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依那西普:获批适应证的疗效和安全性。

Etanercept: efficacy and safety for approved indications.

机构信息

Tufts Medical Center, Department of Dermatology, 800 Washington St. Box 114, Boston, MA 02111, USA.

出版信息

Expert Opin Drug Saf. 2012 Jan;11(1):121-39. doi: 10.1517/14740338.2012.633509. Epub 2011 Nov 11.

Abstract

INTRODUCTION

Etanercept is a tumor necrosis factor alpha (TNF-α) inhibitor, which is approved for the treatment of immune-mediated inflammatory conditions including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and psoriasis (PsO).

AREAS COVERED

Clinical efficacy and safety data of etanercept for the approved indications are reviewed in this paper. Data were obtained from published clinical trials, registries, post-marketing data as well as information provided by Amgen.

EXPERT OPINION

Etanercept is a generally well-tolerated treatment for the approved inflammatory diseases. The most common adverse effect of etanercept treatment is injection site reaction, which is generally self-limiting and often does not require treatment. Etanercept may be associated with an increased risk for infection, the development of malignancy, demyelinating disease and congestive heart failure. Fewer patients withdraw from etanercept due to adverse events than with other biologics. For pediatric patients, there are more data for etanercept than other biologics, and etanercept may have lower rates for the development of malignancy.

摘要

简介

依那西普是一种肿瘤坏死因子-α(TNF-α)抑制剂,已被批准用于治疗免疫介导的炎症性疾病,包括类风湿关节炎(RA)、幼年特发性关节炎(JIA)、银屑病关节炎(PsA)、强直性脊柱炎(AS)和银屑病(PsO)。

涵盖领域

本文综述了依那西普在获批适应证中的临床疗效和安全性数据。数据来自已发表的临床试验、注册、上市后数据以及安进公司提供的信息。

专家意见

依那西普是一种耐受性良好的治疗药物,适用于批准的炎症性疾病。依那西普治疗最常见的不良反应是注射部位反应,通常是自限性的,通常不需要治疗。依那西普可能与感染、恶性肿瘤、脱髓鞘疾病和充血性心力衰竭的风险增加有关。与其他生物制剂相比,因不良反应而停药的患者较少。对于儿科患者,依那西普的数据多于其他生物制剂,并且恶性肿瘤的发生率可能较低。

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