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培戈珠单抗的药物安全性评价。

Drug safety evaluation of certolizumab pegol.

机构信息

University Hospitals Leuven, Department of Gastroenterology , Herestraat 49, B3000 Leuven , Belgium +32 16 34 42 25 ; +32 16 34 44 19 ;

出版信息

Expert Opin Drug Saf. 2014 Feb;13(2):255-66. doi: 10.1517/14740338.2014.851666. Epub 2013 Oct 25.

Abstract

INTRODUCTION

The introduction of antibodies directed against tumor necrosis factor (anti-TNF) has dramatically changed our concept of treating both patients with Crohn's disease (CD) and patients with rheumatoid arthritis (RA). Subcutaneous injections with certolizumab pegol (CZP) have been shown efficacious for both CD and RA. In this review, the authors focus on the safety of CZP among other anti-TNF agents.

AREAS COVERED

A literature search till June 2013 was performed to identify all trials studying CZP in patients with CD and RA. In addition, abstracts of major congresses were assessed. The authors first focused on the mechanism of action of CZP, and evaluated the efficacy of this drug in both CD and RA. Next, they explored the available safety data on CZP, including infection and malignancy risk, injection site reactions, the development of antibodies against CZP, as well as its use during pregnancy.

EXPERT OPINION

Based on the provided literature, CZP seems to have a similar safety profile to other anti-TNF agents. However, in young females considering pregnancy, CZP may be advocated over other anti-TNF agents as it does not actively cross the placenta.

摘要

简介

针对肿瘤坏死因子(anti-TNF)的抗体的引入极大地改变了我们对治疗克罗恩病(CD)和类风湿关节炎(RA)患者的概念。培塞利珠单抗(CZP)的皮下注射已被证明对 CD 和 RA 均有效。在这篇综述中,作者重点关注 CZP 与其他抗 TNF 药物相比的安全性。

涵盖领域

截至 2013 年 6 月,进行了文献检索以确定所有研究 CZP 治疗 CD 和 RA 患者的试验。此外,还评估了主要大会的摘要。作者首先关注 CZP 的作用机制,并评估了该药在 CD 和 RA 中的疗效。接下来,他们探讨了 CZP 的可用安全性数据,包括感染和恶性肿瘤风险、注射部位反应、针对 CZP 的抗体的产生,以及在怀孕期间的使用。

专家意见

基于提供的文献,CZP 似乎具有与其他抗 TNF 药物相似的安全性概况。然而,对于年轻女性,如果考虑怀孕,CZP 可能优于其他抗 TNF 药物,因为它不会主动穿过胎盘。

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