P796 Comparative Effectiveness of First-Line Infliximab and Vedolizumab in Patients with Early Ulcerative Colitis

Abstract

Abstract Background Despite the increasing armamentarium of advanced therapies for the treatment of ulcerative colitis (UC), data comparing the effectiveness of biologics in early disease are scarce. We aimed to categorize selection of patients and assess the effectiveness, therapeutic persistence and safety of biologics used to treat early UC in a bio-naïve patient cohort. Methods This single-center, retrospective study included all bio-naïve UC patients who commenced advanced therapy within two years of diagnosis between 2012-2023. We collected demographic, clinical, and laboratory data. Clinical disease activity was assessed using the Simple Clinical Colitis Activity Index; clinical response was defined as a decrease of ≥ 3 points from baseline and clinical remission defined as an SCCAI of ≤2 Results Out of the 1117 patients with UC who were treated at our center during the study period, 46 bio-naïve patients (mean age 36.7 years (±17)) were treated with either infliximab (IFX) or vedolizumab (VDZ), within 2 years from diagnosis. IFX was the first biologic in 19 (41%) patients and VDZ in 27 (58%) patients. At therapy initiation, 38 (82%) patients were receiving corticosteroids and 7 (15%) concomitant immunomodulators (Table 1). Patients treated with IFX had significantly lower hemoglobin (10.4 (IQR 8.5-11.3) vs 12.1 (IQR 10.8-13.9) g/dL, p=0.007) and albumin (3 (IQR 2.8-3.8) vs. 3.8 (IQR 3.4-4.2) g/dL, p=0.01) and significantly higher C-reactive protein (CRP) (48.5 (IQR 9-119) vs. 2.5 (IQR 2-3) mg/L, p<0.001) compared with patients starting VDZ. Following induction (week 14) clinical response and remission rates were similar in both treatment groups (IFX: 73% and 63%; VDZ: 74% and 67%, respectively; p=0.75). At week 52, clinical response and remission rates were similar in both treatment groups (IFX: 50% for both; VDZ: 50% for both, p=n/s). Corticosteroid (CS)-free remission rates amongst patients receiving CS at baseline (17 patients IFX and 21 patient VDZ) at week 52 were similar in both groups (IFX: 58% vs VDZ 57%, p=n/s). Treatment persistence over 2 years of follow-up was similar between IFX and VDZ (Figure 1). Safety profiles were similar in both treatment groups with no new signals noted. Conclusion In these real-world data in patients with early and bio-naïve UC, first line IFX was used in more severe baseline disease as highlighted by lower albumin and hemoglobin levels and higher CRP at baseline. Despite this, IFX showed equal effectiveness in induction and long-term maintenance and showed similar treatment persistence compared with VDZ.