P45 Combining clinical, biological, and health-related quality of life remission with endoscopic improvements: data from SELECTION

IntroductionFor patients with UC, both subjectively and objectively reported measures are equally important treatment goals. We explored clinical, biological, HRQoL remission and endoscopic improvements as a combined endpoint (CE) from SELECTION (NCT02914522), a phase 2b/3 double-blind trial of filgotinib (FIL), a once-daily, oral, JAK1 preferential inhibitor, for the treatment of UC.MethodsIn SELECTION, patients with moderately to severely active UC were randomized 2:2:1 to FIL 200mg or 100mg (FIL200/100) or placebo (PBO) for an 11-week induction phase followed by a 47-week maintenance period in patients who achieved clinical remission or response. We defined a CE as achieving all of: 1) clinical remission defined as partial Mayo Score (excluding endoscopy domain) ≤2 and no subscore >1, 2) biological remission defined as faecal calprotectin 170 and 4) endoscopic improvement defined as Mayo endoscopic subscore ≤1. We evaluated the CE in patients treated with FIL200 vs PBO at week 10 and 58. Among those achieving the CE, we analysed MCID improvement during induction and decline during maintenance on generic QoL instruments (SF-36 and EQ5D).ResultsOverall population included 381 biologic-naïve and 401 biologic-experienced patients undergoing induction, of whom 297 entered maintenance. A higher proportion of patients receiving FIL200 achieved CE than PBO by week 10 in the biologic-naïve cohort (17.6% vs 4.41%, p