Objectives Efficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthritis (RA) who switched from INF to SB2 with those in patients who maintained treatment with INF or SB2. Methods Patients with moderate to severe RA despite methotrexate treatment were randomised (1:1) to receive SB2 or INF at weeks 0, 2 and 6 and every 8 weeks thereafter until week 46. At week 54, patients previously receiving INF were rerandomised (1:1) to switch to SB2 (INF/SB2 (n=94)) or to continue on INF (INF/INF (n=101)) up to week 70. Patients previously receiving SB2 continued on SB2 (SB2/SB2 (n=201)) up to week 70. Efficacy, safety and immunogenicity were assessed up to week 78. Results Efficacy was sustained and comparable across treatment groups. American College of Rheumatology (ACR) 20 responses between weeks 54 and 78 ranged from 63.5% to 72.3% with INF/SB2, 66.3%%–69.4% with INF/INF and 65.6%–68.3% with SB2/SB2. Treatment-emergent adverse events during this time occurred in 36.2%, 35.6% and 40.3%, respectively, and infusion-related reactions in 3.2%, 2.0% and 3.5%. Among patients who were negative for antidrug antibodies (ADA) up to week 54, newly developed ADAs were reported in 14.6%, 14.9% and 14.1% of the INF/SB2, INF/INF and SB2/SB2 groups, respectively. Conclusions The efficacy, safety and immunogenicity profiles remained comparable among the INF/SB2, INF/INF and SB2/SB2 groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from INF to SB2. Trial registration number NCT01936181; EudraCT number: 2012-005733-37.

中文翻译：

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类风湿性关节炎患者从参考英夫利昔单抗转换为生物仿制药 SB2 后与继续参考英夫利昔单抗和 SB2 相比的安全性、免疫原性和有效性：随机、双盲、III 期过渡研究的结果

目标 SB2（一种参考英夫利昔单抗 (INF) 的生物仿制药）的 III 期研究的疗效、安全性和免疫原性结果先前已报告了 54 周。这一过渡期比较了从 INF 转换为 SB2 的类风湿性关节炎 (RA) 患者与维持 INF 或 SB2 治疗的患者的结果。方法 在第 0、2 和 6 周以及此后每 8 周接受甲氨蝶呤治疗的中至重度 RA 患者随机 (1:1) 接受 SB2 或 INF。在第 54 周，先前接受 INF 的患者被重新随机分配（1 :1) 改用 SB2 (INF/SB2 (n=94)) 或继续使用 INF (INF/INF (n=101)) 直到第 70 周。之前接受 SB2 的患者继续使用 SB2 (SB2/SB2 (n =201)) 直至第 70 周。疗效、安全性和免疫原性评估直至第 78 周。结果 治疗组间的疗效持续且具有可比性。美国风湿病学会 (ACR) 在第 54 周和第 78 周之间的 20 次响应范围为 INF/SB2 的 63.5% 至 72.3%、INF/INF 的 66.3%–69.4% 和 SB2/SB2 的 65.6%–68.3%。在此期间，治疗中出现的不良事件分别为 36.2%、35.6% 和 40.3%，输液相关反应为 3.2%、2.0% 和 3.5%。在第 54 周内抗药物抗体 (ADA) 呈阴性的患者中，INF/SB2、INF/INF 和 SB2/SB2 组的新发 ADAs 分别占 14.6%、14.9% 和 14.1%。结论 直至第 78 周，INF/SB2、INF/INF 和 SB2/SB2 组的疗效、安全性和免疫原性特征仍具有可比性，从 INF 转换为 SB2 后没有出现治疗紧急问题或临床相关的免疫原性。试验注册号NCT01936181；EudraCT 编号：2012-005733-37。