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. 2019 Jul;7(6):750-758.
doi: 10.1177/2050640619841538. Epub 2019 Mar 24.

Impact of first-line infliximab on the pharmacokinetics of second-line vedolizumab in inflammatory bowel diseases

Claire Liefferinckx  1   2 , Bram Verstockt  3   4 , Ann Gils  5 , Sophie Tops  5 , Wouter Van Moerkercke  3   6 , Severine Vermeire  3   4 , Denis Franchimont  1   2
Affiliations

Impact of first-line infliximab on the pharmacokinetics of second-line vedolizumab in inflammatory bowel diseases

Claire Liefferinckx et al. United European Gastroenterol J. 2019 Jul.

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] United European Gastroenterol J. 2019 Aug;7(7):988. doi: 10.1177/2050640619865821. Epub 2019 Jul 31. United European Gastroenterol J. 2019. PMID: 31428426 Free PMC article.

Abstract

Background: Very little is known about the impact of the wash-out period on the pharmacokinetics of a second-line biologic.

Objective: The objective of this article is to explore the impact of two different wash-out periods on the pharmacokinetics of vedolizumab and infliximab.

Methods: 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.

Results: 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 (p = 0.31), whereas median residual infliximab TLs were 0.5 µg/ml and 0 µg/ml (p = 0.034). The rate of treatment discontinuation was similar (p = 0.64), and the infectious events were six and two for the <6 weeks and >6 weeks wash-out period, respectively (p = 0.12) by week 30.

Conclusions: 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.

Keywords: Induction; inflammatory bowel disease; infliximab; pharmacokinetics; trough level; vedolizumab; wash-out.

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Figures

Figure 1.
Figure 1.
Flowchart of the overall population. IBD: inflammatory bowel disease; IFX: infliximab/CT-P13; VDZ: vedolizumab.
Figure 2.
Figure 2.
Residual IFX TLs at first infusion of vedolizumab (baseline) according to wash-out periods. Median residual IFX TL at 7.85 µg/ml (IQR (3.35–19.15), n = 16) for wash-out period <6 weeks and at 0.3 µg/ml (IQR (0–1.55) n = 21) for wash-out period >6 weeks. IFX: infliximab/CT-P13; IQR: interquartile range; TL: trough level; WO: wash-out.
Figure 3.
Figure 3.
(a) VDZ TLs at week 2 according to wash-out periods. Median VDZ TLs at 22.8 µg/ml (IQR (17.1–33.2), n = 25) and 26.9 µg/ml (IQR (20.2–32.8), n = 29) for wash-out period < 6 weeks and >6 weeks, respectively. (b) Residual IFX TLs at second infusion of VDZ according to wash-out periods. Median residual IFX TL at 4.2 µg/ml (IQR (0.8–7.8), n = 19) and 0 µg/ml (IQR (0–0.5) n = 23) for wash-out period <6 weeks and >6 weeks, respectively. IFX: infliximab/CT-P13; IQR: interquartile range; TL: trough level; VDZ: vedolizumab; WO: wash-out.
Figure 4.
Figure 4.
(a) VDZ TLs at week 2 according to wash-out periods. Median VDZ TLs at 22.8 µg/ml (IQR (17.1–33.2), n = 25) and 26.9 µg/ml (IQR (20.2–32.8), n = 29) for wash-out period <6 weeks and >6 weeks, respectively. (b) Residual IFX TLs at third infusion of VDZ (week 6) according to wash-out periods. Median residual IFX TL at 0.5 µg/ml (IQR (0–1.5), n = 19) and 0 µg/ml (IQR (0–0.5) n = 19) for wash-out period <6 weeks and >6 weeks, respectively. IFX: infliximab/CT-P13; IQR: interquartile range; TL: trough level; VDZ: vedolizumab; WO: wash-out.
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