Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study
Merve Sivridaş,
Rob H. Creemers,
Dennis R. Wong,
Paul J. Boekema,
Tessa E. H. Römkens,
Lennard P. L. Gilissen,
Adriaan A. van Bodegraven,
Floris C. Loeff,
Theo Rispens,
Luc J. J. Derijks
Affiliations
Merve Sivridaş
Department of Clinical Pharmacy, Máxima Medical Center, 5504 DB Veldhoven, The Netherlands
Rob H. Creemers
Department of Gastroenterology, Geriatrics, Internal, and Intensive Care Medicine (COMIK), Zuyderland Medical Center, 6130 MB Sittard-Geleen, The Netherlands
Dennis R. Wong
Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, 6162 BG Sittard-Geleen, The Netherlands
Paul J. Boekema
Department of Gastroenterology, Máxima Medical Center, 5504 DB Veldhoven, The Netherlands
Tessa E. H. Römkens
Department of Gastroenterology, Jeroen Bosch Hospital, 5223 GZ Den Bosch, The Netherlands
Lennard P. L. Gilissen
Department of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, 5623 EJ Eindhoven, The Netherlands
Adriaan A. van Bodegraven
Department of Gastroenterology, Geriatrics, Internal, and Intensive Care Medicine (COMIK), Zuyderland Medical Center, 6130 MB Sittard-Geleen, The Netherlands
Floris C. Loeff
Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Academic Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands
Theo Rispens
Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Academic Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands
Luc J. J. Derijks
Department of Clinical Pharmacy, Máxima Medical Center, 5504 DB Veldhoven, The Netherlands
There are limited data on therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) patients treated with vedolizumab (VDZ). Although an exposure–response relation has been demonstrated in the post-induction phase, this relationship is more uncertain in the maintenance phase of treatment. The aim of our study was to determine whether there is an association between VDZ trough concentration and clinical and biochemical remission in the maintenance phase. A prospective, observational multicenter study has been performed on patients with IBD on VDZ in the maintenance treatment (≥14 weeks). Patient demographics, biomarkers, and VDZ serum trough concentrations were collected. Clinical disease activity was scored by the Harvey Bradshaw Index (HBI) for Crohn’s disease (CD) and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Clinical remission was determined as HBI p = 0.019). In this population, higher trough VDZ concentrations were associated with biochemical remission but not with clinical remission.
