Ciclosporin and infliximab have demonstrated short-term similar efficacy as second-line therapies in patients with acute severe ulcerative colitis refractory to intravenous steroids.
Dr David Laharie and colleagues from France assessed long-term outcome of patients included in a randomized trial comparing ciclosporin and infliximab.
Between 2007 and 2010, 115 patients with steroid-refractory acute severe ulcerative colitis were randomized in 29 European centres to receive ciclosporin or infliximab in association with azathioprine.
The team followed patients until death or last news up to 2015.
Colectomy-free survival rates at 1 and 5 years and changes in therapy were estimated through Kaplan-Meier method and compared between initial treatment groups through log-rank test.
The researchers found after a median follow-up of 5 years, colectomy-free survival rates at 1 and 5 years were, respectively, 71% and 62% in patients who received ciclosporin and 69% and 65% in those who received infliximab .
Cumulative incidence of first infliximab use at 1 and 5 years in patients initially treated with ciclosporin was, respectively, 46% and 57% .
The team noted that only 4 patients from the infliximab group were subsequently switched to ciclosporin.
The researchers found that 3 patients died during the follow-up, none directly related to ulcerative colitis or its treatment.
Dr Laharie's team comments, "In this cohort of patients with steroid-refractory acute severe ulcerative colitis initially treated by ciclosporin or infliximab, long-term colectomy-free survival was independent from initial treatment."
"These long-term results further confirm a similar efficacy and good safety profiles of both drugs and do not favour one drug over the other."