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评估利妥昔单抗生物类似药 CT-P10 治疗类风湿关节炎的药代动力学。

A pharmacokinetic evaluation of the rituximab biosimilar CT-P10 in the treatment of rheumatoid arthritis.

机构信息

Hanyang University Hospital for Rheumatic Diseases, Hanyang University , Seoul, Republic of Korea.

Department of Rheumatology, Ajou University School of Medicine , Suwon, Republic of Korea.

出版信息

Expert Opin Drug Metab Toxicol. 2020 Dec;16(12):1125-1132. doi: 10.1080/17425255.2020.1832082. Epub 2020 Nov 3.

Abstract

INTRODUCTION

CT-P10 is the first biosimilar of rituximab (RTX) for the treatment of rheumatoid arthritis (RA). The application of valuable biosimilar for the treatment of RA may decrease economic burden of society, and disease activity of RA. Thus, it is worthwhile to identify the economic advantage and further requirement for the proper use of CT-P10 in real world.

AREAS COVERED

Literature searching was performed to identify suitable references written in English for this review article. Rituximab, biosimilar, CT-P10, and rheumatoid arthritis were used as keywords. Current state of RA treatment, position of RTX in the recommendations for the treatment of RA, current status of RTX biosimilar development were assessed before evaluating CT-P10 itself. Physicochemical property, pharmacokinetic profile through phase I to phase III studies, pharmacodynamics, toxicology data, clinical efficacy, and safety were reviewed.

EXPERT OPINION

As the first biosimilar to originator RTX, CT-P10 may be a useful alternative for the treatment of RA in all indications for originator RTX. In addition, more studies are required to identify long-term effectiveness and safety of CT-P10 in real world. It is also important to find out new indications of CT-P10 and effective mechanisms to lessen nocebo effect against biosimilar including CT-P10.

摘要

简介

CT-P10 是利妥昔单抗(RTX)的首个生物类似药,用于治疗类风湿关节炎(RA)。将有价值的生物类似药应用于 RA 的治疗可能会降低社会的经济负担,减轻 RA 的疾病活动度。因此,有必要确定 CT-P10 在真实世界中的经济优势和合理使用的进一步要求。

涵盖领域

为撰写这篇综述文章,我们用英语进行了文献检索,以确定合适的参考文献。使用了利妥昔单抗、生物类似药、CT-P10 和类风湿关节炎作为关键词。在评估 CT-P10 本身之前,评估了 RA 治疗的现状、RTX 在 RA 治疗推荐中的地位以及 RTX 生物类似药开发的现状。综述了 CT-P10 的理化性质、I 期至 III 期研究的药代动力学特征、药效学、毒理学数据、临床疗效和安全性。

专家意见

作为首个 RTX 的生物类似药,CT-P10 可能是所有 RTX 适应证治疗 RA 的一种有用选择。此外,还需要更多的研究来确定 CT-P10 在真实世界中的长期疗效和安全性。发现 CT-P10 的新适应证和减轻针对生物类似药(包括 CT-P10)的反安慰剂效应的有效机制也很重要。

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