Kim Ji-Won, Jung Ju-Yang, Suh Chang-Hee
Department of Rheumatology, Ajou University School of Medicine , Suwon, Korea.
Expert Opin Biol Ther. 2021 Jan;21(1):57-73. doi: 10.1080/14712598.2020.1812575. Epub 2020 Oct 16.
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.
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.
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.
在风湿性疾病患者中使用生物制剂已实现治疗目标，即缓解或低疾病活动度。随着生物类似药的获批，其份额不断增长，生物类似药因其与原研药等效的疗效、安全性、药代动力学和免疫原性以及减轻的经济负担而得到认可。
在随机对照试验中，正在研究生物类似药与参比产品的生物等效性；然而，由于换药问题和合并症，生物类似药在实际临床实践中的使用较为复杂。因此，本综述描述了生物类似药在类风湿关节炎和脊柱关节炎（包括强直性脊柱炎和银屑病关节炎）治疗这一快速发展领域的真实世界数据。
根据已发表的数据，在现实世界中，使用生物类似药治疗炎性关节炎在治疗效果上并无显著劣势，且能节省大量成本。目前，除了生物类似药的使用，还应解决生物类似药的可互换性问题，包括免疫原性。克服这些问题的策略将提高炎性关节炎患者的治疗效果和安全性。
