Abstract

Abstract Background ICONIC is the largest prospective multi-country (n = 33) observational study assessing burden in adult ulcerative colitis (UC) patients under routine care. Both patient and physician assessments of disease severity, activity and life impact were captured 6 monthly up to 2 years. This local subanalysis evaluates baseline (BL) characteristics and the extent of agreement between patients and physicians in measures of disease activity in UK patients. Methods Adults with early UC (diagnosed ≤36 months) were enrolled irrespective of disease severity or treatment. Patient self-assessments include disease severity, Pictorial Representation of Illness and Self-Measure (PRISM, a tool assessing perception of disease-associated suffering; lower scores indicate greater disease burden), Patient Health Questionnaire-9 (PHQ-9), Short inflammatory bowel disease Questionnaire (SIBDQ) and patient-modified Simple Clinical Colitis Activity Index (P-SCCAI). Physician assessments include clinical parameters, PRISM, SCCAI. Correlation between PRISM and SIBDQ, PHQ-9 and SCCAI were evaluated by Spearman correlation. BL characteristics are based on observed data. Results BL characteristics of 63 UK patients in ICONIC are shown in Table 1. From BL to 2-years, patient/physician PRISM was moderately/strongly correlated with SIBDQ, PHQ-9, P-SCCAI or SCCAI (Table 2). For 62 patients with self and physician assessments, the level of agreement on disease severity at BL (concordant pairs) was: mild 66.7%, moderate 27.8%, severe 45.5%, in remission 50.0%. The mean ± SD P-SCCAI and physician SCCAI values at 2 years were 2.6 ± 2.6 and 1.5 ± 1.5, respectively; the measures were strongly correlated (Table 2). For patient/physician PRISM assessments at 2 years, scores were 5.2 ± 2.6 and 5.2 ± 2.1, respectively, and were moderately/strongly correlated (Table 2). Conclusion Results from this subanalysis of ICONIC demonstrate persistently high UC disease burden over 2-years, despite treatment. EIMs were common and therefore awareness of potential EIM impact is essential. PRISM, used for the first time in UC, was moderately correlated with disease-specific measures (SIBDQ/SCCAI) and a general depression assessment (PHQ-9). Alignment between patients and physicians on disease activity/severity varied according to the instrument used but was greatest for SCCAI.

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