Issue 11

Clinical Question

For patients with Crohn’s disease who have enterocutaneous fistula, are anti-TNFs effective and safe?

Editor’s Bottom Line

Anti-TNF therapy has only moderate efficacy in closing enterocutaneous fistula (33% after induction and 17% long-term) and a potentially high rate of abdominal abscess formation (30%).

Editorial Note

The use of anti-TNF agents to close enterocutaneous fistula needs careful risk-benefit discussion with the patient.

Reference

Amiot A, Setakhr V, Seksik P, et al. Long-term outcome of enterocutaneous fistula in patients with Crohn’s disease treated with anti-TNF therapy: a cohort study from the GETAID. Am J Gastroenterol. 2014 Sep;109(9):1443–9.
https://www.ncbi.nlm.nih.gov/pubmed/25091063

Synopsis

Between 2000 and 2009, GETAID recruited Crohn’s disease patients with enterocutaneous fistula treated with anti-TNF therapy. The primary study endpoint was the closure of all fistulae with no drainage, abscess, or need for surgery within 3 months of starting anti-TNF therapy. In all, 48 patients; n=32 with a single fistula and n=16 with multiple fistulae. The anti-TNFs were infliximab (n=41), adalimumab (n=5), and infliximab followed by adalimumab (n=6) due to 1 case of infusion reaction and 5 cases of infliximab failure. Concomitant immunosuppressant therapy was given to only 37 (77%) patients while 7 (15%) were on steroids.

Enterocutaneous fistula closure within 3 months of anti-TNF therapy occurred in 16 (33%) of patients. After a median follow-up of 3 years, only 8 (17%) of patients experienced long-term fistula closure without relapse.

Multivariate analysis found that patients with multiple fistulous tracts or intestinal stenosis had a higher hazard ratio for persistent fistula drainage (HR 5.80 and HR 4.67, respectively). In spite of anti-TNF therapy, 26 (55%) patients required surgery within a median delay of ~16 months for fistula closure (n=15), intestinal stricture (n=8), and abdominal sepsis (n=3). Since 15 (30%) patients developed abdominal abscesses and there was 1 death after surgery the safety profile of anti-TNF therapy for enterocutaneous fistula needs more examination.

Details

Study Design: Retrospective cohort study
Funding: None
Allocation: n/a
Setting: 12 centres in France and Belgium, GETAID
Level of Evidence: 2b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.