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P410 Extraintestinal manifestations and quality of life in patients with ulcerative colitis: 1-year data from ICONIC

S. Ghosh*1, F. Casellas2, C. O’Shea3, M. Leonard3, J. Petersson4, L. Peyrin-Biroulet5

1University of Birmingham, Birmingham, UK, 2Crohn-Colitis Care Unit (UACC), Hospital Universitari Vall, Vall d'Hebron, Spain, 3AbbVie Ltd., Dublin, Ireland, 4AbbVie Inc., North Chicago, Illinois, USA, 5University of Lorraine, Nancy, France

Background

In addition to their primary disease, ulcerative colitis (UC) patients may concomitantly suffer from extraintestinal manifestations (EIMs), increasing overall disease-related burden. Impact of EIM-augmented burden to patients is poorly understood. ICONIC is the largest ongoing, prospective, multicountry (n = 33) observational study assessing cumulative UC disease burden in patients receiving routine standard of care. Disease severity, activity, and life impact were captured at 6-month intervals through 2 years. This analysis assessed global and regional EIM-associated burden from 1 year of ICONIC.

Methods

Adults with early UC (diagnosed ≤36 months) were enrolled irrespective of disease severity or treatment. EIM presence and impact at baseline and over 1 year were assessed, focussing on health-related quality of life (HRQoL) measures: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and anxiety/depression (Patient Health Questionnaire-9 [PHQ9]). Patients were stratified by physician-assessed baseline disease severity (severe, moderate, mild, in remission). Regional differences in EIM burden and associated site services supporting EIM management were also evaluated. Observed data using descriptive statistics are presented; statistical comparison was performed using Fischer’s exact test.

Results

Of 1794 patients with evaluable 1-year data, 14.1% (n = 253) presented with ≥1 EIM at baseline. At 1 year, 20.1% (n = 361) patients had EIMs, with 3.5% of patients (62/1794) presenting new-onset EIMs at 6 months and 2.6% (46/1794) at 1 year (42.7% increase from baseline to 1 year). Rheumatoid arthritis, ankylosing spondylitis, and erythema nodosum were the most common EIMs. Japan had the lowest overall EIM rate over 1 year (4.3%; 5/117); Western Europe/Canada had a 5.2-fold higher total EIM rate over the same period (22.2%; 184/830). Patients with moderate or severe baseline disease had a significantly higher total EIM rate over 1 year (24.2% or 28.0%, respectively) vs. those with mild disease (14.8%) or in remission (16.1%) at baseline (p < 0.0001). For total study population or when stratified by region, patients with ≥1 EIM had higher PHQ9 and lower SIBDQ mean scores over 1 year vs. patients with no EIMs. Of 231 global sites, 134 (58%) had established multi-disciplinary teams (MDTs) and 86 (37.2%) psychologist in situ.

Conclusion

New-onset EIMs are common in UC, even after 1 year disease course. EIM presence is associated with poorer HRQoL. Despite regional EIM differences, overall EIM impact on HRQoL was similar across the global study population. EIM-augmented patient burden is a concern in UC, and, with >40% sites lacking MDTs and >60% sites lacking in situ psychologists, awareness of EIM impact is essential.