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What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab?

Card, Timothy R.; Xu, Jing; Liang, Huifang; Bhayat, Fatima

What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab? Thumbnail


Authors

Dr TIM CARD tim.card@nottingham.ac.uk
CLINICAL ASSOCIATE PROFESSOR

Jing Xu

Huifang Liang

Fatima Bhayat



Abstract

Background: Progressive multifocal leukoencephalopathy is a serious condition linked to certain diseases and immunosuppressant therapies, including the α4 integrin antagonist natalizumab. No cases have been reported to date with vedolizumab, a selective antagonist of the α4β7 integrin expressed on gut-homing lymphocytes. This analysis aimed to describe the current and future expected occurrence of progressive multifocal leukoencephalopathy with vedolizumab use, were the risk the same as in other populations in which this disease has been studied.

Methods: The expected number of vedolizumab-associated progressive multifocal leukoencephalopathy cases was estimated up to May 19, 2016 and modelled up to 2034. These estimates were based on the cumulative exposure to the drug, assuming an equivalent risk to that of patients treated with natalizumab or those from other reference populations where progressive multifocal leukoencephalopathy has been examined. Future cases were modelled based on similar risks and projected sales.

Results: The cumulative vedolizumab exposure was estimated at 54,619 patient-years, with a 95% confidence interval of 0.0–6.75 cases per 100,000 patient-years. An estimated 30.2 (95% confidence interval 19.4–40.9) cases of progressive multifocal leukoencephalopathy would have occurred if vedolizumab had the same risk as that of natalizumab. There would be a 50% chance of the first case occurring by 2018, assuming an equivalent risk to the general population.

Conclusions: These analyses indicate the risk of progressive multifocal leukoencephalopathy with vedolizumab is small, and unlikely to be above 6.75 cases per 100,000 patient-years.

Citation

Card, T. R., Xu, J., Liang, H., & Bhayat, F. (2018). What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab?. Inflammatory Bowel Diseases, 24(5), https://doi.org/10.1093/ibd/izx097

Journal Article Type Article
Acceptance Date Oct 10, 2017
Online Publication Date Apr 13, 2018
Publication Date Apr 23, 2018
Deposit Date Nov 20, 2017
Publicly Available Date Apr 14, 2019
Journal Inflammatory Bowel Diseases
Print ISSN 1078-0998
Electronic ISSN 1536-4844
Publisher Oxford University Press
Peer Reviewed Peer Reviewed
Volume 24
Issue 5
DOI https://doi.org/10.1093/ibd/izx097
Keywords Epidemiology; Clinical trials; Progressive multifocal leukoencephalopathy; Inflammatory bowel disease; Vedolizumab
Public URL https://nottingham-repository.worktribe.com/output/927561
Publisher URL https://academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izx097/4969878
Contract Date Nov 20, 2017

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