title: Burden of disease and patient-reported outcomes in patients with moderate to severe ulcerative colitis in the last 12 months - Multicenter European cohort study.
abstract: BACKGROUND
  Treatment of ulcerative colitis (UC) is aimed at maintaining corticosteroid-free remission and improving quality of life (QoL).
  
  
  OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology, University Hospitals Leuven, Leuven, Belgium. Electronic address: gert.vanassche@uzleuven.be.
authors.forename: Gert
authors.initials: G
authors.lastname: Van Assche
authors.affiliation: Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
authors.affiliation: Department of Gastroenterology, DRK Kliniken Berlin I Westend, Berlin, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Sturm
authors.affiliation: Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica and Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
authors.forename: Javier P
authors.initials: JP
authors.lastname: Gisbert
authors.affiliation: Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Gaya
authors.affiliation: Gastroenterology Practice, Minden, Germany.
authors.forename: Bern
authors.initials: B
authors.lastname: Bokemeyer
authors.affiliation: Department of Gastroenterology, Evangelismos Hospital, Athens, Greece.
authors.forename: Gerassimos J
authors.initials: GJ
authors.lastname: Mantzaris
authors.affiliation: IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Armuzzi
authors.affiliation: Gastroenterology and IBD Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.
authors.forename: Shaji
authors.initials: S
authors.lastname: Sebastian
authors.affiliation: IMS Health, Real World Evidence Solutions, Barcelona, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Lara
authors.affiliation: IMS Health, Real World Evidence Solutions, Barcelona, Spain.
authors.forename: Mark
authors.initials: M
authors.lastname: Lynam
authors.affiliation: IMS Health, Real World Evidence Solutions, Barcelona, Spain.
authors.forename: Sonia
authors.initials: S
authors.lastname: Rojas-Farreras
authors.affiliation: Merck & Co., Inc., Rahway, NJ, United States.
authors.forename: Tao
authors.initials: T
authors.lastname: Fan
authors.affiliation: Merck & Co., Inc., Rahway, NJ, United States.
authors.forename: Qian
authors.initials: Q
authors.lastname: Ding
authors.affiliation: Merck & Co., Inc., Rahway, NJ, United States.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Black
authors.affiliation: Merck & Co., Inc., Rahway, NJ, United States.
authors.forename: Sumesh
authors.initials: S
authors.lastname: Kachroo
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003430:Cross-Sectional Studies; D005060:Europe; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D012189:Retrospective Studies; D012720:Severity of Illness Index
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal
keywords: Control of disease; Health related quality of life; Inflammatory bowel disease; Unmet needs