QS114 - Real-World Evidence Comparing Advanced Therapy with Definitive Surgical Closure versus Advanced Therapy Alone for Crohn’s Disease Anal Fistulas

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Purpose/Background: Anal fistulas are common in patients with Crohn’s disease (CD) and can be challenging to achieve long-term closure. Various medical and surgical approaches have been proposed to promote fistula closure, alleviate symptoms such as pain, discharge, and abscess formation, and improve the overall quality of life. The controlled PISA-II Trial showed long-term outcomes of surgical closure compared favorably to medical treatment alone. Although RCTs remain the highest level of evidence to compare varying treatments, real-world observational studies allow for investigations of comparative effectiveness among patients receiving care in usual clinical practice. This study aims to compare outcomes of surgical and medical treatment of CD patients with an anal fistula.

Methods/Interventions: Charts of CD patients with an anal fistula at a single center were reviewed. After seton placement, all patients were treated with advanced therapy for at least four months. Patients were then assigned to either continued medical treatment (continued advanced therapy +/- seton removal) or surgical treatment (continued advanced therapy with definitive surgical closure). Treatment decisions were at the discretion of the clinician. Outcomes of interest were clinical healing (closure of external wounds, cessation of drainage, and absence of pain) and radiologic healing (fibrosis on MRI). Demographic and disease characteristics were compared between groups using Fisher’s exact test or Wilcoxon rank sum test.

Results/Outcomes: The study cohort of 136 patients had a median age of 38 (range 9-83) years and included 74 (54%) males. Fistulas were categorized as transsphincteric (n=83), intersphincteric (n=61) or vaginal (n=11). Fifty-five (40%) patients had multiple fistulas. The most common advanced therapy was infliximab (n=80;59%) and adalimumab (n=50; 37%). Patients were assigned to medical (n=44; 32%) or surgical treatment (n=92; 68%). The most common surgical procedures were ligation of the intersphincteric fistula tract (n=45; 33%) and primary fistulotomy (n=21;15%). There was no significant difference in any patient or disease feature between the medical and surgical treatment groups. Clinical healing was similar between the medical treatment (n=31;70%) and surgical treatment (n=67;72%) groups. MRI evaluation was performed in 41 (93%) medical treated patients and 84 (91%) surgical treatment patients. MRI healing was higher (p=0.06) in surgery-treated patients (n=52;57%) compared to medical-treated patients (n=18;44%).

Conclusion/Discussion: Definitive surgery with advanced therapy is associated with similar clinical healing but more radiologic healing than advanced therapy alone in patients with CD anal fistulas. This real-world data supports recent controlled data demonstrating the critical role of definitive surgery in these CD patients.