Introduction

The use of biological agents in patients with rheumatic diseases has achieved the therapeutic target, i.e., remission or low disease activity. The share of biological agents has been growing with the approval of biosimilars, which have been recognized for their equivalent efficacy, safety, pharmacokinetics, and immunogenicity to the original as well as their reduced economic burden.

Area covered

Biosimilars are being examined for their bioequivalence to reference products in randomized controlled trials; however, the use of biosimilars in actual clinical practice is complicated owing to issues with switching and comorbidities. Therefore, this review describes real-world data in the rapidly evolving field of biosimilars in the treatment of rheumatoid arthritis and spondyloarthropathy, including ankylosing spondylitis and psoriatic arthritis.

Expert Opinion

According to published data, the use of biosimilars for inflammatory arthritis led to no significant inferiority in treatment outcomes and resulted in considerable cost savings in the real- world. Currently, beyond the use of biosimilars, issues with the interchangeability of biosimilars, including immunogenicity, should be addressed. Strategies to overcome these concerns will improve treatment efficacy and safety in patients with inflammatory arthritis.

中文翻译：

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生物仿制药在炎性关节炎治疗中的现实观察研究：系统的文献综述

介绍

在风湿性疾病患者中使用生物制剂已达到治疗目标，即缓解或疾病活性低。随着生物仿制药的批准，生物制剂的份额一直在增​​长，生物仿制药的等效功效，安全性，药代动力学和与原始药物的免疫原性以及减轻的经济负担已得到公认。

覆盖面积

在随机对照试验中，正在研究生物仿制药与参考产品的生物等效性；然而，由于转换和合并症的问题，在实际临床实践中使用生物仿制药很复杂。因此，本综述描述了在治疗类风湿性关节炎和脊柱关节炎（包括强直性脊柱炎和银屑病关节炎）的生物仿制药快速发展领域中的真实数据。

专家意见

根据已公布的数据，使用生物仿制药治疗炎性关节炎不会导致治疗效果显着降低，并且在现实世界中可节省大量成本。当前，除了使用生物仿制药之外，还应该解决生物仿制药的互换性问题，包括免疫原性。克服这些担忧的策略将改善炎性关节炎患者的治疗效果和安全性。