Ulcerative Colitis Resource Center

Ulcerative Colitis Resource Center

February 17, 2016
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Limited data suggest Remicade may be superior to cyclosporine in steroid-refractory UC

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Patients with steroid-refractory severe ulcerative colitis appear to have better treatment response with Remicade compared with cyclosporine in nonrandomized studies, while no definitive difference has been shown in randomized trials, according to results from a systematic review and meta-analysis. The researchers said prospective studies comparing the two treatment options as rescue agents in patients with steroid-refractory UC are needed.

Researchers from Farncombe Family Digestive Health Research Institute at McMaster University in Ontario, Canada, along with Jean-Frédéric Colombel, MD, director of the Susan and Leonard Feinstein IBD Clinical Center at Mount Sinai, New York, evaluated 16 studies with a total of 1,473 participants that included data on Remicade (infliximab, Janssen) and cyclosporine as treatment options for patients with steroid-refractory UC. Studies spanned the years 1950 to September 2015 and were found in the MEDLINE, Embase and PubMed databases.

Jean-Frédéric Colombel

Short-term response to treatment was the primary outcome evaluated. Rates of colectomy at 3 and 12 months, adverse reactions to the drugs, complications following colectomy in patients who had received rescue therapy initially, and mortality were all secondary outcomes in the review.

Three of the 16 studies were randomized trials, which found no significant difference regarding treatment response or 3- and 12-month colectomy rates between infliximab and cyclosporine. In the other 13 nonrandomized studies, significantly higher rates of treatment response were seen with infliximab compared with cyclosporine (pooled OR = 2.96; 95% CI, 2.12-4.14). Lower 12-month colectomy rates were also found with infliximab compared with cyclosporine in nonrandomized studies (pooled OR = 0.42; 95% CI, 0.22-0.83), while there was no significant difference found in the 3-month colectomy rate.

The research team also found no significant differences between the treatment options regarding adverse drug reactions, complications after colectomy or mortality.

“This meta-analysis does not find any definitive preference with regard to [infliximab] and cyclosporine for steroid-refractory acute severe UC,” the researchers concluded. “Observational data suggest better treatment response and lower risk of colectomy at 12 months with [infliximab] compared with cyclosporine, with comparable short-term adverse events; however, this increase in apparent benefit from observational studies may well reflect residual confounding rather than true causality. Studies are ongoing to determine how to maximize the therapeutic benefit of [infliximab] in the setting of acute severe UC … and prospective studies comparing dose-optimized [infliximab] to cyclosporine may provide more definitive insight into this debate.” – by Suzanne Reist

Disclosures: Colombel reports he has served as a consultant, an advisory board member, or a speaker for Abbvie, Amgen, Bristol-Myers Squibb, Celltrion, Ferring, Genentech, Giuliani SPA, Merck & Co., Mitsubishi, Nestlé Nutrition Science Partners Ltd., Pfizer Inc., Prometheus Laboratories, Receptos, Takeda/Millenium Pharmaceuticals Inc., UCB Pharma and Vertex. Please see the full study for a list of all other researchers’ relevant financial disclosures.