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The Impact of Setons on Perianal Fistula Outcomes in Patients With Crohn's Disease Treated With Anti-TNF Therapy: A
Jeffrey McCurdy1,2, Javeria Munir3, Simon Parlow1
1Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Insights
Setons did not improve outcomes for patients with perianal fistulising Crohn's disease (PFCD) treated with anti-TNF therapy. This study found no significant difference in major adverse fistula outcomes or remission rates between patients with and without setons.
Area of Science:
- Gastroenterology
- Surgical Gastroenterology
- Inflammatory Bowel Disease Research
Background:
- Perianal fistulising Crohn's disease (PFCD) presents a significant management challenge.
- Anti-tumor necrosis factor (anti-TNF) therapy is a cornerstone treatment for PFCD.
- The role of setons in conjunction with anti-TNF therapy requires further elucidation.
Purpose of the Study:
- To evaluate the impact of setons on treatment outcomes in PFCD patients receiving anti-TNF therapy.
- To compare major adverse fistula outcomes (MAFO) and fistula remission rates in patients with and without setons.
Main Methods:
- A multicenter retrospective cohort study included 221 patients with PFCD treated with their first anti-TNF therapy.
- Patients were stratified based on the presence of one or more setons at anti-TNF initiation.
- 1:1 cardinality matching and propensity score weighting were employed to control for confounding factors, including fistula severity assessed by MRI.
Main Results:
- No significant difference in MAFO was observed between patients with setons (n=81) and without setons (n=140) (HR 1.23; 95% CI, 0.68-2.21).
- Fistula remission rates at 6 and 12 months were similar in both groups (6-month OR, 0.81; 12-month OR, 0.63).
- Sensitivity analyses confirmed the stability of these findings.
Conclusions:
- Setons were not associated with improved fistula outcomes in PFCD patients undergoing anti-TNF therapy.
- Further prospective, controlled studies are necessary to definitively establish the role of setons in this patient population.
Background And Aims:
We aimed to assess the impact of setons on perianal fistula outcomes in patients with perianal fistulising Crohn's disease (PFCD) treated with anti-TNF therapy.
Methods:
We included patients treated with their first anti-TNF therapy for PFCD after undergoing a pelvic MRI between 2005 and 2022 from 6 North American centres. Our exposure was one or more setons at the time of anti-TNF therapy. Our primary outcome was major adverse fistula outcome (MAFO), a composite of repeat local surgical intervention, hospitalisation, or faecal diversion for PFCD, and our secondary outcome was fistula remission defined clinically. We used 1:1 cardinality matching and propensity score weighting to control for fistula severity based on centrally read MRIs, luminal characteristics, and concomitant therapies.
Results:
Our analysis included 221 patients: 81 with setons and 140 without setons. After cardinality matching, our cohorts were balanced (standardised difference < 0.1 for all covariates). Patients with setons had similar rates of MAFO (HR 1.23; 95% CI, 0.68-2.21) and fistula remission at 6 months (OR, 0.81; 95% CI, 0.41-1.59) and 12 months (OR, 0.63; 95% CI, 0.31-1.27) compared to patients without setons. Our results remained stable when analysed by propensity score weighting and in a sensitivity analysis of patients who underwent an exam under anaesthesia. In patients with abscesses, there were lower rates of MAFO (HR, 0.49; 95% CI, 0.19-1.25) but not statistically significant in patients with setons.
Conclusions:
In this multicentre, setons were not associated with improved fistula outcomes. Future prospective controlled studies are warranted.
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