Horneff Gerd, Ebert Annette, Fitter Sigrid, Minden Kirsten, Foeldvari Ivan, Kümmerle-Deschner Jasmin, Thon Angelika, Girschick Herrmann J, Weller Frank, Huppertz Hans I
Department of Paediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.
Rheumatology (Oxford). 2009 Aug;48(8):916-9. doi: 10.1093/rheumatology/kep122. Epub 2009 May 29.
Etanercept, a recombinant TNF receptor fusion protein, has been approved for the treatment of resistant polyarticular course juvenile idiopathic arthritis at a dosage of 0.4 mg/kg twice weekly in children older than 4 years. In adult patients, efficacy and safety of etanercept 25 mg twice weekly was comparable with 50 mg once weekly. Therefore, safety and efficacy of etanercept once weekly 0.8 mg/kg up to 50 mg s.c. was evaluated in a 3 month open label trial.
Twenty patients 4 to 17 years old received 0.8 mg of etanercept per kilogram of body weight subcutaneously once weekly for 3 months in an open multicentre trial. Active polyarticular disease was defined by the presence of five or more active joints with swelling, alternatively with pain or tenderness combined with limitation of motion. Safety assessments were based on adverse events (AEs) reports. Efficacy was assessed using the PedACR30/50/70 criteria.
At the start of treatment the patients showed high disease activity. A rapid reduction of all disease activity parameters was observed. A PedACR30/50/70 response was reached by 75%/35%/10% of patients after 4 weeks, 90%/75%/35% after 8 weeks and 95%/75%/75% after 12 weeks of treatment. There were 37 AEs, none of them serious, with injection site reactions and minor infections being the most frequent. There was no drop out. Long-term follow-up of the patients will be carried out in the German JIA Registry.
Treatment with etanercept once weekly using a double dosage leads to a significant improvement of disease activity in patients with active polyarticular course juvenile idiopathic arthritis and is well tolerated.
依那西普是一种重组肿瘤坏死因子受体融合蛋白，已被批准用于治疗4岁以上儿童耐药性多关节型幼年特发性关节炎，剂量为0.4mg/kg，每周两次。在成年患者中，依那西普25mg每周两次的疗效和安全性与50mg每周一次相当。因此，在一项为期3个月的开放标签试验中评估了依那西普每周一次0.8mg/kg皮下注射至50mg的安全性和疗效。
在一项开放的多中心试验中，20名4至17岁的患者每周一次皮下注射每千克体重0.8mg依那西普，持续3个月。活动性多关节疾病定义为存在五个或更多伴有肿胀的活动关节，或者伴有疼痛或压痛并伴有活动受限。安全性评估基于不良事件（AE）报告。使用PedACR30/50/70标准评估疗效。
治疗开始时患者疾病活动度较高。观察到所有疾病活动参数迅速降低。治疗4周后，75%/35%/10%的患者达到PedACR30/50/70反应，8周后为90%/75%/35%，12周后为95%/75%/75%。共有37例不良事件，均不严重，最常见的是注射部位反应和轻微感染。无患者退出。将在德国幼年特发性关节炎注册中心对患者进行长期随访。
每周一次双倍剂量的依那西普治疗可使活动性多关节型幼年特发性关节炎患者的疾病活动度显著改善，且耐受性良好。
