P246. Disease control and unmet needs among moderate to severe ulcerative colitis patients treated with conventional therapies in Europe: The UC CARES (Ulcerative Colitis condition, attitude, resources and educational study) study
G. Van Assche1, L. Peyrin-Biroulet2, T. Fan3, M. Lynam4, S. Rojas-Farreras4, Q. Ding3, 1University Hospital Leuven, Gastroenterology, Leuven, Belgium, 2Nancy University Hospital, Université de Lorraine, Gastroenterology and Hepatology, Vandoeuvre-les-Nancy, France, 3Merck & Co., Inc, Global Health Outcomes, Whitehouse Station, United States, 4IMS Health, Health Economics and Outcomes Research, Barcelona, Spain
A large proportion of moderate to severe ulcerative colitis (UC) patients rely on conventional therapies (5-ASA, steroids and/or thiopurine) to maintain remission. No prior study has comprehensively evaluated their effectiveness in disease control in real world clinical practice.
Patients with moderate to severe active UC (Mayo score ≥6), aged ≥18 years who received conventional therapies during the 12 months prior to the enrollement date were recruited from 46 hospitals across the following 11 European countries: Belgium, France, Germany, Greece, Italy, The Netherlands, Spain, Sweden, Switzerland, Turkey, and The United Kingdom. Patients who received biologics, colectomy procedure or ileo-anal J-pouch reconstruction were excluded. Medical charts for the last 12 months were reviewed to collect clinical data and patient-completed questionnaires were administrated to collect information on satisfaction with UC treatment, Quality of Life and level of disease control. The primary endpoint was disease control, defined as maintaining remission status, measured by full or partial mayo scores, and patients had to have no corticosteroid use the past 2 months. Descriptive and multivariate analyses were performed to describe patients' disease control status, treatment satisfaction, and factors associated with these outcomes.
A total of 253 patients were included in the final analysis. Patients' mean age was 46.6 (SD =16.2) and 59% were male. The median duration of UC was 6.5 years (IQR 2.3–14.1). Extent of UC included 21.1% proctitis, 28.3% left-sided, and 49.8% extensive. At the enrollment date, the percentages of patients receiving thiopurines, aminosalicylates, corticosteroids and other types of immunosuppressants were 63.2%, 76.5%, 23.9% and 3.6%, respectively. The mean Mayo score was 6.2 (SD=3.1) 12 months ago and 4.9 (SD=3.0) at the enrollment date. 83.2% of patients did not achieve disease control. Specifically, 81% of patients were not in remission at the enrollment date and 23.9% were treated with corticosteroids in the previous 2 months. Overall, 47.8% of patients were not satisfied with current UC therapies, and 74.4% still have uncontrolled UC according to endoscopy results, indicating active inflammation. The correlation coefficient between perceived severity and objective measures of disease status was 0.5.
The majority of biologics naïve UC patients were not under control and half of patients were dissatisfied with their UC treatment.
There was a significant gap between disease control perceived by patients and control measured objectively.
A tight disease control and step-up in therapy should be considered in UC patients who did not achieve full disease control while on standard medications.