DOP036Real-world corticosteroid use in patients with Ulcerative Colitis receiving filgotinib up to week 24: An interim analysis 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 adults with moderately to severely active Ulcerative Colitis (UC) 1. In the phase 2b/3 SELECTION trial, FIL demonstrated corticosteroid (CS) -sparing effects in patients with UC. 2, 3 Here, we aimed to characterise real-world systemic CS use in patients with UC receiving FIL. 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. Baseline (BL) characteristics, systemic CS use during FIL treatment, and effectiveness outcomes through W24 were analysed for patients receiving FIL with BL CS use (FIL+CS) or without BL CS use (FIL–CS). Effectiveness outcomes assessed at BL, W10 and W24 were the partial Mayo Clinic Score (pMCS), two-item patient-reported outcome (PRO2) score and the proportion of patients in pMCS or PRO2 remission. Results As of 15 January 2025, 353 enrolled patients had BL data; 253 and 164 patients had data at W10 and W24, respectively. At BL, CS use was low; 93 out of 353 patients (26. 3%) were in the FIL+CS group and 260 out of 353 patients (73. 7%) were in the FIL–CS group. BL characteristics are summarized in Table I. Compared with FIL–CS, the FIL+CS group included a higher proportion of men (66. 7% vs 45. 8%) and more prior 5-aminosalicylate use (80. 6% vs 69. 2%), but fewer patients with prior exposure to advanced therapies (54. 8% vs 79. 6%). In the FIL+CS group, the proportion of patients using CS decreased from BL to 59. 4% (41/69 patients) and 46. 5% (20/43 patients) at W10 and at W24, respectively. A small number of patients in the FIL–CS group were using CS at W10 (4. 4% 8/180 patients) and W24 (3. 4% 3/88 patients) (Figure I). Improvements from BL in pMCS and PRO2 score were observed at W10 and W24 in both the FIL+CS and FIL–CS groups (Figure I). In addition, the proportion of patients in pMCS remission increased from 37. 5% (24/64 patients) to 45. 2% (19/42 patients) in the FIL+CS group and 43. 0% (74/172 patients) to 57. 6% (53/92 patients) in the FIL–CS group at W10 and W24, respectively. A similar pattern was observed for PRO2 remission (Figure I). Conclusion This real-world analysis showed that in the small number of patients with UC using CS at BL, over half were no longer using CS by W24 after initiating FIL. Patients achieved symptomatic remission and showed improvements in clinical symptoms over time following FIL treatment, irrespective of CS use at BL. These findings support that FIL treatment offers an opportunity for patients to reduce or minimise their CS use, consistent with results from the SELECTION trial. 3 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. Loftus EV et al. J Crohns Colitis. 2023;17 (2): 211–220. Conflict of interest: Schreiber, Stefan Wolfgang: 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 Keir Murison, PhD, of PharmaGenesis London, London, UK, and was funded by Alfasigma S. p. A. 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. 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). Reinisch, Walter: 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. Seenan, John Paul: JPS reports speaker fees from AbbVie, Astra-Zeneca, 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. Høivik, Marte: 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). 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. Gilletta de Saint Joseph, Cyrielle: CGdSJ reports speaker and/or consultancy fees from AbbVie, Alfasigma, Amgen, Celltrion, Galapagos, Janssen Pharmaceuticals, MSD, Pfizer and Takeda. 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. 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. Rudolph, Christine: CR was an employee of Galapagos NV (former study sponsor) and is now an employee of Alfasigma S. p. A. Sendersky, Veronica: VS is a consultant funded by Alfasigma S. p. A. 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.