Introduction
Filgotinib has shown efficacy in ulcerative colitis (UC) in clinical trials, but long-term real-world data are scarce, particularly in patients with prior biologic exposure. We aimed to evaluate the durability of response to filgotinib, focusing on 12- and 18-month outcomes.
Aims & Methods
This retrospective multicentre study included UC patients initiating filgotinib across 13 Andalusian (Spain) hospitals. Clinical activity (partial Mayo score), C-reactive protein, and faecal calprotectin were assessed longitudinally from baseline to 18 months. Clinical remission was defined as partial Mayo score <3; steroid-free remission as clinical remission without corticosteroid use; and combined clinical-biochemical remission as clinical remission with normalization of inflammatory markers (CRP and faecal calprotectin <250 µg/g). Subgroup analyses were performed according to prior biologic exposure.
Results
| Outcome | Baseline | Week 8 | Week 16 | 6M | 12M | 18M |
| Partial Mayo (median) | 6 | 2 | 1 | 0 | 0 | 0 |
| CRP mg/L (median) | 5 | 2.2 | 2.3 | 2 | 1 | 1 |
| Calprotectin µg/g (median) | 2000 | 427.2 | 347 | 249 | 160 | 173.5 |
| Clinical remission (%) | 7.8 | 59.8 | 58.0 | 58.9 | 50.7 | 39.7 |
| Clinical-biochemical (%) | 3.4 | 31.4 | 23.9 | 31.1 | 26.0 | 22.4 |
A total of 118 patients were included, with a mean disease duration of 12.4 years and a high rate of prior advanced therapies (mean 1.9) (table 1-2). Clinical and biochemical improvements observed early were sustained over time. At 12 months, clinical remission was achieved in 50.7% of patients, with 26.0% reaching combined clinical-biochemical remission and 37.0% achieving steroid-free remission. At 18 months, clinical remission persisted in 39.7%, with 22.4% maintaining combined remission and 24.1% remaining steroid-free. Median partial Mayo score remained at 0, and inflammatory markers (CRP and faecal calprotectin) were consistently reduced from baseline, indicating sustained disease control (table 1). Treatment effectiveness was influenced by prior biologic exposure, with higher remission rates in less pre-treated patients. Only 2.8% of patients required treatment discontinuation due to adverse events.
Conclusion
In this real-world multicentre cohort, filgotinib demonstrated durable effectiveness up to 18 months in patients with UC, including a heavily pre-treated population. Approximately half of patients maintained clinical remission at 1 year, with sustained steroid-free and biochemical control in a substantial proportion. These findings support the role of filgotinib as a long-term therapeutic option, with greater benefit when used earlier in the treatment sequence.
References
Caballero-Mateos AM, Trigo-Salado C, Suárez-Toribio Á, Martín-Rodríguez MDM, Rodríguez-González FJ, Valdés-Delgado T, Pallarés-Manrique H, Trapero-Martínez AM, Olmedo-Martín R, Bailón-Gaona C, Benitez Cantero JM, Gros B, Sáez-Díaz A, Hernández-Martínez Á. Long-term clinical outcomes with filgotinib in ulcerative colitis: 12-month results from the FILGUITO study. World J Gastroenterol. 2026 Feb 14;32(6):115941. doi: 10.3748/wjg.v32.i6.115941.
Disclosure
FAA has received fees for lectures, consultancy work, or research support from: Lilly, Abbvie, Johnson & Johnson, Takeda, Pfizer, Alfasigma, Ferring, Farmasierra, Kern, Faesfarma.