Abstract

BACKGROUND: Real-world patients with ulcerative colitis (UC) in remission have reported impairment in many patient-reported outcome (PRO) measures. This study examined factors associated with PROs among UC patients in the Corrona Inflammatory Bowel Disease (IBD) Registry who were in remission. METHODS: Analysis included patients enrolled in the Corrona IBD Registry from May 3, 2017 through September 3, 2019 with a diagnosis of UC who were in remission (defined as partial Mayo score of <2) at the time of enrollment. Patient-Reported Outcomes Measurement Information System (PROMIS) and the Work Productivity and Activity Impairment (WPAI) questionnaires were collected at enrollment. Descriptive statistics were used to describe patient enrollment characteristics and were stratified by PROMIS status (moderate/severe ≥60 vs normal/mild <60) for Fatigue, Pain Interference, and Anxiety domains, and by WPAI impairment status (any vs none) for Presenteeism, Work Productivity Loss, and Activity Impairment domains. Characteristics with absolute standardized mean differences >0.10 suggest meaningful differences between groups defined by PRO impairment. RESULTS: Among patients enrolled in the registry, 731 were diagnosed with UC and 385 were in remission. UC patients in remission who reported moderate/severe fatigue were more likely to have a history of arthritis (n = 10/54,18.5% vs n = 26/325, 8.0%), had an earlier age of disease onset (mean, 33.4 vs 39.0 years), and increased urgency of defecation (n = 16/54, 29.6% vs n = 52/325, 16.0%) than those with normal/mild fatigue. Additionally, a higher proportion of patients with moderate/severe fatigue reported a history of corticosteroid use (n = 33/54, 61.1% vs n = 156/325, 48.0%), a history of antibiotic use (n = 15/54, 27.8% vs n = 49/325, 15.1%), as well as a shorter duration of current IBD treatment (mean, 2.3 vs 3.3 years).These treatment trends were also seen in patients who reported moderate/severe pain interference and anxiety vs normal/mild. A higher proportion of patients with moderate/severe fatigue reported current biologic treatment (n = 23/54, 42.6% vs n = 109/325, 33.5%) compared with those who reported normal/mild scores. Overall, those in remission reporting any Presenteeism impairment were more likely to have a history of arthritis (n = 11/97, 11.3% vs n = 11/157, 7.0%), to have greater urgency of defecation (n = 26/97, 26.8% vs n = 24/157, 15.3%), and to be currently treated with corticosteroids (n = 11/97, 11.3% vs n = 11/157, 7.0%) compared with those who reported none. The same trends were seen in those reporting any Work Productivity Loss: history of arthritis, n = 10/93 (10.8%) vs n = 10/144 (6.9%); urgency of defecation, n = 26/93 (28.0%) vs n = 23/144 (16.0%); and current corticosteroid treatment, n = 10/93 (10.8%) vs n = 10/144 (6.9%). In UC patients in remission reporting any Activity Impairment, the trend was seen for history of arthritis (n = 19/167, 11.4% vs n = 18/217, 8.3%), and urgency of defecation (n = 43/167, 25.7% vs n = 28/217,12.9%). CONCLUSION: Despite being in remission based on partial Mayo Score, patients with UC who reported impaired work productivity or had elevated fatigue, anxiety, or pain interference were more likely to have a history of arthritis and urgency. History of steroid use was seen more often in patients with impaired PROMIS scores. Further investigation is needed to address the unmet medical needs in these patients.

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