Park Won, Suh Chang-Hee, Shim Seung Cheol, Molina Francisco Fidencio Cons, Jeka Slawomir, Medina-Rodriguez Francisco G, Hrycaj Pawel, Wiland Piotr, Lee Eun Young, Shesternya Pavel, Kovalenko Volodymyr, Myasoutova Leysan, Stanislav Marina, Radominski Sebastiao, Lim Mie Jin, Choe Jung-Yoon, Lee Sang Joon, Lee Sung Young, Kim Sung Hwan, Yoo Dae Hyun
School of Medicine, IN-HA University, Incheon, Republic of Korea.
Ajou University School of Medicine, Suwon, Republic of Korea.
BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6.
CT-P10 is a biosimilar candidate of innovator rituximab (RTX) that demonstrated a comparable clinical profile to RTX in a phase I randomized controlled trial (RCT) in rheumatoid arthritis (RA) (ClinicalTrials.gov identifier: NCT01534884).
This open-label extension (OLE) study (NCT01873443) compared the efficacy and safety of CT-P10 in patients with RA who received CT-P10 from the outset (i.e., from the start of the RCT and also in the OLE; 'maintenance group') with those who received RTX during the RCT and switched to CT-P10 during the OLE ('switch group').
Patients who completed the RCT were recruited. Based on the Disease Activity Score using 28 joints (DAS28) and predefined safety criteria, patients could receive up to two courses of CT-P10 during the OLE. Efficacy [DAS28 and European League Against Rheumatism (EULAR) response], safety and immunogenicity were assessed.
Eighty-seven patients were enrolled; 58 and 29 had previously received CT-P10 or RTX, respectively, in the RCT. Of these, 38 (65.5%) and 20 (69.0%) were treated with CT-P10 in the OLE and therefore comprised the maintenance and switch groups, respectively. The mean change in DAS28-erythrocyte sedimentation rate (ESR) from baseline (week 0 of RCT) at week 24 of the first OLE treatment course in the maintenance and switch groups was -2.7 and -2.4, respectively. The proportion of patients with good/moderate EULAR responses was also comparable between groups. Antidrug antibodies were detected in 13.2 and 15.0% of patients in the maintenance and switch groups, respectively, at week 24 of the first OLE course. CT-P10 treatment was well-tolerated when administered for up to 2 years or after switching from RTX.
In this study population, comparable efficacy and safety profiles were observed in patients who switched from RTX to CT-P10 and those maintained on CT-P10 throughout treatment.
CT-P10是创新型利妥昔单抗（RTX）的生物类似药候选产品，在一项类风湿关节炎（RA）的I期随机对照试验（RCT）（ClinicalTrials.gov标识符：NCT01534884）中显示出与RTX相当的临床特征。
这项开放标签扩展（OLE）研究（NCT01873443）比较了从一开始就接受CT-P10治疗的RA患者（即从RCT开始时以及在OLE中均接受CT-P10治疗；“维持组”）与在RCT期间接受RTX治疗并在OLE期间转换为CT-P10治疗的患者（“转换组”）中CT-P10的疗效和安全性。
招募完成RCT的患者。根据28个关节疾病活动评分（DAS28）和预定义的安全标准，患者在OLE期间最多可接受两个疗程的CT-P10治疗。评估疗效（DAS28和欧洲抗风湿病联盟（EULAR）反应）、安全性和免疫原性。
共纳入87例患者；在RCT中，分别有58例和29例之前接受过CT-P10或RTX治疗。其中，38例（65.5%）和20例（69.0%）在OLE中接受CT-P10治疗，因此分别构成维持组和转换组。在第一个OLE治疗疗程的第24周，维持组和转换组中DAS28-红细胞沉降率（ESR）相对于基线（RCT第0周）的平均变化分别为-2.7和-2.4。两组中具有良好/中等EULAR反应的患者比例也相当。在第一个OLE疗程的第24周，维持组和转换组中分别有13.2%和15.0%的患者检测到抗药抗体。CT-P10治疗长达2年或从RTX转换后使用时耐受性良好。
在该研究人群中，从RTX转换为CT-P10的患者与整个治疗过程中维持使用CT-P10的患者观察到了相当的疗效和安全性。
