Retrospective Cohort Study
Copyright ©The Author(s) 2020 Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 14, 2020; 26(30): 4428-4441
Published online Aug 14, 2020. doi: 10.3748/wjg.v26.i30.4428
Vedolizumab for ulcerative colitis: Real world outcomes from a multicenter observational cohort of Australia and Oxford
Samba Siva Reddy Pulusu, Ashish Srinivasan, Krupa Krishnaprasad, Daniel Cheng, Jakob Begun, Charlotte Keung, Daniel Van Langenberg, Lena Thin, Tamara Mogilevski, Peter De Cruz, Graham Radford-Smith, Emma Flanagan, Sally Bell, Soleiman Kashkooli, Miles Sparrow, Simon Ghaly, Peter Bampton, Elise Sawyer, Susan Connor, Quart-ul-ain Rizvi, Jane M Andrews, Gillian Mahy, Paola Chivers, Simon Travis, Ian Craig Lawrance
Samba Siva Reddy Pulusu, Ian Craig Lawrance, Centre for Inflammatory Bowel Diseases, St John of God Hospital, Subiaco 6008, Western Australia, Australia
Ashish Srinivasan, Simon Travis, Translational Gastroenterology Unit, NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford OX3 9DU, United Kingdom
Krupa Krishnaprasad, Inflammatory Bowel Disease Research Group, Queensland institute of Medical Research, Herston 4006, Queensland, Australia
Daniel Cheng, Department of Gastroenterology, Mater Hospital, Brisbane 4101, Queensland, Australia
Jakob Begun, Graham Radford-Smith, Department of Gastroenterology, Mater Hospital, South Brisbane 4101, Queensland, Australia
Charlotte Keung, Daniel Van Langenberg, Department of Gastroenterology, Eastern Health, Box Hill 3128, Victoria, Australia
Lena Thin, Department of Gastroenterology, Fiona Stanley Hospital, Murdoch 6150, Western Australia, Australia
Tamara Mogilevski, Peter De Cruz, Department of Gastroenterology, Austin Health, Heidelberg 3084, Victoria, Australia
Emma Flanagan, Sally Bell, Department of Gastroenterology, St Vincent’s Hospital, Fitzroy 3065, Victoria, Australia
Soleiman Kashkooli, Department of Gastroenterology, Northern Health, Epping 3076, Victoria, Australia
Miles Sparrow, Department of Gastroenterology, The Alfred Hospital, Melbourne 3004, Victoria, Australia
Simon Ghaly, Department of Gastroenterology, St Vincent’s Hospital, Darlinghurst 2010, New South Wales, Australia
Peter Bampton, Department of Gastroenterology, Flinders Medical Centre, Bedford Park 5042, South Australia, Australia
Elise Sawyer, Susan Connor, Department of Gastroenterology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
Quart-ul-ain Rizvi, Jane M Andrews, Department of Gastroenterology, Royal Adelaide Hospital & University of Adelaide, Adelaide 5000, South Australia, Australia
Gillian Mahy, Department of Gastroenterology, Townsville Hospital, Douglas 4814, Queensland, Australia
Paola Chivers, Institute for Health Research, University of Notre Dame, Fremantle 6160, Western Australia, Australia
Ian Craig Lawrance, School of Medicine and Pharmacology, University of Western Australia, Crawley 6009, Western Australia, Australia
Author contributions: Lawrance IC is the main supervisor of the study involved in study conceptualization, funding acquisition, provision of resources, methodology design, review, editing of the manuscript and project administration; Writing up the original draft of the paper, data curation, formal analysis, manuscript editing, literature review was done by Pulusu SSR; Krishnaprasad K involved in project administration, data curation and manuscript editing; Data collection was done by Pulusu SSR, Srinivasan A, Cheng D, Keung C, Mogilevski T, Flanagan E, Sawyer E, and Rizvi Q; Data collection, project administration, supervision, manuscript revision and correction was done by Begun J, Van Langenberg D, Thin L, De Cruz P, Radford-Smith G, Bell S,, Kashkooli S, Sparrow M, Ghaly S, Bampton P, Connor S , Andrews JM, Mahy G, and Travis S; Data validation and visualization, biostatistics was done by Chivers P; all authors reviewed and approved the final manuscript.
Institutional review board statement: This study comes under the investigation into natural history of inflammatory bowel disease approved by South Metropolitan area health service.
Informed consent statement: Patients were not required to give informed consent for the study because the data obtained and used for analysis was anonymous.
Conflict-of-interest statement: All authors declare no conflict of interest related to this article.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
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:
Corresponding author: Ian Craig Lawrance, FRCP (Hon), MBBS, PhD, Professor, Centre for Inflammatory Bowel Diseases, St John of God Hospital, 25 McCourt Street, Subiaco 6008, Western Australia, Australia.
Received: April 4, 2020
Peer-review started: April 4, 2020
First decision: April 26, 2020
Revised: July 18, 2020
Accepted: July 30, 2020
Article in press: July 30, 2020
Published online: August 14, 2020
Processing time: 132 Days and 1 Hours
Research background

Vedolizumab (VDZ) is a gut selective anti-integrin used for treatment of ulcerative colitis (UC). Evidence needed to assess it efficacy and safety in a real world setting.

Research motivation

Efficacy and safety of VDZ needs to be assessed, involving multiple inflammatory bowel disease (IBD) centers from two countries to reduce physician, site and country biases.

Research objectives

In this real world study, we aim to assess the clinical response, clinical, endoscopic remission and the factors influencing them in UC patients from Australia and Oxford in United Kingdom treated with VDZ.

Research methods

Retrospective review of prospectively entered patient database, treated with VDZ. Three hundred and three UC patients from 14 Australian centers and Oxford (United Kingdom) were included. Clinical response and remission was assessed at 3, 6 and 12 mo using Mayo score across all centers. Endoscopic remission was assessed at 6 mo using mayo endoscopic score in Australia and ulcerative colitis endoscopic score of severity score in Oxford. Cox regression models and Kaplan Meier curves were performed to assess the time to remission, time to failure and the covariates influencing them. Safety was assessed through adverse event reporting.

Research results

Clinical response for all patients was 79% at 3 mo and number of patients achieving clinical remission increased from 3 mo (56%) to 6 mo (62%) and remained almost stable at 12 mo (60%). No significant difference was observed between the two countries in achieving clinical remission at all points and a significantly greater proportion of Australian patients achieved mucosal healing compared to Oxford, which could be due to more patients using concomitant immunomodulation in Australia. Anti-tumor necrosis factor (anti-TNF) exposed patients were almost twice more likely to lose response to VDZ compared to anti-TNF naïve patients but no difference in outcomes were observed between patients who had a primary and secondary loss of response to anti-TNF agents. The role of concomitant immunomodulation in achieving above outcomes need to be elucidated in future prospective studies.

Research conclusions

VDZ can be safely and effectively used to treat UC patients in a real world setting. However patients who had prior anti-TNF therapy were more likely to fail compared to anti-TNF naïve patients.

Research perspective

VDZ use was reviewed in real world setting involving multiple IBD centers from two countries. This study helps physicians find VDZ its place in the treatment algorithm of complex IBD patient management. Future prospective studies are needed to evaluate the benefit of using concomitant immunomodulation with VDZ.