Department of Pediatrics, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan.
Mod Rheumatol. 2012 Sep;22(5):720-6. doi: 10.1007/s10165-011-0578-5. Epub 2012 Jan 4.
Previous short-term trials found etanercept (0.2 or 0.4 mg/kg) to be effective and well tolerated in Japanese children with juvenile idiopathic arthritis (JIA) who were intolerant/resistant to methotrexate. The aim of this study was to evaluate the long-term safety and efficacy of etanercept in Japanese children with JIA.
Patients (4-19 years) who received etanercept in one of three short-term studies continued onto this long-term open-label study.
Of the 32 patients enrolled, 18 (56.3%) completed 192 weeks of the study and 14 (43.8%) were discontinued; 7 (21.9%) for patient refusal, 2 (6.3%) for adverse events (AEs), and 5 (15.6%) for lack of efficacy. All patients reported AEs; 31 (96.9%) reported infections and 6 (18.8%) reported serious AEs. Main efficacy assessments included change from baseline in the American College of Rheumatology Pediatric core components, including mean improvements from baseline in the physician global assessment (90.7%), patient/guardian global assessments (54.1%), Childhood Health Assessment Questionnaire (84.6%), and median improvements in C-reactive protein levels (92.7%). No unexpected safety results were reported, and early efficacy responses were sustained in the long term.
This study provides further evidence that etanercept is an effective therapeutic option for Japanese children with polyarticular-course JIA.
先前的短期试验发现，依那西普（0.2 或 0.4mg/kg）对不耐受/耐药甲氨蝶呤的日本幼年特发性关节炎（JIA）患儿有效且耐受性良好。本研究旨在评估依那西普在日本 JIA 患儿中的长期安全性和疗效。
在三项短期研究中接受依那西普治疗的患者（4-19 岁）继续进入这项长期开放标签研究。
在纳入的 32 名患者中，18 名（56.3%）完成了 192 周的研究，14 名（43.8%）被停药；7 名（21.9%）因患者拒绝，2 名（6.3%）因不良事件（AE），5 名（15.6%）因疗效不佳。所有患者均报告 AE；31 名（96.9%）报告感染，6 名（18.8%）报告严重 AE。主要疗效评估包括美国风湿病学会儿科核心指标从基线的变化，包括医生总体评估（90.7%）、患者/监护人总体评估（54.1%）、儿童健康评估问卷（84.6%）和 C 反应蛋白水平中位数改善（92.7%）。未报告意外的安全性结果，并且长期维持了早期的疗效反应。
本研究进一步证明，依那西普是一种治疗日本多关节型 JIA 患儿的有效治疗选择。
