Treatment of Ulcerative Colitis

Wojciech Blonski; Anna M. Buchner; Gary R. Lichtenstein


Curr Opin Gastroenterol. 2014;30(1):84-96. 

In This Article


Treatment with intravenous cyclosporine A has been reserved as a second-line (rescue) therapy in patients presenting with severe and corticosteroid-refractory ulcerative colitis. Alternatively, the use of anti-TNF therapy with infliximab has been also advocated in this clinical scenario. Both treatments aim at avoiding surgery and are considered to be equivalent in clinical cases of severe ulcerative colitis with the lack of response to 7 to 10-day treatment with high-dose oral or intravenous corticosteroids. No difference was found between infliximab and cyclosporine in colectomy rates after 3 months (OR = 0.86, 95% CI 0.31–2.41) and 9 months (OR = 0.60, 95% CI 0.19–1.89), in postoperative complications (OR = 1.66, 95% CI 0.26–10.50) and adverse reactions (OR = 0.76, 95% CI 0.34–1.70) based on data from recent meta-analysis of six retrospective cohort studies.[48]

A Cochrane meta-analysis of two double-blind RCTs[49,50] revealed that intravenous cyclosporine given for up to 14 days (4 mg/kg/day) along with intravenous hydrocortisone was significantly more efficacious than treatment with placebo and intravenous hydrocortisone (failure to induce remission: RR of 0.18; 95% CI 0.05–0.64) in patients with severe ulcerative colitis who did not respond to an at least 7-day course of intravenous corticosteroids and had the same effectiveness given for up to 8 days as intravenous methylprednisolone (40 mg/day) (failure to induce remission: RR of 0.71; 95% CI 0.29–1.75) in patients with severe corticosteroid-refractory ulcerative colitis.[51] Both trials reported similar time to response to cyclosporine (7 and 5.2 days).[51] The risk of colectomy was similar in both trials between treatment arms.[51] In a placebo-controlled trial with 1-month follow-up, the risk of colectomy in the cyclosporine group was similar to that of placebo (RR = 0.6; 95% CI 0.18–2.06), whereas in the methylprednisolone-controlled trial with 1-year follow-up, the risk of colectomy in cyclosporine was similar to that of methylprednisolone (RR = 1.0; 95% CI 0.24–4.18).[51] However, it should be pointed out that there is still limited evidence suggesting efficacy of cyclosporine in severe ulcerative colitis because of the small number of RCTs with the trials having a relatively small number of patients.[51]

It was suggested that cyclosporine has a role as a short-term treatment of severe ulcerative colitis serving as a bridge to either treatment with immune modulators or prior to undergoing a colectomy.[52,53] There is a lack of RCTs evaluating a large number of patients that would elucidate the efficacy of cyclosporine and AZA in avoiding colectomy.

The main adverse events associated with cyclosporine treatment such as hypertension, paresthesias and vomiting were observed in both RCTs.[51] There was no statistical difference between cyclosporine and control arms with respect to the occurrence of any adverse event.[51]