Burden of disease and patient-reported outcomes in patients with moderate to severe ulcerative colitis in the last 12 months - Multicenter European cohort study

BACKGROUND: Treatment of ulcerative colitis (UC) is aimed at maintaining corticosteroid-free remission and improving quality of life (QoL). AIM: Assess patients' perception of disease burden and unmet clinical needs in moderate/severe UC patients. METHODS: Adults surgery-free conventionally treated patients with Mayo score ≥6 were enrolled in an observational, cross-sectional, retrospective study in 11 European countries. Disease control was defined as Mayo score ≤2 with no sub-score >1. No corticosteroid was used the previous two months. Unmet clinical needs were defined as: non-controlled disease, self-perception of 'moderate'/'severe' disease, and dissatisfaction with treatments. Disease burden on QoL and work productivity were assessed (EuroQol-5D-5L, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and Work Productivity and Activity Impairment (WPAI) in UC questionnaire). RESULTS: UC patients (n=253) with mean Mayo score at enrolment of 4.9, 44.3% of patients had Mayo score ≥6. Main treatment was 5-ASA (75%). Overall, 25% met the composite endpoint for unmet clinical needs. Mean (SD) questionnaire scores were: EQ-5D-5L-VAS, 71 (19.1), EQ-5D-5L utility, 0.77 (0.19), SIBDQ, 4.8 (1.3), and WPAI, 26% (32%). CONCLUSIONS: Patients with moderate/severe UC in the last 12 months treated with conventional therapies felt that their disease was not controlled and 25% reported unmet clinical needs. QoL and work productivity were seriously impaired