Department of Rheumatology, Ajou University School of Medicine, Suwon, Republic of Korea.
Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul, 04763, Republic of Korea.
BioDrugs. 2019 Feb;33(1):79-91. doi: 10.1007/s40259-018-00331-4.
The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks.
In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed.
Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (- 2.7 and - 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles.
CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. CLINICALTRIALS.
NCT02149121.
本研究旨在探讨 CT-P10（利妥昔单抗生物类似药）与来自美国和欧盟的利妥昔单抗参考产品（US-RTX 和 EU-RTX）在类风湿关节炎（RA）中长达 48 周的扩展治疗的长期临床结局。
在这项多中心、随机、双盲试验中，接受甲氨蝶呤治疗的活动性 RA 成人患者接受了最多两个疗程的 CT-P10、US-RTX 或 EU-RTX 治疗。疗效终点包括疾病活动度 28 关节计数（DAS28）和美国风湿病学会（ACR）应答率。还评估了药代动力学、药效学、免疫原性和安全性。
在随机接受研究药物的 372 名患者中，330 名（88.7%）完成了第二疗程。从基线到第 48 周，CT-P10 和联合利妥昔单抗（US-RTX 和 EU-RTX）组的 DAS28-C 反应蛋白的平均变化值相当（分别为-2.7 和-2.6）。第 48 周时 ACR20、ACR50 和 ACR70 应答率表明组间无差异（CT-P10 组分别为 80.6%、55.4%和 31.7%，联合利妥昔单抗组分别为 79.8%、53.9%和 33.7%）。所有组的健康评估问卷残疾指数和所有健康调查短表 36 项健康状况调查的医疗结局都有类似的改善，包括身体和心理健康。第 48 周时，CT-P10、US-RTX 和 EU-RTX 组分别有 4.9%、9.4%和 8.6%的患者检测到抗药物抗体。CT-P10 与利妥昔单抗具有相似的药代动力学、药效学和安全性特征。
在第 48 周时，CT-P10 在疗效、药代动力学、药效学、免疫原性和安全性方面与 EU-RTX 和 US-RTX 相似。临床试验.gov 标识符：NCT02149121。
