Department of Rheumatology, Doctor Peset University Hospital, Gaspar Aguilar Avenue 90, 46017, Valencia, Spain.
Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (FISABIO), Valencia, Spain.
Drugs R D. 2017 Sep;17(3):481-485. doi: 10.1007/s40268-017-0194-8.
CT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment.
In this retrospective real-world study, patients with inflammatory diseases treated with RP were switched to CT-P13 (n = 7) or continued on RP (n = 6). Clinical outcomes were compared between groups after four treatment cycles.
CT-P13 demonstrated comparable effectiveness to its RP. All patients who switched to the biosimilar maintained or improved their clinical response, including two who remained in remission and three who moved into remission. In the RP group, five patients maintained their clinical response, with one achieving remission. Safety profiles were similar between groups.
CT-P13 was equally effective as infliximab RP in this real-world study. CT-P13 is a valid, lower-cost alternative for patients currently receiving RP.
CT-P13 是一种与参考产品（RP）英夫利昔单抗具有可比药代动力学、疗效和安全性的生物类似药。研究表明，从 RP 转换为 CT-P13 不会降低治疗的有效性或安全性。
在这项回顾性真实世界研究中，接受 RP 治疗的炎症性疾病患者被转换为 CT-P13（n=7）或继续接受 RP（n=6）。在四个治疗周期后，比较两组的临床结果。
CT-P13 与 RP 具有相当的疗效。所有转换为生物类似药的患者均保持或改善了其临床反应，包括两名仍处于缓解期和三名进入缓解期的患者。在 RP 组中，五名患者保持了临床反应，一名患者达到缓解期。两组的安全性概况相似。
在这项真实世界研究中，CT-P13 与英夫利昔单抗 RP 同样有效。CT-P13 是目前正在接受 RP 治疗的患者的一种有效、成本更低的替代选择。
