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©The Author(s) 2026. Published by Baishideng Publishing Group Inc. All rights reserved.
Long-term clinical outcomes with filgotinib in ulcerative colitis: 12-month results from the FILGUITO study
Antonio M Caballero-Mateos, Claudio Trigo-Salado, Álvaro Suárez-Toribio, María del Mar Martín-Rodríguez, Francisco J Rodríguez-González, Teresa Valdés-Delgado, Héctor Pallarés-Manrique, Ana María Trapero-Martínez, Raúl Olmedo-Martín, Cristina Bailón-Gaona, José Manuel Benitez Cantero, B Gros, Antonia Sáez-Díaz, Álvaro Hernández-Martínez
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.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ 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
BACKGROUND
Filgotinib, a JAK1-preferential inhibitor, has demonstrated efficacy in pivotal clinical trials for moderate-to-severe ulcerative colitis (UC), leading to regulatory approvals. While emerging real-world studies provide short-term effectiveness data, comprehensive long-term evidence—particularly beyond 6 months—remains scarce, especially in heavily biologic-experienced populations.
AIM
To evaluate the 12-month effectiveness, safety, and predictors of response to filgotinib in a real-world cohort of patients with moderate-to-severe UC treated across multiple centers in Andalusia, Spain.
METHODS
This multicenter, ambispective observational study (FILGUITO registry) included 104 adults with moderate-to-severe UC initiating filgotinib therapy. Demographic, clinical, laboratory, and endoscopic data were collected at baseline and at 8 weeks, 6 months, and 12 months. Effectiveness outcomes included clinical remission (Mayo partial score < 3 with no subscore > 1 and no rectal bleeding), clinical-biochemical remission (clinical remission plus fecal calprotectin < 250 μg/g), and steroid-free remission (clinical remission with no corticosteroid courses from week 8). Safety was assessed through adverse event monitoring.
RESULTS
The median age was 40.7 years (IQR: 29.5-51.0), with 56.7% male patients. The majority (79.8%) had prior advanced therapy exposure, with a median of 1 prior biologic (IQR: 1-3). Clinical remission rates were 60.8% at 8 weeks, 61.4% at 6 months, and 60.3% at 12 months (all P < 0.001 vs baseline). Clinical-biochemical remission reached 33.0%, 38.6%, and 31.0% at the same timepoints. Steroid-free remission was achieved in 60.0% at 6 months and 56.9% at 12 months. Median fecal calprotectin decreased significantly from 2000 μg/g at baseline (IQR: 755.8-2392.5) to 153 μg/g at 12 months (IQR: 21.3-569.0, P < 0.001). 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 a favorable safety profile. Patients with only one prior biologic showed higher remission rates compared to those with multiple prior treatments.
CONCLUSION
Filgotinib demonstrates sustained clinical effectiveness and a favorable safety profile over 12 months in a real-world UC cohort with extensive prior biologic exposure. Effectiveness is optimized at earlier treatment lines, though meaningful benefit persists in heavily pre-treated populations.
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.
