Etanercept in the treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory polyarticular course juvenile idiopathic arthritis: experience from Japanese clinical trials
Etanercept in the treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory polyarticular course juvenile idiopathic arthritis: experience from Japanese clinical trials
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DOI：
10.1007/s10165-011-0450-7
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发表时间：
2011-12-01
影响因子：
2.2
通讯作者：
Wajdula, Joseph S.
中科院分区：
文献类型：
--
作者：
Mori, Masaaki;Takei, Syuji;Wajdula, Joseph S.
4项研究（3项开放标签研究（OL）和1项随机双盲研究（DB））的疗效、安全性和药代动力学结果为依那西普在日本被批准用于治疗改善疾病的抗风湿药物(DMARD)-难治性青少年特发性关节炎（JIA）提供了数据。本文报道了3个短期研究（2个OL和1个DB）的结果。参加OL研究的受试者（4-17岁）有活动性JIA，即关节肿胀（千分之一）和关节活动受限、疼痛或压痛（千分之一）。参加初级OL研究的受试者接受依那西普0.4 mg/kg的皮下注射，每周两次；在低剂量OL研究中，受试者接受依那西普0.2 mg/kg。在最初的OL研究中，在48周内完成千分之一剂量的受试者可以继续进入12周的DB剂量降低扩展研究，其中受试者每周两次接受依那西普0.4或0.2 mg/kg。所有3项研究的主要终点，即12周时美国风湿病学会JIA标准（ACR Pedi 30）改善30%，在第2周达到了千分之一，并持续到第12周。常见的不良事件有注射部位反应、鼻咽炎和肠胃炎。这些结果进一步证明依那西普是治疗dmard难治性多关节性JIA的有效方法。
Efficacy, safety, and pharmacokinetics results from 4 studies-3 open-label (OL) and 1 randomized double-blind (DB)-have provided data for approval of etanercept for treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory juvenile idiopathic arthritis (JIA) in Japan. Results from the 3 shorter-term (2 OL and 1 DB) studies are reported here. Subjects (4-17 years) enrolled in the OL studies had active JIA, i.e. a parts per thousand yen5 swollen joints and a parts per thousand yen3 joints with limitation of motion and pain or tenderness. Subjects enrolled in the primary OL study received etanercept 0.4 mg/kg subcutaneously twice weekly; in the lower-dose OL study subjects received etanercept 0.2 mg/kg. Subjects in the primary OL study who completed a parts per thousand yen48 weeks could continue into a 12-week DB dose-down extension study in which subjects received etanercept 0.4 or 0.2 mg/kg twice weekly. The primary endpoint in all 3 studies, i.e. 30% improvement in the American College of Rheumatology criteria for JIA (ACR Pedi 30) at 12 weeks, was achieved by a parts per thousand yen80% of subjects by week 2 and sustained to week 12. Common adverse events reported were injection site reactions, nasopharyngitis, and gastroenteritis. These results provide further evidence that etanercept is effective therapy for DMARD-refractory polyarticular JIA patients.