Observational studyWorld journal of gastroenterology2026
Long-term clinical outcomes with filgotinib in ulcerative colitis: 12-month results from the FILGUITO study.
Observational study in World journal of gastroenterology, 2026. 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
backgroundFilgotinib, a JAK1-preferential inhibitor, has demonstrated efficacy in pivotal clinical trials for moderate-to-severe ulcerative colitis (UC), leading to regulatory approvals. While emerging real-world studies provide short-term effectiveness data, comprehensive long-term evidence-particularly beyond 6 months-remains scarce, especially in heavily biologic-experienced populations.
aimTo evaluate the 12-month effectiveness, safety, and predictors of response to filgotinib in a real-world cohort of patients with moderate-to-severe UC treated across multiple centers in Andalusia, Spain.
methodsThis multicenter, ambispective observational study (FILGUITO registry) included 104 adults with moderate-to-severe UC initiating filgotinib therapy. Demographic, clinical, laboratory, and endoscopic data were collected at baseline and at 8 weeks, 6 months, and 12 months. Effectiveness outcomes included clinical remission (Mayo partial score < 3 with no subscore > 1 and no rectal bleeding), clinical-biochemical remission (clinical remission plus fecal calprotectin < 250 μg/g), and steroid-free remission (clinical remission with no corticosteroid courses from week 8). Safety was assessed through adverse event monitoring.
resultsThe median age was 40.7 years (IQR: 29.5-51.0), with 56.7% male patients. The majority (79.8%) had prior advanced therapy exposure, with a median of 1 prior biologic (IQR: 1-3). Clinical remission rates were 60.8% at 8 weeks, 61.4% at 6 months, and 60.3% at 12 months (all
conclusionFilgotinib demonstrates sustained clinical effectiveness and a favorable safety profile over 12 months in a real-world UC cohort with extensive prior biologic exposure. Effectiveness is optimized at earlier treatment lines, though meaningful benefit persists in heavily pre-treated populations.
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