ArticleInflammatory intestinal diseases
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.
Article in Inflammatory intestinal diseases. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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 long-term extension (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 ± standard deviation 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% confidence interval]: 2.288 [1.003-5.216]; 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.
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