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P365 Correlation between patient-reported outcomes (PROs) and patient-reported disease activity in Ulcerative Colitis (UC): Findings from the ICONIC study

Ghosh, S.(1);Casellas, F.(2);Kligys, K.(3);Sanchez Gonzalez, Y.(4);Peyrin-Biroulet, L.(5);

(1)University of Birmingham and University Hospitals Birmingham, National Health Service Trust, Birmingham, United Kingdom;(2)Hospital Universitari Vall d’Hebron, Physiology I Digestive Pathophysiology, Barcelona, Spain;(3)AbbVie Inc., Gastroenterology, North Chicago, United States;(4)AbbVie Inc., Health Economics and Outcomes Research, North Chicago, United States;(5)University of Lorraine, Gastroenterology, Nancy, France

Background

This analysis aimed to examine the correlation of patient-reported outcomes (PROs) with patient-reported disease activity, and to identify individual questions of the Patient Simple Clinical Colitis Activity Index (P-SCCAI) associated with Work Productivity and Activity Impairment (WPAI) questionnaire domains in patients from the ICONIC study.1

Methods

ICONIC enrolled unselected outpatients (N=1804) with recent-onset UC.1 Correlations between PRO measures (Rating Form of Inflammatory Bowel Disease Patient Concerns [RFIPC], Patient Health Questionnaire-9 [PHQ-9], and Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) at baseline (visit [V]1) and 2 years (V5) were assessed using Spearman’s rank correlation coefficient. WPAI domains and PHQ-9 were evaluated at V1 and V5 using a multivariable logistic regression model with individual P-SCCAI questions.

Results

Significantly higher work productivity impairment scores, lower reported quality of life (QoL), and higher worries/concerns at V1 and V5 were observed in patients with active disease (P-SCCAI ≥5) vs inactive disease (P-SCCAI <5) (Figures 1 and 2). A strong correlation (0.70–0.89) was found between the SIBDQ and the P-SCCAI and PHQ-9 (Table 1). WPAI presenteeism, total activity impairment and total work productivity impairment were moderately correlated (0.40–0.69) with P-SCCAI and PHQ-9 (Table 1). At V1, a significant positive association of disease severity and nocturnal bowel urgency was observed with WPAI presenteeism, absenteeism, and total activity impairment. At V1 and V5, lower patient-assessed PHQ-9 scores were significantly associated with female gender, no bowel urgency, and no joint pain.

Conclusion

These observational data in patients with UC suggest strong correlations between some PRO measures and patient-reported disease activity. Nocturnal bowel urgency was a key driver of total work productivity impairment, suggesting it is an important PRO to monitor when assessing overall patient QoL.

References
1. Ghosh S et al. J Crohn’s Colitis 2020;Jul 29:jjaa159. doi: 10.1093/ecco-jcc/jjaa159




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