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

Abstract

BACKGROUND AND AIMS:

Ulcerative 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.

METHODS:

In 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.

RESULTS:

Analyses 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.

CONCLUSIONS:

Filgotinib 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.

• Authors: Stefan Schreiber, Brian G Feagan, Laurent Peyrin-Biroulet, Séverine Vermeire, Margaux Faes, Kristina Harris, Alessandra Oortwijn, Patrick Daniele, Haridarshan Patel, Silvio Danese
• Journal: Journal of Crohn's & colitis (J Crohns Colitis) Vol. 17 Issue 6 Pg. 863-875 (Jun 16 2023) ISSN: 1876-4479 [Electronic] England
• PMID: 36756874 (Publication Type: Randomized Controlled Trial, Journal Article)
• Copyright: © The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.

Chemical References

• GLPG0634
• Pyridines
• Janus Kinase Inhibitors
• Biological Products

Topics

• Adult
• Humans
• Colitis, Ulcerative (drug therapy)
• Quality of Life
• Pyridines (therapeutic use)
• Janus Kinase Inhibitors (therapeutic use)
• Biological Products (therapeutic use)
• Double-Blind Method