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类风湿关节炎治疗药物中改善病情抗风湿药的比较安全性:叙述性综述。

A narrative review of the comparative safety of disease-modifying anti-rheumatic drugs used for the treatment of rheumatoid arthritis.

机构信息

Division of Clinical Immunology and Rheumatology, The University of Alabama Birmingham, Birmingham, AL, USA.

Medicine/Rheumatology Birmingham Veterans Affairs Medical Center (VAMC), Birmingham, AL, USA.

出版信息

Expert Opin Drug Saf. 2024 Jun;23(6):687-714. doi: 10.1080/14740338.2024.2348575. Epub 2024 May 23.

Abstract

INTRODUCTION

Disease-modifying anti-rheumatic drugs (DMARDs) have improved the outcomes of patients with rheumatoid arthritis (RA). DMARDs are classified into three categories: conventional synthetic DMARDs, biological DMARDs (including biosimilars), and targeted synthetic DMARDs. DMARDs, by way of their effect on the immune system, are associated with increased risk of adverse events, including infections, malignancies, cardiovascular disease, gastrointestinal perforations, and other less common events.

AREAS COVERED

In this narrative literature review performed with searches of the PubMed database from 1 January 2010 through 1 January 2023, we compare the risk of safety events between DMARDs using data from both randomized clinical trials and observational studies.

EXPERT OPINION

DMARD use in RA is associated with higher rates of serious infections, tuberculosis reactivation, opportunistic infections, and possibly malignancies. Specific biologic DMARDs and higher doses are associated with elevated risks of various adverse events (gastrointestinal perforations, thromboembolism, serious infection). Shared decision-making is paramount when choosing a treatment regimen for patients based on their own comorbidities. JAKi are the newest class of medications used for RA with robust safety data provided in clinical trials. However, more real-world evidence and phase-IV pharmacovigilance data are needed to better understand comparative safety profile of DMARDs in RA.

摘要

简介

改变病情的抗风湿药物(DMARDs)改善了类风湿关节炎(RA)患者的预后。DMARD 分为三类:传统合成 DMARD、生物 DMARD(包括生物类似药)和靶向合成 DMARD。DMARD 通过对免疫系统的作用,与不良事件风险增加相关,包括感染、恶性肿瘤、心血管疾病、胃肠道穿孔和其他较少见的事件。

涵盖领域

在这项叙述性文献综述中,我们通过对 2010 年 1 月 1 日至 2023 年 1 月 1 日期间 PubMed 数据库的搜索,比较了来自随机临床试验和观察性研究的数据中 DMARD 之间的安全事件风险。

专家意见

RA 中 DMARD 的使用与严重感染、结核再激活、机会性感染和可能的恶性肿瘤的发生率较高相关。特定的生物 DMARD 和更高的剂量与各种不良事件(胃肠道穿孔、血栓栓塞、严重感染)的风险升高相关。在根据患者自身合并症为其选择治疗方案时,共同决策至关重要。JAKi 是用于 RA 的最新一类药物,临床试验提供了可靠的安全性数据。然而,需要更多的真实世界证据和四期药物警戒数据,以更好地了解 RA 中 DMARD 的比较安全性概况。

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