Ciclosporin no more effective than infliximab in severe UC

Oct 18 2012

Ciclosporin and infliximab have similar efficacy for the treatment of patients with refractory severe ulcerative colitis (UC), show the findings of a multinational trial.

"Contrary to our initial hypothesis, ciclosporin was not more effective than infliximab in patients with acute severe [UC] refractory to intravenous steroids," write David Laharie (Université Bordeaux, France) and colleagues in The Lancet. They explain that an absence of head-to-head data has prevented guidance over the superiority of either agent.

The 98-day trial was conducted at 27 centers in France, Spain, Belgium, and Finland. Overall, 115 patients with acute severe UC, who had not responded to at least 5 days of intravenous steroids, were randomly assigned to receive intravenous ciclosporin 2 mg/kg per day or infliximab 5 mg/kg at baseline and again on days 14 and 42.

At day 98, there was no significant difference in the percentage of patients with treatment failure which was 60% in the ciclosporin group and 54% in the infliximab group. The number of patients with a clinical response at day 7 was also similar at 86% in the ciclosporin group and 84% in the infliximab group. Overall, 17% of patients in the ciclosporin group underwent colectomy during the study, as did 21% of the infliximab group.

There were also no statistical differences in terms of mucosal healing or time to clinical response between the two groups.

The use of infliximab for refractory UC has been controversial as there are limited data to support its use in this group of patients, while the use of ciclosporin has been limited by concerns over toxicity.

Laharie and colleagues conclude that their results do not favor one drug over another and that treatment should therefore be physician- and center-guided.

However, in an accompanying comment, Barrett Levesque and William Sandborn (both from University of California, San Diego, USA) say that they expect the findings to change clinical practice: "Because of ciclosporin's lack of clear superiority, its administration difficulties and unfavorable safety profile, and the inability to give it as maintenance treatment (because of toxic effects), we suspect that most practitioners will preferentially give infliximab in this population."

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