背景:等效疗效和可比的药代动力学,免疫原性,据报道,在3期研究的第24周(治疗期[TP]1),生物仿制药BAT1806/BIIB800和参考托珠单抗(TCZ)在中度至重度类风湿性关节炎(RA)参与者中的安全性.在这里,我们介绍了TP2的结果(研究24-48周)。
方法:在此阶段3,多中心,多区域,双盲,主动控制,等效性研究,尽管存在甲氨蝶呤,但仍存在活动性RA的参与者被随机分配(1:1:2),每4周至48周静脉内给予8mg/kgTCZ(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个关节的疾病活动评分从基线的变化(DAS28)评估TP2的功效。药代动力学(谷水平),安全,和免疫原性也进行了评估。
结果:在621名随机参与者中,577(92.9%)完成TP1并输入TP2(TCZ:N=145[93.5%];TCZ至BAT1806/BIIB800:N=142[92.2%];BAT1806/BIIB800:N=290[92.9%])。在整个TP2中,ACR20应答者的比例在治疗组之间相似(87.8%,90.3%,90.4%,分别,在第48周),ACR50和ACR70反应者的比例也是如此,减少DAS28。治疗组之间的药物谷水平和抗药物抗体发生率相当。不良事件在治疗组之间平衡,没有报告致命事件。
结论:在TP2中,疗效,安全,免疫原性,和药代动力学曲线在TCZ之间相当,TCZ至BAT1806/BIIB800和BAT1806/BIIB800组。
背景:NCT03830203和EudraCT2018-002202-31。
BACKGROUND: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups.
BACKGROUND: NCT03830203 and EudraCT 2018-002202-31.