Abstract
Filgotinib (FIL), a once-daily, oral Janus kinase 1 preferential inhibitor, was approved for the treatment of Ulcerative Colitis (UC) following the phase 2b/3, randomized SELECTION clinical trial.1 Real-world data on the effectiveness and safety of FIL are needed to complement the results of clinical trials for applicability in daily clinical practice.
GALOCEAN (NCT05817942) is a European, multicenter, prospective, observational study that will recruit ~600 adults with UC receiving FIL in clinical care. In this interim analysis, we report data for up to 24 weeks. Effectiveness outcomes were the Mayo Clinic Score (MCS), the partial MCS (pMCS) and the two-item patient-reported outcome (PRO2) score, as well as Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and Urgency Numerical Rating Scale (NRS) scores. Safety assessments included treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs). Data were analyzed for the overall patient group, and for those receiving FIL without baseline concomitant therapies (FIL−ct) or FIL with baseline concomitant therapies (FIL+ct; including conventional therapies, biologics and synthetic targeted small molecules).
As of June 2024, 277 patients had been enrolled in GALOCEAN. Of these, 223 had available baseline data; 139 and 83 completed 10 and 24 weeks of treatment, respectively. At baseline, 53% of patients (118/223) received FIL−ct and 47% (105/223) received FIL+ct, of whom 92.4% (97/105) received aminosalicylates. Baseline characteristics are shown in Table 1. MCS, pMCS, PRO2, SIBDQ, FACIT-Fatigue and Urgency NRS data are shown in Table 2. At week 24, remission was achieved by 30% of patients (FIL−ct, 29%; FIL+ct, 31%) for the MCS, 47% (FIL−ct, 47%; FIL+ct, 47%) for the pMCS and 50% (FIL−ct, 44%; FIL+ct, 55%) for the PRO2 score. At week 24, minimal clinically important differences (MCIDs) were achieved by 66% of patients (FIL−ct, 75%; FIL+ct, 58%) for the SIBDQ score, 64% (FIL−ct, 72%; FIL+ct, 57%) for the FACIT-Fatigue score and 43% (FIL−ct, 50%; FIL+ct, 36%) for the Urgency NRS score. Overall, 30% of patients (FIL−ct, 25%; FIL+ct, 36%) had ≥1 TEAE and 6% (6% in each subgroup) had ≥1 AESI.
This study highlights the overall effectiveness and safety profile of filgotinib up to 24 weeks in a real-world cohort, both when used alone or with concomitant therapy. The safety profiles were consistent with previous data. The GALOCEAN study is ongoing.
1.Feagan BG et al. Lancet 2021;397:2372–84.
