Windschall D, Horneff G
Department of Pediatrics, Asklepios Hospital Weissenfels, Naumburger-Strasse 76, 06667, Weissenfels, Germany.
Department of Pediatrics, Center for Pediatric Rheumatology, Asklepios Hospital Sankt Augustin, Arnold-Janssen-Strasse 29, 53757, St. Augustin, Germany.
Clin Rheumatol. 2016 Dec;35(12):2925-2931. doi: 10.1007/s10067-016-3439-y. Epub 2016 Oct 5.
The TNF inhibitors etanercept (ETA) and adalimumab (ADA) are approved for treating patients older than 2 years with polyarticular juvenile idiopathic arthritis (JIA). Because long-term experience of treating children younger than 4 years is limited, we evaluated the efficacy and safety of ETA or ADA in patients aged 2-4 years. This prospective, long-term, observational registry study documented baseline demographics, clinical characteristics, disease activity parameters, and safety of patients treated with ETA or ADA. Efficacy was determined using the JADAS-10, the JADAS criteria for minimal disease activity (MDA) and remission, and the PedACR response criteria after 3, 6, 12, 18, and 24 months. Between January 2001 and March 2015, 85 patients with polyarticular JIA aged 2-4 years started anti-TNF-α treatment. Seventy-four (54 girls) patients were treated with ETA and 11 (7 girls) with ADA. After 6/12/24 months of treatment, JADAS-MDA was reached by 55/58/58 % of ETA patients and 50/71/66 % of ADA patients. Furthermore, JADAS-Remission was achieved by 35/44/50 % of ETA patients and 16/28/66 % of ADA patients. PedACR 50/70/90 response was achieved by 64/54/41 % of ETA patients and 56/33/22 % of ADA patients at the last treatment observation. Discontinuation because of remission or inefficacy was recorded in 24 (29 %) and 28 (33 %) patients, respectively. Seventy-nine adverse events and four serious adverse events were reported. Administration of ETA and ADA in JIA patients younger than 4 years was efficacious, well tolerated, and safe. Patients younger than 4 years may show marked improvement following anti-TNF-alpha therapy.
肿瘤坏死因子抑制剂依那西普（ETA）和阿达木单抗（ADA）已被批准用于治疗2岁以上的多关节型幼年特发性关节炎（JIA）患者。由于治疗4岁以下儿童的长期经验有限，我们评估了ETA或ADA在2至4岁患者中的疗效和安全性。这项前瞻性、长期、观察性注册研究记录了接受ETA或ADA治疗患者的基线人口统计学、临床特征、疾病活动参数和安全性。在3、6、12、18和24个月后，使用JADAS-10、JADAS最小疾病活动（MDA）和缓解标准以及PedACR反应标准来确定疗效。在2001年1月至2015年3月期间，85例2至4岁的多关节型JIA患者开始抗TNF-α治疗。74例（54名女孩）患者接受ETA治疗，11例（7名女孩）接受ADA治疗。在治疗6/12/24个月后，ETA组分别有55/58/58%的患者达到JADAS-MDA，ADA组分别有50/71/66%的患者达到。此外，ETA组分别有35/44/50%的患者实现JADAS缓解，ADA组分别有16/28/66%的患者实现。在最后一次治疗观察时，ETA组分别有64/54/41%的患者达到PedACR 50/70/90反应，ADA组分别有56/33/22%的患者达到。分别有24例（29%）和28例（33%）患者因缓解或无效而停药。报告了79例不良事件和4例严重不良事件。在4岁以下的JIA患者中使用ETA和ADA是有效的、耐受性良好且安全的。4岁以下的患者在抗TNF-α治疗后可能会有显著改善。
