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Background & Aims

Fistulizing Crohn's disease (CD) is challenging to treat. We report results from ENTERPRISE, a randomized, double-blind, phase IV trial, evaluating two vedolizumab intravenous dosing regimens in patients with fistulizing CD.

Methods

Patients with moderately to severely active CD and 1-3 active perianal fistulae (identified on magnetic resonance imaging [MRI]), received vedolizumab 300 mg intravenously at weeks 0, 2, 6, 14, and 22 (VDZ) or the same regimen plus an additional vedolizumab dose at week 10 (VDZ+wk10). Reduction from baseline in draining perianal fistulae and disease activity, MRI assessments, health-related quality of life (HRQoL), and safety were evaluated. Enrollment was stopped prematurely due to recruitment challenges; analyses are descriptive.

Results

Of 32 patients with ≥1 active fistula at baseline per MRI and post-baseline fistulae healing assessment, 28 (14 per dosing regimen) had ≥1 draining fistula at baseline (assessed by gentle finger compression during clinical exam). Rapid and sustained fistula closure was observed: 53.6% (VDZ, 64.3%; VDZ+wk10, 42.9%) and 42.9% (VDZ, 50.0%; VDZ+wk10, 35.7%) of patients achieved ≥50% decrease in draining fistulae and 100% fistulae closure, respectively, at week 30. Mean (standard deviation) CD and Perianal Disease Activity Index scores decreased by 51.1 (78.3) and 4.1 (3.3), respectively, at week 30. HRQoL improved throughout the study. No new safety signals were observed.

Conclusions

Sustained improvements in fistulizing CD were seen with both vedolizumab regimens. An additional dose at week 10 does not appear to alter treatment outcomes. Safety profile was consistent with other vedolizumab studies.

You can read an interview with two of the study authors here, and about the clinical implications of the study here.