For patients with Crohn’s disease who have enterocutaneous fistula, are anti-TNFs effective and safe?
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%).
The use of anti-TNF agents to close enterocutaneous fistula needs careful risk-benefit discussion with the patient.
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.
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.
Study Design: Retrospective cohort study
Setting: 12 centres in France and Belgium, GETAID
Level of Evidence: 2b (Oxford Levels of Evidence)
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