In this large multi-centre study two treatments for severe active ulcerative colitis (UC) were compared in adults. Severe active ulcerative colitis is the most concerning form of the disease and lack of response to medical treatments can lead to colectomy. The patients in this study had not responded to the standard first treatment (high dose steroids) and were given either ciclosporin or infliximab after a random selection. All patients in both treatment groups were also taking azathioprine. 115 adults from many centres around Europe took part in this study; 58 received ciclosporin and 57 received infliximab. The study looked at various outcomes and was designed to identify treatment failure at any time.
No significant differences were found between treatment with ciclosporin and infliximab. Treatment failure at day 98 was seen in 60% of patients given ciclosporin compared to 54% given infliximab. At the start of treatment if patients showed improvement they did so within 7 days in both groups. 16% of patients treated with ciclosporin and 25% of those treated with infliximab had problems with the treatment. This mainly involved worsening of symptoms but included other problems such as severe infections and liver or kidney disease. 17% of patients taking ciclosporin and 21% of patients taking infliximab had a colectomy for disease that did not respond to treatment.
This is the first study to compare the two most common treatments for severe active UC that is unresponsive to steroids. From the results of previous studies, ciclosporin may have been expected to work better than infliximab but this study showed no difference. The authors concluded that the choice of which drug to use should come down to the local hospital experience.
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