Outcome of biological therapies in chronic antibiotic-refractory pouchitis: A retrospective single-centre experience

United European Gastroenterol J. 2019 Nov;7(9):1215-1225. doi: 10.1177/2050640619871797. Epub 2019 Aug 20.

Abstract

Background: In limited retrospective series, infliximab, adalimumab and vedolizumab have demonstrated efficacy in chronic antibiotic-refractory pouchitis. Here, we report single-centre data of all biological therapies in refractory pouchitis.

Methods: We retrospectively assessed all records from patients with ulcerative colitis and ileal pouch -anal anastomosis who received infliximab, adalimumab or vedolizumab for pouchitis. Clinically relevant remission, defined as a modified Pouchitis Disease Activity Index <5 and a reduction of modified Pouchitis Disease Activity Index ≥2 points from baseline, was assessed at week 14.

Results: Thirty-three unique patients were identified. Prior to colectomy, patients had been exposed to cyclosporine (n = 14), infliximab (n = 12), adalimumab (n = 3), and/or vedolizumab (n = 3). All developed chronic antibiotic-refractory pouchitis, for which they received infliximab (n = 23), adalimumab (n = 13) or vedolizumab (n = 15). Clinically relevant remission was observed in 43.5% of patients in the infliximab group, and in 38.5% and 60.0% in the adalimumab and vedolizumab group, respectively. In the long-term, significantly more patients continued vedolizumab compared to anti-tumour necrosis factor (anti-TNF) therapy (hazard ratio 3.0, p = 0.04). Adverse events (mainly infusion reactions) explained 40.7% of the patients discontinuing anti-TNF therapy, whereas discontinuation of vedolizumab was only related to insufficient efficacy. Four patients eventually required a permanent ileostomy.

Conclusion: In this case series of chronic antibiotic-refractory pouchitis, biological therapy was effective in the majority of patients and only a minority eventually required a permanent ileostomy. The use of anti-TNF agents was hampered by a high rate of adverse events, partly related to immunogenicity as some patients had been exposed to anti-TNF prior to colectomy. Vedolizumab was also efficacious and may provide a safe alternative in these chronic antibiotic-refractory pouchitis patients.

Keywords: Chronic pouchitis; adalimumab; biological therapy; infliximab; ulcerative colitis; vedolizumab.

MeSH terms

  • Adalimumab / therapeutic use*
  • Adult
  • Anti-Bacterial Agents / therapeutic use
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Biological Products / therapeutic use
  • Chronic Disease
  • Colitis, Ulcerative / surgery
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Infliximab / therapeutic use*
  • Male
  • Middle Aged
  • Pouchitis / drug therapy*
  • Proctocolectomy, Restorative
  • Retrospective Studies
  • Treatment Failure
  • Treatment Outcome
  • Tumor Necrosis Factor Inhibitors / therapeutic use*

Substances

  • Anti-Bacterial Agents
  • Antibodies, Monoclonal, Humanized
  • Biological Products
  • Gastrointestinal Agents
  • Tumor Necrosis Factor Inhibitors
  • vedolizumab
  • Infliximab
  • Adalimumab