What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab?
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 g...
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| Format: | Article |
| Language: | English |
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Lippincott, Williams & Wilkins
2018
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| Online Access: | https://eprints.nottingham.ac.uk/48172/ |
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| author | Card, Timothy R. Xu, Jing Liang, Huifang Bhayat, Fatima |
| author_facet | Card, Timothy R. Xu, Jing Liang, Huifang Bhayat, Fatima |
| author_sort | Card, Timothy R. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:08:10Z |
| format | Article |
| id | nottingham-48172 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T20:08:10Z |
| publishDate | 2018 |
| publisher | Lippincott, Williams & Wilkins |
| recordtype | eprints |
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| spelling | nottingham-481722019-04-13T04:30:13Z https://eprints.nottingham.ac.uk/48172/ 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 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. Lippincott, Williams & Wilkins 2018-04-23 Article PeerReviewed application/pdf en https://eprints.nottingham.ac.uk/48172/1/171004%20PML%20proof%20IBD%20%28002%29.pdf Card, Timothy R., Xu, Jing, Liang, Huifang and Bhayat, Fatima (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). pp. 953-959. ISSN 1536-4844 Epidemiology; Clinical trials; Progressive multifocal leukoencephalopathy; Inflammatory bowel disease; Vedolizumab https://academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izx097/4969878 doi:10.1093/ibd/izx097 doi:10.1093/ibd/izx097 |
| spellingShingle | Epidemiology; Clinical trials; Progressive multifocal leukoencephalopathy; Inflammatory bowel disease; 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? |
| title | What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab? |
| title_full | What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab? |
| title_fullStr | What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab? |
| title_full_unstemmed | What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab? |
| title_short | What is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or Crohn’s Disease treated with vedolizumab? |
| title_sort | what is the risk of progressive multifocal leukoencephalopathy in patients with ulcerative colitis or crohn’s disease treated with vedolizumab? |
| topic | Epidemiology; Clinical trials; Progressive multifocal leukoencephalopathy; Inflammatory bowel disease; Vedolizumab |
| url | https://eprints.nottingham.ac.uk/48172/ https://eprints.nottingham.ac.uk/48172/ https://eprints.nottingham.ac.uk/48172/ |