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Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease
BACKGROUND: Selective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness. METHODS: A systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC)...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Japan
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132930/ https://www.ncbi.nlm.nih.gov/pubmed/29869016 http://dx.doi.org/10.1007/s00535-018-1480-0 |
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author | Schreiber, Stefan Dignass, Axel Peyrin-Biroulet, Laurent Hather, Greg Demuth, Dirk Mosli, Mahmoud Curtis, Rebecca Khalid, Javaria Mona Loftus, Edward Vincent |
author_facet | Schreiber, Stefan Dignass, Axel Peyrin-Biroulet, Laurent Hather, Greg Demuth, Dirk Mosli, Mahmoud Curtis, Rebecca Khalid, Javaria Mona Loftus, Edward Vincent |
author_sort | Schreiber, Stefan |
collection | PubMed |
description | BACKGROUND: Selective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness. METHODS: A systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC) or Crohn’s disease (CD). MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with UC/CD reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, 2014–June 22, 2017. Response and remission rates were combined in random-effects meta-analyses. RESULTS: At treatment week 14, 32% of UC patients [95% confidence interval (CI) 27–39%] and 30% of CD patients (95% CI 25–34%) were in remission; and at month 12, 46% for UC (95% CI 37–56%) and 30% for CD (95% CI 20–42%). For UC, the rates of corticosteroid-free remission were 26% at week 14 (95% CI 20–34%) and 42% at month 12 (95% CI 31–53%); for CD they were 25% at week 14 (95%, CI 20–31%) and 31% at month 12 (95%, CI 20–45%). At month 12, 33–77% of UC and 6–63% of CD patients had mucosal healing. Nine percent of patients reported serious adverse events. CONCLUSIONS: Vedolizumab demonstrated real-world effectiveness in patients with moderate-to-severely active UC or CD, with approximately one-half and one-third of patients, respectively, in remission at treatment month 12. These findings are consistent with clinical trial data and support the long-term benefit–risk profile of vedolizumab. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00535-018-1480-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6132930 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer Japan |
record_format | MEDLINE/PubMed |
spelling | pubmed-61329302018-09-13 Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease Schreiber, Stefan Dignass, Axel Peyrin-Biroulet, Laurent Hather, Greg Demuth, Dirk Mosli, Mahmoud Curtis, Rebecca Khalid, Javaria Mona Loftus, Edward Vincent J Gastroenterol Original Article—Alimentary Tract BACKGROUND: Selective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness. METHODS: A systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC) or Crohn’s disease (CD). MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with UC/CD reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, 2014–June 22, 2017. Response and remission rates were combined in random-effects meta-analyses. RESULTS: At treatment week 14, 32% of UC patients [95% confidence interval (CI) 27–39%] and 30% of CD patients (95% CI 25–34%) were in remission; and at month 12, 46% for UC (95% CI 37–56%) and 30% for CD (95% CI 20–42%). For UC, the rates of corticosteroid-free remission were 26% at week 14 (95% CI 20–34%) and 42% at month 12 (95% CI 31–53%); for CD they were 25% at week 14 (95%, CI 20–31%) and 31% at month 12 (95%, CI 20–45%). At month 12, 33–77% of UC and 6–63% of CD patients had mucosal healing. Nine percent of patients reported serious adverse events. CONCLUSIONS: Vedolizumab demonstrated real-world effectiveness in patients with moderate-to-severely active UC or CD, with approximately one-half and one-third of patients, respectively, in remission at treatment month 12. These findings are consistent with clinical trial data and support the long-term benefit–risk profile of vedolizumab. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00535-018-1480-0) contains supplementary material, which is available to authorized users. Springer Japan 2018-06-04 2018 /pmc/articles/PMC6132930/ /pubmed/29869016 http://dx.doi.org/10.1007/s00535-018-1480-0 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Article—Alimentary Tract Schreiber, Stefan Dignass, Axel Peyrin-Biroulet, Laurent Hather, Greg Demuth, Dirk Mosli, Mahmoud Curtis, Rebecca Khalid, Javaria Mona Loftus, Edward Vincent Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease |
title | Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease |
title_full | Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease |
title_fullStr | Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease |
title_full_unstemmed | Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease |
title_short | Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease |
title_sort | systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease |
topic | Original Article—Alimentary Tract |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132930/ https://www.ncbi.nlm.nih.gov/pubmed/29869016 http://dx.doi.org/10.1007/s00535-018-1480-0 |
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