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幼年特发性关节炎患者使用肿瘤坏死因子-α抑制剂的经验:来自匈牙利国家风湿病学和物理治疗学研究所注册中心的数据。

Experiences with tumour necrosis factor-{alpha} inhibitors in patients with juvenile idiopathic arthritis: Hungarian data from the National Institute of Rheumatology and Physiotherapy Registry.

机构信息

Department of Clinical Immunology, Adult and Paediatric Rheumatology, National Institute of Rheumatology and Physiotherapy, Frankel Leo Str. 38-40, Budapest 1023, Hungary.

出版信息

Rheumatology (Oxford). 2011 Jul;50(7):1337-40. doi: 10.1093/rheumatology/ker103. Epub 2011 Mar 3.

Abstract

OBJECTIVE

To report the efficacy and safety of TNF-α inhibitors (etanercept and adalimumab) in a cohort of patients with JIA treated in a single paediatric rheumatological centre.

METHODS

Patients with JIA under the age of 18 years, treated with TNF-α blockers at the Paediatric Rheumatologic Centre of the National Institute of Rheumatology and Physiotherapy (Budapest, Hungary) from 2002, were enrolled in an open, observational study. At baseline, patient and disease characteristics were registered. Disease activity was evaluated (before the start of the treatment and after every 3 months) according to the JIA core set of the ACR paediatric definition of improvement (ACR Pedi). Adverse events (AEs) were documented.

RESULTS

In all, 72 patients were evaluated. Mean (S.D.) age at onset was 5.5 (3.8) years, mean disease duration was 7.4 (3.9) years. All disease activity parameters improved significantly in the first 3 months of treatment. After 3 and 12 months of treatment, 88 and 76% of patients, respectively, achieved the criteria of the ACR Pedi 30. AEs were uncommon. After 12 months, >85% of patients continued the therapy.

CONCLUSION

Anti-TNF-α agents (etanercept and adalimumab) are effective, safe and well tolerated in JIA patients. Extension of this study for a longer follow-up period and to the patients with JIA after the age of 18 years (with validated and comparable disease activity parameters) is needed to evaluate the long-term effectiveness and safety of the TNF-α inhibitors.

摘要

目的

报告 TNF-α 抑制剂(依那西普和阿达木单抗)在单家儿科风湿病中心治疗的 JIA 患者中的疗效和安全性。

方法

2002 年在匈牙利国家风湿病与物理治疗研究所儿科风湿病中心接受 TNF-α 阻滞剂治疗的年龄在 18 岁以下的 JIA 患者入组一项开放性观察性研究。在基线时,登记患者和疾病特征。根据 ACR 儿科改良定义的 JIA 核心集(ACR Pedi)评估疾病活动度(在治疗开始前和每 3 个月后)。记录不良事件(AE)。

结果

共评估了 72 例患者。发病时的平均(SD)年龄为 5.5(3.8)岁,平均病程为 7.4(3.9)年。治疗的前 3 个月,所有疾病活动参数均显著改善。治疗 3 个月和 12 个月后,分别有 88%和 76%的患者达到 ACR Pedi30 标准。AE 不常见。治疗 12 个月后,>85%的患者继续接受治疗。

结论

抗 TNF-α 药物(依那西普和阿达木单抗)在 JIA 患者中有效、安全且耐受性良好。需要对该研究进行延长随访期和扩展到 18 岁以上 JIA 患者(使用已验证且可比的疾病活动参数),以评估 TNF-α 抑制剂的长期疗效和安全性。

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