Equivalent efficacy and comparable pharmacokinetic, immunogenicity, and safety profiles of the biosimilar BAT1806/BIIB800 and reference tocilizumab (TCZ) in participants with moderate-to-severe rheumatoid arthritis (RA) have been reported up to week 24 (treatment period [TP] 1) of the phase 3 study. Here we present results for TP2 (study weeks 24–48). In this phase 3, multicenter, multiregional, double-blind, active-controlled, equivalence study, participants with active RA despite methotrexate were randomized (1:1:2) to intravenous administration of 8 mg/kg TCZ every 4 weeks to week 48 (TCZ group), or TCZ to week 24 followed by BAT1806/BIIB800 to week 48 (TCZ to BAT1806/BIIB800 group), or BAT1806/BIIB800 to week 48 (BAT1806/BIIB800 group). Efficacy in TP2 was evaluated using American College of Rheumatology (ACR) response criteria (ACR20/50/70) and change from baseline in Disease Activity Score on 28 joints (DAS28). Pharmacokinetics (trough levels), safety, and immunogenicity were also evaluated. Of 621 randomized participants, 577 (92.9%) completed TP1 and entered TP2 (TCZ: N = 145 [93.5%]; TCZ to BAT1806/BIIB800: N = 142 [92.2%]; BAT1806/BIIB800: N = 290 [92.9%]). Proportions of ACR20 responders were similar between treatment groups throughout TP2 (87.8%, 90.3%, and 90.4%, respectively, at week 48), as were proportions of ACR50 and ACR70 responders, and reduction in DAS28. Drug trough levels and antidrug antibody incidences were comparable between the treatment groups. Adverse events were balanced across the treatment groups and no fatal events were reported. In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups. NCT03830203 and EudraCT 2018-002202-31.

中文翻译：

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一项 3 期、随机、双盲、活性对照临床试验，在对甲氨蝶呤反应不足的中重度类风湿关节炎参与者中比较 BAT1806/BIIB800（一种托珠单抗生物类似药）与托珠单抗参考产品：治疗第 2 期分析（第 24 周至第 48 周）


截至第 24 周（治疗期 [TP] 1），生物仿制药 BAT1806/BIIB800 和参照托珠单抗 (TCZ) 在中重度类风湿性关节炎 (RA) 受试者中的疗效相当，药代动力学、免疫原性和安全性相当。 ）第三阶段研究。在这里，我们展示 TP2（研究第 24-48 周）的结果。在这项 3 期、多中心、多区域、双盲、主动对照、等效性研究中，尽管服用甲氨蝶呤，仍患有活动性 RA 的参与者被随机 (1:1:2) 静脉注射 8 mg/kg TCZ，每 4 周至第 48 周（TCZ 组），或 TCZ 至第 24 周，然后 BAT1806/BIIB800 至第 48 周（TCZ 至 BAT1806/BIIB800 组），或 BAT1806/BIIB800 至第 48 周（BAT1806/BIIB800 组）。使用美国风湿病学会 (ACR) 反应标准 (ACR20/50/70) 和 28 个关节疾病活动评分相对于基线的变化 (DAS28) 评估 TP2 的疗效。还评估了药代动力学（谷水平）、安全性和免疫原性。在 621 名随机参与者中，577 名 (92.9%) 完成了 TP1 并进入 TP2（TCZ：N = 145 [93.5%]；TCZ 至 BAT1806/BIIB800：N = 142 [92.2%]；BAT1806/BIIB800：N = 290 [92.9%] ]）。在整个 TP2 期间，治疗组之间 ACR20 应答者的比例相似（第 48 周时分别​​为 87.8%、90.3% 和 90.4%），ACR50 和 ACR70 应答者的比例以及 DAS28 的减少也是如此。治疗组之间的药物谷水平和抗药物抗体发生率相当。各治疗组的不良事件是平衡的，并且没有致命事件的报告。在 TP2 中，TCZ、TCZ 与 BAT1806/BIIB800 和 BAT1806/BIIB800 组之间的功效、安全性、免疫原性和药代动力学特征相当。 NCT03830203 和 EudraCT 2018-002202-31。