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首页> 外文期刊>Ecological restoration >Proposed rituximab biosimilar BCD-020 versus reference rituximab for treatment of patients with indolent non-Hodgkin lymphomas: An international multicenter randomized trial
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Proposed rituximab biosimilar BCD-020 versus reference rituximab for treatment of patients with indolent non-Hodgkin lymphomas: An international multicenter randomized trial

机译：提出的Rituximab BioSimilar BCD-020与参考RITUXIMAB用于治疗惰性非霍奇金淋巴瘤患者：国际多中心随机试验

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BCD-020 is a proposed rituximab biosimilar, which has shown high similarity to rituximab in quality and nonclinical studies in vitro and in vivo. International multicenter clinical trial was conducted to compare efficacy and safety of BCD-020 and reference rituximab in adult (older than 18 years) patients with indolent lymphomas (follicular lymphoma grade 1-2, splenic marginal zone lymphoma, and nodal marginal zone lymphoma). Pharmacokinetics, pharmacodynamics, and immunogenicity were also studied. Patients with no previous biologic treatment for lymphoma were randomly assigned 1:1 to receive BCD-020 or comparator 375 mg/m(2) for 4 weeks. Primary study outcome was day 50 overall response rate defined as complete or partial remission. Equivalence range was -20% to 20% for 95% CI for overall response rates difference. Secondary outcomes included adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity. One hundred seventy-four patients were enrolled, 89 in BCD-020 arm and 85 in comparator arm. The overall response rate was 44.71% in BCD-020 arm and 41.89% in comparator arm. Limits of 95% confidence interval (CI) for difference of overall response rates between arms were (-12.62%-18.24%) showing equivalent efficacy. Sixty-one (68.54%) and 59 (69.41%) patients had at least one adverse event in BCD-020 arm or comparator arm, respectively. No unexpected adverse reactions were reported. Antidrug antibodies with no neutralizing activity were detected in two patients in comparator arm on day 14 further declining below detection threshold. Rituximab concentrations had equivalent pattern after intravenous administration of both drugs. Both drugs caused depletion of B-cells without significant influence on other blood cell lineages. In this study, we showed equivalent efficacy of BCD-020 and reference rituximab when used in patients with CD20-positive indolent lymphomas. We also confirmed pharmacokinetic equivalence of BCD-020 and reference rituximab. Safety profile, pharmacodynamics, and immunogenicity of BCD-020 were also comparable with those of reference rituximab.
机译：BCD-020是一种提出的丽酸生物纤维单体，其在体外和体内的质量和非临床研究中表现出高度相似性和中的毒素。进行国际多中心临床试验，以比较BCD-020的疗效和安全性，并参考Rituximab在成人（年龄超过18岁）的惰性淋巴瘤（滤泡淋巴瘤1-2，脾脏边缘区淋巴瘤和节点边缘区淋巴瘤）患者中。研究了药代动力学，药效学和免疫原性。未经先前的淋巴瘤生物处理的患者随机分配1：1以接收BCD-020或比较器375mg / m（2）持续4周。初级研究结果是第50天总响应率定义为完全或部分缓解。对于总体响应率差异，同比范围为-20％至20％至20％，为95％CI。二次结果包括不良事件，药代动力学，药效学和免疫原性。一百七十四名患者在BCD-020 ARM中注册了89名，在比较器臂中为85。 BCD-020 ARM的整体反应率为44.71％，比较器臂中的41.89％。 95％置信区间的限制（CI）用于武器之间的总响应率差异（-12.62％-18.24％），显示等效功效。六十一（68.54％）和59名（69.41％）患者分别在BCD-020臂或比较器臂中具有至少一个不良事件。没有报道任何意外的不良反应。在第14天的两名患者中检测到没有中和活性的抗胚抗体，在第14天在检测阈值以下进一步下降。静脉内施用两种药物后，Rituximab浓度具有等同的图案。两种药物导致B细胞的耗竭，而不会对其他血细胞谱系产生重大影响。在该研究中，当CD20阳性惰性淋巴瘤患者使用时，我们显示BCD-020和参考RITUXIMAb的等效效果。我们还确认了BCD-020的药代动力学等效性和参考rituximab。 BCD-020的安全性曲线，药效学和免疫原性也与参考Rituximab的含量也可比较。

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