Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.
Department of Rheumatology and Clinical Immunology, University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina.
Rheumatology (Oxford). 2019 Dec 1;58(12):2193-2202. doi: 10.1093/rheumatology/kez152.
To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA.
Patients received 48 weeks' treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48-72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed.
At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups.
Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety.
ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121.
评估 CT-P10（一种利妥昔单抗生物类似药）在一项涉及 RA 患者的多国、随机、双盲 3 期试验中的疗效和安全性，在此试验中患者进行了单次转换。
患者接受了 48 周的 CT-P10 或美国或欧盟来源的参考利妥昔单抗（分别为 US-RTX 和 EU-RTX）治疗。进入扩展期（第 48-72 周）的患者继续接受 CT-P10（CT-P10/CT-P10；n=122）或 US-RTX（US-RTX/US-RTX；n=64）治疗，或从 US-RTX 转换为 CT-P10（US-RTX/CT-P10；n=62）或 EU-RTX（EU-RTX/CT-P10；n=47）进行额外疗程。疗效终点包括 28 个关节疾病活动度评分（DAS28）、美国风湿病学会（ACR）反应率和与生活质量相关的参数。还评估了药效学、免疫原性和安全性。
在扩展期的四个治疗组中，通过疾病活动参数（包括 DAS28 和 ACR 反应率）观察到类似的改善。在所有组中，在扩展期，与基线相比，在第 72 周时也观察到生活质量的改善。在扩展期的研究药物输注后，两名患者检测到新产生的抗药物抗体。在各个组中观察到相似的药效学和安全性特征。
CT-P10 的长期使用长达 72 周是有效和耐受良好的。此外，在 RA 中从参考利妥昔单抗转换为 CT-P10 是耐受良好的，并且在疗效、药效学、免疫原性和安全性方面没有导致任何临床意义上的差异。
ClinicalTrials.gov，网址：http://clinicaltrials.gov，NCT02149121。
