Combining Pentoxifylline With Vedolizumab for Crohn's Disease: Results of a Randomised, Placebo-controlled Pilot Study. (1st June 2022)

• Record Type: Journal Article
• Authors: Berera, Shivali; Ioannou, Stephanie C; Morillo, Diana; Mantero, Alejandro M A; Pignac-Kobinger, Judith; Colina, Niurka; Santander, Ana M; Fernandez, Irina; Quintero, Maria Alejandra; Rodriguez, Jennifer; Kerman, David H; Damas, Oriana M; Czul, Frank; Sussman, Daniel A; Abreu, Maria T; Deshpande, Amar R
• Is Part Of: Journal of Crohn's and colitis. Volume 16:Number 11(2022)
• Page Start: 1687
• Page End: 1695
• Publication Date: 2022-06-01
• Subjects: Vedolizumab -- pentoxifylline -- Crohn's disease; Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjac074
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background and Aims: The efficacy of current biologics may be limited by targeting only one pathway. Pentoxifylline [PTX] interferes with tumour necrosis factor [TNF] gene expression. We performed a randomised, placebo-controlled pilot study to determine if PTX plus vedolizumab [VDZ] in patients with Crohn's disease [CD] is safe and improves response compared with VDZ monotherapy. Methods: Thirty adult patients with active CD were randomised 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%, odds ratio [OR] 0.76, 95% confidence interval [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 Simple Endoscopic Score-CD [SES-CD] and C-reactive protein [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.