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Abstracts

P039  Factors Associated with Impaired Patient-Reported Outcomes and Work Productivity Among Patients with Crohn’s Disease in Remission

AIBD

P039  Factors Associated with Impaired Patient-Reported Outcomes and Work Productivity Among Patients with Crohn’s Disease in Remission
 


Hudesman David1, Sauk Jenny2, Zhuo Joe3, Harrison Ryan4, Kerti Samantha4, Emeanuru Kelechi4, Ahmad Harris3, Sreih Antoine3, Nguyen Joehl3, Cross Raymond5, Horst Sara6
1 NYU Langone Health, New York City, United States, 2 Ronald Reagan UCLA Medical Center, Los Angeles, United States, 3 Bristol Myers Squibb, Princeton, United States, 4 Corrona, LLC, Waltham, United States, 5 University of Maryland School of Medicine, Baltimore, United States, 6 Vanderbilt University Medical Center, Nashville, United States

BACKGROUND: We have previously observed poor patient-reported outcomes (PROs) in patients with Crohn’s disease (CD). In this analysis, we investigated differences in enrollment characteristics between CD patients in remission reporting impaired PROs versus those without impairment within the Corrona Inflammatory Bowel Disease (IBD) Registry.

METHODS: Analysis included patients, enrolled in the Corrona IBD Registry from May 3, 2017 through September 3, 2019, with a diagnosis of CD who were in remission (defined as Harvey-Bradshaw Index <5) at the time of enrollment. Patient-Reported Outcomes Measurement Information System (PROMIS) and Work Productivity and Activity Impairment (WPAI) questionnaires were collected at enrollment. Descriptive statistics were used to describe patient enrollment characteristics and stratified by PROMIS status (moderate/severe, ≥60 vs normal/mild, <60) for Sleep Disturbance, 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: At the time of the study, a total of 812 CD patients were enrolled in the Corrona IBD Registry, of whom 547 were in remission and included in the analysis. Compared with patients who reported normal/mild fatigue, patients with moderate/severe fatigue had a higher proportion of ileocolonic disease location (n=41/103, 39.8% vs n=147/439, 33.5%); this was also seen in the Sleep Disturbance and Anxiety domains. Patients with moderate/severe fatigue were younger (mean age, 42.5 vs 47.9 years) and were more likely to be obese (body mass index ≥30: 32.0% vs 26.0%) than those with normal/mild fatigue. Additionally, a greater proportion with moderate/severe fatigue reported a history of extraintestinal manifestations such as arthritis (n=20/103, 19.4% vs n=60/439, 13.7%) and skin manifestations (n=5/103, 4.9% vs n=12/439, 2.7%). There were no meaningful differences in PROMIS scores (mild/normal vs moderate/severe impairment) in CD patients in remission on biologics with the exception of a lower proportion of patients with moderate/severe pain interference. The impaired Presenteeism group had differences in disease location and behavior, with more impaired patients reporting ileal disease location (n=81/192, 42.2% vs n=62/176, 35.2%), as well as a greater proportion with penetrating disease (n=27/190, 14.2% vs n=19/173,11.0%), compared with non-impaired patients. The same trend was seen for patients reporting any work productivity loss rather than none: ileal, n=81/188 (43.1%) versus n=53/158 (33.5%); and penetrating disease, n=27/186 (14.5%) versus n=17/155 (11.0%), respectively. Corticosteroid use was higher among patients with impaired Presenteeism (n=24/192,12.5% vs n=12/176, 6.8%), Work Productivity Loss (n=24/188, 12.8% vs n=11/158, 7.0%), or Activity Impairment (n=40/311, 12.9% vs n=18/234, 7.7%); however, there were no differences seen in the proportions of patients currently on biologics.

CONCLUSION(S): Overall, in CD patients in remission, disease location, phenotype, extraintestinal manifestations, and steroid use were associated with impaired status on either PROMIS or WPAI measures, or both. This highlights the need for more effective treatment strategies for CD to address patient quality of life outcomes not conventionally captured by measures of clinical remission.

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