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

Digestive and Liver Disease, In Press, Accepted Manuscript, Available online 29 January 2016

Abstract

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.

Keywords: Inflammatory bowel disease, control of disease, health related quality of life, unmet needs.

Footnotes

a Division of Gastroenterology, University Hospitals Leuven, Leuven Belgium

b Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France

c Department of Gastroenterology, DRK Kliniken Berlin I Westend, Berlin, Germany

d Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

e Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK

f Gastroenterology Practice, Minden, Germany

g Department of Gastroenterology, Evangelismos Hospital, Athens, Greece

h IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy

i Gastroenterology and IBD Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull, United Kingdom

j IMS Health, Real World Evidence Solutions, Barcelona, Spain

k Merck & Co., Inc. 126 E. Lincoln Avenue, Rahway, NJ

Corresponding author. Division of Gastroenterology, Leuven University Hospitals, 49 Herestraat, BE 3000, Leuven, Belgium,Tel.: +32 16 34 42 25.