Safety and efficacy of long-term filgotinib treatment in Japanese patients with ulcerative colitis: an interim subgroup analysis of the SELECTION long-term extension study.

BACKGROUND

Filgotinib is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for ulcerative colitis. This interim analysis assessed long-term outcomes of filgotinib in Japanese patients with moderate-to-severe ulcerative colitis.

METHODS

In the long-term extension of the phase 2b/3 SELECTION trial (SELECTIONLTE; NCT02914535), SELECTION completers (Week 10 responders) continued filgotinib 200 mg (FIL200), filgotinib 100 mg (FIL100), or placebo, and non-responders received FIL200. Here, safety was evaluated over ⁓4 years in Japanese patients who received FIL200 in SELECTIONLTE using exposure-adjusted incidence rates (EAIRs) per 100 censored patient-years of exposure (cPYE). Efficacy was assessed over 96 weeks in Japanese completers and 144 weeks in Japanese non-responders who received filgotinib (FIL200 for completers; FIL100 or FIL200 for non-responders) in SELECTION and FIL200 in SELECTIONLTE by partial Mayo Clinic Score (pMCS), inflammatory biomarkers, and health-related quality of life (HRQoL).

RESULTS

This analysis included 86 patients (15 completers, 37 non-responders). EAIRs for all infections and herpes zoster were 54.4 and 3.9 per 100 cPYE, respectively. Among completers, the pMCS remission rate increased (LTE Week 96: 69%); and HRQoL and biomarker remission rates remained >50% (LTE Week 96: 85% and 54%, respectively). In non-responders, pMCS, HRQoL, and biomarker remission rates increased (LTE Week 144: 69%, 62%-67% and 60%-69%, respectively).

CONCLUSIONS

Filgotinib demonstrated an acceptable long-term benefit-risk profile in Japanese patients, maintaining and improving symptomatic and HRQoL remission for up to 3 years. Japanese patients had a numerically higher incidence of infections and herpes zoster than the overall SELECTIONLTE population.