P1068Real-world effectiveness of filgotinib by prior advanced treatment and predictors of clinical response in Ulcerative Colitis: Interim results up to week 24 from the prospective, observational GALOCEAN study

Abstract Background Filgotinib (FIL) is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for the treatment of moderately to severely active Ulcerative Colitis (UC). 1, 2 We evaluated the real-world effectiveness of FIL by prior use of advanced treatment (AT) and predictors of clinical response in UC. Methods GALOCEAN (NCT05817942) is an ongoing, European, multicentre, prospective, observational study of adults with UC receiving FIL in routine care; this interim analysis reports data up to week (W) 24. Effectiveness outcomes (partial Mayo Clinic Score pMCS and the two-item patient-reported outcome PRO2 score) were analysed by prior use of AT (AT-naive, 1, 2 or ≥ 3 ATs). Health-related quality of life (HRQoL) outcomes (defined in Table I) were analysed at baseline (BL), W10 and W24. Data are reported as descriptive statistics. Univariate and multivariate logistic regression analyses assessed BL characteristics predictive of pMCS and PRO2 remission at W10. Results As of 15 January 2025, there were 353 enrolled patients with available BL data; 253 and 164 patients had data at W10 and W24, respectively. At BL, 26. 9% (95/353) of patients were AT-naive and 27. 8% (98/353), 24. 6% (87/353) and 20. 7% (73/353) had previously received 1, 2 or ≥ 3 ATs, respectively. BL characteristics are shown in Table I. The pMCS and PRO2 score improved from BL to W10 and from BL to W24 for all subgroups, with the largest improvement in the AT-naive group (Figure I). The proportions of patients in pMCS and PRO2 remission were numerically highest for the AT-naive subgroup versus the 1, 2 and ≥3 AT subgroups at W10 and W24 (Figure I). All HRQoL outcomes improved from BL by W10 and W24, irrespective of prior AT. Several BL characteristics were predictive of pMCS remission (predictor vs comparator: prior AT naive vs experienced, Urgency NRS none/mild vs moderate/severe and pMCS at BL; p0. 05) and PRO2 remission (prior AT naive vs experienced, FACIT-Fatigue score mild vs moderate/severe and PRO2 score at BL; p0. 05) at W10. Conclusion In the real-world GALOCEAN study, FIL showed sustained effectiveness regardless of prior AT use, with the greatest estimated benefit in AT-naive patients with UC. HRQoL at BL was severely impaired for many patients, which improved after FIL initiation, regardless of prior AT use. Being naive to AT and having symptoms associated with moderate disease at BL was predictive of both pMCS and PRO2 remission at W10. These results are consistent with findings from the SELECTION trial, which suggest that BL characteristics may predict clinical outcomes with FIL. 2-4 References: 1. Alfasigma S. p. A. Summary of product characteristics, Jyseleca. EMA, 2023. Accessed 13 October 2025. https: //www. ema. europa. eu/en/documents/product-information/ jyseleca-epar-product-informationₑn. pdf. 2. Feagan BG et al. Lancet. 2021;397 (10292): 2372–2384. 3. Dotan I et al. J Crohns Colitis. 2023;17 (8): 1207–1216. 4. Schreiber S et al. United European Gastroenterol J. 2024;12 (9): 1243–1255. Conflict of interest: Prof. Dr. Reinisch, Walter: The GALOCEAN study is sponsored by Alfasigma S. p. A. , who funded these analyses. Medical writing support for the development of this abstract was provided by Annika Pecchia-Bekkum, PhD, of PharmaGenesis London, London, UK, and was funded by Alfasigma S. p. A. WR reports speaker and/or consultancy fees from AbbVie, Amgen, AOP Health (formerly AOP Orphan), Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, InDex Pharmaceuticals, Janssen Pharmaceuticals, MedAhead, MEDICE, Microbiotica, MSD, Pfizer, Roche, Sobi and Takeda advisory board fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Janssen Pharmaceuticals and Pfizer and research funding from AbbVie, Janssen Pharmaceuticals, Sandoz, Sanofi and Takeda. Löwenberg, Mark: ML reports consultancy/lecture fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen-Cilag, Johnson & Johnson, Medtronic, Pfizer, Takeda and Tillotts Pharma and grants from Alfasigma, Galapagos, Dutch and the Netherlands Federation of University Medical Centres, the Netherlands Organisation for Health Research and Development (ZonMw) and the Top Consortia for Knowledge and Innovation (TKI). Armuzzi, Alessandro: AA reports consultancy and/or advisory board fees from AbbVie, Alfasigma, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Giuliani, Janssen Pharmaceuticals, LIONHEALTH Benefit Society, Merck, Nestlé, Pfizer, Roche, Samsung Bioepis, Sandoz, Sanofi, Takeda and Tillotts Pharma lecture and/or speaker bureau fees from AbbVie, AG Pharma, Alfasigma, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Janssen Pharmaceuticals, LIONHEALTH Benefit Society, Merck, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda and Teva Pharmaceuticals and research grants from Biogen, MSD, Pfizer and Takeda. Ricart Gomez, Elena: ER reports speaker fees from AbbVie, Faes Farma, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, Kern Pharma, MSD, Pfizer and Takeda and consultancy fees from AbbVie, Eli Lilly, Fresenius Kabi, Galapagos, Janssen Pharmaceuticals, MSD and Pfizer. Gilletta de Saint Joseph, Cyrielle: CGdSJ reports speaker and/or consultancy fees from AbbVie, Alfasigma, Amgen, Celltrion, Galapagos, Janssen Pharmaceuticals, MSD, Pfizer and Takeda. Høivik, Marte Lie: MLH reports research grants, speaker and/or advisory board fees from AbbVie, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, MSD, Pfizer, Takeda, Tillotts Pharma and Viatris (formerly Meda). Seenan, John Paul: JPS reports speaker fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Fresenius Kabi Limited, Janssen-Cilag, Pharmacosmos UK Ltd, Pfizer, Takeda UK Ltd, Tillotts Pharma UK. and advisory board fees from AbbVie, Dr. Falk Pharma (UK) and Galapagos. Schreiber, Stefan Wolfgang: SS reports personal fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Dr. Falk Pharma, Eli Lilly, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos/Gilead Sciences, Hikma Pharmaceuticals, I-Mab, Janssen Pharmaceuticals, Morphic Therapeutic, MSD, Mylan, Pfizer, Protagonist Therapeutics, Provention Bio, Sandoz/Hexal, Takeda, Theravance Biopharma and Ventyx Biosciences and funding from the Deutsche Forschungsgemeinschaft Excellence Cluster. Vermeire, Séverine: SV reports financial support for research from AbbVie, Galapagos, Johnson & Johnson, Pfizer and Takeda speaker and/or consultancy fees from AbbVie, Abivax, AbolerIS Pharma, Agomab Therapeutics, Alimentiv (formerly Robarts Clinical Trials), Arena Pharmaceuticals, AstraZeneca, Biora Therapeutics (formerly Progenity), Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cytoki Pharma, Dr. Falk Pharma, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Genentech-Roche, Gilead Sciences, GSK, Hospira, IMIDomics, Janssen Pharmaceuticals, Johnson & Johnson, Materia Prima, Mestag Therapeutics, MiroBio, Morphic Therapeutic, MRM Health, MSD, Mundipharma, Pfizer, ProDigest, Prometheus Biosciences, Surrozen, Takeda, Theravance Biopharma, Tillotts Pharma, VectivBio, Ventyx Biosciences and Zealand Pharma and participation on a data safety monitoring board for Sanofi. Saldaña, Roberto: RS reports no financial disclosures or conflicts of interest. Sawyer, Will: WS was a consultant funded by Galapagos NV (former study sponsor) and is now a consultant funded by Alfasigma S. p. A. Sendersky, Veronica: VS is a consultant funded by Alfasigma S. p. A. Rudolph, Christine: CR was an employee of Galapagos NV (former study sponsor) and is now an employee of Alfasigma S. p. A. Doherty, Glen: GD reports research/educational grants and/or speaker/personal fees from Abbott, AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Dr. Falk Pharma, Galapagos, Genuity Science, Gilead Sciences, Janssen Pharmaceuticals, MSD, Pfizer, Takeda/Shire and Tillotts Pharma.