Department of Rheumatology, Ajou University School of Medicine , Suwon , Korea.
Expert Opin Biol Ther. 2019 Oct;19(10):979-986. doi: 10.1080/14712598.2019.1665018. Epub 2019 Sep 18.
: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by long-standing inflammation in multiple joints. Rituximab, a monoclonal antibody, which binds to CD20, is effective in suppressing disease activity and preventing joint damage in RA. CT-P10 was developed as a biosimilar of rituximab and approved for use to treat hematologic malignancies and immune diseases including RA. : This article describes the need for this biosimilar and summarizes the non-clinical studies verifying the physicochemical and biologic similarities and the clinical studies confirming the clinical similarity of CT-P10 to rituximab in patients with RA. : CT-P10 had been evaluated and proven the efficacy and safety in RA in Phase I and III randomized controlled trial with extension studies including a switching regimen. Therefore, CT-P10 is recommended in the treatment of RA.
类风湿关节炎（RA）是一种慢性炎症性疾病，其特征是多个关节长期存在炎症。利妥昔单抗是一种单克隆抗体，与 CD20 结合，可有效抑制 RA 的疾病活动并防止关节损伤。CT-P10 是利妥昔单抗的生物类似药，已被批准用于治疗血液恶性肿瘤和免疫性疾病，包括 RA。本文介绍了这种生物类似药的需求，并总结了验证 CT-P10 的理化性质和生物学相似性的非临床研究，以及确认 CT-P10 与 RA 患者的利妥昔单抗临床相似性的临床研究。CT-P10 已在包括转换方案在内的扩展研究的 I 期和 III 期随机对照试验中进行了评估，并证明了其在 RA 中的疗效和安全性。因此，推荐 CT-P10 用于 RA 的治疗。
