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Cyclosporine, infliximab similarly effective in patients with severe ulcerative colitis
Patients with steroid-refractory, acute severe ulcerative colitis treated with cyclosporine experienced similar results to those treated with infliximab in a recent study.
In a parallel, open-label controlled trial, researchers randomly assigned 115 adult patients with severe ulcerative colitis from 27 European facilities to either 2 mg/kg intravenous cyclosporine daily for 1 week, followed by 4 mg/kg orally administered treatment until day 98 (n=58); or 5 mg/kg intravenous infliximab upon initiation and on days 14 and 42 (n=57). Clinical response at day 7 resulted in both groups receiving azathioprine. Patients assigned cyclosporine maintained drug blood concentrations of 150 ng/mL to 250 ng/mL, with dose adjustments as needed. All participants previously had been unresponsive to high dosages of intravenous steroids.
Treatment failure occurred in 60% of the cyclosporine group and 54% of those receiving infliximab (P=.52 for difference). Sixteen percent of the cyclosporine group experienced adverse events compared with 25% of the infliximab group, with worsening ulcerative colitis reported most frequently.
Multivariate analysis indicated that patients aged more than 40 years (OR=2.7; 95% CI, 1.2-6.1) and hemoglobin concentrations between 95 g/L and 125 g/L (OR=2.5; 95% CI, 0.9-6.7) or greater than 125 g/L (OR=8.5; 95% CI, 2.3-31.7) were independently predictive of failure. That risk was similar between cyclosporine and infliximab before (OR=1.3; 95% CI, 0.6-2.7) and after adjusting for these factors (OR=1.4; 95% CI, 0.6-3.2).
Clinical response after 7 days occurred in 86% of the cyclosporine group and 84% of the infliximab group (P=.76 for difference). Among evaluable patients, 47% in the cyclosporine group and 45% in the infliximab group experienced mucosal healing (P=.85 for difference).
“Contrary to our initial hypothesis, cyclosporine was not more effective than infliximab in patients with acute severe ulcerative colitis refractory to intravenous steroids,” the researchers wrote. “When used in association with azathioprine, both drugs had high efficacy and good safety profiles in this difficult population. Our short-term results do not favor one drug over the other … treatment choice should be guided by physician and center experience.”
Disclosure: See the study for a full list of relevant disclosures.