Mori Masaaki, Takei Syuji, Imagawa Tomoyuki, Imanaka Hiroyuki, Maeno Nobuaki, Kurosawa Rumiko, Kawano Yoshifumi, Yokota Shumpei
Department of Pediatrics, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Mod Rheumatol. 2005;15(6):397-404. doi: 10.1007/s10165-005-0431-9.
We examined and evaluated the pharmacokinetics, efficacy, and safety of etanercept in patients with methotrexate (MTX)-refractory polyarticular juvenile idiopathic arthritis (JIA) in Japan. All MTX-refractory polyarticular JIA patients 4-17 years old received 0.4 mg of etanercept per kilogram of body weight subcutaneously twice weekly for up to 3 months in the open-label, prospective, and multicenter trial. A response was defined as an improvement of 30%, 50%, 70%, or more from baseline in at least three of six indicators of disease activity, with no more than one indicator worsening by more than 30% from baseline (30%, 50%, or 70% definition of improvement, respectively), and disease activity score (DAS28) by EULAR (European League Against Rheumatism) response criteria. At the end of the 12-week study, 20 of the 22 patients (90.9%) had responses with both 30% and 50% definition of improvement after etanercept treatment. To our surprise, 15 of 22 patients (68.2%) had a response with 70% definition of improvement. Moreover, in DAS28, eight patients were evaluated as having a good response and there were no patients with a poor response to etanercept. Treatment had to be stopped in one patient who developed joint contracture during the study period, but there were no significant adverse events in the other patients. In conclusion, treatment with etanercept leads to significant improvement in patients with active polyarticular JIA in Japan. Etanercept is well tolerated by pediatric patients as well as adults.
我们在日本对甲氨蝶呤（MTX）难治性多关节型幼年特发性关节炎（JIA）患者进行了依那西普的药代动力学、疗效及安全性研究与评估。在这项开放标签、前瞻性、多中心试验中，所有4至17岁的MTX难治性多关节型JIA患者接受皮下注射依那西普，剂量为每千克体重0.4毫克，每周两次，持续3个月。反应定义为疾病活动的六个指标中至少三个指标较基线改善30%、50%、70%或更多，且不超过一个指标较基线恶化超过30%（分别为30%、50%或70%改善定义），并根据欧洲抗风湿病联盟（EULAR）反应标准评估疾病活动评分（DAS28）。在12周研究结束时，22例患者中有20例（90.9%）在接受依那西普治疗后达到30%和50%改善定义的反应。令我们惊讶的是，22例患者中有15例（68.2%）达到70%改善定义的反应。此外，在DAS28方面，8例患者被评估为反应良好，没有患者对依那西普反应不佳。有1例患者在研究期间出现关节挛缩，不得不停止治疗，但其他患者未出现严重不良事件。总之，在日本，依那西普治疗可使活动性多关节型JIA患者显著改善。依那西普在儿科患者和成人中耐受性良好。
