Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study
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...
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MDPI AG
2023-03-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/15/3/972 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Merve Sivridaş |
| collection | DOAJ |
| description | 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 < 5 and SCCAI < 3. Biochemical remission was defined as fecal calprotectin <250 mg/kg and serum CRP <5 mg/L. A total of 159 patients (59 CD, 100 UC) were included. In none of the patient groups, a statistically significant correlation between trough VDZ concentration and clinical remission was observed. Patients in biochemical remission had higher VDZ trough concentrations (<i>p</i> = 0.019). In this population, higher trough VDZ concentrations were associated with biochemical remission but not with clinical remission. |
| first_indexed | 2024-03-11T06:01:23Z |
| format | Article |
| id | doaj.art-935e6f04083545d584795100813406b1 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-11T06:01:23Z |
| publishDate | 2023-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-935e6f04083545d584795100813406b12023-11-17T13:17:00ZengMDPI AGPharmaceutics1999-49232023-03-0115397210.3390/pharmaceutics15030972Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY StudyMerve Sivridaş0Rob H. Creemers1Dennis R. Wong2Paul J. Boekema3Tessa E. H. Römkens4Lennard P. L. Gilissen5Adriaan A. van Bodegraven6Floris C. Loeff7Theo Rispens8Luc J. J. Derijks9Department of Clinical Pharmacy, Máxima Medical Center, 5504 DB Veldhoven, The NetherlandsDepartment of Gastroenterology, Geriatrics, Internal, and Intensive Care Medicine (COMIK), Zuyderland Medical Center, 6130 MB Sittard-Geleen, The NetherlandsDepartment of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, 6162 BG Sittard-Geleen, The NetherlandsDepartment of Gastroenterology, Máxima Medical Center, 5504 DB Veldhoven, The NetherlandsDepartment of Gastroenterology, Jeroen Bosch Hospital, 5223 GZ Den Bosch, The NetherlandsDepartment of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, 5623 EJ Eindhoven, The NetherlandsDepartment of Gastroenterology, Geriatrics, Internal, and Intensive Care Medicine (COMIK), Zuyderland Medical Center, 6130 MB Sittard-Geleen, The NetherlandsDepartment of Immunopathology, Sanquin Research and Landsteiner Laboratory, Academic Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The NetherlandsDepartment of Immunopathology, Sanquin Research and Landsteiner Laboratory, Academic Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The NetherlandsDepartment of Clinical Pharmacy, Máxima Medical Center, 5504 DB Veldhoven, The NetherlandsThere 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 < 5 and SCCAI < 3. Biochemical remission was defined as fecal calprotectin <250 mg/kg and serum CRP <5 mg/L. A total of 159 patients (59 CD, 100 UC) were included. In none of the patient groups, a statistically significant correlation between trough VDZ concentration and clinical remission was observed. Patients in biochemical remission had higher VDZ trough concentrations (<i>p</i> = 0.019). In this population, higher trough VDZ concentrations were associated with biochemical remission but not with clinical remission.https://www.mdpi.com/1999-4923/15/3/972vedolizumabtrough leveltherapeutic drug monitoringmaintenanceIBDulcerative colitis |
| spellingShingle | 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 Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study Pharmaceutics vedolizumab trough level therapeutic drug monitoring maintenance IBD ulcerative colitis |
| title | Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study |
| title_full | Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study |
| title_fullStr | Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study |
| title_full_unstemmed | Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study |
| title_short | Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment—TUMMY Study |
| title_sort | therapeutic drug monitoring of vedolizumab in inflammatory bowel disease patients during maintenance treatment tummy study |
| topic | vedolizumab trough level therapeutic drug monitoring maintenance IBD ulcerative colitis |
| url | https://www.mdpi.com/1999-4923/15/3/972 |
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