North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg, Russia.
V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia.
Rheumatol Int. 2019 Sep;39(9):1537-1546. doi: 10.1007/s00296-019-04359-9. Epub 2019 Jul 10.
BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [- 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences (p > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.Trial registration ClinicalTrials.gov ID, number NCT02762838.
BCD-055 是创新型英夫利昔单抗（IFX）的生物类似药。在这里，我们呈现了一项 3 期临床试验的 54 周结果，该试验纳入了类风湿关节炎（RA）患者。本研究旨在证明 BCD-055 与 IFX 在活动期类风湿关节炎患者中的等效疗效和安全性。426 名活动期 RA 成年患者被纳入研究。患者按 2:1 的比例随机分为 2 组，分别接受 BCD-055 或 IFX 创新药治疗，剂量均为 3mg/kg，分别于第 0、2、6 周给药，此后每 8 周给药 1 次，直至第 54 周。主要疗效终点为第 14 周时美国风湿病学会（ACR）20 应答率。等效性边界设定为 15%。免疫原性和安全性也进行了评估。在 PP（符合方案）人群中，第 14 周时 BCD-055 组的 ACR20 应答率为 71.2%，IFX 组为 67.9%。两组间 ACR20 应答率的差异为 3.2%，95%CI[-7.0%；13.5%]（p=0.587）。在整个 54 周研究期间，两组在所有时间点的 ACR20/50/70 应答率均相似，无显著差异（p>0.05）。两组不良事件（AE）发生率相似（BCD-055 组为 74.64%，IFX 组为 66.67%，p=0.111）。BCD-055 组有 28.46%的患者和 IFX 组有 26.56%的患者检测到抗英夫利昔单抗抗体（p=0.786）。在整个 54 周研究期间，BCD-055 与 IFX 在疗效（包括影像学进展）、安全性和免疫原性方面相当。试验注册临床试验.gov 注册号，NCT02762838。
