Biologic Therapy in Ulcerative Colitis: A Retrospective Real-World Study in a Brazilian Tertiary University Hospital

Background: This study aimed to describe the demographic and clinical characteristics, biologic exposure history, switching patterns, treatment disruptions, selected complications/extraintestinal manifestations, disease extent, and chart-documented symptomatic status of patients with ulcerative colitis (UC) exposed to biologic therapy at a Brazilian tertiary university hospital. Methods: This was a retrospective descriptive chart review using Aplicativo de Gestão para Hospitais Universitários/Empresa Brasileira de Serviços Hospitalares (AGHU/EBSERH) electronic medical records. Adults aged 18-80 years with confirmed UC and current or previous chart-documented biologic exposure for UC, followed between June 2022 and January 2024, were included. Data were abstracted and verified from August 2023 to July 2024. Variables included demographics, UC extent, biologics used, switching patterns and recorded reasons, treatment interruptions or discontinuation, selected complications and extraintestinal manifestations, and chart-documented symptomatic status. Because standardized disease activity indices, biomarkers, endoscopic assessments, and steroid-use data were not consistently available, symptomatic status was based on routine physician documentation. Analyses were descriptive; Wilson 95% confidence intervals (CIs) were calculated for key proportions. Results: Among 132 UC outpatients followed during the study period, 127 met protocol-defined eligibility criteria after exclusions, and 34/127 (26.8%; 95% CI, 19.8%-35.1%) had current or previous biologic exposure. Most biologic-exposed patients were female (20/34, 58.8%) and lived in the Federal District (28/34, 82.4%). Infliximab was the most frequently documented biologic exposure (30/34, 88.2%; 95% CI, 73.4%-95.3%), followed by vedolizumab (13/34, 38.2%; 95% CI, 23.9%-55.0%) and adalimumab (8/34, 23.5%; 95% CI, 12.4%-40.0%). Thirteen patients (13/34, 38.2%; 95% CI, 23.9%-55.0%) had at least one biologic switch; allergic reactions (9/34, 26.5%; 95% CI, 14.6%-43.1%) and lack of response documented in the chart (4/34, 11.8%; 95% CI, 4.7%-26.6%) were the most common recorded reasons. Chart-documented symptomatic improvement or absence of gastrointestinal symptoms was recorded in 22/34 patients (64.7%; 95% CI, 47.9%-78.5%). Pancolitis was the most frequent disease extent (19/34, 55.9%; 95% CI, 39.5%-71.1%). Conclusion: In this single-center Brazilian tertiary-care cohort, infliximab was the most frequent chart-documented biologic exposure, and biologic switching was common. Although many patients had chart-documented symptomatic improvement or absence of gastrointestinal symptoms, these findings should be interpreted cautiously because the study was retrospective and descriptive, and symptomatic status was not assessed using standardized disease activity indices or objective treat-to-target measures.