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Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: A randomized, placebo-controlled study

Jarnerot, G; Hertervig, Erik LU ; Friis-Liby, I; Blomquist, L; Karle, P; Granno, C; Vilien, M; Strom, M; Danielsson, A and Verbaan, Hans LU , et al. (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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Contribution to journal
publication status
published
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Gastroenterology
volume
128
issue
7
pages
1805 - 1811
publisher
W B Saunders
external identifiers
  • pmid:15940615
  • wos:000229662900007
  • scopus:20444479336
ISSN
1528-0012
DOI
10.1053/j.gastro.2005.03.003
language
English
LU publication?
yes
id
5ac9e7ef-6d79-48fc-bead-23e45d7fe084 (old id 237483)
date added to LUP
2007-08-15 11:14:17
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2017-10-29 03:40:22
@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    = {W B Saunders},
  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},
  volume       = {128},
  year         = {2005},
}