TBA (22W134)

Impact Of Concomitant Thiopurine n The Efficacy And Safety Of Filgotinib Treatment In Patients With Ulcerative Colitis: Post Hoc Analysis Of The Phase 2b/3 SELECTION Study

Author(s)

K Boland,1 K Watanabe,2 L Peyrin-Biroulet,3 S Danese,4 K Emoto,5 Y Fujitani,5 F-O Le-Brun,6 A Oortwijn,7 T Ueno,5 J O Lindsay,8 G Rogler,9 T Hibi10

Department(s)/Institutions

1Beaumont Hospital, Dublin, Ireland 2Center for Inflammatory Bowel Disease, Division of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan 3University Hospital of Nancy, University of Lorraine, Nancy, France 4IBD Center, Humanitas Research Hospital, Milan, Italy 5Gilead Sciences K.K., Tokyo, Japan 6Galapagos GmbH, Basel, Switzerland 7Galapagos NV, Leiden, Netherlands 8Centre for Immunobiology, Blizard Institute, Barts and the London School of Medicine, Queen Mary University of London, London, UK 9University Hospital of Zurich, University of Zurich, Zurich, Switzerland 10Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan

Introduction

Thiopurines (azathioprine, 6-mercaptopurinea) and other immunomodulators (IM) are used in the treatment of ulcerative colitis (UC).

Aims/Background

This post hoc analysis aimed to assess the impact of protocol-accepted concomitant thiopurine use on the efficacy and safety of FIL treatment in SELECTION (NCT02914522).

Method

Patients, including those already receiving IM, were randomized (2:2:1) in two cohorts (A: biologic-naive; B: biologic-experienced) to receive FIL 200 mg (n=507), FIL 100 mg (n=562) or PBO (n=279) for 11 weeks (induction). At week 10, patients achieving clinical remission were re-randomized to continue assigned FIL or PBO for 47 weeks (maintenance).

Results

At week 10, clinical remission was achieved by a similar proportion of patients treated with FIL 200 mg with or without concomitant IM in cohorts A and B. Proportion of patients achieving MCS response at week 10 was also similar across these subgroups in both cohort A and B. At week 58, clinical remission rates for patients receiving FIL 200 mg were similar in patients with or without concomitant IM. The proportion of patients achieving MCS response at week 58 with FIL 200 mg was also similar across these subgroups. Over 58 weeks, the proportion of patients receiving FIL 200 mg who experienced adverse events was similar with or without concomitant IM. There were two deaths (patients receiving FIL 200 mg), one each in the +IM and −IM groups; neither was considered treatment-related.

Conclusions

Concomitant treatment with IM had no clear impact on the efficacy and safety of FIL in the SELECTION study.