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P182 One and two year outcomes of filgotinib in ulcerative colitis in a large real-world cohort

gutjnl · 2026-06-23 · canonical JSON source

15 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction In a post-biosimilar era, where cost-effectiveness impacts therapeutic choices, filgotinib is an attractive option for UC. Whilst pivotal trial data and short-term real-world studies are positive, long-term outcomes data are lacking. We aimed to assess the long-term (>12 months) effectiveness and safety of filgotinib in a large well-characterised UC cohort.Methods All UC patients treated with filgotinib at the Edinburgh IBD Unit with a minimum of 12 months since drug commencement were assessed. The primary outcome was clinical remission at 1 year (partial Mayo score <2). Secondary outcomes were clinical remission at 2 years, drug persistence at 1 and 2 years and baseline factors associated with persistence. Patients who stopped therapy were included as failures for subsequent time points. AE of interest were recorded.Results A total of 281 patients with UC were treated with filgotinib between 2022 and 2025. 175/281 patients were included in the long-term analysis, with a median follow-up of 734 days (IQR 484-937); 154/175 (88%) and 88/175 (50%) of patients had 1 and 2 years follow-up, respectively. Of note, 123/175 (70%) of patients were bio-naïve. Of the bioexposed, filgotinib was used as the second line in 66.7% (34/51).Clinical remission rates were 43% (46/130) and 36% (31/86) at 1 and 2 years, respectively. Changes in partial Mayo score, CRP and FC are depicted in figure 1B-D. Persistence was 72% and 49% at one and two years, respectively (figure 1A). In the multi-variable analysis, previous exposure to an advanced therapy (HR 1.85 [95%CI 1.08-3.18], p=0.026) and proctitis (HR 2.05 [95%CI 1.11-3.81], p=0.022) were associated with a greater risk of drug cessation. The most frequent reason for drug discontinuation in patients during the first year was primary non response (27/50) and after the first year, secondary loss of response (20/31).Herpes Zoster reactivation occurred in 4 patients (2.3%), none of whom had received the recombinant zoster vaccination. Serious infection, malignancy and MACE were described in 1.1% (2/175), 1.1% (2/175) and 0.6% (1/175).Conclusions Our cohort, which has the longest follow-up reported to date, demonstrates promising long-term effectiveness and treatment persistence outcomes, especially in the subset of bio-naïve patients. Interestingly, patients with proctitis had poor persistence reinforcing the notion that this is a refractory and difficult-to-treat phenotype.Abstract P182 Figure 1A) Kaplan Meier curve for filgotinib persistence stratified by previous exposure to advanced therapies; B) Change in Partial Mayo Score at one, two and three years; C) Change in faecal calprotectin at one, two and three years; D) Change in C-reactive protein at one, two and three years