- Location
- Montréal, Canada
Efficacy of vedolizumab in fistulising Crohn's disease: Exploratory analyses of data from GEMINI 2.:
Abstract
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).
Methods:
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 Cox proportional hazards model with adjustments for significant covariates.
Results:
At entry into 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], -11.4-43.9) achieved fistula closure. Corresponding rates at week 52 were 31% and 11% (absolute risk reduction [ARR]: 19.7%; 95% CI, -8.9-46.2). 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.
Conclusions:
Our findings are consistent with the beneficial effect of vedolizumab treatment for fistulising CD.
Abstract
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).
Methods:
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 Cox proportional hazards model with adjustments for significant covariates.
Results:
At entry into 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], -11.4-43.9) achieved fistula closure. Corresponding rates at week 52 were 31% and 11% (absolute risk reduction [ARR]: 19.7%; 95% CI, -8.9-46.2). 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.
Conclusions:
Our findings are consistent with the beneficial effect of vedolizumab treatment for fistulising CD.