Vedolizumab in the treatment of inflammatory bowel disease: evolving paradigms

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Abstract

Inflammatory bowel diseases, comprising Crohn’s disease (CD) and ulcerative colitis (UC), are chronic, relapsing and remitting immune-mediated inflammatory diseases affecting the gastrointestinal tract. Vedolizumab is the first licensed drug in a group of ‘gut-selective’ biological agents used to treat inflammatory bowel diseases. The GEMINI registrational trials established the efficacy of vedolizumab for the induction and maintenance of remission in both CD and UC, with the most favourable results in tumour necrosis factor (TNF)-antagonist-naive patients. In recent years, a wealth of ‘real-world’ data has emerged supporting positive clinical, endoscopic and histological outcomes in patients treated with vedolizumab (VDZ) as well as reassuring safety data. More recently, the results of the first head-to-head trials of VDZ and TNF antagonists have been reported, as well as the results of a number of studies exploring the role of therapeutic drug monitoring with VDZ. This review brings together data reported on VDZ to date, including from the GEMINI trials, real-world data and emerging studies regarding therapeutic drug monitoring and immunogenicity. The safety profile of VDZ is also reviewed. Evolving treatment paradigms are explored, including data regarding the role of VDZ in perianal CD, post-operative complications and recurrence, extraintestinal manifestations and pregnancy.

Keywords: Crohn’s disease, inflammatory bowel diseases, mucosal healing, safety, therapeutic drug monitoring, ulcerative colitis, vedolizumab.

Citation: Crooks B, Barnes T, Limdi JK. Vedolizumab in the treatment of inflammatory bowel disease: evolving paradigms. Drugs in Context 2020; 9: 2019-10-2. DOI: 10.7573/dic.2019-10-2

Contributions: BC, TB and JKL coauthored the initial draft of the manuscript. JKL subsequently revised and edited the manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: BC has a non-pharmaceutical investigator-initiated sponsored research grant from Takeda. JKL has a non-pharmaceutical investigator-initiated sponsored research grant from Takeda and has received lecture fees from Takeda. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2020/02/dic.2019-10-2-COI.pdf

Acknowledgements: None.

Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2020 Crooks B, Barnes T, Limdi JK. https://doi.org/10.7573/dic.2019-10-2. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2020 Crooks B, Barnes T, Limdi JK. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/vedolizumab-in-the-treatment-of-inflammatory-bowel-disease:-evolving-paradigms/

Correspondence: Jimmy K Limdi, The Pennine Acute Hospitals NHS Trust, Head- Section of IBD – Division of Gastroenterology, Manchester; Manchester Academic Health Science Centre, University of Manchester; Hon Professor-Manchester Metropolitan University, Manchester, UK. Jimmy.Limdi@nhs.net

Provenance: invited; externally peer reviewed.

Submitted: 29 October 2019; Peer review comments to author: 21 January 2020; Revised manuscript received: 21 January 2020; Accepted: 27 January 2020; Publication date: 2 March 2020.

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