Krstic Marko, Devaud Jean-Christophe, Marti Joachim, Sadeghipour Farshid
Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland.
Service of Pharmacy, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Drugs Real World Outcomes. 2022 Sep;9(3):425-436. doi: 10.1007/s40801-022-00299-2. Epub 2022 May 19.
CT-P13 is an infliximab biosimilar that was granted market authorization in Switzerland in 2016. Despite the growing literature supporting the equivalence of CT-P13 compared with originator infliximab regarding the efficacy, safety, and immunogenicity and the undeniable cost-saving opportunities, CT-P13 remains widely underused in Switzerland.
Leaving aside the phenomenon of a low initiation rate, this study aimed to explore the reasons behind the high discontinuation rate observed among the patients taking CT-P13 in a large tertiary hospital in Western Switzerland.
We performed a retrospective cohort study using routinely collected data. Patients were eligible if they received originator infliximab or CT-P13 between September 2017 and December 2020. They were included if they had received at least two CT-P13 infusions during the same period. Patients were excluded if the follow-up was incomplete prior to or 6 months after their first CT-P13 infusion and if they had an oncological main diagnosis. Primary outcomes were the reasons for treatment discontinuation.
One hundred and fifty-six patients were included and classified into two groups: switchers who were treated with originator infliximab and were switched to CT-P13 (n = 85, 54%) and initiators who did not receive originator infliximab prior to CT-P13 treatment (n = 71, 46%). Included patients belonged to three different groups of diagnosis: gastroenterological (67, 43%), rheumatological (61, 39%), and immunological (28, 18%). Twenty-three (27%) switchers and 35 (49%) initiators discontinued CT-P13 after 12 months. Main reasons for CT-P13 discontinuation were lack of efficacy (n = 21, 36%) and secondary loss of response (n = 16, 28%); however, objective assessments were not available. Initiators' probability to discontinue CT-P13 at 12 months was significantly higher than switchers' (p < 0.01).
Lack of efficacy and secondary loss of response were the main reasons for the high CT-P13 discontinuation rate observed in a large tertiary hospital in Western Switzerland. Lack of active training and coordination among healthcare professionals and little education in patients may have exacerbated patients' subjective complaints and increased the CT-P13 discontinuation rate.
CT-P13是一种英夫利昔单抗生物类似药，于2016年在瑞士获得市场授权。尽管越来越多的文献支持CT-P13在疗效、安全性和免疫原性方面与原研英夫利昔单抗等效，且有不可否认的成本节约机会，但CT-P13在瑞士的使用仍普遍不足。
抛开起始治疗率低的现象，本研究旨在探究瑞士西部一家大型三级医院中服用CT-P13的患者停药率高的原因。
我们使用常规收集的数据进行了一项回顾性队列研究。2017年9月至2020年12月期间接受原研英夫利昔单抗或CT-P13治疗的患者符合入选条件。同期接受至少两次CT-P13输注的患者被纳入研究。首次CT-P13输注前或输注后6个月内随访不完整以及主要诊断为肿瘤的患者被排除。主要结局是治疗中断的原因。
156例患者被纳入研究并分为两组：转换者，即接受原研英夫利昔单抗治疗后转换为CT-P13的患者（n = 85，54%）和起始者，即CT-P13治疗前未接受原研英夫利昔单抗治疗的患者（n = 71，46%）。纳入的患者属于三种不同的诊断组：胃肠病学组（67例，43%）、风湿病学组（61例，39%）和免疫学组（28例，18%）。23例（27%）转换者和35例（49%）起始者在12个月后停用CT-P13。CT-P13停药的主要原因是疗效不佳（n = 21，36%）和继发性反应丧失（n = 16，28%）；然而，缺乏客观评估。起始者在12个月时停用CT-P13的概率显著高于转换者（p < 0.01）。
疗效不佳和继发性反应丧失是瑞士西部一家大型三级医院中观察到的CT-P13高停药率的主要原因。医疗保健专业人员之间缺乏积极培训和协调以及对患者教育不足可能加剧了患者的主观抱怨并提高了CT-P13的停药率。
