Early symptomatic improvement is informing long-term quality-of-life outcomes with filgotinib treatment in ulcerative colitis: a post-hoc analysis of the SELECTION and SELECTIONLTE trials

Introduction Ulcerative colitis is a chronic inflammatory condition of the colon that significantly impairs quality-of-life. While filgotinib (FIL) has shown long-term efficacy in improving disease-specific quality-of-life via Inflammatory Bowel Disease Questionnaire (IBDQ) total scores, its impact on individual bowel/systemic symptoms remains unclear. This post-hoc analysis assessed FIL’s long-term effects on these symptoms and explored factors associated with sustained remission. Methods This analysis included 148 patients from SELECTION trial patients who completed induction and maintenance phases, enrolled in SELECTIONLTE, and continued 200-mg FIL (FIL200) without treatment change. Changes from induction baseline in IBDQ total and subscores (bowel/systemic symptoms) were assessed at Week-10, 58, and LTE Week-96. Remission was defined as IBDQ ≥170 and partial Mayo clinic score (pMCS) ≤1 at each timepoint. Results At Week-10, for patients with vs without pMCS remission, the mean±SD change in IBDQ total score was 72.98±39.37 vs 53.46±31.75, respectively. At Week-58, it was 80.42±34.44 vs 49.97±38.24 and at LTE Week-96, it was 84.14±35.22 vs 49.10±28.00, respectively. Overall, bowel and systemic symptom scores were numerically higher in patients with vs without pMCS remission at Week-10, slightly increased at Week-58, and remained consistent at LTE Week-96. Symptomatic remission at Week-10 and IBDQ remission at LTE Week-96 were associated significantly (odds ratio [95% CI]: 2.288 [1.003-5.216]; P=0.049). Conclusions FIL200 improved bowel and systemic symptoms beyond rectal bleeding and stool frequency, enhancing disease-specific quality-of-life. Week-10 symptomatic remission was marginally associated with higher odds of long-term IBDQ remission, suggesting that early symptomatic remission provides clinically relevant information on sustained quality-of-life improvement.