TBA (22W133)

Predictors of response to filgotinib in ulcerative colitis: post hoc analysis from the SELECTION study

Author(s)

K Boland,1 B Feagan,2,3 L Peyrin-Biroulet,4 E Louis,5 V Taliadouros,6 F-O Le Brun,7 A Oortwijn,6 H Patel, 8 A de Haas6 and T Hisamatsu9

Department(s)/Institutions

1 Beaumont Hospital, Dublin, Ireland 2Alimentiv, London, ON, Canada 3Division of Gastroenterology, London Health Sciences Centre, Western University, London, ON, Canada 4Department of Gastroenterology, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France 5Department of Gastroenterology, CHU Liège University Hospital, Liège, Belgium 6Galapagos NV, Leiden, Netherlands 7Galapagos GmbH, Basel, Switzerland 8Galapagos NV, Mechelen, Belgium 9Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan

Introduction

Filgotinib (FIL) is a once-daily, oral, preferential JAK1 inhibitor approved for the treatment of ulcerative colitis (UC). In SELECTION, FIL 200 mg (FIL200) was efficacious in inducing and maintaining clinical remission vs placebo (PBO).1

Aims/Background

We aimed to identify clinical and demographic factors associated with increased likelihood of achieving Mayo Clinic Score (MCS) response and/or clinical remission following induction and maintenance treatment with FIL200, FIL 100 mg (FIL100) or PBO.

Method

These post hoc analyses used univariate and multivariate logistic regression models to identify patient factors associated with MCS response and/or clinical remission at the end of induction (week 10), and clinical remission at the end of maintenance (week 58). Factors associated (p≤0.05) with MCS response and/or clinical remission in the univariate analysis were included in the multivariate analysis.

Results

Multivariate analysis of FIL200 showed that only sex, biologic-naive status and lower CRP levels at baseline, and RB=0 with SF≤1 on day 7, were associated with MCS response/remission at week 10.

Conclusions

These results suggest that low disease burden measured by CRP, as well as quick onset of treatment effect measured by day 7 RB and SF, were good predictive factors for achieving response and remission at week 10. Other than week 10 SF, no strong predictive factors were identified for clinical remission at week 58. Given that the associations with sex, current smoking and biologic-naive status were similar across treatment groups, these are likely to be disease-related factors.