Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: A randomized, placebo-controlled study
2005 (English)In: Gastroenterology, ISSN 0016-5085, Vol. 128, no 7, 1805-1811 p.Article in journal (Refereed) Published
Background & Aims: Despite treatment with corticosteroids, severe to moderately severe attacks of ulcerative colitis have a high colectomy rate. We intended to find a rescue therapy other than cyclosporin A, which imposes a high risk of side effects and cyclosporine-related mortality. Methods: This was a randomized double-blind trial of infliximab or placebo in severe to moderately severe ulcerative colitis not responding to conventional treatment. Patients were randomized to infliximab/placebo either on day 4 after the initiation of corticosteroid treatment if they fulfilled the index criteria for fulminant ulcerative colitis on day 3 or on day 6-8 if they fulfilled index criteria on day 5-7 for a severe or moderately severe acute attack of ulcerative colitis. Results were analyzed according to the intention-to-treat principle. The primary end point was colectomy or death 3 months after randomization. Secondary end points were clinical and endoscopic remission at that time in patients who did not undergo operation. Results: Forty-five patients were included (24 infliximab and 21 placebo). No patient died. Seven patients in the infliximab group and 14 in the placebo group had a colectomy (P =. 017, odds ratio, 4.9, 95% confidence interval, 1.4-17) within 3 months after randomization. No serious side effects occurred. Three patients in the placebo group required operation for septic complications. Conclusions: Infliximab 4-5 mg/kg is an effective and safe rescue therapy in patients experiencing an acute severe or moderately severe attack of ulcerative colitis not responding to conventional treatment. © 2005 by the American Gastroenterological Association.
Place, publisher, year, edition, pages
2005. Vol. 128, no 7, 1805-1811 p.
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-34978DOI: 10.1053/j.gastro.2005.03.003Local ID: 24405OAI: oai:DiVA.org:liu-34978DiVA: diva2:255826