Hoang Thomas Tam, Reid Jacqueline, Galorport Cherry, Bressler Brian, Leung Yvette, Rosenfeld Greg
Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, BC V5Z 1M9, Canada.
Division of Gastroenterology, Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, BC V5Z 1M9, Canada.
J Can Assoc Gastroenterol. 2024 Mar 23;7(4):299-305. doi: 10.1093/jcag/gwae011. eCollection 2024 Aug.
Despite infliximab biosimilars becoming widely used in inflammatory bowel disease (IBD) patients, real-world non-medical switching is sparse. A biosimilar non-medical switch was launched in British Columbia in 2019, the first Canadian province to do so, from Remicade to an approved biosimilar (CT-P13 or SB2).
This study aims to obtain real-world evidence evaluating the clinical outcomes of non-medical switching from Remicade to the infliximab biosimilars.
This is a retrospective observational study of stable IBD patients from the IBD Centre of BC who underwent the non-medical infliximab switch. The primary outcome is treatment continuation at 12 ± 2 months post-switch. Secondary outcomes include frequency of loss of response, adverse events, and immunogenicity within the first 12 months post-switch. A control group of patients maintained on the originator served as a comparison.
Patients in the biosimilar switch group ( = 264) and originator group ( = 99), show similar demographics and disease characteristics. There was no difference in infliximab continuation between the biosimilar group (94.9%) and the originator group (90.1%) ( = 0.18). Reasons for discontinuation of infliximab included loss of response (4.04% vs 4.91%), immunogenicity (1.01% vs 0.75%), or adverse effect (1.01% vs 2.3%) in the infliximab originator vs biosimilar switch group, respectively. Similarly, no differences in safety or efficacy were observed between patients switched to CT-P13 or SB2.
Non-medical biosimilar switch of infliximab demonstrates similar clinical outcomes compared to originator molecule continuation for therapy of IBD. These data support the safety and efficacy of non-medical infliximab switching in IBD patients.
尽管英夫利昔单抗生物类似药在炎症性肠病（IBD）患者中得到广泛应用，但现实世界中的非医疗换药情况却很罕见。2019年，加拿大不列颠哥伦比亚省启动了生物类似药的非医疗换药，成为加拿大首个这样做的省份，从类克（Remicade）换成了一种获批的生物类似药（CT-P13或SB2）。
本研究旨在获取现实世界中的证据，以评估从类克换成英夫利昔单抗生物类似药的非医疗换药的临床结局。
这是一项对不列颠哥伦比亚省IBD中心的稳定IBD患者进行的回顾性观察研究，这些患者接受了非医疗英夫利昔单抗换药。主要结局是换药后12±2个月的治疗持续情况。次要结局包括换药后前12个月内反应丧失、不良事件和免疫原性的发生频率。一组继续使用原研药的患者作为对照组进行比较。
生物类似药换药组（n = 264）和原研药组（n = 99）的患者在人口统计学和疾病特征方面相似。生物类似药组（94.9%）和原研药组（90.1%）之间的英夫利昔单抗持续使用情况没有差异（P = 0.18）。英夫利昔单抗停药的原因分别为原研药组和生物类似药换药组中的反应丧失（4.04%对4.91%）、免疫原性（1.01%对0.75%）或不良反应（1.01%对2.3%）。同样，换成CT-P13或SB2的患者之间在安全性或疗效方面未观察到差异。
与继续使用原研药分子治疗IBD相比，英夫利昔单抗的非医疗生物类似药换药显示出相似的临床结局。这些数据支持IBD患者非医疗英夫利昔单抗换药的安全性和有效性。
