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培戈洛珠单抗治疗斑块状银屑病:妊娠相关问题。

Certolizumab Pegol in Plaque Psoriasis: Considerations for Pregnancy.

机构信息

Northern Ontario School of Medicine, Thunder Bay, ON, Canada.

Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

出版信息

Skin Therapy Lett. 2021 Mar;26(2):1-5.

Abstract

Psoriasis is a chronic, immune-mediated skin condition which commonly affects women of childbearing age. Certolizumab pegol (CZP) is an anti-tumor necrosis factor-alpha (anti-TNFα) agent that has demonstrated long-term safety and efficacy in treating moderate-to-severe plaque psoriasis. Previously, there has been limited safety data surrounding its use in pregnancy. The objective of this article is to review pivotal clinical trial data for CZP and explore safety considerations for this agent in pregnancy. This review demonstrates that CZP offers a safe and effective treatment option for women during childbearing years based on pharmacokinetics and available safety data. The observed occurrence of major congenital malformations and miscarriages appears to be no greater than the background occurrence of those in the general population, and risks to the mother are minimal based on its known safety profile. The use of CZP for treatment of plaque psoriasis should be considered and discussed with patients considering childbearing or whom are currently pregnant or breastfeeding.

摘要

银屑病是一种慢性、免疫介导的皮肤疾病,常见于育龄妇女。培塞利珠单抗(CZP)是一种抗肿瘤坏死因子-α(anti-TNFα)药物,在治疗中重度斑块型银屑病方面已显示出长期的安全性和疗效。此前,关于其在妊娠期间的使用安全性数据有限。本文的目的是回顾 CZP 的关键临床试验数据,并探讨该药物在妊娠期间的安全性考虑因素。这篇综述表明,基于药代动力学和现有安全性数据,CZP 为育龄妇女提供了一种安全有效的治疗选择。观察到的主要先天畸形和流产的发生率似乎并不高于一般人群中的发生率,而且根据其已知的安全性,对母亲的风险极小。对于正在考虑生育或已经怀孕或哺乳的患者,应考虑并讨论使用 CZP 治疗斑块型银屑病。

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