Treatment patterns and outcomes of patients with complex Crohn’s perianal fistula in five European countries: the PREFACE study

Background and study aims: Crohn’s disease (CD) is often complicated by perianal fistulas or abscesses that worsen patient’s quality of life, with 52-88% of CD-related perianal fistulas (CPFs) being complex. This retrospective study describes sociodemographic characteristics, treatment patterns and outcomes of patients with complex CPFs in five European countries.

Patients and methods: PREFACE is a multi-national medical chart review study of CD patients who started medical or surgical treatment for a new episode of complex CPFs between September 2011 and September 2014 (index date). Effectiveness outcomes were assessed as fistula remission rates based on fistula drainage assessment. The most recent assessments prior to each timepoint were used to calculate fistula remission rates.

Results: In total, 372 patients (51.3% male, mean age at index date 37.8 years) with 498 complex CPFs between index date and end of data collection were included. A quarter of patients with CPF already had perianal fistulas at CD diagnosis. Of the complex index CPFs, 39.8% were treated with antitumour necrosis factor, 33.3% with antibiotics and 16.3% with immunosuppressants. At least one surgery was performed for 93.8% of complex CPFs. By end of follow-up (median (IQR) 6.0 (5.2, 6.9) years), 61.2% of complex CPFs were not draining anymore. Fistula remission rate at patient level was 28.0% after 6 months, 35.2% after 12 months and 64.8% overall.

Conclusions: Current therapeutic algorithms for CPFs are not successful in a considerable proportion of patients. Improved therapeutic strategies and new treatment options are required to achieve better outcomes in complex CPFs.

Keywords: complex perianal fistula, Crohn’s disease, anti-TNF, fistula remission.