Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.
J Intern Med. 2019 Jun;285(6):653-669. doi: 10.1111/joim.12880. Epub 2019 Apr 12.
The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures.
Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis.
Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.
The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.
52 周、随机、双盲、非劣效性、政府资助的 NOR-SWITCH 试验表明，从英夫利昔单抗原研药转换为更便宜的生物类似药 CT-P13 与继续使用英夫利昔单抗原研药相比不劣效。NOR-SWITCH 扩展试验旨在评估在整个 78 周研究期间接受 CT-P13 治疗的患者（维持组）与在第 52 周转换为 CT-P13 的患者（转换组）的疗效、安全性和免疫原性。主要结局是根据特定疾病的综合指标在随访期间疾病恶化。
从挪威的 24 家医院招募患者，完成主要研究的 438 名患者中的 380 名：维持组 197 名，转换组 183 名。在全分析集中，127 名（33%）患有克罗恩病，80 名（21%）患有溃疡性结肠炎，67 名（18%）患有强直性脊柱炎，55 名（15%）患有类风湿关节炎，20 名（5%）患有银屑病关节炎，31 名（8%）患有慢性斑块状银屑病。
转换时（第 52 周）两组的基线特征相似。维持组中有 32 名（16.8%）患者发生疾病恶化，转换组中有 20 名（11.6%）患者发生疾病恶化（符合方案集）。调整后的风险差异为 5.9%（95%CI-1.1 至 12.9）。不良事件、抗药物抗体、一般疾病变量和特定疾病综合指标的变化在两组之间相当。该研究没有足够的效力来检测个别疾病的非劣效性。
NOR-SWITCH 扩展试验表明，维持 CT-P13 的患者与从英夫利昔单抗原研药转换为 CT-P13 的患者之间在安全性和疗效方面没有差异，支持从英夫利昔单抗原研药转换为 CT-P13 是安全有效的。
