Abstract
IntroductionICONIC is the largest prospective, multi-country observational study assessing cumulative disease-associated burden in adults with ulcerative colitis (UC) under routine care. This local subanalysis evaluated patient worries and concerns over 2 years in UK patients using the Rating Form of Inflammatory Bowel Disease (IBD) Patient Concerns (RFIPC) questionnaire.MethodsAdults with early UC (diagnosed ≤36 months) were included irrespective of treatment regimen/disease severity. Patients completed RFIPC (a 25-item questionnaire about frequently reported worries/concerns in IBD) at each visit (6-month intervals). Responses are scored on a 10-cm visual analogue scale (0=‘no concerns’ to 10=‘a great deal’; total score=mean of all items). Data are reported using descriptive statistics at baseline (BL, visit 1 [V1]), 1-year (V3), and 2-years (V5) and scores stratified by physician-assessed disease severity (in remission, mild, moderate, severe) at BL.Results63 patients were included (37 [59%] female; mean±SD age 43.4±15.7 years; median time since diagnosis 126 days; physician-assessed severity: in remission 16 [25%], mild 18 [29%], moderate 18 [29%], severe 11 [17%]). Mean±SD total RFIPC scores for all patients were 2.9±2.3 (n=63) at V1, 2.7±2.5 (n=40) at V3, and 2.2±2.0 (n=35) at V5. At BL, mean±SD RFIPC total scores by disease severity were: in remission 1.8±1.7, mild 3.2±1.9; moderate 2.6±2.6; severe 4.8±2.4. The changes from BL to V5, stratified by disease severity at BL, were: in remission -0.2±1.0, mild -1.2±1.4; moderate -0.7±1.7; severe -2.2±2.7. The specific concerns with the highest scores (mean RFIPC score >4.0) at BL were ‘energy level’, ‘having an ostomy bag’ and ‘effects of medication’; the mean total scores for these items decreased between V1 and V5 for all patients. Of 5 UK sites, all had established multidisciplinary teams (MDTs) and 4 had a psychologist in situ.ConclusionDespite all centres having MDTs and most having onsite psychologists, this subanalysis from ICONIC demonstrated a high burden of worries and concerns in early UC patients with more severe disease. Concerns were most notable at BL, appearing to decrease over time. The greatest concerns were with treatment and complications of UC, including energy levels, indicating fatigue remains an unmet need for UC patients.