©The Author(s) 2026. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 14, 2026; 32(6): 115941
Published online Feb 14, 2026. doi: 10.3748/wjg.v32.i6.115941
Published online Feb 14, 2026. doi: 10.3748/wjg.v32.i6.115941
Long-term clinical outcomes with filgotinib in ulcerative colitis: 12-month results from the FILGUITO study
Antonio M Caballero-Mateos, Department of Internal Medicine, Santa Ana Hospital, Motril 18600, Spain
Claudio Trigo-Salado, Álvaro Suárez-Toribio, Department of Gastroenterology, Virgen del Rocio University Hospital, Sevilla 41013, Spain
María del Mar Martín-Rodríguez, Division of Digestive Diseases, Inflammatory Bowel Diseases Unit, Virgen de las Nieves University Hospital, Granada 18014, Spain
Francisco J Rodríguez-González, Department of Gastroenterology, Virgen de la Victoria University Hospital, Málaga 29101, Spain
Teresa Valdés-Delgado, Department of Gastroenterology, Virgen Macarena University Hospital, Seville 41009, Spain
Héctor Pallarés-Manrique, Department of Gastroenterology, Juan Ramón Jiménez Hospital, Huelva 21005, Spain
Ana María Trapero-Martínez, Department of Gastroenterology, Jaén University Hospital, Jaén 23007, Spain
Raúl Olmedo-Martín, Department of Gastroenterology, Hospital Regional Universitario de Malaga, Málaga 29010, Spain
Cristina Bailón-Gaona, Department of Gastroenterology, San Cecilio University Hospital, Granada 18016, Spain
José Manuel Benitez Cantero, B Gros, Department of Gastroenterology, Reina Sofia University Hospital, Córdoba 14004, Spain
Antonia Sáez-Díaz, Department of Statistics, Axioma Comunicaciones, Sevilla 41006, Spain
Álvaro Hernández-Martínez, Division of Digestive Diseases, Inflammatory Bowel Diseases Unit, Hospital Universitario Torrecárdenas, Almeria 04009, Spain
Author contributions: Study conception and design was performed by Caballero-Mateos AM and Hernández-Martínez Á; data acquisition and collection were performed by 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, and Sáez-Díaz A; statistical analysis and data interpretation were performed by Gros B and Sáez-Díaz A; manuscript drafting was performed by Caballero-Mateos AM; critical revision of the manuscript for important intellectual content were performed by Rodríguez-González FJ, Gros B, Olmedo-Martín R, and Hernández-Martínez Á; supervision and final approval were performed by Caballero-Mateos AM and Hernández-Martínez Á; guarantor of article were performed by Caballero-Mateos AM; all authors have read and approved the final version.
Institutional review board statement: The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with protocol approval obtained from the Ethics Committee of Granada, Spain (Approval No. 1348-N-23).
Informed consent statement: Informed consent requirements were waived according to local regulations, with patients informed through opt-out procedures where required. Patient confidentiality was maintained throughout the study with data anonymized before analysis, and all investigators adhered to applicable data protection regulations.
Conflict-of-interest statement: Caballero-Mateos AM has received fees for lectures, consultancy work, or research support from Lilly, Abbvie, Johnson & Johnson, Takeda, Pfizer, Alfasigma, Ferring, Farmasierra, Kern, and Faesfarma. Valdés-Delgado T has served as speaker, consultant, and advisory member for, or has received research funding from Janssen, Tillotts Pharma, and Galapagos. Gros B has served as a speaker for Abbvie, Johnson and Johnson, Takeda, Roche, Gilead, Pfizer and Alfasigma and has served as an advisor for Roche, Gilead, Abbvie, Alfasigma and Takeda. Olmedo-Martín R has received payments as fees-for-service and advisory work from MSD, Abbvie, Takeda, Ferring, Faes Farma, and Janssen. Hernández-Martínez Á has received payments as fees-for-service, participation in scientific meetings, and funding for attendance from Abbvie, Ferring, Janssen, MSD, Pfizer, Sandoz, and Takeda.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Data sharing statement: The data that support the findings of this study are available from the authors on reasonable request.
Corresponding author: Antonio M Caballero-Mateos, MD, PhD, Department of Internal Medicine, Santa Ana Hospital, Avenida Enrique Martín Cuevas s/n, Motril 18600, Spain. ogy1492@hotmail.com
Received: October 29, 2025
Revised: November 19, 2025
Accepted: December 18, 2025
Published online: February 14, 2026
Processing time: 96 Days and 12.8 Hours
Revised: November 19, 2025
Accepted: December 18, 2025
Published online: February 14, 2026
Processing time: 96 Days and 12.8 Hours
Core Tip
Core Tip: This multicenter real-world study (FILGUITO) evaluated 12-month effectiveness and safety of filgotinib in 104 patients with moderate-to-severe ulcerative colitis, predominantly biologic-experienced. Clinical remission remained sustained at approximately 60% throughout follow-up, with clinical-biochemical remission reaching 38.6% at 6 months. Fecal calprotectin decreased significantly from 2000 μg/g to 153 μg/g at 12 months. Treatment discontinuation occurred in 22.1% of patients. Patients with fewer prior biologic failures showed superior outcomes. Filgotinib demonstrated sustained effectiveness and favorable safety over 12 months, with optimal benefit when used earlier in the treatment algorithm.