Abstract

INTRODUCTION: ICONIC is an observational study assessing disease burden in adults with ulcerative colitis (UC) under routine care over 2 years. The final analysis of the study is presented. METHODS: Adults with early UC (diagnosed ≤36 months) were enrolled irrespective of disease severity or treatment. The primary objective was to evaluate Pictorial Representation of Illness & Self-Measure (PRISM) as a tool to assess disease associated suffering. Lower PRISM scores represent greater suffering associated with illness. Correlation between pt and physician perception of disease was also assessed. Patient self-assessments included PRISM, Patient Health Questionnaire-9 (PHQ-9), Short IBD Questionnaire (SIBDQ), and patient-modified Simple Clinical Colitis Activity Index (P-SCCAI). Physician assessments included clinical parameters, PRISM, and SCCAI. Data are presented as-observed. Mean differences between pt and physician measures, and differences between the 2-year and first visits were calculated using Wilcoxon signed-rank test. Correlation between PRISM and SIBDQ, PHQ-9, and SCCAI were performed using Spearman correlation. RESULTS: A total of 1806 patients were enrolled; 336 (18.6%) discontinued the study. 2-year data were available for 1265 pts. Mean ± SD patient-reported PRISM score and P-SCCAI were significantly different than the physician measures, with pts reporting higher disease burden than that perceived by the physician (pt PRISM: 5.1 ± 2.5 and physician PRISM: 5.6 ± 2.4; P < 0.0001; P-SCCAI: 2.5 ± 2.8 and SCCAI: 1.3 ± 2.1; P < 0.0001; Table 1). A high correlation was observed between pt and physician PRISM scores and between P-SCCAI and SCCAI. Mean ± SD scores for PHQ-9 and SIBDQ were 4.2 ± 4.6 and 55.7 ± 11.6, respectively. Significant differences in mean ± SD scores between the 2-year visit and the first visit were observed for all measures (PHQ-9: -1.8 ± 5.5; P-SCCAI: -1.6 ± 4.0; SCCAI: -1.5 ± 3.2, SIBDQ: 6.8 ± 13.9; patient pt PRISM: 1.2 ± 3.0; physician PRISM: 1.3 ± 2.9; P < 0.0001 for all measures). CONCLUSION: PRISM may be a valuable tool to assess disease burden in pts recently diagnosed with UC. Although pt and physician measures of disease related suffering and disease severity were strongly correlated, the perception of UC-related burden significantly differed between physician- and pt- assessments. These discrepancies between pt and physician ratings warrant further investigation.

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