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

TL;DR

This study evaluated the long-term safety and effectiveness of filgotinib in Japanese patients with ulcerative colitis, finding it to be generally safe and beneficial over up to three years.

Contribution

The study provides new long-term safety and efficacy data for filgotinib in Japanese patients with ulcerative colitis.

Findings

Filgotinib showed acceptable long-term safety with infection and herpes zoster rates of 54.4 and 3.9 per 100 cPYE, respectively.

Completers maintained over 50% remission in health-related quality of life and biomarkers after 96 weeks.

Non-responders showed improved remission rates in symptoms, quality of life, and biomarkers after 144 weeks.

Abstract

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.

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).

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).

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.

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