P801 Treatment patterns of complex perianal fistula in Crohn’s disease in five European countries: the PREFACE study, a retrospective chart review

M. Ferrante1, L. Siproudhis2, G. Poggioli3, M. Reinshagen4, S. Milicevic5, M. Roset6, B. Thun7, N. Bent-Ennakhil8, R. D′Ambrosio8, A. Fernandez-Nistal5, J. Panes9

1University Hospitals Leuven- KU Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium, 2Centre Hospitalier Universitaire Pontchaillou, Gastroenterology, Rennes, France, 3S. Orsola-Malpighi Hospital, Dept. of Digestive Diseases, Bologna, Italy, 4Klinikum Braunschweig, Medizinische Klinik I, Braunschweig, Germany, 5Takeda Pharmaceuticals International AG, Medical Affairs- Europe & Canada, Zürich, Switzerland, 6IQVIA, Health Economics and Outcome Research, Barcelona, Spain, 7IQVIA Commercial GmbH & Co. OHG, Health Economics and Outcome Research, München, Germany, 8Takeda Pharmaceutical International AG, Medical Affairs- Europe & Canada, Zürich, Switzerland, 9Hospital Clínic de Barcelona, Department of Gastroenterology, Barcelona, Spain

Background

Presence of fistulas in Crohn’s disease (CD) is an indicator of poor prognosis; 22.1% of CD patients suffer from fistulising disease1 with high variability in complex perianal fistula (CPF) prevalence2. There is limited information available about the management of CPF in a real-world setting. This study describes the treatment patterns of patients with CPF in CD in Europe.

Methods

Retrospective medical chart review of consecutive patients with CD receiving treatment for a new episode of CPF during the period (September 2011 to September 2014), in Belgium, France, Germany, Italy and Spain. Index date was defined as the date of treatment initiation for a new episode of CPF during the eligibility period. 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 CPFs episodes since CD diagnosis.

Results

A total of 386 patients (51% female) were included with a mean (SD) age of 38 (13) and 10 (9) years since CD diagnosis. At CD diagnosis, 28% of patients had ileal, 29% colonic and 39% ileocolonic involvement; 24% of study patients had anal or perianal fistula. Prior to index date, 42% of patients had at least one surgery, being partial resection of small bowel the most common one. ASA-5, anti-TNFs and immunosuppressants were used for CD or complications in 47%, 48% and 42% of patients. Patients presented 584 CPFs during the study period. More than half of these CPFs were trans-sphincteric (60%). Out of the 584 CPFs, 92% were treated with at least one surgical intervention (most frequent: 56% long-term seton placement, 46% surgical drainage), and 86.6% with at least one medical treatment. Medical treatments most frequently used for CPFs or CD and complications (overlapping a CPF episode) were anti-TNFs (49%), antibiotics (44%) and immunosuppressants (26%).

Conclusion

Almost one fourth of the patients with CPF already had anal or perianal fistulas at CD diagnosis. Based on ECCO guidelines it was expected that almost all CPFs in CD patients should be treated with anti-TNF with or without surgical intervention. However, the use of anti-TNF during CPF episodes was lower than expected. Surgical drainage and seton placement were performed in a majority of patients in at least 3 years following treatment intensification, with a low rate of other types of surgery. Almost two third of CPFs were trans-sphincteric and if inadequately treated, sphincter function may be compromised.