P1160Filgotinib in Biologic-Experienced Ulcerative Colitis: One-Year Real-World Results from the FILGUITO Study

Abstract Background Filgotinib, a JAK1-preferential inhibitor, has shown efficacy in clinical trials for moderate-to-severe ulcerative colitis (UC), yet long-term real-world data remain limited. The FILGUITO registry aimed to assess 12-month effectiveness, safety, and response predictors of filgotinib in biologic-experienced UC patients across Andalusia, Spain. Methods This multicenter ambispective observational study enrolled 104 adults with moderate-to-severe UC initiating filgotinib therapy between October 2023 and August 2025. Clinical remission (Mayo partial score 3), clinical-biochemical remission (clinical remission plus fecal calprotectin 250 μg/g), and steroid-free remission were evaluated at 8 weeks, 6 months, and 12 months. Results The cohort comprised predominantly biologic-experienced patients (79.8%), with a median of 1 prior biologic (IQR 1-3). Clinical remission rates were sustained at 60.8% (week 8), 61.4% (6 months), and 60.3% (12 months), all p 0.001 versus baseline. Clinical-biochemical remission reached 38.6% at 6 months and 31.0% at 12 months. Steroid-free remission was achieved in 60.0% at 6 months and 56.9% at 12 months. Fecal calprotectin dropped significantly from baseline (2000 μg/g, IQR 755.8-2392.5) to 153 μg/g (IQR 21.3-569.0) at 12 months (p 0.001). Patients with fewer prior biologics demonstrated superior outcomes: those with one prior biologic achieved 89.7% clinical remission at 6 months versus 54.5% in those with ≥3 prior biologics (p = 0.030). Treatment discontinuation occurred in 22.1% of patients by 12 months, primarily due to lack of response. Serious adverse events were rare (2.8%), with excellent overall tolerability. Conclusion Filgotinib demonstrates sustained effectiveness and favorable safety through 12 months in a heavily pre-treated real-world UC cohort. Optimal benefit is observed when positioned earlier in the treatment algorithm, though meaningful efficacy persists even after multiple biologic failures. References: 1. Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017;389(10080):1756–1770. 2. Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, et al. European Crohn’s and Colitis Organisation (ECCO) position paper: Third European evidence-based consensus on diagnosis and management of ulcerative colitis. J Crohns Colitis. 2017;11(6):649–670. 3. Sandborn WJ, Ghosh S, Panés J, Schreiber S, D’Haens G, Tanida S, et al. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2017;376(18):1723–1736. 4. Caballero-Mateos AM, Cañadas-de la Fuente GA. Game changer: How Janus kinase inhibitors are reshaping the landscape of ulcerative colitis management. World J Gastroenterol. 2024 Sep 21;30(35):3942-3953. doi: 10.3748/wjg.v30.i35.3942. Conflict of interest: Dr. Caballero Mateos, Antonio M: has received fees for lectures, consultancy work, or research support from: Lilly, Abbvie, Johnson & Johnson, Takeda, Pfizer, Alfasigma, Ferring, Farmasierra, Kern. Trigo Salado, Claudio: has received fees for lectures, consultancy work, or research support from: Lilly, Abbvie, Johnson & Johnson, Takeda, Pfizer, Alfasigma, Ferring, Farmasierra, Kern. Suarez, Alvaro: None Martin Rodríguez, María Del Mar: As a speaker or recipient of educational funding from MSD, Takeda, Janssen, Johnson & Johnson, Dr. Falk Pharma, Abbvie, Tillotts Pharma, Chiesi, Otsuka Pharmaceutical, Pfizer, Galápagos, Ferring and Lilly. Rodriguez Gonzalez, Francisco Jose: None Valdes, Teresa: none Pallarés-Manrique, Héctor: None Trapero Martinez, Ana María: None Olmedo-Martín, Raúl V: has received fees for lectures, consultancy work, or research support from: Lilly, Abbvie, Johnson & Johnson, Takeda, Pfizer, Alfasigma, Ferring, Farmasierra, Kern. Moreno Barrueco, Melody: None Benítez Cantero, José Manuel: None Sáez Díaz, Antonia: None Hernandez Martinez, Alvaro: None