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依那西普(恩利)治疗幼年特发性关节炎。

Etanercept (Enbrel) in the treatment of juvenile idiopathic arthritis.

机构信息

Pediatric Rheumatologist, Western University, Children's Hospital, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A5W9 , Canada +519 685 8138 ; +519 685 8156 ;

出版信息

Expert Opin Biol Ther. 2013 Nov;13(11):1623-30. doi: 10.1517/14712598.2013.840580. Epub 2013 Sep 26.

DOI:10.1517/14712598.2013.840580
PMID:24070010
Abstract

INTRODUCTION

Juvenile idiopathic arthritis (JIA) is a relatively common multidimensional and heterogeneous chronic disease of childhood. Children with JIA are at risk for significant morbidity in terms of joint damage, impairments in physical function and health-related quality of life. Outcomes for children with JIA have significantly improved with the use of biologic therapies in the past 15 years, with the most clinical experience being with etanercept .

AREAS COVERED

Basic pharmacokinetic and pharmacodynamic data for etanercept will be highlighted. This article will review the clinical trials and open-label registry data for the efficacy and safety of etanercept for use in JIA.

EXPERT OPINION

Etanercept is very effective for the treatment of JIA. Data from clinical trials and open-label studies support its clinical efficacy in 80% of patients which appears to be sustained over several years for the majority of treated patients. The safety profile is also acceptable with a serious adverse event rate of 0.03 - 0.12 per patient-year. Further research is needed to evaluate any possible link between biologic therapy, JIA and malignancy, to obtain more long-term safety data, and to document improvements in quality of care and cost-benefit for associated with biologic therapies which may additionally assist in access to these medications. Further, identification of potential clinical or laboratory markers allowing for prediction of response and timing of starting and cessation of this biologic therapy are urgently required.

摘要

简介

幼年特发性关节炎(JIA)是一种相对常见的儿童多维度和异质性慢性疾病。患有 JIA 的儿童在关节损伤、身体功能和健康相关生活质量方面存在显著发病风险。在过去 15 年中,生物疗法的应用显著改善了儿童 JIA 的预后,其中最具临床经验的是依那西普。

涵盖领域

将重点介绍依那西普的基本药代动力学和药效学数据。本文将回顾依那西普治疗 JIA 的疗效和安全性的临床试验和开放标签注册数据。

专家意见

依那西普对 JIA 的治疗非常有效。临床试验和开放标签研究的数据支持其在 80%的患者中具有临床疗效,且在大多数接受治疗的患者中,这种疗效似乎可持续数年。安全性状况也可以接受,严重不良事件发生率为每患者年 0.03-0.12。需要进一步研究以评估生物疗法、JIA 和恶性肿瘤之间的任何可能联系,以获得更多的长期安全性数据,并记录与生物疗法相关的护理质量和成本效益的改善,这可能有助于获得这些药物。此外,迫切需要确定潜在的临床或实验室标志物,以预测对该生物疗法的反应,并确定开始和停止这种生物疗法的时间。

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Etanercept (Enbrel) in the treatment of juvenile idiopathic arthritis.依那西普(恩利)治疗幼年特发性关节炎。
Expert Opin Biol Ther. 2013 Nov;13(11):1623-30. doi: 10.1517/14712598.2013.840580. Epub 2013 Sep 26.
2
Efficacy and safety of etanercept in patients with the enthesitis-related arthritis category of juvenile idiopathic arthritis: results from a phase III randomized, double-blind study.依那西普治疗幼年特发性关节炎附着点炎症型患者的疗效和安全性:一项 III 期随机、双盲研究的结果。
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Duration of etanercept treatment and reasons for discontinuation in a cohort of juvenile idiopathic arthritis patients.依那西普治疗持续时间及幼年特发性关节炎患者停药原因的队列研究。
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Improvement in health-related quality of life for children with juvenile idiopathic arthritis after start of treatment with etanercept.接受依那西普治疗后幼年特发性关节炎儿童的健康相关生活质量得到改善。
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Long-term follow-up on effectiveness and safety of etanercept in juvenile idiopathic arthritis: the Dutch national register.依那西普治疗青少年特发性关节炎有效性和安全性的长期随访:荷兰国家登记研究
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Etanercept improves lipid profile and oxidative stress measures in patients with juvenile idiopathic arthritis.依那西普可改善幼年特发性关节炎患者的血脂谱和氧化应激指标。
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Development of inflammatory bowel disease in patients with juvenile idiopathic arthritis treated with etanercept.接受依那西普治疗的幼年特发性关节炎患者中炎症性肠病的发展。
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