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GP2015 作为一种有前途的类风湿性关节炎治疗方法。

GP2015 as a promising therapy for rheumatoid arthritis.

机构信息

a Leeds Institute of Musculoskeletal Medicine , University of Leeds, Chapel Allerton Hospital , Leeds , UK.

b NIHR Leeds Biomedical Research Centre , Leeds Teaching Hospitals NHS Trust , Leeds , UK.

出版信息

Expert Opin Biol Ther. 2018 Apr;18(4):477-481. doi: 10.1080/14712598.2018.1452909.

Abstract

Rheumatoid arthritis is a common inflammatory joint disease with a myriad of systemic manifestations. Over the last 20 years its treatment has been revolutionised by the introduction of a number of different biologic drugs, including the TNF-receptor Fc fusion protein, Etanercept. However, these drugs are expensive and their widespread use puts a financial burden on healthcare systems. As many biologic treatments begin to come off patent new 'biosimilar' versions are being developed which can lead to significant cost savings. GP2015 (Erelzi®) is the second biosimilar version of Etanercept which is licensed for the treatment of rheumatoid arthritis. Areas covered: We discuss the Chemistry, pharmacokinetics and pharmacodynamics of GP2015 in relation to reference Etanercept. Preclinical trials have shown pharmacokinetic equivalence between GP2015 and the reference drug. The recently completed Phase III, randomised, double blind EQUIRA study has shown equivalent efficacy and safety between GP2015 and Etanercept in patients with rheumatoid arthritis. Expert opinion: GP2015 has shown equivalent efficacy and safety to reference Etanercept. With a growing number of biosimilar medications becoming available and another biosimilar Etanercept already being widely prescribed it is likely to be the cost of the drug that will determine if it is used widely.

摘要

类风湿关节炎是一种常见的炎性关节疾病,具有多种全身表现。在过去的 20 年中,随着许多不同的生物药物的引入,包括 TNF 受体 Fc 融合蛋白依那西普,其治疗方法发生了革命性的变化。然而,这些药物价格昂贵,广泛使用给医疗保健系统带来了经济负担。随着许多生物治疗药物开始失去专利,新的“生物类似物”版本正在开发中,这可以带来显著的成本节约。GP2015(Erelzi®)是依那西普的第二种生物类似物版本,已获得批准用于治疗类风湿关节炎。

涵盖领域

我们讨论了 GP2015 与参照依那西普的化学、药代动力学和药效学。临床前试验表明 GP2015 与参比药物具有相同的药代动力学特征。最近完成的 III 期、随机、双盲 EQUIRA 研究表明,在类风湿关节炎患者中,GP2015 与依那西普具有等效的疗效和安全性。

专家意见

GP2015 已显示出与参照依那西普等效的疗效和安全性。随着越来越多的生物类似药物上市,另一种生物类似物依那西普已经广泛使用,因此,药物的成本将决定它是否会被广泛使用。

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