P47 Re-treatment with filgotinib in patients with ulcerative colitis following treatment interruption: SELECTION and SELECTIONLTE data

IntroductionLong-term treatment regimens for UC present challenges for patients who may need to interrupt therapy. Filgotinib (FIL) is an oral JAK1 preferential inhibitor. We performed a post hoc analysis of data from patients treated with FIL in the phase 2b/3 SELECTION programme to assess the efficacy and safety of re–treatment following treatment interruption.MethodsThe SELECTION programme comprises two Induction Studies and a Maintenance Study (NCT02914522) and a long-term extension (LTE) study (NCT02914535). Adults 18–75 years old with moderately to severely active UC, with clinical remission or Mayo Clinic Score (MCS) response to FIL 200 mg or 100 mg (FIL200/100) at SELECTION week 10 were re-randomized 2:1 to continue assigned FIL dose or placebo (PBO) from week 11–58. Patients with disease worsening (DW) in the Maintenance Study could enter the LTE to receive open-label FIL200 once daily. We assessed the efficacy of FIL in patients treated with induction FIL200 or FIL100, randomized to maintenance PBO and re-treated with open-label FIL in the LTE. Efficacy endpoints included partial MCS (pMCS) response and remission during the LTE study. A non-responder imputation approach was used.ResultsAnalyses evaluated 50 patients treated with induction FIL200 and 35 with FIL100, withdrawn and re-treated upon DW. Baseline characteristics were similar among patients in the FIL200 and FIL100 groups, with median time to DW of 16.9 and 13.3 weeks, respectively. Mean pMCS declined rapidly in both groups from LTE baseline to week 2, reaching pMCS