• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

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.

DOI:10.1080/17425255.2020.1832082
PMID:33012214
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。

相似文献

1
A pharmacokinetic evaluation of the rituximab biosimilar CT-P10 in the treatment of rheumatoid arthritis.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。
Expert Opin Drug Metab Toxicol. 2020 Dec;16(12):1125-1132. doi: 10.1080/17425255.2020.1832082. Epub 2020 Nov 3.
2
Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial.类风湿关节炎患者中,利妥昔单抗生物类似药CT-P10与原研利妥昔单抗多达两个疗程的疗效、安全性及药代动力学:一项I期随机对照试验第72周的结果
BioDrugs. 2017 Aug;31(4):357-367. doi: 10.1007/s40259-017-0232-7.
3
Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial.生物类似药 CT-P10 与利妥昔单抗治疗类风湿关节炎的长期疗效和安全性:一项随机 III 期试验的 48 周结果。
BioDrugs. 2019 Feb;33(1):79-91. doi: 10.1007/s40259-018-00331-4.
4
Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial.比较 CT-P10 生物类似药和利妥昔单抗原研药治疗类风湿关节炎患者的疗效:一项随机对照 3 期临床试验。
MAbs. 2018 Aug/Sep;10(6):934-943. doi: 10.1080/19420862.2018.1487912. Epub 2018 Jul 16.
5
Pharmacokinetics, efficacy and safety of the rituximab biosimilar CT-P10.利妥昔单抗生物类似药 CT-P10 的药代动力学、疗效和安全性。
Expert Rev Clin Pharmacol. 2017 Sep;10(9):923-933. doi: 10.1080/17512433.2017.1359537. Epub 2017 Aug 2.
6
Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.在类风湿关节炎中从利妥昔单抗转换至生物类似药 CT-P10 的疗效和安全性:一项随机 3 期试验的 72 周数据。
Rheumatology (Oxford). 2019 Dec 1;58(12):2193-2202. doi: 10.1093/rheumatology/kez152.
7
Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis.与继续使用CT-P10治疗相比,从原研利妥昔单抗转换为生物类似药CT-P10的疗效和安全性:一项针对类风湿关节炎患者的56周开放标签研究结果
BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6.
8
Rituximab biosimilar CT-P10 for the treatment of rheumatoid arthritis.利妥昔单抗生物类似药 CT-P10 治疗类风湿关节炎。
Expert Opin Biol Ther. 2019 Oct;19(10):979-986. doi: 10.1080/14712598.2019.1665018. Epub 2019 Sep 18.
9
Safety and effectiveness of biosimilar of Rituximab CT-P10 in the treatment of cryoglobulinemic vasculitis: the MARBLe study (Mixed cryoglobulinemiA Rituximab BiosimiLar).利妥昔单抗 CT-P10 生物类似药治疗冷球蛋白血症性血管炎的安全性和有效性:MARBLe 研究(混合性冷球蛋白血症的利妥昔单抗生物类似药研究)。
Intern Emerg Med. 2021 Jan;16(1):149-156. doi: 10.1007/s11739-020-02386-0. Epub 2020 Jun 10.
10
A Developer's Perspective on Clinical Evidence and Benefits for Rituximab Biosimilar Uptake, with a Focus on CT-P10.从开发者视角看利妥昔单抗生物类似药的临床证据和获益,以 CT-P10 为例
Clin Drug Investig. 2022 Apr;42(4):285-300. doi: 10.1007/s40261-022-01133-x. Epub 2022 Mar 24.

引用本文的文献

1
Rituximab, Apremilast, and Upadacitinib as Selected Biosimilar and Targeted Synthetic Disease-Modifying Antirheumatic Drugs with Diverse Mechanisms of Action: Their Current Use in Slowing Down the Progression of Disease.利妥昔单抗、阿普米司特和乌帕替尼作为具有不同作用机制的选定生物类似药和靶向合成改善病情抗风湿药:它们目前在减缓疾病进展方面的应用。
J Clin Med. 2025 Apr 10;14(8):2605. doi: 10.3390/jcm14082605.