Literature DB >> 29560811

A prospective cohort study to assess the relevance of vedolizumab drug level monitoring in IBD patients.

Hermann Schulze1, Philip Esters1, Franz Hartmann1, Juergen Stein2, Christina Christ3, Michael Zorn3, Axel Dignass1.   

Abstract

BACKGROUND: Vedolizumab (VDZ) drug monitoring strategies in inflammatory bowel disease (IBD) patients have not been systematically investigated so far. We evaluated the correlation between VDZ trough levels (VTL) and the treatment response in IBD.
METHODS: Fifty-one patients with active IBD on or starting a therapy with VDZ were enrolled in this prospective and observational single centre study. Disease activity indices, blood tests, and anthropometric parameters were assessed over a time period of 6 months. One hundred and fifty-five VDZ serum trough levels were measured directly before the next scheduled application using liquid chromatography mass spectrometry (LC-MS/MS).
RESULTS: VDZ treatment was found to be clinically effective (Harvey Bradshaw Index (HBI) dropping from 10 to 5.5 points (p < .0005) in Crohn's disease (CD) patients; partial Mayo score (pMS) from 4.4 to 2.1 points (p < .0005) in ulcerative colitis patients (UC). CRP levels tended to decrease and haemoglobin levels to increase under VDZ therapy. CD patients with a serum CRP level lower than 5 mg/l exhibited significantly higher VTL than those with elevated CRP levels (34.9 versus 21.7 µg/ml, p = .00153). UC patients with haemoglobin levels higher 12 g/dl at the time of VTL measurement had significantly higher VTL compared to patients with lower haemoglobin levels (35.4 versus 15.6 µg/ml, p < .0005).
CONCLUSIONS: Our data suggest a significant correlation between VTL and response to therapy in IBD patients (higher VTL associated with better response).

Entities:  

Keywords:  Crohn’s disease; Vedolizumab; drug monitoring; inflammatory bowel disease; trough level; ulcerative colitis

Mesh:

Substances:

Year:  2018        PMID: 29560811     DOI: 10.1080/00365521.2018.1452974

Source DB:  PubMed          Journal:  Scand J Gastroenterol        ISSN: 0036-5521            Impact factor:   2.423


  8 in total

1.  Early vedolizumab trough levels predict combined endoscopic and clinical remission in inflammatory bowel disease.

Authors:  Jurij Hanžel; Nejc Sever; Ivan Ferkolj; Borut Štabuc; Nataša Smrekar; Tina Kurent; Matic Koželj; Gregor Novak; Griet Compernolle; Sophie Tops; Ann Gils; David Drobne
Journal:  United European Gastroenterol J       Date:  2019-03-19       Impact factor: 4.623

Review 2.  A product review of vedolizumab in inflammatory bowel disease.

Authors:  Robert Battat; Parambir S Dulai; Vipul Jairath; Niels Vande Casteele
Journal:  Hum Vaccin Immunother       Date:  2019-05-07       Impact factor: 3.452

3.  Going Third Class: Treatment of Steroid-Dependent Ulcerative Colitis.

Authors:  Helen Lee; Yecheskel Schneider; Gary R Lichtenstein
Journal:  Dig Dis Sci       Date:  2019-05       Impact factor: 3.199

4.  Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease.

Authors:  Luisa Guidi; Daniela Pugliese; Tommaso Panici Tonucci; Lorenzo Bertani; Francesco Costa; Giuseppe Privitera; Barbara Tolusso; Clara Di Mario; Eleonora Albano; Gherardo Tapete; Elisa Gremese; Alfredo Papa; Antonio Gasbarrini; Gian Ludovico Rapaccini; Alessandro Armuzzi
Journal:  United European Gastroenterol J       Date:  2019-09-03       Impact factor: 4.623

Review 5.  Vedolizumab trough level monitoring in inflammatory bowel disease: a state-of-the-art overview.

Authors:  Lieven Pouillon; Séverine Vermeire; Peter Bossuyt
Journal:  BMC Med       Date:  2019-05-08       Impact factor: 8.775

6.  Monitoring of Vedolizumab Infusion Therapy (MOVE-IT) Response With Fecal Inflammation Markers, Ultrasound, and Trough Serum Level in Patients With Ulcerative Colitis: Protocol for a Multicentric, Prospective, Noninterventional Study.

Authors:  Jimmi Cording; Margit Blömacher; Berit Inga Wiebe; Jost Langhorst; Torsten Kucharzik; Andreas Sturm; Stefan Schreiber; Ulf Helwig
Journal:  JMIR Res Protoc       Date:  2019-11-08

7.  Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation.

Authors:  Mark T Osterman; Maria Rosario; Karen Lasch; Morris Barocas; Jayson D Wilbur; Nathanael L Dirks; Marc R Gastonguay
Journal:  Aliment Pharmacol Ther       Date:  2019-01-20       Impact factor: 8.171

8.  Vedolizumab Efficacy, Safety, and Pharmacokinetics With Reduced Frequency of Dosing From Every 4 Weeks to Every 8 Weeks in Patients With Crohn's Disease or Ulcerative Colitis.

Authors:  Séverine Vermeire; Milan Lukáš; Fernando Magro; Shashi Adsul; Dirk Lindner; Maria Rosario; Jeannine Roth; Silvio Danese
Journal:  J Crohns Colitis       Date:  2020-09-07       Impact factor: 9.071

  8 in total

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