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Published on 17 May 2016

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Almost half of patients with UC using conventional therapies are dissatisfied with their treatments

MSD, known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada, announced the publication of two papers1 for the pan-European Ulcerative Colitis Condition, Attitude, Resources and Educational Study (UC CARES), the first study conducted to assess patients’ perception of disease burden and unmet clinical needs in moderate-to-severe ulcerative colitis (UC).2

MSD, known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada, announced the publication of two papers1 for the pan-European Ulcerative Colitis Condition, Attitude, Resources and Educational Study (UC CARES), the first study conducted to assess patients’ perception of disease burden and unmet clinical needs in moderate-to-severe ulcerative colitis (UC).2

UC CARES shows that the majority (87.2%; n=218) of the 250 patients with moderate-to-severe UC treated with conventional therapies (not biologics) failed to achieve controlled disease status*,2 and nearly half of all patients in the study (48%; n=117) were not satisfied with their current UC treatments, (including corticosteroids, aminosalicylates [5-ASA], and thiopurine immunomodulators [AZA and 6-MP].1

Treatment attributes reported by patients as the most important were effectiveness (96.9%), long-lasting action (89.1%), rapidity of action (83.8%) and reduced number of side effects (81.8%).1 Mode of administration, dosing frequency and financial costs to the patient were of lower importance to patients (25.3%, 32.3% and 31% respectively).1

*Defined as maintaining remission status, measured by full or partial Mayo scores (both < or =2 with no individual sub-score >1) -the scoring system used to assess UC activity- and no corticosteroid use in the past two months.2

The UC CARES results clearly show that disease control is suboptimal in many patients with moderate to severe ulcerative colitis”, says Dr Gert Van Assche, Head of the Division of Gastroenterology and Hepatology at the University Hospitals of Leuven, Belgium. “In a cross-sectional analysis of IBD clinic visits, the disease was not controlled without steroids in the majority of patients.

Additional data from UC CARES show that 25.4% of patients reported unmet clinical needs (determined by: uncontrolled disease, patient self-perception of ‘moderate’ or ‘severe’ disease activity, and dissatisfaction with current treatments),1 presenting a medical challenge to gastroenterology physicians.

Dr Van Assche comments, “Not only were many patients’ abdominal and extra-intestinal IBD-related symptoms not adequately controlled, but also their quality of life and work productivity were suboptimal. The results emphasise once again the need for continuous remission, close monitoring and patient empowerment.

Patient-reported health-related quality of life (HRQoL) and work productivity and impairment (WPAI) data were collected via validated questionnaires, including EQ-5D-5L. Controlled-disease patients showed a trend for better HRQoL than uncontrolled-disease patients.2 HRQoL and work productivity were significantly impaired in patients with uncontrolled disease.2 Both controlled- and uncontrolled-disease patients who were employed at the start of the study were assessed as having a 10% work impairment overall,2 and statistically significant differences in activity impairment were observed between non-controlled and controlled patients (20.0% versus 0.0%; respectively; P = 0.0244).

Patient perception of their disease as ‘normal’ or ‘in remission’ tended towards better self-reported HRQoL and better work productivity.2 Although most patients (82.8%) agreed that their doctor cares about how UC affects their lives, 77.5% of patients believe that their doctor does not understand difficulties related to living with UC.1

UC CARES demonstrates that patient-reported control of their UC is more closely aligned to HRQoL and work productivity measures than control of disease according to clinical measurement of symptoms, such as Mayo Score, suggesting endoscopy results, for example, are not always an accurate reflection of a patient’s day-to-day experience of the condition.2

Our real-world data on patient-reported outcomes such as HRQoL and work productivity suggests that physicians may underestimate the impact and disease burden of UC on the lives of their patients”, says Dr Peyrin-Biroulet, Head of the IBD Unit at the University Hospital of Nancy, France. “Measuring only the clinical markers of IBD control may leave gaps, and patients undertreated. Patients are looking for effectiveness and long-lasting action that helps them return to a normal life. While physicians are now well aware of disease burden in their Crohn’s disease patients, the impact of UC on patients requires greater understanding and recognition.

 

References

  1. Peyrin-Biroulet L et al. Treatment satisfaction, preferences and perception gaps between patients and physicians in the Ulcerative Colitis CARES Study: A real world-based study. Digestive and Liver Disease 2016;48:601–7. Also available online at http://www.dldjournalonline.com/article/S1590-8658(15)30044-X/pdf.
  2. Van Assche G et al. 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 2016; 48:592–600. Also available online at http://www.dldjournalonline.com/article/S1590-8658(15)30235-8/pdf.


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