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DOI: 10.1055/a-2744-5136
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 assoziiertAuthors
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 levelSchlüsselwörter
therapeutisches Drug Monitoring - Vedolizumab - chronisch entzündliche Darmerkrankung - Morbus Crohn - DarmPublication 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
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