Vedolizumab yields sustained improvements in fistulizing Crohn’s disease

Intravenous dosing regimens of vedolizumab appear to favourably alter outcomes in patients with fistulizing Crohn’s disease (CD), according to data from the phase IV ENTERPRISE trial.

ENTERPRISE included patients with moderately to severely active CD and 1–3 active perianal fistulae (identified on magnetic resonance imaging [MRI]) at baseline. They were randomized to treatment with either vedolizumab 300 mg intravenously at weeks 0, 2, 6, 14, and 22 (VDZ) or the same regimen but with an additional vedolizumab dose at week 10 (VDZ+wk10).

Outcomes included changes in draining perianal fistulae and disease activity, MRI assessments, health-related quality of life (HRQoL), and safety. However, the study was terminated prematurely due to recruitment challenges, making the present analyses descriptive.

Among 32 patients with ≥1 active fistula at baseline per MRI and postbaseline fistulae healing assessment, 28 (14 per dosing regimen) had ≥1 draining fistula at baseline (evaluated using gentle finger compression during clinical exam).

Both vedolizumab regimens produced rapid and sustained fistula closure. At week 30, 53.6 percent of the population achieved ≥50 percent decrease in draining fistulae (64.3 percent with VDZ and 42.9 percent with VDZ+wk10) and 42.9 percent achieved 100 percent fistulae closure (50.0 percent with VDZ and 35.7 percent with VDZ+wk10).

Mean CD score dropped by 51.1, while Perianal Disease Activity Index score decreased by 4.1. HRQoL also improved throughout the study.

There were no new safety signals that emerged.