P618 Treatment outcomes of patients with Crohn’s disease and complex perianal fistula in five European countries: the PREFACE retrospective study

Ferrante, M.(1);Siproudhis, L.(2);Poggioli, G.(3);Reinshagen, M.(4);Milicevic, S.(5);Roset, M.(6);Bent-Ennakhi, N.(5);D‘Ambrosio, R.(5);Fernandez-Nistal, A.(7);Panes, J.(8);

(1)University Hospitals Leuven- KU Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium;(2)CHU Pontchaillou, Gastroenterology, Rennes, France;(3)Hospital St. Orsola, Department of Digestive Diseases, Bologna, Italy;(4)Klinikum Braunschweig, Medizinische Klinik I, Braunschweig, Germany;(5)Takeda Pharmaceuticals International AG, Medical Affairs- Europe & Canada, Glattpark-Opfikon Zurich, Switzerland;(6)IQVIA, Real World Solutions, Barcelona, Spain;(7)Takeda Farmaceutica Espana, Evidence and Value Generation Iberia, Madrid, Spain;(8)Hospital Clínic de Barcelona, Department of Gastroenterology, Barcelona, Spain


Presence of fistulas in Crohn’s disease (CD) is an indicator of poor prognosis; 20% of CD patients suffer from perianal fistula. There are few studies specifically designed to assess treatment outcomes in complex perianal fistula (CPF) in CD. This retrospective chart review study describes the outcomes of patients with CPF in CD in five European countries after medical and/or surgical treatment.


Adult patients with CD receiving treatment for a new episode of CPF during the eligibility period (September 2011 to September 2014), in Belgium, France, Germany, Italy and Spain, were included. Index date was defined as date of any medical or surgical CPF treatment initiation. Data was collected from CD diagnosis to at least 3 years after index date (except for deceased or lost to follow-up patients) to describe patient characteristics and treatments used for all CPF episodes since CD diagnosis. Effectiveness outcomes were measured as remission rates based on Fistula Drainage Assessment (FDA) recorded in medical charts for fistula reported at index date (index fistula). Remission rates are expressed as percentage rates on patient level after 6- and 12-months follow-up period. For calculation of treatment outcomes, the most recent FDA prior to the respective timepoint was used.


A total of 372 patients (51% male) with a mean (SD) age of 38 (13) were included by 31 sites. Median time since CD diagnosis was 7 years, and median length of follow-up was 6 years. A total of 498 CPFs were presented at index date and during FU period. Out of the 498 CPFs, 94% were treated with at least one surgical intervention (most frequent: 61% long-term seton placement, 51% surgical drainage) and 82% with at least one medical treatment (most frequent: 40% anti-TNFs, 33% antibiotics, 16% immunosuppressants). After 6 months the remission rate at patient level for index fistula was 28% and after 12 months 35%.


Current standards of care achieved remission in one third of patients with CPF in CD over a period of one year. Improved therapeutic strategies and new treatment options are required to improve outcomes in this manifestation of CD.