The Impact of Setons on Perianal Fistula Outcomes in Patients With Crohn's Disease Treated With Anti‐<scp>TNF</scp> Therapy: A Multicentre Study
Jeffrey D. McCurdy, Javeria Munir, Simon Parlow, Gagan Deep Singh Sambhi, Jacqueline Reid, Russell Yanofsky, Talal Alenezi, Joseph Meserve, Kuan‐Hung Yeh, Brenda Becker, Zubin Lahijanian, Anas Hussam Eddin, Ranjeeta Mallick, Tim Ramsay, Greg Rosenfeld, Ali Bessissow, Talat Bessissow, Vipul Jairath, David H. Bruining, Blair Macdonald, Siddharth Singh
Abstract
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.