O21 Long-term efficacy and safety of filgotinib 200 mg in ulcerative colitis: 5-year interim data from SELECTIONLTE

Introduction Filgotinib (FIL), a once-daily, oral, Janus kinase 1 preferential inhibitor, is approved for the treatment of ulcerative colitis (UC). FIL was effective in inducing and maintaining clinical remission and generally well tolerated in the placebo-controlled phase 2b/3 SELECTION trial (NCT02914522).1 Methods The efficacy and safety of continued treatment with FIL 200 mg (FIL200) are being assessed in the open-label, long-term extension (LTE) study (SELECTIONLTE: NCT02914535). The study design of SELECTION has been published previously.1 This interim analysis reports the efficacy and safety of open-label FIL200 for up to 5 years of treatment: LTE week 192 in completers (who completed SELECTION induction and maintenance studies) and LTE week 240 in induction non-responders (those with no response at SELECTION week 10). The data cut-off of 23 March 2023 was used for this interim analysis. Proportions of patients with partial Mayo Clinic Score (pMCS) remission (pMCS ≤1) and Inflammatory Bowel Disease Questionnaire (IBDQ) remission (score ≥170) were reported both as observed data and with non-responder imputation (NRI). Adverse events (AEs) and AEs of special interest (AESIs) were evaluated as exposure-adjusted incidence rates per 100 patient-years of exposure (PYE). Results This analysis included 148 completers and 372 non-responders. AEs and AESIs in patients receiving open-label FIL200 (2464.7 PYE) showed no new safety signals; safety events were similar to those from previous analyses. Proportions of patients in pMCS remission increased with FIL200 in SELECTION to 72.4% (as observed) at week 58/LTE baseline, and increased further for completers in SELECTIONLTE (85.0% at LTE week 192). Proportions in pMCS remission increased gradually in SELECTIONLTE to 66.7% (FIL200–FIL200, as observed) at LTE week 240 in non-responders. Similar patterns were seen for IBDQ remission; 78.5% (FIL200, as observed) of completers had IBDQ remission at week 58/LTE baseline, increasing to 84.8% by LTE week 192. In non-responders, increases in proportions of patients in IBDQ remission were gradual, up to 77.8% (FIL200–FIL200, as observed) at LTE week 240. NRI analyses showed similar but more conservative results than observed analyses for both groups for both endpoints. Conclusions FIL200 was effective in maintaining symptomatic remission and health-related quality of life for up to 5 years. No new safety signals were identified, and rates of AEs with long-term FIL exposure were similar to those previously reported.1 2 Prolonged treatment with filgotinib is efficacious for the long-term management of UC, and together with its proven safety profile, results in an acceptable benefit–risk profile. References Feagan BG, et al. Lancet 2021;397:2372–84. Feagan BG, et al. J Crohns Colitis. 2023;17(Suppl1):i47–50.

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