Filgotinib Improved Health-Related Quality of Life and Led to Comprehensive Disease Control in Individuals with Ulcerative Colitis: Data from the SELECTION Trial

Author:

Schreiber Stefan1,Feagan Brian G23,Peyrin-Biroulet Laurent45,Vermeire Séverine6ORCID,Faes Margaux7,Harris Kristina8,Oortwijn Alessandra9,Daniele Patrick10,Patel Haridarshan7,Danese Silvio1112ORCID

Affiliation:

1. University Hospital Schleswig-Holstein , Kiel , Germany

2. Alimentiv Inc., London , Ontario , Canada

3. Western University , London, Ontario , Canada

4. Department of Gastroenterology, University of Lorraine, CHRU-Nancy , Nancy , France

5. University of Lorraine, Inserm, NGERE , Nancy , France

6. Department of Gastroenterology and Hepatology, University Hospitals Leuven , KU Leuven, Leuven , Belgium

7. Galapagos NV , Mechelen , Belgium

8. Galapagos NV , Milan , Italy

9. Galapagos NV , Leiden , Netherlands

10. Cytel Health Canada , Toronto , Canada

11. Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele , Milan , Italy

12. Vita-Salute San Raffaele University , Milan , Italy

Abstract

AbstractBackground and AimsUlcerative colitis [UC] impacts patients’ health-related quality of life [HRQoL]. We assessed HRQoL and an exploratory patient-level composite endpoint (‘Comprehensive Disease Control’ [CDC]) in individuals receiving filgotinib [an oral JAK1 preferential inhibitor] in the SELECTION trial.MethodsIn SELECTION [NCT02914522], a double-blind, randomized, placebo-controlled, phase 2b/3 trial, adults with moderately to severely active UC received once-daily filgotinib 200 mg, filgotinib 100 mg or placebo for 11 weeks in Induction Study A [biologic-naïve] or B [biologic-experienced]. Filgotinib responders [week 10 clinical remission/response] were re-randomized to their filgotinib regimen or placebo for the 48-week Maintenance Study. We assessed week 10 and week 58 SF-36, EQ-5D, WPAI and IBDQ scores. Achievement of CDC (patient-level partial Mayo Clinic Score [pMCS] remission [pMCS ≤2, no individual rectal bleeding, stool frequency or physician’s global assessment subscore >1], endoscopic improvement [endoscopic subscore ≤1], faecal calprotectin <150 µg/g and IBDQ score ≥170) and its association with HRQoL and histological outcomes were also explored.ResultsAnalyses included 382 biologic-naïve and 404 biologic-experienced patients. Filgotinib 200 mg induced and maintained improvements vs placebo in SF-36, EQ-5D, WPAI and IBDQ scores, and restored HRQoL by week 10. Proportionally more filgotinib 200 mg- than placebo-treated patients achieved CDC at weeks 10 and 58 [p < 0.01]. CDC was associated with clinically important improvements in HRQoL and histological remission over both periods.ConclusionsFilgotinib 200 mg results in short- and long-term improvements in HRQoL. High-level improvement of HRQoL relates to a stringent composite endpoint suggesting meaningful disease control in a subset of filgotinib-treated individuals.ClinicalTrials.gov identifier: NCT02914522

Funder

Gilead Sciences Inc

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology,General Medicine

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