Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.
Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.
BioDrugs. 2020 Oct;34(5):681-694. doi: 10.1007/s40259-020-00438-7.
The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested.
The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials.
The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period.
The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events.
Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.
ClinicalTrials.gov, number NCT02148640.
NOR-SWITCH 主要和扩展试验表明，在六种疾病中，从原研药切换到生物类似药英夫利昔单抗（CT-P13）是有效且安全的。然而，主要试验中克罗恩病（CD）的亚组分析显示，原研药英夫利昔单抗更具优势，因此需要更多的科学数据。
本研究旨在评估 NOR-SWITCH 试验中 CD 和溃疡性结肠炎（UC）的探索性亚组分析中的治疗疗效、安全性和免疫原性。
这项为期 52 周、随机、非劣效性、双盲、多中心、4 期 NOR-SWITCH 研究之后进行了 26 周的开放性扩展试验，所有患者均接受 CT-P13 治疗。在 78 周的研究期间，评估了 CD 和 UC 患者的治疗疗效、安全性和免疫原性。
主要和扩展试验分别纳入了 155 例和 93 例 CD 患者，93 例和 80 例 UC 患者。两组患者的人口统计学和基线特征在各患者组内具有可比性。在主要和扩展试验中，CD 和 UC 患者的活动指数、C 反应蛋白、粪便钙卫蛋白、患者和医生对疾病活动的总体评估以及患者报告的结局测量均无差异。此外，在 CD 和 UC 中，两种药物的血清浓度、抗药物抗体的存在以及报告的不良事件也具有相似的结果。
在 NOR-SWITCH 主要和扩展试验中，CD 和 UC 患者使用原研药和生物类似药英夫利昔单抗的疗效、安全性和免疫原性相当。这些探索性亚组分析证实，在 CD 和 UC 中，从原研药英夫利昔单抗转换为 CT-P13 不存在重大问题。
ClinicalTrials.gov，编号 NCT02148640。
