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Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes

BACKGROUND: Crohn’s disease [CD] is a chronic inflammatory bowel disease that, with progression, may require surgical intervention. AIM: To determine whether vedolizumab treatment of CD earlier in the disease course [≤2 or ≤5 years of disease duration] influences risk of CD-related surgery after acc...

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Autores principales: Dulai, Parambir S, Peyrin-Biroulet, Laurent, Demuth, Dirk, Lasch, Karen, Hahn, Kristen A, Lindner, Dirk, Patel, Haridarshan, Jairath, Vipul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904078/
https://www.ncbi.nlm.nih.gov/pubmed/32691844
http://dx.doi.org/10.1093/ecco-jcc/jjaa153
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author Dulai, Parambir S
Peyrin-Biroulet, Laurent
Demuth, Dirk
Lasch, Karen
Hahn, Kristen A
Lindner, Dirk
Patel, Haridarshan
Jairath, Vipul
author_facet Dulai, Parambir S
Peyrin-Biroulet, Laurent
Demuth, Dirk
Lasch, Karen
Hahn, Kristen A
Lindner, Dirk
Patel, Haridarshan
Jairath, Vipul
author_sort Dulai, Parambir S
collection PubMed
description BACKGROUND: Crohn’s disease [CD] is a chronic inflammatory bowel disease that, with progression, may require surgical intervention. AIM: To determine whether vedolizumab treatment of CD earlier in the disease course [≤2 or ≤5 years of disease duration] influences risk of CD-related surgery after accounting for probability of response. METHODS: Post hoc analyses of data from CD patients treated with vedolizumab in the GEMINI 2, GEMINI 3, and GEMINI LTS trials [N = 1253] evaluated CD-related surgery [bowel resection or colectomy] with stratification by probability of response to vedolizumab [low/intermediate or high]. Analyses used a previously validated clinical decision support tool and both logistic regression and Cox proportional hazard analyses. RESULTS: In total, 113 [9.0%] vedolizumab-treated patients required CD-related surgery. Surgical rates were 6.1% and 9.8% for the high and low/intermediate probability of response groups, respectively. Risk of surgery was lower for patients with a high probability of response versus those with a low/intermediate probability of response (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.29 to 0.85). For patients with a low/intermediate probability of vedolizumab response, there was a consistent trend for association between earlier treatment [≤2 or ≤5 years since diagnosis] and a lower risk of surgery relative to later treatment (≤2 years versus >2 years: odds ratio [OR] 0.77, 95% CI 0.38 to 1.58; ≤5 years versus >5 years: OR 0.61, 95% CI 0.37 to 1.00]. CONCLUSIONS: Earlier intervention with vedolizumab may be associated with lower rates of surgery. Use of the clinical decision support tool may help identify patients most likely to benefit from earlier intervention with vedolizumab.
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spelling pubmed-79040782021-03-01 Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes Dulai, Parambir S Peyrin-Biroulet, Laurent Demuth, Dirk Lasch, Karen Hahn, Kristen A Lindner, Dirk Patel, Haridarshan Jairath, Vipul J Crohns Colitis Original Articles BACKGROUND: Crohn’s disease [CD] is a chronic inflammatory bowel disease that, with progression, may require surgical intervention. AIM: To determine whether vedolizumab treatment of CD earlier in the disease course [≤2 or ≤5 years of disease duration] influences risk of CD-related surgery after accounting for probability of response. METHODS: Post hoc analyses of data from CD patients treated with vedolizumab in the GEMINI 2, GEMINI 3, and GEMINI LTS trials [N = 1253] evaluated CD-related surgery [bowel resection or colectomy] with stratification by probability of response to vedolizumab [low/intermediate or high]. Analyses used a previously validated clinical decision support tool and both logistic regression and Cox proportional hazard analyses. RESULTS: In total, 113 [9.0%] vedolizumab-treated patients required CD-related surgery. Surgical rates were 6.1% and 9.8% for the high and low/intermediate probability of response groups, respectively. Risk of surgery was lower for patients with a high probability of response versus those with a low/intermediate probability of response (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.29 to 0.85). For patients with a low/intermediate probability of vedolizumab response, there was a consistent trend for association between earlier treatment [≤2 or ≤5 years since diagnosis] and a lower risk of surgery relative to later treatment (≤2 years versus >2 years: odds ratio [OR] 0.77, 95% CI 0.38 to 1.58; ≤5 years versus >5 years: OR 0.61, 95% CI 0.37 to 1.00]. CONCLUSIONS: Earlier intervention with vedolizumab may be associated with lower rates of surgery. Use of the clinical decision support tool may help identify patients most likely to benefit from earlier intervention with vedolizumab. Oxford University Press 2020-07-21 /pmc/articles/PMC7904078/ /pubmed/32691844 http://dx.doi.org/10.1093/ecco-jcc/jjaa153 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Articles
Dulai, Parambir S
Peyrin-Biroulet, Laurent
Demuth, Dirk
Lasch, Karen
Hahn, Kristen A
Lindner, Dirk
Patel, Haridarshan
Jairath, Vipul
Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes
title Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes
title_full Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes
title_fullStr Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes
title_full_unstemmed Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes
title_short Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes
title_sort early intervention with vedolizumab and longer-term surgery rates in crohn’s disease: post hoc analysis of the gemini phase 3 and long-term safety programmes
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904078/
https://www.ncbi.nlm.nih.gov/pubmed/32691844
http://dx.doi.org/10.1093/ecco-jcc/jjaa153
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