Comparison of safety and effectiveness between etanercept biosimilar LBEC0101 and reference in patients with rheumatoid arthritis in real-world data using the KURAMA cohort.

IF 1.8 4区医学 Q3 RHEUMATOLOGY

Modern Rheumatology Pub Date : 2024-10-15 DOI:10.1093/mr/roae018

Tomoya Kawakami, Sho Masui, Akira Onishi, Hideo Onizawa, Takayuki Fujii, Kosaku Murakami, Koichi Murata, Masao Tanaka, Takashi Shimada, Shunsaku Nakagawa, Shuichi Matsuda, Akio Morinobu, Tomohiro Terada, Atsushi Yonezawa

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引用次数: 0

Abstract

Objectives: Biosimilars are anticipated to be widely used in the treatment of rheumatoid arthritis (RA), owing to their cost efficiency; LBEC0101 was the first etanercept (ETN) biosimilar approved in Japan. However, there are limited real-world data comparing its safety and effectiveness with those of a reference product.

Methods: This study used data from the Kyoto University Rheumatoid Arthritis Management Alliance cohort, including patients with RA who received ETN therapy-ETN reference product (ETN-RP) or LBEC0101-between 2015 and 2021. Serum ETN levels were measured using liquid chromatography-tandem mass spectrometry.

Results: The 1-year continuation rates of ETN-RP and LBEC0101 were 58.7% and 74.4%, respectively. Effectiveness of treatment was evaluated in 18 patients; both products significantly reduced the 28-joint RA disease activity score and erythrocyte sedimentation rate (DAS28-ESR). Moreover, to determine equivalence, we analysed 11 patients who switched from ETN-RP to LBEC0101; the DAS28-ESR and serum ETN levels before and after switching were not significantly different.

Conclusions: This real-world cohort study confirmed that the biosimilar of ETN, LBEC0101, was comparable to the reference product in terms of continuation rate, effectiveness at initiation of introduction, and effect persistence before and after switching in clinical practice.

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利用 KURAMA 队列的真实数据，比较依那西普生物仿制药 LBEC0101 和参照药在类风湿关节炎患者中的安全性和有效性。

目标：由于生物仿制药具有成本效益，预计将广泛用于类风湿关节炎（RA）的治疗；LBEC0101是日本批准的首个依那西普（ETN）生物仿制药。然而，将其安全性和有效性与参比产品进行比较的真实世界数据非常有限：本研究使用了京都大学类风湿关节炎管理联盟队列中的数据，包括2015年至2021年间接受ETN治疗的RA患者--ETN参比产品（ETN-RP）或LBEC0101。血清ETN水平采用液相色谱-串联质谱法测定：ETN-RP和LBEC0101的1年持续治疗率分别为58.7%和74.4%。对18名患者的治疗效果进行了评估；两种产品都能显著降低28关节RA疾病活动度评分和红细胞沉降率（DAS28-ESR）。此外，为了确定等效性，我们分析了11名从ETN-RP转用LBEC0101的患者；转用前后的DAS28-ESR和血清ETN水平无明显差异：这项真实世界队列研究证实，在临床实践中，ETN的生物仿制药LBEC0101与参比产品在继续用药率、开始用药时的有效性以及换药前后的效果持续性方面具有可比性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Modern Rheumatology RHEUMATOLOGY-

CiteScore

4.90

自引率

9.10%

发文量

146

审稿时长

1.5 months

期刊介绍： Modern Rheumatology publishes original papers in English on research pertinent to rheumatology and associated areas such as pathology, physiology, clinical immunology, microbiology, biochemistry, experimental animal models, pharmacology, and orthopedic surgery. Occasional reviews of topics which may be of wide interest to the readership will be accepted. In addition, concise papers of special scientific importance that represent definitive and original studies will be considered. Modern Rheumatology is currently indexed in Science Citation Index Expanded (SciSearch), Journal Citation Reports/Science Edition, PubMed/Medline, SCOPUS, EMBASE, Chemical Abstracts Service (CAS), Google Scholar, EBSCO, CSA, Academic OneFile, Current Abstracts, Elsevier Biobase, Gale, Health Reference Center Academic, OCLC, SCImago, Summon by Serial Solutions