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CC BY 4.0 · Z Gastroenterol
DOI: 10.1055/a-2744-5136
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Post-induction serum vedolizumab levels are not associated with better maintenance outcomes in patients with Crohn’s disease

Vedolizumab-Talspiegel nach der Induktionsphase sind bei Morbus-Crohn-Patienten mit dem Therapieansprechen nicht assoziiert

Authors

  • Jagoda Pokryszka 

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)

  • Christian Primas

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)

  • Michael Stadlmann

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)

  • Nathalie Gerold

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)

  • Cornelia Lichtenberger

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)

  • Sieglinde Reinisch

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)
    2   Magen-Darm-Gesundheitszentrum, Mödling, Austria

  • Gottfried Novacek

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)

  • Walter Reinisch

    1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Wien, Austria (Ringgold ID: RIN27271)
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Abstract

Aim

Results on exposure-efficacy relationships for vedolizumab in patients with Crohn’s disease are contentious. Our study aimed at exploring the relationship between vedolizumab serum concentrations measured during induction and maintenance and treatment outcomes in Crohn’s disease patients in a real-world setting.

Methods

Crohn’s disease patients treated with vedolizumab between January 2014 and July 2022 at our tertiary care centre were included. Serum vedolizumab concentrations were measured on at least one of the following time points: week 2, 6, 12, 26, and/or 52. Treatment efficacy was evaluated at weeks 12, 26 and 52 as clinical remission based on patients reported outcomes, faecal calprotectin and C-reactive protein remission.

Results

In total, 58 patients (55.2% females) were included. At baseline, active disease, defined either by increased faecal calprotectin, C-reactive protein or patients reported outcomes, was observed in 53 patients (91.4%). Week 12 vedolizumab serum levels were higher in clinical remitters versus non-remitters at weeks 12 and 52 (p <0.05). However, in adjusted multivariate analyses no association between vedolizumab levels and therapy outcomes was observed.

Conclusion

In our retrospective study, vedolizumab serum concentrations measured during induction treatment were not associated with clinical and feacal calprotecin remission at weeks 12, 26 and 52.

Zusammenfassung

Hintergrund

Die großen randomisierten Studien haben einen Zusammenhang zwischen Vedolizumab-Talspiegeln und Ansprechen auf diese Therapie bei Patienten mit Morbus Crohn gezeigt. Die sog. “real-world”-Studien haben allerdings ein heterogenes Bild ergeben. Das Ziel dieses Projekts war daher, diese Assoziation genauer zu untersuchen.

Methodik

Alle Morbus-Crohn-Patienten, die zwischen 01/2014 und 07/2022 an unserem tertiären Zentrum mit Vedolizumab behandelt wurden und von denen wir über min. eine Vedolizumab-Talspiegelmessung verfügten (Woche 2, 6, 12, 26 oder 52), wurden inkludiert. Das Ansprechen wurde zur Woche 12, 26 und 52 anhand der klinischen Faktoren (PROs) oder biochemischen Marker (fäkales Calprotectin (fCP); C-reaktives-Protein (CRP)) evaluiert. Die Assoziation zwischen den Talspiegeln und der Remission wurde mittels logistischer Regression berechnet.

Ergebnisse

Insgesamt wurden 58 Patienten (davon 55,2% Frauen) inkludiert. Zu Beginn der Therapie hatten 53 Patienten (91,4%) eine aktive Erkrankung, die durch erhöhtes fCP, CRP oder PROs definiert wurde. Die Vedolizumab-Talspiegel zur Woche 12 (nach der Induktionsphase) waren höher bei denjenigen, die zur Woche 12 und 52 eine klinische Remission erreicht haben (p<0,05). In einer adjustierten multivariablen Analyse wurde allerdings der Zusammenhang zwischen diesen Talspiegeln und dem Ansprechen nicht bewiesen.

Zusammenfassung

In unserer retrospektiven Studie konnte keine Assoziation zwischen den Vedolizumab-Talspiegeln und dem klinischen oder biochemischen Ansprechen bei Patienten mit Morbus Crohn festgestellt werden.

Keywords

drug level monitoring - vedolizumab - exposure-outcome relation - Crohn’s disease - trough level

Schlüsselwörter

therapeutisches Drug Monitoring - Vedolizumab - chronisch entzündliche Darmerkrankung - Morbus Crohn - Darm

Supplementary Material



Publication History

Received: 28 June 2025

Accepted after revision: 03 November 2025

Article published online:
12 January 2026

© 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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