S1829 Characterizing Indicators of Suboptimal Treatment With Conventional Therapies for Ulcerative Colitis (UC): A Systematic Literature Review

Introduction: Synthesis of evidence on rates, definitions and outcomes of indicators of suboptimal treatment with conventional therapies (CTs) in patients with ulcerative colitis (UC) are needed to clarify interpretation of study outcomes, inform future study designs, and develop predictive risk tools for early identification of suboptimal treatment with CT for treatment escalation and optimization. Methods: A systematic literature review following Cochrane Collaboration and PRISMA guidelines was conducted for studies assessing definitions and rates of indicators of suboptimal treatment and disease burden with CTs (5-ASAs, corticosteroids, immunomodulators). It included full papers (Jan 2014–Nov 2024) and conference abstracts (Jan 2022–Nov 2024) published in English for observational cohort studies and post-hoc analyses of clinical trials of adult patients with UC. Results: Overall, 78 studies were included (Europe, 45%; United States, 21%) using medical records (69%), claims (18%), registries (8%) and surveys (5%). Among the 61 studies with indicators of suboptimal treatment with CTs, 5% explicitly defined ‘suboptimal’ for assessment of CTs, 39% defined ≥1 suboptimal indicator, and 56% had undefined suboptimal indicators. Given differences in study designs and indicator definitions, findings may not be comparable across studies. Disease burden associated with indicators of CT suboptimal treatment was high with nearly double the rate of inpatient visits and higher medical and drug costs compared with those without suboptimal indicators. Studies showed that few patients transitioned to an advanced therapy (AT) including 5.9% switching to AT in a US study (mean follow-up, 2.3 years) and low biologic use in the 6th line (14.2%; mean follow-up, 3.2 years) in a Japanese study. Four studies assessed predictive risk factors of indicators of 5-ASA suboptimal treatment, with greater disease extent and higher disease activity as common significant predictors. Conclusion: Although definitions and study designs varied, many patients with UC receiving CTs had an indicator of suboptimal treatment and higher disease burden and costs. Few patients transitioned to an AT over the study periods, suggesting a need for validated predictive models or clinical scoring tools that may aid with appropriate escalation of therapy.