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生物类似药在慢性炎症性疾病管理中的应用:荷兰的经验

Biosimilars in the management of chronic inflammatory diseases: The Dutch experience.

作者信息

Müskens Wieland D, Rongen-van Dartel Sanne A A, Adang Eddy M M, van Riel Piet L C M

机构信息

Department of IQ Healthcare, Radboudumc, Nijmegen, The Netherlands.

Department of Rheumatology, Bernhoven, Uden, The Netherlands.

出版信息

Mediterr J Rheumatol. 2019 May 31;30(Suppl 1):76-81. doi: 10.31138/mjr.30.1.76. eCollection 2019 Jun.

DOI:10.31138/mjr.30.1.76
PMID:32524082
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7280871/
Abstract

These days, the use of biosimilars for the treatment of bio-naive patients is well established. However, the transition of patients being treated with a bio-originator to its biosimilar is still a topic of discussion. The main issue is which approach to use when initiating the non-medical transition. The first real-world examples contain both mandatory and non-mandatory approaches, resulting in a variety of acceptance and discontinuation rates. At this moment a non-mandatory approach, based on shared decision making, is preferred by international guidelines and the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases. However, clear definitions of mandatory and non-mandatory are lacking, as a result of which these terms may be wrongly used in some studies. This article aims to provide an overview of transition approaches used in the Netherlands, and how the approach used relates to acceptance and discontinuation rates of the biosimilar.

摘要

如今,生物类似药用于初治患者的治疗已得到充分确立。然而,正在接受原研生物药治疗的患者向其生物类似药的转换仍是一个讨论话题。主要问题是在启动非医疗转换时采用哪种方法。首批真实世界案例包含强制性和非强制性方法,导致了各种接受率和停药率。目前,基于共同决策的非强制性方法受到国际指南以及生物类似药治疗风湿性疾病工作组的青睐。然而,缺乏对强制性和非强制性的明确定义,因此这些术语在一些研究中可能被错误使用。本文旨在概述荷兰使用的转换方法,以及所采用的方法与生物类似药的接受率和停药率之间的关系。

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本文引用的文献

1
Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review.非医疗原因下从原研生物制剂转换为生物类似药的经济影响:系统文献回顾。
Adv Ther. 2019 Aug;36(8):1851-1877. doi: 10.1007/s12325-019-00998-3. Epub 2019 Jun 5.
2
Efficacious transition from reference infliximab to biosimilar infliximab in clinical practice.在临床实践中,从参考用英夫利昔单抗有效地转换为生物类似药英夫利昔单抗。
Int J Rheum Dis. 2019 May;22(5):869-873. doi: 10.1111/1756-185X.13512. Epub 2019 Feb 14.
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To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry.是否切换:全国强制性从原研药切换至生物类似药依那西普的指南结果。DANBIO 登记处 2061 例炎性关节炎患者的 1 年治疗结果。
Ann Rheum Dis. 2019 Feb;78(2):192-200. doi: 10.1136/annrheumdis-2018-213474. Epub 2018 Nov 5.
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Nocebos in rheumatology: emerging concepts and their implications for clinical practice.风湿病中的非生理性反应:新兴概念及其对临床实践的影响。
Nat Rev Rheumatol. 2018 Dec;14(12):727-740. doi: 10.1038/s41584-018-0110-9.
5
Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent.转换药物时的非药物效应:从原创药到生物类似药转换时的反安慰剂效应。
BioDrugs. 2018 Oct;32(5):397-404. doi: 10.1007/s40259-018-0306-1.
6
The Biosimilar Nocebo Effect? A Systematic Review of Double-Blinded Versus Open-Label Studies.《生物类似药的反安慰剂效应?双盲与开放标签研究的系统评价》
J Manag Care Spec Pharm. 2018 Oct;24(10):952-959. doi: 10.18553/jmcp.2018.24.10.952.
7
Biosimilar switching - current state of knowledge.生物类似药转换——知识现状
Reumatologia. 2018;56(4):234-242. doi: 10.5114/reum.2018.77975. Epub 2018 Aug 31.
8
Acceptance rate and sociological factors involved in the switch from originator to biosimilar etanercept (SB4).从原研药到生物类似药依那西普(SB4)转换过程中的接受率和社会学因素。
Semin Arthritis Rheum. 2019 Apr;48(5):927-932. doi: 10.1016/j.semarthrit.2018.07.005. Epub 2018 Jul 20.
9
Drug Survival and Immunogenicity After Switching From Remicade to Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: Two-year Follow-up of a Prospective Observational Cohort Study.炎症性肠病患者从 Remicade 转换为生物类似药 CT-P13 后的药物生存和免疫原性:前瞻性观察队列研究的两年随访。
Inflamm Bowel Dis. 2019 Jan 1;25(1):172-179. doi: 10.1093/ibd/izy227.
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Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study.开放性、非强制性由依那西普原研药转换为生物类似药 SB4:一项对照队列研究的 6 个月结果。
Arthritis Rheumatol. 2018 Sep;70(9):1408-1418. doi: 10.1002/art.40516. Epub 2018 Aug 6.