TBA (22W137)

Radiologic Evaluation Of Filgotinib Treatment In Perianal Fistulizing Crohn’s Disease Using A Novel Scoring System

Author(s)

N Kennedy,1 J Rimola,2 KB Gecse,3 A Serone,4 J-F Colombel,5 GR D'Haens,3 T Masior,6 M McKevitt,4 X Ren,4 DA Schwartz,7 W Reinisch8

Department(s)/Institutions

1 Royal Devon & Exeter Hospital Trust, United Kingdom 2Hospital Clinic of Barcelona, Inflammatory Bowel Disease Unit, Department of Radiology, Barcelona, Spain 3Amsterdam University Medical Centre, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands 4Gilead Sciences, Inc., Foster City, United States 5Icahn School of Medicine at Mount Sinai, The Dr. Henry D. Janowitz Division of Gastroenterology, New York, United States 6Galapagos NV, Mechelen, Belgium 7Vanderbilt University Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Nashville, United States 8Medical University of Vienna, Department of Internal Medicine and Gastroenterology, Vienna, Austria

Introduction

A modified VAI (mVAI) was introduced to improve measurement of clinical response and intra- and interrater reliability.

Aims/Background

The Perianal Fistula Activity Index (PFAI) was developed as part of a proof of concept study conducted in patients with perianal fistulizing Crohn’s disease that assessed clinical and radiologic efficacy of filgotinib (FIL) (DIVERGENCE 2; NCT03077412).

Method

Pelvic MRIs conducted at baseline and week 24 were scored using all three indices by a blinded central reader to enable index comparison.

Results

MRIs of patients receiving FIL 100 mg, FIL 200 mg, or placebo (PBO) were scored at baseline (N=57) and week 24 (N=31). At baseline, all indices were generally balanced across treatment groups with higher scores in the FIL 200 mg group. Greater decreases were observed at week 24 in the FIL 200 mg group using the PFAI than the other indices. At week 24, greater decreases were observed in the PFAI inflammation sub-score than the anatomy sub-score.

Conclusions

In this phase 2 study, the PFAI was shown to enable a higher dynamic range and may be more sensitive to change in comparison to the modified Van Assche Index. More pronounced decreases in the PFAI were observed in the FIL 200 mg group compared to placebo.