EFFICACY AND SAFETY OF LONG-TERM TREATMENT WITH FILGOTINIB FOR ULCERATIVE COLITIS: DATA FROM SELECTIONLTE

Introduction

Filgotinib (FIL) is a once-daily, oral, JAK1 preferential inhibitor approved for UC. In the phase 2b/3 SELECTION trial, FIL 200 mg (FIL200) was well tolerated and effective in induction (IND) and maintenance (MNT) of clinical remission vs placebo (PBO). We assessed the efficacy and safety of continued FIL200 in its long-term extension (LTE) study.

Methods

The SELECTION programme comprised SELECTION (NCT02914522) and its ongoing LTE (NCT02914535). Adults with moderately to severely active UC received IND FIL200 or FIL100 or PBO for 11 weeks in SELECTION. Patients in clinical remission or Mayo Clinic Score (MCS) response at week 10 (responders) could enter the 47-week MNT study. Patients who completed IND and MNT (completers), IND non-responders and patients with disease worsening during MNT could enter the LTE. This interim analysis assessed the efficacy of open-label FIL200 among completers and non-responders up to LTE weeks 48 and 96, respectively. Partial MCS (pMCS) and minimal clinically important difference (MCID) in total HRQoL IBDQ score (≥16-point increase vs baseline) were assessed over time. Exposure-adjusted incidence rates per 100 PYE of adverse events (AEs) and AEs of interest were assessed in patients treated with open-label FIL200 in the LTE.

Results

Analyses included 147 completers and 372 non-responders (IND FIL200, n=160; IND FIL100, n=212). Data were available for 136 completers at LTEweek48 and for 97 IND FIL200 and 139 IND FIL100 non-responders at LTEweek96. Among completers, mean pMCS reductions observed in SELECTION were maintained up to LTE week 48 (Figure 1a). Among non-responders, mean pMCS decreased from LTE baseline to week 96 (Figure 1b). Proportions of patients achieving the MCID in total IBDQ score increased over time among completers (IND week 10, 90.4%; LTE week 48, 96.1%) and FIL200 non-responders (LTE week 48, 60.6%; LTE week 96, 66.7%). Safety events among patients on open-label FIL200 in the LTE (total PYE, 970.9) were as expected based on initial data.

Conclusion

FIL200 was effective in maintaining long-term improvements in UC symptoms and HRQoL among patients who completed SELECTION. In non-responders, initiating open-label FIL200 in the LTE study led to symptom and HRQoL improvements that were sustained over time.