Department of Gastroenterology, Hôpital Erasme, ULB, Brussels, Belgium.
Laboratoire de gastroenterology experimentale, ULB, Brussels, Belgium.
United European Gastroenterol J. 2019 Jul;7(6):750-758. doi: 10.1177/2050640619841538. Epub 2019 Mar 24.
Very little is known about the impact of the wash-out period on the pharmacokinetics of a second-line biologic.
The objective of this article is to explore the impact of two different wash-out periods on the pharmacokinetics of vedolizumab and infliximab.
Patients switching from infliximab to vedolizumab were retrospectively identified. The population was divided into two groups according to wash-out period: <6 weeks or >6 weeks. Vedolizumab and infliximab trough levels (TLs) were determined and correlated with clinical and biological outcomes.
A total of 71 inflammatory bowel disease patients were included. At week 6, in patients previously treated with infliximab, median vedolizumab TLs were 21.9 µg/ml and 24.9 µg/ml for the <6 weeks and >6 weeks wash-out period, respectively ( = 0.31), whereas median residual infliximab TLs were 0.5 µg/ml and 0 µg/ml ( = 0.034). The rate of treatment discontinuation was similar ( = 0.64), and the infectious events were six and two for the <6 weeks and >6 weeks wash-out period, respectively ( = 0.12) by week 30.
This study suggests clinicians may not need to be concerned about the impact of wash-out period on the pharmacokinetics of the second-line biologic when switching infliximab to vedolizumab. More data are required on the impact of wash-out period on safety.
对于二线生物制剂的洗出期对药代动力学的影响，人们知之甚少。
本文旨在探讨两种不同洗出期对维多珠单抗和英夫利昔单抗药代动力学的影响。
回顾性地确定了从英夫利昔单抗转为维多珠单抗的患者。根据洗出期将人群分为两组：<6 周或>6 周。测定了维多珠单抗和英夫利昔单抗的谷浓度（TL），并与临床和生物学结果相关联。
共纳入 71 例炎症性肠病患者。在先前接受英夫利昔单抗治疗的患者中，第 6 周时，<6 周和>6 周洗出期的中位维多珠单抗 TL 分别为 21.9μg/ml 和 24.9μg/ml（ = 0.31），而中位残留英夫利昔单抗 TL 分别为 0.5μg/ml 和 0μg/ml（ = 0.034）。停药率相似（ = 0.64），第 30 周时，<6 周和>6 周洗出期的感染事件分别为 6 例和 2 例（ = 0.12）。
本研究表明，当从英夫利昔单抗转换为维多珠单抗时，临床医生可能不必担心洗出期对二线生物制剂药代动力学的影响。需要更多关于洗出期对安全性影响的数据。
