Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: A randomized, placebo-controlled study
(2005) In Gastroenterology 128(7). p.1805-1811- Abstract
- 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. Method : 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... (More)
- 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. Method : 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. (Less)
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- author
- organization
- publishing date
- 2005
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Gastroenterology
- volume
- 128
- issue
- 7
- pages
- 1805 - 1811
- publisher
- Elsevier
- external identifiers
-
- pmid:15940615
- wos:000229662900007
- scopus:20444479336
- ISSN
- 1528-0012
- DOI
- 10.1053/j.gastro.2005.03.003
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Emergency medicine/Medicine/Surgery (013240200), Medicine (Lund) (013230025)
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- 5ac9e7ef-6d79-48fc-bead-23e45d7fe084 (old id 237483)
- date added to LUP
- 2016-04-01 12:22:59
- date last changed
- 2024-02-24 06:39:19
@article{5ac9e7ef-6d79-48fc-bead-23e45d7fe084,
abstract = {{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. Method : 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.}},
author = {{Jarnerot, G and Hertervig, Erik and Friis-Liby, I and Blomquist, L and Karle, P and Granno, C and Vilien, M and Strom, M and Danielsson, A and Verbaan, Hans and Hellstrom, PM and Magnuson, A and Curman, B}},
issn = {{1528-0012}},
language = {{eng}},
number = {{7}},
pages = {{1805--1811}},
publisher = {{Elsevier}},
series = {{Gastroenterology}},
title = {{Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: A randomized, placebo-controlled study}},
url = {{http://dx.doi.org/10.1053/j.gastro.2005.03.003}},
doi = {{10.1053/j.gastro.2005.03.003}},
volume = {{128}},
year = {{2005}},
}