Drugs For Acute Severe Ulcerative Colitis Assessed

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Irritable-Bowel Syndrome
Article Date: 19 Sep 2008 - 6:00 PDT

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The National Institute for Health Research Health Technology Assessment (NIHR HTA) programme has funded a £1.6 million clinical trial to compare two powerful drugs for people with steroid resistant acute severe ulcerative colitis (UC). UC affects approximately 150,000 people in the UK and is a major burden on patients and NHS resources, as it often leads to severe morbidity, grossly impaired quality of life, frequent and long inpatients stays and emergency colectomy.

Recent studies have reported that infliximab and ciclosporin are effective in treating patients with chronic UC resistant to oral steroids, but there is a lack of evidence in acutely ill patients. NICE have recently highlighted the need for a large, high-quality trial to address in particular the long-term impact on patient outcomes, and costs. Researchers led by Professor John G Williams of Swansea University will use a two arm trial to compare the clinical and cost-effectiveness of infliximab and ciclosporin over a ten year period. They aim to recruit around 480 patients across 40 centres in the UK to assess and compare quality of life, death rates, colectomy, severe illness, NHS and patient borne costs, and patient views after these treatments.

"UC is a chronic debilitating disease and is one of the most important conditions seen by gastroenterologists. Acutely ill patients who do not respond to steroid treatment usually require surgical removal of the large bowel." says Professor Williams. "Few alternative treatments exist for severe steroid-resistant UC, so it is important that this research is conducted to help identify whether infliximab and ciclosporin are cost-effective options with proven benefits for this group of patients."

To view the full project details visit http://www.hta.ac.uk/1737

Notes

1. The HTA programme is a programme of the National Institute for Health Research (NIHR) and produces high quality research information about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest of the NIHR programmes and publishes the results of its research in the Health Technology Assessment journal, with over 440 issues published to date. The journal's 2007 Impact Factor (3.87) ranked it in the top 10% of medical and health-related journals. All issues are available for download free of charge from the website, http://www.hta.ac.uk The HTA programme is coordinated by the NIHR Coordinating Centre for Health Technology Assessment (NCCHTA), based at the University of Southampton.

2. The National Institute for Health Research provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained and managed as a national research facility. The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the Government and its partners alongside high-quality patient care, education and training. Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients.

National Institute for Health Research

University of Southampton