P56 Prolonged benefit of filgotinib in patients with ulcerative colitis in SELECTION

IntroductionFilgotinib (FIL) is an oral, JAK1 preferential inhibitor approved for the treatment of patients with UC. In the phase 2b/3 SELECTION trial (NCT02914522), FIL 200 mg (FIL200) was effective in inducing and maintaining clinical remission vs placebo (PBO) in patients with UC. This post hoc analysis of SELECTION data further evaluated the prolonged benefit of FIL treatment from week 10 (W10) until W58.MethodsIn SELECTION, adults with moderately to severely active UC were randomized 2:2:1 to receive FIL200, FIL 100 mg (FIL100) or PBO once daily for 11 weeks in Induction Studies A (biologic-naïve patients) and B (biologic-experienced patients). Patients in clinical remission or with a Mayo Clinic Score (MCS) response at W10 (responders) were rerandomized 2:1 to continue their induction FIL dose in the 47-week Maintenance (MNT) Study. This post hoc analysis evaluated the hazard ratio (HR) for protocol-specified disease worsening (DW) in patients who continued FIL200 during MNT (FIL200→FIL200) vs those rerandomized to PBO (FIL200→PBO). The proportion of patients with a prolonged benefit at W58 was evaluated across all FIL200 and FIL100 MNT arms. Prolonged benefit was defined as clinical remission or an MCS response at W58, among W10 responders. Among patients with prolonged benefit at W58, the proportion of those who had Inflammatory Bowel Disease Questionnaire (IBDQ) remission at W58 was assessed across all FIL200 and FIL100 MNT arms.ResultsBaseline characteristics were similar between MNT arms. FIL200→FIL200 treatment (n=199) reduced the risk of DW by 74% vs FIL200→PBO (n=98) (HR [95% CI]: 0.26 [0.17–0.40]; p