Abstract Background 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 June 2022 and October 2025. 175/281 patients were included in the long-term analysis, with a median follow-up of 734 days (IQR 484-937) (table 1); 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 bio-exposed, 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 (54%; 27/50) and after the first year secondary loss of response (65%; 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). Conclusion 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. Conflict of interest: Ms. Ramos Belinchon, Clara: No conflicts Staworko, Magdalena Martyna: No conflicts of interest declared. Gros, Beatriz: Beatriz Gros has served as a speaker for Abbvie, Johnson and Johnson, Takeda, Roche, Gilead, Pfizer and Galapagos and has served as an advisor for Roche, Gilead, Abbvie, Galapagos and Takeda Nicholls, Jack: No conflict of interest. Orti Cuerva, Marina: None Gupta, Eksha: No conflict of interest Constantine-Cooke, Nathan: NCC reports no conflicts of interest. Gemmell, Elliot: No conflict of interest Arnott, Ian: Conflicts of interest with Alphasigma, Galapagos, Abbvie, BSM, Lilly, Vifor, Dr Falk, Takeda Lees, Charlie: Consultancy and lecture fees: Abbvie, Oshi Health, Gilead, Pfizer, Takeda, Janssen, Shire, Samsung Bioepis, Dr Falk, GSK, Galapagos, Trellus Health, Iterative Scopes, Fresnius Kabi Plevris, Nikolas: Speaker fees / travel support from Abbvie, Pfizer, Janssen, Lilly, Ferring
Belinchon et al. (Thu,) studied this question.