The Association Between Disease Activity and Patient-Reported Outcomes in Patients With Moderate-to-Severe Ulcerative Colitis in the United States

Abstract

Introduction: Patients with ulcerative colitis (UC) experience periods of recurring and episodic clinical signs and symptoms. This study sought to establish the association between disease activity and healthrelated quality of life and other patient-reported outcomes. Methods: Data from the 2015 and 2017 Adelphi Inflammatory Bowel Disease Specific Programmes (IBD-DSP) were used. The IBD-DSP is a database of patient chart information abstracted by selected gastroenterologists across the United States (US). Eligible gastroenterologists who agreed to participate were asked to complete patient record forms for their next seven consecutive eligible adult patients with UC. Using available chart information (including endoscopy results based on Mayo scoring), physicians classified their patients into one of the following categories: remission with an endoscopic Mayo subscore= 0 (“deep remission”), remission without an endoscopic Mayo subscore=0 (“remission”), or active disease. Patients were then invited to complete a survey including various patient-reported outcomes: EuroQoL-5D (EQ-5D), Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ), and Work Productivity and Activity Impairment-Ulcerative Colitis (WPAI-UC) questionnaire. Only patients with moderate-to-severe UC were included in the analysis (defined as those who had used either an immunomodulator [IM] or a biologic). Differences among disease activity categories with respect to patient-reported outcomes were analyzed using generalized linear models, controlling for demographic (age, sex) and clinical factors (body mass index, smoking history, years diagnosed, and the Charlson comorbidity index) as confounders. Results: A total of N=289 patient charts with linked surveys were included (51.2% male, mean age=42.9, SD=14.9). Patients had been diagnosed for a mean of 6.4 years (SD=7.0). 40.1% had active disease, 48.0% were in remission, and 11.9% were in deep remission. Patients with active disease reported significantly lower levels of quality of life (EQ-5D and SIBDQ) and higher levels of work and activity-related impairment as shown in Table 1. Conclusion: Among patients with moderate-to-severe UC in the US, active disease was associated with significant impairments in health-related quality of life and impairments in work and leisure activities.621 Figure 1. Adjusted means of each patient reported outcome measure by disease activity.