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是否有更多的 IL-6 阻断空间? Sarilumab 治疗类风湿关节炎。

Room for more IL-6 blockade? Sarilumab for the treatment of rheumatoid arthritis.

机构信息

a Division of Rheumatology, Department of Medicine , Penn State MS Hershey Medical Center , Hershey , PA , USA.

出版信息

Expert Opin Biol Ther. 2016 Oct;16(10):1303-9. doi: 10.1080/14712598.2016.1217988. Epub 2016 Aug 8.

Abstract

INTRODUCTION

Rheumatoid arthritis (RA) treatment has been revolutionized by the development of highly efficacious biotherapeutics. However, a significant subset of RA patients has persistently active disease and ongoing erosive joint damage despite the available therapies. Sarilumab targets interleukin-6, one of the main cytokines mediating inflammation in RA. Positive results with sarilumab in RA clinical trials support the licensing application currently under review with the US Food and Drug Administration.

AREAS COVERED

The rationale for IL-6 targeting in RA, the pharmacologic properties of sarilumab, and the clinical trial results are reviewed focusing on the pending application for the RA indication. Comparisons with other IL-6 targeting biologics as well as additional potential therapeutic directions are discussed.

EXPERT OPINION

Sarilumab is a highly active therapeutic in patients with RA. While pharmacologic data demonstrate that sarilumab has a higher affinity than tocilizumab for the target receptor, available clinical results suggest that efficacy and adverse event profiles are similar to this other IL-6 blocker, which is currently approved for the treatment of RA. Whether there are other distinct differences or advantages of sarilumab that will support the approval and successful marketing of this drug, over existing therapies, remains to be determined.

摘要

简介

类风湿关节炎(RA)的治疗已经因高效生物疗法的发展而发生了革命性变化。然而,尽管有可用的疗法,仍有相当一部分 RA 患者的疾病持续活动且存在进行性侵蚀性关节损伤。Sarilumab 靶向白介素-6,这是介导 RA 炎症的主要细胞因子之一。Sarilumab 在 RA 临床试验中的积极结果支持了目前正在接受美国食品和药物管理局审查的许可申请。

涵盖的领域

RA 中靶向 IL-6 的原理、Sarilumab 的药理特性以及临床试验结果进行了回顾,重点关注 RA 适应证的待决申请。讨论了与其他 IL-6 靶向生物制剂的比较以及其他潜在的治疗方向。

专家意见

Sarilumab 是一种在 RA 患者中具有高度活性的治疗药物。虽然药理数据表明 Sarilumab 与目标受体的亲和力高于托珠单抗,但现有临床结果表明,其疗效和不良事件谱与目前批准用于治疗 RA 的其他 IL-6 阻滞剂相似。Sarilumab 是否具有其他独特的优势,使其能够获得批准并成功上市,优于现有疗法,仍有待确定。

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