Prospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 14, 2025; 31(2): 101292
Published online Jan 14, 2025. doi: 10.3748/wjg.v31.i2.101292
Vedolizumab serum trough concentrations with and without thiopurines in ulcerative colitis: The prospective VIEWS pharmacokinetics study
Thanaboon Chaemsupaphan, Aviv Pudipeddi, Hui-Yu Lin, Sudarshan Paramsothy, Viraj C Kariyawasam, Melissa Kermeen, Rupert W Leong
Thanaboon Chaemsupaphan, Aviv Pudipeddi, Hui-Yu Lin, Sudarshan Paramsothy, Melissa Kermeen, Rupert W Leong, Department of Gastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney 2139, New South Wales, Australia
Thanaboon Chaemsupaphan, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Aviv Pudipeddi, Sudarshan Paramsothy, Rupert W Leong, Faculty of Medicine and Health, University of Sydney, Sydney 2139, New South Wales, Australia
Hui-Yu Lin, Department of Gastroenterology, Tan Tock Seng Hospital, Singapore 308433, Singapore
Sudarshan Paramsothy, Rupert W Leong, Faculty of Medicine and Health Sciences, Macquarie University, Sydney 2139, New South Wales, Australia
Viraj C Kariyawasam, Department of Gastroenterology and Hepatology, Blacktown Hospital, Sydney 2148, New South Wales, Australia
Viraj C Kariyawasam, Blacktown Clinical School, Western Sydney University, Sydney 2148, New South Wales, Australia
Author contributions: Leong RW designed and supervised the study; Chaemsupaphan T, Pudipeddi A, Paramsothy S, Leong RW were involved in methodology; Chaemsupaphan T, Pudipeddi A, Kermeen M, and Kariyawasam VC conducted the investigation; Chaemsupaphan T, Pudipeddi A, and Lin HY performed data analysis; Chaemsupaphan T and Leong RW wrote the original draft. All authors have edited and approved the final manuscript.
Supported by Takeda Australia, No. IISR-2016-101883.
Institutional review board statement: The study was reviewed and approved by the Sydney Local Health District Human Research Ethics Committee (Approval No. HREC/17/CRGH/22).
Clinical trial registration statement: This study is registered at Australian New Zealand Clinical trials registry website (https://www.anzctr.org.au/). The registration identification number is ACTRN12618000812291.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Data, analytic methods, and study materials are available to other researchers upon request to the corresponding author.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Rupert W Leong, AGAF, FRACP, MBBS, MD, Professor, Department of Gastroenterology and Liver Services, Concord Repatriation General Hospital, Hospital Road, Sydney 2139, New South Wales, Australia. rupert.leong@health.nsw.gov.au
Received: September 12, 2024
Revised: October 22, 2024
Accepted: November 18, 2024
Published online: January 14, 2025
Processing time: 96 Days and 19.2 Hours
Core Tip

Core Tip: This prospective study investigated the pharmacokinetic relationship between vedolizumab trough concentrations and clinical outcomes in ulcerative colitis patients who had achieved clinical remission, on vedolizumab with or without thiopurine. Vedolizumab levels remained stable over 48 weeks, regardless of thiopurine withdrawal. Significant associations between vedolizumab trough concentrations and endoscopic, histologic, and histo-endoscopic remission at week 48 suggest that monitoring vedolizumab levels could be beneficial, with a threshold of > 11.3 µg/mL linked to sustained clinical remission. Although thiopurine withdrawal did not affect vedolizumab levels, it may necessitate higher vedolizumab trough concentrations to maintain remission.