ABSTRACT

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：

---

生物仿制药治疗炎症性关节炎的真实世界观察研究：系统文献综述。

摘要

介绍

在风湿性疾病患者中使用生物制剂已经达到了治疗目标，即缓解或低疾病活动度。随着生物仿制药的批准，生物制剂的份额一直在增​​长，生物仿制药的功效、安全性、药代动力学和免疫原性与原药相当，而且经济负担也有所减轻。

覆盖面积

正在随机对照试验中检查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，本综述描述了生物仿制药治疗类风湿性关节炎和脊柱关节病（包括强直性脊柱炎和银屑病关节炎）的快速发展领域的真实数据。

专家意见

根据已发表的数据，使用生物仿制药治疗炎症性关节炎不会导致治疗结果显着劣势，并在现实世界中节省了可观的成本。目前，除了使用生物仿制药外，还应解决生物仿制药的互换性问题，包括免疫原性。克服这些问题的策略将提高炎症性关节炎患者的治疗效果和安全性。