From the Guidelines
Infliximab is the most effective treatment for refractory Crohn's fistula, with approximately 50-60% of patients achieving complete fistula closure, making it the preferred option for this challenging complication of Crohn's disease. The standard regimen involves induction doses of 5 mg/kg at weeks 0,2, and 6, followed by maintenance infusions every 8 weeks 1. This biologic therapy works by blocking tumor necrosis factor, a key inflammatory cytokine in Crohn's disease, thereby reducing inflammation and promoting fistula healing. Some key points to consider when treating refractory Crohn's fistula with infliximab include:
- Higher infliximab doses may be beneficial for perianal fistulising disease, with target levels >10 μg/mL associated with better response 1
- Combination therapy with an immunomodulator, such as azathioprine, may be used to reduce immunogenicity and improve treatment outcomes 1
- The ECCO guidelines recommend infliximab for the induction and maintenance of remission in complex perianal fistulae in Crohn’s disease, with a strong recommendation and low quality of evidence 1 While total parenteral nutrition may provide nutritional support and bowel rest, prednisone can actually worsen fistulas due to impaired wound healing, and azathioprine, though useful as maintenance therapy, has limited efficacy as monotherapy for fistula closure. In contrast to the other options, infliximab has demonstrated significant efficacy in closing and maintaining closure of fistulas in patients with Crohn's disease who have not responded to conventional therapies, making it the preferred option for this challenging complication of Crohn's disease 1.
From the FDA Drug Label
The safety and efficacy of infliximab were assessed in 2 randomized, double-blind, placebo-controlled studies in patients with fistulizing Crohn's disease with fistula(s) that were of at least 3 months duration. Fistula response (≥ 50% reduction in number of enterocutaneous fistulas draining upon gentle compression on at least 2 consecutive visits without an increase in medication or surgery for Crohn's disease) was seen in 68% (21/31) of patients in the 5 mg/kg infliximab group (P = 0. 002) and 56% (18/32) of patients in the 10 mg/kg infliximab group (P = 0.021) vs. 26% (8/31) of patients in the placebo arm. RENFLEXIS is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.
The most effective option for treating refractory Crohn’s fistula is (c) infliximab 2.
From the Research
Effective Treatments for Refractory Crohn's Fistula
- Infliximab is an effective treatment for refractory Crohn's fistula, with studies showing that it can lead to closure of fistulas in 45-75% of cases 3, 4.
- The combination of infliximab with immunosuppressants such as azathioprine or methotrexate may be more effective than infliximab alone, with one study showing that 75% of patients achieved complete closure of fistulas 3.
- Azathioprine is also an effective drug in Crohn's disease and can lead to closure of fistulas in 30-40% of cases 3, 5.
- Total parenteral nutrition and prednisone are not specifically mentioned as effective treatments for refractory Crohn's fistula in the provided studies.
Treatment Outcomes
- The median time to complete closure of fistulas with infliximab treatment can be as short as 14 days 3.
- Maintenance treatment with infliximab can be effective in prolonging the response to treatment and preventing recurrence of fistulas 6, 7.
- The optimal timing of infliximab use is highly individualized and should be determined by a multidisciplinary team 7.