Early Intervention With Vedolizumab on Longer Term Surgery Rates in Crohn's Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programs.

Journal of Crohn's & Colitis
Parambir S DulaiVipul Jairath

Abstract

Crohn's disease (CD) is a chronic inflammatory bowel disease that, with progression, may require surgical intervention. To determine whether vedolizumab treatment of CD earlier in the disease course (≤2 or ≤5 years disease duration) influences risk of CD-related surgery after accounting for probability of response. 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. 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 (HR 0.50; 95%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 year...Continue Reading

References

Feb 24, 2010·Gut·Laurent Peyrin-BirouletWilliam J Sandborn
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Aug 24, 2013·The New England Journal of Medicine·William J SandbornUNKNOWN GEMINI 2 Study Group
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Oct 11, 2016·Gastroenterology·Jean-Frederic ColombelLaurent Peyrin-Biroulet
Dec 5, 2016·Lancet·Joana TorresLaurent Peyrin-Biroulet
Apr 4, 2017·Journal of Crohn's & Colitis·Maja NomanGert Van Assche
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Jan 10, 2019·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·David M FaleckRyan Ungaro

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Methods Mentioned

BETA
surgical resection

Clinical Trials Mentioned

NCT00783692
NCT01224171
NCT00790933

Software Mentioned

GEMINI

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