Abstract
A post hoc analysis of the SELECTION trial (NCT02914522) showed that patients with moderately active Ulcerative Colitis (UC) were more likely to respond to filgotinib (FIL), a once-daily, oral Janus kinase 1 preferential inhibitor, than those with severely active UC.1 Real-world data exploring FIL effectiveness in different populations are needed.
This is an interim analysis of GALOCEAN (NCT05817942), a European, multicenter, prospective, observational study of ~600 patients with UC receiving FIL in clinical care. Here we report effectiveness and safety data for up to 24 weeks among patients with moderately or severely active UC, defined as a partial Mayo Clinic Score (pMCS) of 5 or 6, or pMCS ≥7, respectively. The Mayo Clinic Score (MCS), the pMCS and the two-item patient-reported outcome (PRO2) score were assessed, as well as patient-reported outcomes (Short Inflammatory Bowel Disease Questionnaire [SIBDQ], Urgency Numerical Rating Scale [NRS] and Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue] scores). Safety assessments included treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs).
As of June 2024, 277 patients were enrolled. Of these, 219 had available baseline data including a baseline pMCS score; 137 and 82 completed weeks 10 and 24, respectively. At baseline (Table 1), 37% of patients (81/219) had moderately active UC and 32% (70/219) had severely active UC. The remaining patients had mild or inactive UC and were not included in this analysis. Mean scores, changes from baseline and proportions of patients achieving remission or the minimal clinically important difference (MCID) for effectiveness and patient-reported outcomes up to week 24 are shown in Table 2. At week 24, for patients with moderately and severely active UC, respectively, MCS remission was achieved by 33% and 25% of patients pMCS remission by 56% and 43% of patients, and PRO-2 remission by 57% and 44% of patients. The MCID in the SIBDQ score was achieved by 75% and 68% of patients with moderately and severely active UC, respectively, the MCID in FACIT-Fatigue score by 76% and 59%, and the MCID in the Urgency NRS score by 35% and 42%. At week 24, 30% of patients in each group had ≥1 TEAE, and 6% (moderately active UC) and 7% (severely active UC) had ≥1 AESI.
In the real-world GALOCEAN study, patients receiving FIL had improved UC symptoms and reduced disease activity over 24 weeks. Numerically greater proportions of patients with moderately active UC achieved remission and clinically meaningful improvements in patient-reported outcomes than those with severely active UC, particularly at week 10. The safety profile was similar between groups.
1. Schreiber S et al. United European Gastroenterol J. Forthcoming 2024.
