Clinical Characteristics and Treatment Experience of Patients With Complex Crohn’s Perianal Fistulas Requiring Surgical Interventions in the SPOTLITE Study: An Interim Analysis

Background: There is limited real-world evidence that describes the population, clinical characteristics and treatment experience of patients with complex Crohn’s perianal fistulas (CPF) in the perioperative setting. Here, we report baseline sociodemographic characteristics, clinical characteristics and treatment experiences of patients requiring surgery for complex CPF enrolled in the SPOTLITE study (NCT04940611). Methods: SPOTLITE is an ongoing international, prospective, observational, multicohort study on the clinical outcomes of surgical interventions in complex fistulizing conditions, conducted in up to 12 countries (up to 60 sites) across North America, Europe and Israel. The study evaluates short-term (3 months) and long-term (24 months) clinical outcomes post-index surgical intervention in patients with fistulizing conditions (complex CPF, complex cryptoglandular fistulas [CCF] or Crohn’s disease rectovaginal fistulas [CD-RVF]). Patients aged 18 years and older with a physician-confirmed diagnosis of complex CPF, CCF or CD-RVF and a physician decision to treat the fistulizing condition with a surgical intervention were eligible for recruitment. Data collected at baseline included patient characteristics, clinical disease history, fistula characteristics and surgical/medical treatment history. Reported here are baseline data for patients enrolled in the complex CPF cohort at cut-off (January 17, 2023), analyzed using descriptive statistics. Results: The 83 enrolled patients were predominantly White (71%) with a mean (standard deviation [SD]) age of 39.5 years (11.43). Approximately half were male (53%), overweight/obese (51%) and current/former smokers (47%). Imaging was used to diagnose complex CPF in 61% of patients: all receiving pelvic magnetic resonance imaging (61%) and a proportion receiving computerized tomography scan (5%) and/or lower gastrointestinal endoscopy (4%). The mean (SD) duration from symptom onset and diagnosis to surgical intervention was 68.7 (77.7) months and 68.7 (78.0) months, respectively. The mean/median (min, max) number of active fistulas per patient was 1.4/1.0 (1.0, 5.0), and the location of fistulas targeted for surgical intervention included high transsphincteric (57%), high intersphincteric (13%), suprasphincteric (5%) and extrasphincteric (1%). Medications used at baseline were biologics (28%), immunomodulators (18%) and antibiotics (2%). The majority of patients had received at least one prior surgical intervention (69%); seton use for palliative purposes being the most common procedure (39%), followed by fistulotomy (12%), fistulectomy (11%) and ligation of intersphincteric fistula tract (8%). Other procedures included advancement flap (7%), colostomy (7%), ileostomy (4%), fibrin glue (2%), abdominal procedure (1%), bioprosthetic plugs (1%), flap repair (1%) and stem cell therapy (1%). At the time of surgery, 34% of patients used biologics (all receiving 1 medication) and 30% of patients used non-biologics, including antibiotics and immunomodulators, (1–2 medications). Conclusions: These interim data highlight that patients with complex CPF experience considerable periods between symptom onset/diagnosis and surgical intervention; the majority require at least one surgical intervention. SPOTLITE is an ongoing study that will provide further data in the future to confirm these preliminary observations. SPOTLITE continues to provide real-world data on a range of clinical outcomes that will address the paucity of data regarding clinical characteristics and treatment experiences of patients with complex CPF in the postsurgical setting.