Reuber Kathrin, Kostev Karel
Int J Clin Pharmacol Ther. 2019 Jun;57(6):323-328. doi: 10.5414/CP203474.
Biosimilars are becoming more and more important for the treatment of many diseases. However, it is not understood how they are tolerated. Our aim was to analyze the behavior of switching from two anti-TNF biosimilars back to biologic reference products in German patients.
Patients switching from etanercept reference to an etanercept biosimilar between February 2016 and December 2017 and those switching from the infliximab reference product to an infliximab biosimilar between February 2015 and December 2017 were included in the study (index date). The main outcome of this study, the rate of switching from these two biosimilars back to reference products, was analyzed using Kaplan-Meier curves. A multivariate Cox regression model was used to predict the switch-back behavior.
A total of 2,956 patients were included in this study. After 3 months, 14.7% and, after 12 months, 30.2% of them were switched back from a biosimilar to the reference product. Sex, age, physician specialty, and co-therapy were not significantly associated with this switch.
Almost one third of the patients treated with one of two biosimilar drugs after previous biologic therapy are switched back to reference products in Germany.
生物类似药在多种疾病的治疗中变得越来越重要。然而，人们并不清楚它们的耐受性如何。我们的目的是分析德国患者从两种抗TNF生物类似药换回生物参考产品的行为。
纳入2016年2月至2017年12月期间从依那西普参考产品换用依那西普生物类似药的患者，以及2015年2月至2017年12月期间从英夫利昔单抗参考产品换用英夫利昔单抗生物类似药的患者（索引日期）。本研究的主要结果，即从这两种生物类似药换回参考产品的比例，采用Kaplan-Meier曲线进行分析。使用多变量Cox回归模型预测换回行为。
本研究共纳入2956例患者。3个月后，14.7%的患者，12个月后，30.2%的患者从生物类似药换回了参考产品。性别、年龄、医生专业和联合治疗与这种换回行为无显著相关性。
在德国，先前接受生物治疗后使用两种生物类似药之一治疗的患者中，近三分之一换回了参考产品。
