P491 Efficacy and safety outcomes of long-term treatment with filgotinib 200 mg among patients with Ulcerative Colitis: An interim analysis of SELECTIONLTE
FeaganSenior Scientific Officer, B.G.(1,2);Matsuoka, K.(3);Rogler, G.(4);Faes, M.(5);Oortwijn, A.(6);de Haas, A.(6);Rudolph, C.(6);Patel, H.(5);Peyrin-Biroulet, L.(7);
(1)Alimentiv, Inc., London- Ontario, Canada;(2)London Health Sciences Centre- Western University, Division of Gastroenterology, London- Ontario, Canada;(3)Toho University Sakura Medical Center, Department of Gastroenterology and Hepatology, Chiba, Japan;(4)University Hospital Zurich- University of Zurich, Department of Gastroenterology and Hepatology, Zurich, Switzerland;(5)Galapagos, Nv, Mechelen, Belgium;(6)Galapagos, Nv, Leiden, The Netherlands;(7)University Hospital of Nancy- University of Lorraine, Department of Gastroenterology, Vandoeuvre-lès-Nancy, France;
Background
Filgotinib (FIL) is a once-daily, oral, Janus kinase 1 preferential inhibitor in development as an ulcerative colitis (UC) therapy. In the phase 2b/3 SELECTION trial, FIL 200 mg (FIL200) was well tolerated and effective in inducing and maintaining clinical remission vs placebo (PBO) in patients with UC.1 We assessed the efficacy and safety of continued FIL200 therapy in the SELECTION long-term extension (LTE) study.
Methods
The SELECTION programme comprised SELECTION (NCT02914522)1 and an ongoing LTE study, SELECTIONLTE (NCT02914535). Adults with moderately to severely active UC received induction (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 Maintenance (MNT) Study. Patients who completed the SELECTION IND and MNT studies (completers), IND non-responders and patients with disease worsening during MNT could enter SELECTIONLTE. This interim analysis assessed the efficacy of open-label FIL200 among completers and non-responders in SELECTIONLTE up to LTE weeks 48 and 96, respectively. Partial MCS (pMCS) and achievement of the minimal clinically important difference (MCID) in total health-related quality of life (HRQoL) IBDQ score (≥16-point increase vs baseline) were assessed over time. Exposure-adjusted incidence rates per 100 patient-years of exposure (PYE) of treatment-emergent adverse events (TEAEs) and TEAEs of interest were assessed in patients treated with open-label FIL200 in the LTE.
Results
These analyses included 147 completers and 372 non-responders (IND FIL200, n=160; IND FIL100, n=212). Data were available for 136 completers at LTE week 48 and for 97 IND FIL200 and 139 IND FIL100 non-responders at LTE week 96. Among completers, the mean pMCS reductions observed in SELECTION were maintained up to LTE week 48 (Figure 1). Among IND FIL200 and FIL100 non-responders, mean pMCS decreased from LTE baseline to week 96 (Figure 2). The proportion 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 IND FIL200 non-responders (LTE week 48, 60.6%; LTE week 96, 66.7%) (Table 1). Safety events among patients treated with open-label FIL200 in the LTE study (total PYE, 970.9) to the date analysed are reported in Table 2.
Conclusion
FIL200 was effective in maintaining long-term improvements in UC symptoms and HRQoL among patients who completed SELECTION. Among non-responders, initiating open-label FIL200 in the LTE study led to improvements in UC symptoms and HRQoL that were sustained over time. Safety events were as expected in the LTE study based on initial data.
1. Feagan BF et al. Lancet 2021;397:2372–84.