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