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Combining pentoxifylline with vedolizumab for Crohn's disease: results of a randomized, placebo-controlled pilot study.

BACKGROUND AND AIMS
The efficacy of current biologics may be limited by targeting only one pathway. Pentoxifylline (PTX) interferes with tumor necrosis factor (TNF) gene expression. We performed a randomized, placebo-controlled pilot study to determine if PTX plus vedolizumab (VDZ) in patients with Crohn's disease (CD) is safe and improves response compared to VDZ monotherapy.


METHODS
Thirty adult patients with active CD were randomized to VDZ/PTX or VDZ/placebo and followed for 24 weeks. Endoscopic activity and inflammatory cytokines were measured at baseline and week 24. Descriptive statistics were used to determine estimates of effect.


RESULTS
Demographics were similar but baseline disease activity was higher in the VDZ/PTX group. There was no difference in clinical remission at week 14 (60.0% vs 66.67%, OR 0.76, 95% CI 0.16-3.51) or steroid-free clinical remission at week 24 in patients receiving VDZ/PTX. Improved clinical response was noted in the VDZ/PTX group at weeks 6, 14, and 24 (week 6- 20% vs 6.67%, week 14- 26.67% vs 6.67%, week 24- 40% vs 20%). The rate of endoscopic remission was similar between the groups (40% vs 33.33%), with a greater mean decrease in SES-CD and CRP with VDZ/PTX (SES-CD -3.17 vs -0.15, CRP -5.56 vs 0.46). An increase in serum TNF-α concentration was observed with VDZ/placebo group; PTX mitigated this effect. No serious adverse events occurred.


CONCLUSIONS
VDZ/PTX did not provide benefit over VDZ monotherapy in clinical or endoscopic remission but appeared to improve clinical response and was safe. These data should inform a fully powered study.