OBJECTIVES

To assess the impact of Janus kinase 1 preferential inhibitor filgotinib on EQ-5D-5L utility scores in patients with established rheumatoid arthritis (RA) from phase 3 FINCH 1 and 2 trials (NCT02889796/NCT02873936).

METHODS

In FINCH 1, patients with inadequate response to methotrexate (MTX-IR) were randomized 3:3:2:3 to 52 weeks (W) filgotinib 200 mg (FIL200, n=475), filgotinib 100 mg (FIL100, n=480), or adalimumab (ADA, n=325); or 24W of placebo (PBO, n=475) then re-randomized to FIL200 or FIL100 (n=475) at W24—all with background MTX. In FINCH 2, patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARD-IR) were randomized 1:1:1 to W24 FIL200 (n=147), FIL100 (n=153), or PBO (n=148)—all with background conventional synthetic DMARDs. EQ-5D-5L was administered at baseline and W24. Health utilities calculations used the US value set. For each arm, least square mean (LSM) changes in utility from baseline (CFB) within and between treatments were estimated using a mixed-effects model, with treatment, visit (categorical), treatment by visit, stratification factors, and baseline utilities as fixed effects and subjects as random effects. All analyses are exploratory.

RESULTS

Baseline mean utilities for MTX-IR patients were balanced across treatment groups. At W24, LSM±standard error (SE) CFB was 0.336±0.018, FIL200; 0.348±0.018, FIL100; 0.330±0.020, ADA; and 0.268±0.019, PBO. Compared with PBO, W24 CFB differed by LSM±SE 0.067±0.015 for FIL200 and 0.079±0.015 for FIL100 (both P<0.001). Baseline mean utilities for bDMARD-IR patients were balanced across treatment groups. At W24, LSM±SE CFB was 0.300±0.028, FIL200; 0.244±0.028, FIL100; and 0.182±0.030, PBO. Compared with PBO, W24 CFB differed by LSM±SE 0.118±0.033 (P<0.001)/0.062±0.034 (P=0.068) for FIL200/FIL100. These treatment differences exceeded the reported minimally important difference for EQ-5D-5L.

CONCLUSIONS

At W24, MTX-IR patients with RA reported improved health-related quality of life with FIL200 and FIL100 vs PBO; bDMARD-IR patients reported improvements with FIL200, not FIL100, vs PBO.