼年类风湿性关节炎 (JRA) 儿童的长期疗效和安全性，该试验正在进行一项多中心、开放标签、延伸治疗试验。所有患者均参加了依那西普的初步随机疗效和安全性试验。方法。依那西普以 0.4 mg/kg（最大 25 mg）的剂量每周皮下注射两次。每 3-4 个月进行一次安全性和有效性评估。 JRA 30% 改善的定义 (DOI) 被定义为用于评估疾病活动性的 6 个反应变量中的至少 3 个改善大于或等于 30%，其中不超过 1 个变量恶化超过 30%。结果。截至分析时，58 名患者中的 48 名 (83%) 仍在参与研究；其中 43 人 (74%) 已完成 2 年的治疗。在这 43 名患者中，81% 满足 JRA 30% DOI，79% 满足 JRA 50% DOI，67% 满足 JRA 70% DOI。 10 名儿童在第一年后开始使用低剂量甲氨蝶呤。在 32 名服用泼尼松的儿童中，剂量减少至持续依那西普治疗 2 年。依那西普通常耐受性良好。随着时间的推移，不良事件的发生率没有增加。然而，服用依那西普的儿童应密切监测感染情况。
Objective. To evaluate the long-term efficacy and safety of etanercept in children with juvenile rheumatoid arthritis (JRA) participating in an ongoing multicenter, open-label, extended-treatment trial. All patients had been participants in an initial randomized efficacy and safety trial of etanercept.Methods. Etanercept was administered at a dosage of 0.4 mg/kg (maximum 25 mg) subcutaneously twice each week. Safety and efficacy evaluations were performed every 3-4 months. The JRA 30% definition of improvement (DOI) was defined as improvement of greater than or equal to30% in at least 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 30%.Results. At the time of analysis, 48 of the 58 patients (83%) were still enrolled in the study; 43 of them (74%) had completed 2 years of treatment. Of these 43 patients, 81% met the JRA 30% DOI, 79% met the JRA 50% DOI, and 67% met the JRA 70% DOI. Ten children started low-dose methotrexate after year 1. Of the 32 children taking prednisone, the dosage was decreased to 2 years of continuous etanercept treatment. Etanercept was generally well-tolerated. There were no increases in the rates of adverse events over time. However, children taking etanercept should be monitored closely for infections.