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Treating severe, steroid resistant, ulcerative colitis

Date: 29 June 2016

Research published in The Lancet Gastroenterology & Hepatology has found that the two drugs commonly used to treat steroid resistant ulcerative colitis are equally effective.

Ulcerative colitis, inflammation of the colon and rectum, affects about 150,000 people in the UK. The impact on patients can include severe ill-health, grossly impaired quality of life, unplanned stays in hospital and emergency surgery.

Acute severe ulcerative colitis affects up to 25 percent of patients with ulcerative colitis, leading to unscheduled admission to hospital. Initial treatment is with intravenous steroids but about 30 percent of patients fail to respond to this, and until fairly recently, removal of the colon was the next step. Two drugs, infliximab and ciclosporin, that suppress the immune system in different ways, have been shown to work in some patients in this situation, but their comparative clinical and cost effectiveness has not previously been assessed.

A trial funded by the HTA Programme has compared the clinical and cost-effectiveness of two drugs in treating patients admitted acutely with severe colitis to 52 hospitals across the UK. 270 patients who had not improved after five days of intravenous steroids, were given either infliximab or ciclosporin in a random order.

Researchers, led by Professor John Williams of Swansea University, found that there was no difference between the drugs in terms of quality of life, colectomy rates, safety, or mortality. Although 40 percent of patients still needed to have the colon removed within one year, their quality of life had improved. Infliximab was found to be more expensive, for two reasons: firstly, patients needed to take this drug for a longer period and secondly, it was more expensive to buy.

“Our trial has shown that both infliximab and ciclosporin improve quality of life in people suffering from acute severe colitis that has not responded to intravenous steroids” commented Professor Williams. “We plan to follow the patients for ten years to monitor what happens to them, including the impact on their quality of life. Ulcerative colitis can be a very debilitating disorder, and we hope that the improvement in quality of life that we have seen is maintained long-term.”

Read the full report in Health Technology Assessment