TBA (22W136)

Assessment Of Histological Remission In Patients Treated With Filgotinib By Different Scores And Concordance With Endoscopic And Health-Related Quality Of Life Outcomes: Post Hoc Analysis From The SEL

Author(s)

K Boland,1 F Magro,2,3 L Peyrin-Biroulet,4 G Rogler,5 A Oortwijn,6 H Patel,7 A de Haas,6 E Santermans,7 H Ruan,8 L Dron9 and B Feagan10,11

Department(s)/Institutions

1Beaumont Hospital, Dublin, Ireland 2Department of Biomedicine, Unit of Pharmacology and Therapeutics, University of Porto, Porto, Portugal 3Department of Gastroenterology, São João University Hospital, Porto, Portugal 4Department of Gastroenterology, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France 5University Hospital of Zurich, University of Zurich, Zurich, Switzerland 6Galapagos NV, Leiden, Netherlands 7Galapagos NV, Mechelen, Belgium 8Cytel, Toronto, ON, Canada 9Cytel, Vancouver, BC, Canada 10Alimentiv, London, ON, Canada 11Division of Gastroenterology, London Health Sciences Centre, Western University, London, ON, Canada

Introduction

Histological remission is not a formal therapeutic target for ulcerative colitis (UC), but acknowledged to be highly associated with improved long-term outcomes.

Aims/Background

In these post hoc analyses of patients treated with filgotinib (FIL) or placebo (PBO) in SELECTION, we evaluated histological remission by derived Nancy Index (NI), Robarts Histopathology Index (RHI) and continuous Geboes score (GS), as well as measured categorical GS histological remission, and assessed the concordance between endoscopic/Inflammatory Bowel Disease Questionnaire (IBDQ) outcomes and categorical GS remission.

Method

Patients were randomized at baseline to receive FIL 200 mg (FIL200), FIL 100 mg (FIL100) or PBO through to week 10 (induction). Induction responders were re-randomized to their assigned FIL dose (‘FIL200–FIL200’ or ‘FIL100–FIL100’) or PBO (‘FIL200–PBO’ or ‘FIL100–PBO’) through to week 58 (maintenance). SELECTION reported outcomes of categorical GS remission, endoscopic remission (Mayo endoscopic subscore [MES]=0), endoscopic response (MES=0 or 1) and IBDQ remission (IBDQ total score >170) at weeks 10 and 58.

Results

Endoscopic response and IBDQ remission showed higher negative predictive values (NPVs) than positive predictive values (PPVs) for categorical GS remission. The correlation between MES and continuous GS was RS=0.55, and between IBDQ total score and continuous GS was RS=−0.34.

Conclusions

FIL200 was efficacious in inducing and maintaining histological remission. Absence of IBDQ remission and endoscopic remission were associated with absence of histological remission, with high NPVs. Nevertheless, the lower PPVs than NPVs suggest the need for histological assessment even when endoscopic and health-related quality of life improvements are achieved.