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Infliximab salvage therapy more effective than cyclosporine in acute severe ulcerative colitis
Patients with steroid-refractory acute severe ulcerative colitis experienced better outcomes with infliximab salvage therapy than cyclosporine recipients in a recent study.
In a prospective study, researchers evaluated 83 patients treated for steroid-refractory acute severe ulcerative colitis (UC) between 1999 and 2009 at Royal Brisbane and Women’s Hospital in Australia. Participants received salvage therapy with either cyclosporine (n=45) or infliximab (n=38), with total colectomy recommended when nonresponse occurred. Two cyclosporine patients were excluded from per-protocol analysis because they required emergency colectomy before receiving 3 days of treatment.
The majority of both groups had not undergone colectomy at discharge, although colectomy was significantly less common among those who received a single, 5 mg/kg infliximab dose compared with those who received cyclosporine for 72 hours or more (colectomy not required in 84% of patients vs. 56%; P=.006).
Among 80 evaluable participants, infliximab recipients continued to undergo colectomy less frequently than cyclosporine recipients at 3 months (colectomy not required in 76% vs. 53% of cases; P=.04) and 12 months of follow-up (65% vs. 42%; P=.04). Two serious adverse events among cyclosporine patients occurred, and no patients died during the study.
Steroid dependence at 12 months post-treatment was observed in five of 15 evaluable patients in the cyclosporine group, compared with three of 23 infliximab recipients (P=.13 for difference). Inclusion of the need for additional biological therapy in this analysis indicated that more cyclosporine recipients required biologics or steroids, but the difference was not significant (33% of cases vs. 26%; P=.63).
“Superior efficacy and safety were encountered with the use of [infliximab] compared with [cyclosporine],” the researchers concluded. “This is a durable effect, with disparate rates of colectomy avoidance being observed at the 12-month post-admission time point. Further randomized controlled trials are required to discern whether there is a clear discrepancy between the efficacies of these agents in steroid-refractory acute severe UC.”
Disclosure: See the study for a full list of relevant disclosures.