OBJECTIVES

To assess impact of filgotinib on EQ-5D-5L utility scores in patients with ulcerative colitis (UC) from the randomized, double-blind, placebo-controlled phase 2b/3 SELECTION trial (NCT02914522).

METHODS

Biologic-naïve (Induction Study A) and -experienced (Induction Study B) patients with moderate-to-severe UC were randomized 2:2:1 to once-daily filgotinib 200 mg (FIL200), filgotinib 100 mg (FIL100), or placebo (PBO) for 10 weeks (W). Patients on FIL100 or FIL200 achieving clinical remission or Mayo Clinic Score response at W10 were rerandomized at W11 2:1 to continue assigned FIL dose or PBO through W58 (Maintenance Study). EQ-5D-5L scores were measured at baseline, W10, and W58. Health utilities calculations used the US value set. Utility changes from baseline (CFB) were estimated by analysis of covariance, adjusting for baseline utilities and trial stratification factors. Missing responses were imputed by last observation carried forward.

RESULTS

Baseline mean health utilities in Induction Study A were similar across treatment arms (~0.7). Least squares mean (LSM)±standard error (SE) CFB at W10 were 0.145±0.012, FIL200 (n=245); 0.141±0.011, FIL100 (n=277); and 0.056±0.015, PBO (n=137). Baseline mean health utilities in Induction Study B were similar across treatment arms (0.63–0.69). LSM±SE CFB at W10 was 0.149±0.014, FIL200 (n=262); 0.116±0.014, FIL100 (n=285); and 0.049±0.019, PBO (n=142). Increases in health utilities at W10 exceeded the reported minimally important difference for both FIL treatments but not for PBO.

At Maintenance baseline, mean utility was similar for patients continuing FIL200, FIL100, and respective PBOs (0.87–0.90). LSM±SE utility CFB at W58 for FIL200 (n=199) was 0.008±0.012 vs −0.033±0.016 for respective PBO (n=98), (P=0.0301). LSM±SE utility CFB at W58 was −0.017±0.011 for FIL100 (n=172) vs −0.029±0.015 for respective PBO (n=89), (P=0.4838).

CONCLUSIONS

Compared with PBO, filgotinib provided greater improvements in health-related quality of life at W10 for both doses and W52 for FIL200 for patients with UC measured by EQ-5D-5L.