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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 PRO2 score) were analysed by prior use of AT (AT-naive, 1, 2 or ≥3 ATs). Health-related quality of life (HRQoL) outcomes 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. 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 ( table 1). 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; p<0.05) and PRO2 remission (prior AT [naive vs experienced], FACIT-Fatigue score [mild vs moderate/severe] and PRO2 score at BL; p<0.05) at W10.Conclusion In the GALOCEAN study, FIL showed sustained effectiveness regardless of prior AT use, with the greatest estimated benefit in AT-naive patients with UC. HRQoL 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 pMCS and PRO2 remission at W10.References Jyseleca SmPC. Accessed 13.1. 2026.Feagan BG, et al. Lancet. 2021;397(10292):2372–2384.Abstract FP14 Table 1(proportion of patients in remission)W10AT-Naïve1 AT2 AT≥3 AT pMCS56.9%33.9%39.1%33.3%n/N37/6521/6225/6415/45PRO260.5%37.1%35.9%32.6%n/N46/7623/6223/6415/46W24AT-Naïve1 AT2 AT≥3 AT pMCS68.8%36.4%52.9%47.4%n/N33/48 12/33 18/34 9/19PRO276.4%37.8%45.9%45.0%n/N42/5514/3717/37 9/20 Data are for patients with BL data and valid effectiveness data for at least one time point after FIL initiation. pMCS remission = pMCS≤1. PRO2 remission = PRO score of 0