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J Crohns Colitis. 2018 Apr 27;12(5):621-626. doi: 10.1093/ecco-jcc/jjy019.

Efficacy of Vedolizumab in Fistulising Crohn's Disease: Exploratory Analyses of Data from GEMINI 2.

Author information

Robarts Clinical Trials, Robarts Research Institute, Western University, London, ON, Canada.
Inflammatory Bowel Disease Center, Vanderbilt University Medical Center, Nashville, TN, USA.
IBD Center, Humanitas Clinical and Research Center, Humanitas University, Rozzano, Milan, Italy.
University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.
Takeda Pharmaceuticals USA, Inc., Deerfield, IL, USA.
Takeda Pharmaceuticals International Co., Cambridge, MA, USA.


Background and Aims:

Medical management of fistulising Crohn's disease [CD] is constrained by the limited number of available therapies. We evaluated the efficacy of vedolizumab, a gut-selective α4β7 integrin antagonist approved for treating moderately to severely active CD, in a subpopulation of patients with fistulising CD who participated in the GEMINI 2 trial [NCT00783692].


Exploratory analyses of data from the GEMINI 2 trial were conducted in 461 responders to 6-week vedolizumab induction therapy who received maintenance placebo [VDZ/PBO, N = 153] or vedolizumab [VDZ/VDZ, N = 308]. Fistula closure rates were assessed at Weeks 14 and 52, and the time to fistula closure was analysed by the Cox proportional hazards model with adjustments for significant covariates.


At entry into the maintenance period, 153 [33%] patients had a history of fistulising disease and 57 [12%] patients had ≥1 active draining fistula. By Week 14, 28% of VDZ/VDZ-treated patients compared with 11% of VDZ/PBO-treated patients (95% confidence interval [CI], -11.4 to 43.9) achieved fistula closure. Corresponding rates at Week 52 were 31% and 11% (absolute risk reduction [ARR]: 19.7%; 95% CI, -8.9 to 46.2). Similarly, VDZ/VDZ-treated patients had faster time to fistula closure and were more likely to have fistula closure at Week 52 [33% vs 11%; HR: 2.54; 95% CI, 0.54-11.96]. Prior failure of antibiotic therapy was a negative predictor of fistula closure [HR: 0.217; 95% CI, 0.059-0.795; p = 0.021], whereas trough vedolizumab concentrations did not affect closure rates.


Our findings are consistent with the beneficial effect of vedolizumab treatment for fistulising CD.

[Indexed for MEDLINE]
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