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
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References
- Medical and surgical management of chronic ulcerative colitis.Archives of Surgery. 2005; 140: 300-310
- Immune dysfunction in inflammatory bowel disease.Translational Research. 2007; 149: 173-186
- Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review.Gastroenterology. 2012; 142 (46–54.e42; quiz e30)
- Current approaches to the management of new-onset ulcerative colitis.Clinical and Experimental Gastroenterology. 2014; 7: 111-132
- Direct and indirect healthcare resource utilization and costs associated with ulcerative colitis in a privately-insured employed population in the US.Journal of Medical Economics. 2015; 18: 447-456
- Current misunderstandings in the management of ulcerative colitis.Gut. 2011; 60: 1294-1299
- Influence of inflammatory bowel disease on different dimensions of quality of life.European Journal of Gastroenterology and Hepatology. 2001; 13: 567-572
- Systematic review: the costs of ulcerative colitis in Western countries.Alimentary Pharmacology and Therapeutics. 2010; 31: 693-707
- European Crohn's and Colitis Organization Guidelines: Second European evidence-based consensus on the diagnosis and management of ulcerative colitis.2012 ([accessed 02.09.15])
- The SIBDQ: further validation in ulcerative colitis patients.American Journal of Gastroenterology. 2000; 95: 145-151
- Clinical status, psychosocial impairments, medical treatment and health care costs for patients with inflammatory bowel disease (IBD) in Germany: an online IBD registry.Journal of Crohn's and Colitis. 2013; 7: 355-368
- Treating beyond symptoms with a view to improving patient outcomes in inflammatory bowel diseases.Journal of Crohn's and Colitis. 2014; 8: 927-935
- An optimized patient-reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index.Inflammatory Bowel Diseases. 2014; 20: 1070-1078
- Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L).Quality of Life Research. 2011; 20: 1727-1736
Euroqol publications. http://www.euroqol.org/about-eq-5d/publications.html (accessed 2 September 2015).
- Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease.Health and Quality of Life Outcomes. 2004; 2: 12
- The validity and reproducibility of a work productivity and activity impairment instrument.PharmacoEconomics. 1993; 4: 353-365
- Treatment of ulcerative colitis.Current Opinion in Gastroenterology. 2014; 30: 84-96
- Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort.Gastroenterology. 2007; 133: 412-422
- Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study).Scandinavian Journal of Gastroenterology. 2009; 44: 431-440
- Surveillance of patients with chronic ulcerative colitis. WHO Collaborating Centre for the Prevention of Colorectal Cancer.Bulletin of the World Health Organization. 1991; 69: 121-126
- Perception gaps between patients with ulcerative colitis and healthcare professionals: an online survey.BMC Gastroenterology. 2012; 12: 108
- Clinical aspects and pathophysiology of inflammatory bowel disease.Clinical Microbiology Reviews. 2002; 15: 79-94
- Health-related quality of life improves during one year of medical and surgical treatment in a European population-based inception cohort of patients with Inflammatory Bowel Disease – an ECCO-EpiCom study.Journal of Crohn's and Colitis. 2014; 8: 1030-1042
- Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2014; 146 (96–109.e1)
- Biologic therapy in inflammatory bowel disease.Danish Medical Journal. 2013; 60: B4652
- Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2014; 146: 85-95
- Psychological disorders in gastrointestinal disease: epiphenomenon, cause or consequence?.Annals of Gastroenterology. 2014; 27: 224-230
- Personality dimensions and type D personality in female patients with ulcerative colitis.International Journal of Research in Medical Sciences. 2012; 17: 898-904
- The INSPIRE study: are different personality traits related to disease-specific quality of life (IBDQ) in distressed patients with ulcerative colitis and Crohn's disease?.Inflammatory Bowel Diseases. 2008; 14: 680-686
- Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis.Inflammatory Bowel Diseases. 2007; 13: 1135-1140
- The influence of demographic and disease-related factors on health-related quality of life in patients with ulcerative colitis.European Journal of Gastroenterology and Hepatology. 2003; 15: 1011-1020
- Relationship between disease severity and quality of life and assessment of health care utilization and cost for ulcerative colitis in Australia: a cross-sectional, observational study.Journal of Crohn's and Colitis. 2014; 8: 598-606
- Health-related quality of life in patients with ulcerative colitis after a 10-year disease course: results from the IBSEN study.Inflammatory Bowel Diseases. 2012; 18: 1540-1549
- Clinical outcomes in continuous clinical responders with moderately to severely active ulcerative colitis: sub-analyses from the Pursuit-SC maintenance study.2014
- Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease.Clinical Gastroenterology and Hepatology. 2014; 12 (1246–1256.e6)
- Treatment of ulcerative colitis from the patient's perspective: a survey of preferences and satisfaction with therapy.Alimentary Pharmacology and Therapeutics. 2009; 29: 1114-1120
- An exploration of the follow-up up needs of patients with inflammatory bowel disease.Journal of Crohn's and Colitis. 2013; 7: e386-e395
- Impact of ulcerative colitis from patients’ and physicians’ perspectives: results from the UC: NORMAL survey.Inflammatory Bowel Diseases. 2009; 15: 581-588
- Mood disorders in inflammatory bowel disease: relation to diagnosis, disease activity, perceived stress, and other factors.Inflammatory Bowel Diseases. 2012; 18: 2301-2309
Article info
Publication history
Published online: February 26, 2016
Accepted:
January 18,
2016
Received:
September 30,
2015
Identification
Copyright
© 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.