Intestinal research · 2026
Impact of filgotinib on health-related quality of life over 3 years in Japanese patients with ulcerative colitis: a post hoc analysis of the SELECTION and SELECTION long-term extension trials.
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Matsuoka Katsuyoshi, Schreiber Stefan, Hata Erina, Kaise Toshihiko, Hibi Toshifumi
Аннотация
BACKGROUND/AIMS: This post hoc analysis of the phase 2b/3 SELECTION (NCT02914522) study and its long-term extension (SELECTIONLTE; NCT02914535) evaluated the impact of filgotinib 200 mg (FIL200) on health-related quality of life (HRQoL) and work productivity in Japanese patients with ulcerative colitis over 3 years.
METHODS: Patients in SELECTION were randomized to FIL200, filgotinib 100 mg, or placebo (PBO) during the induction phase. Week-10 responders were re-randomized to continue assigned treatment or PBO in the 47-week maintenance phase. Patients who completed the SELECTION induction and maintenance phases (completers) and week-10 non-responders could enter SELECTIONLTE. HRQoL and work productivity were assessed using EQ 5-dimension (EQ-5D), EQ visual analog scale, Inflammatory Bowel Disease Questionnaire (IBDQ), 36-item Short Form Health Survey (SF-36), and Work Productivity and Activity Impairment (WPAI) questionnaires at week 10 (FIL200 vs. PBO), and at week 10 and years 1-3 (completers and non-responders who received only FIL200 in SELECTION+SELECTIONLTE).
RESULTS: Proportions of patients with minimal clinically important differences (MCIDs) at week 10 were higher with FIL200 versus PBO for IBDQ total score (77% vs. 54%), SF-36 mental component summary (58% vs. 21%), and SF-36 physical component summary (54% vs. 36%). All measures (except WPAI absenteeism) showed mean score changes from baseline at week 10 in the direction of improved HRQoL with FIL200 versus PBO. MCID rates were maintained in completers up to 3 years and increased notably in non-responders (except WPAI absenteeism and EQ-5D) from week 10 to years 1-3.
CONCLUSIONS: FIL200 treatment was associated with sustained improvements in HRQoL and work productivity over 3 years in Japanese patients with ulcerative colitis, consistent with the overall SELECTION and SELECTIONLTE trial populations.
METHODS: Patients in SELECTION were randomized to FIL200, filgotinib 100 mg, or placebo (PBO) during the induction phase. Week-10 responders were re-randomized to continue assigned treatment or PBO in the 47-week maintenance phase. Patients who completed the SELECTION induction and maintenance phases (completers) and week-10 non-responders could enter SELECTIONLTE. HRQoL and work productivity were assessed using EQ 5-dimension (EQ-5D), EQ visual analog scale, Inflammatory Bowel Disease Questionnaire (IBDQ), 36-item Short Form Health Survey (SF-36), and Work Productivity and Activity Impairment (WPAI) questionnaires at week 10 (FIL200 vs. PBO), and at week 10 and years 1-3 (completers and non-responders who received only FIL200 in SELECTION+SELECTIONLTE).
RESULTS: Proportions of patients with minimal clinically important differences (MCIDs) at week 10 were higher with FIL200 versus PBO for IBDQ total score (77% vs. 54%), SF-36 mental component summary (58% vs. 21%), and SF-36 physical component summary (54% vs. 36%). All measures (except WPAI absenteeism) showed mean score changes from baseline at week 10 in the direction of improved HRQoL with FIL200 versus PBO. MCID rates were maintained in completers up to 3 years and increased notably in non-responders (except WPAI absenteeism and EQ-5D) from week 10 to years 1-3.
CONCLUSIONS: FIL200 treatment was associated with sustained improvements in HRQoL and work productivity over 3 years in Japanese patients with ulcerative colitis, consistent with the overall SELECTION and SELECTIONLTE trial populations.