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Clinical trial: colectomy after rescue therapy in ulcerative colitis-3-year follow-up of the Swedish-Danish controlled infliximab study

Gustavsson, A. ; Jarnerot, G. ; Hertervig, Erik LU ; Friis-Liby, I. ; Blomquist, L. ; Karlen, P. ; Granno, C. ; Vilien, M. ; Strom, M. and Verbaan, Hans LU , et al. (2010) In Alimentary pharmacology & therapeutics 32(8). p.984-989
Abstract
P>Background The long-term efficacy of infliximab as rescue therapy in steroid-refractory ulcerative colitis is not well described. Aim To examine the long-term efficacy of infliximab as a rescue therapy through a 3-year follow-up of a previous placebo-controlled trial of infliximab in acute steroid-refractory ulcerative colitis. Method In the original study, 45 patients were randomized to a single infusion of infliximab 5 mg/kg or placebo, and at 3 months, 7/24 patients given infliximab were operated vs. 14/21 patients given placebo. Three years or later, patients were asked to participate in a clinical follow-up. Results Another seven patients underwent colectomy during follow-up: five in the infliximab group and two in the placebo... (More)
P>Background The long-term efficacy of infliximab as rescue therapy in steroid-refractory ulcerative colitis is not well described. Aim To examine the long-term efficacy of infliximab as a rescue therapy through a 3-year follow-up of a previous placebo-controlled trial of infliximab in acute steroid-refractory ulcerative colitis. Method In the original study, 45 patients were randomized to a single infusion of infliximab 5 mg/kg or placebo, and at 3 months, 7/24 patients given infliximab were operated vs. 14/21 patients given placebo. Three years or later, patients were asked to participate in a clinical follow-up. Results Another seven patients underwent colectomy during follow-up: five in the infliximab group and two in the placebo group. After 3 years, a total of 12/24 (50%) patients given infliximab and 16/21 (76%) given placebo (P = 0.012) had a colectomy. None of eight patients in endoscopic remission at 3 months later had a colectomy compared with 7/14 (50%) patients who were not in remission (P = 0.02). There was no mortality. Conclusion The benefit of rescue therapy with infliximab in steroid-refractory acute ulcerative colitis remained after 3 years. The main advantage of infliximab treatment occurred during the first 3 months, whereas subsequent colectomy rates were similar in the two groups. Mucosal healing at 3 months influenced later risk of colectomy. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Alimentary pharmacology & therapeutics
volume
32
issue
8
pages
984 - 989
publisher
Wiley-Blackwell
external identifiers
  • wos:000282221200004
  • scopus:77957226063
  • pmid:20937043
ISSN
0269-2813
DOI
10.1111/j.1365-2036.2010.04435.x
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)
id
6ad36113-868d-435c-b727-39c45a603c77 (old id 1695758)
date added to LUP
2016-04-01 14:05:23
date last changed
2020-10-07 03:32:41
@article{6ad36113-868d-435c-b727-39c45a603c77,
  abstract     = {P>Background The long-term efficacy of infliximab as rescue therapy in steroid-refractory ulcerative colitis is not well described. Aim To examine the long-term efficacy of infliximab as a rescue therapy through a 3-year follow-up of a previous placebo-controlled trial of infliximab in acute steroid-refractory ulcerative colitis. Method In the original study, 45 patients were randomized to a single infusion of infliximab 5 mg/kg or placebo, and at 3 months, 7/24 patients given infliximab were operated vs. 14/21 patients given placebo. Three years or later, patients were asked to participate in a clinical follow-up. Results Another seven patients underwent colectomy during follow-up: five in the infliximab group and two in the placebo group. After 3 years, a total of 12/24 (50%) patients given infliximab and 16/21 (76%) given placebo (P = 0.012) had a colectomy. None of eight patients in endoscopic remission at 3 months later had a colectomy compared with 7/14 (50%) patients who were not in remission (P = 0.02). There was no mortality. Conclusion The benefit of rescue therapy with infliximab in steroid-refractory acute ulcerative colitis remained after 3 years. The main advantage of infliximab treatment occurred during the first 3 months, whereas subsequent colectomy rates were similar in the two groups. Mucosal healing at 3 months influenced later risk of colectomy.},
  author       = {Gustavsson, A. and Jarnerot, G. and Hertervig, Erik and Friis-Liby, I. and Blomquist, L. and Karlen, P. and Granno, C. and Vilien, M. and Strom, M. and Verbaan, Hans and Hellstrom, P. M. and Magnuson, A. and Halfvarson, J. and Tysk, C.},
  issn         = {0269-2813},
  language     = {eng},
  number       = {8},
  pages        = {984--989},
  publisher    = {Wiley-Blackwell},
  series       = {Alimentary pharmacology & therapeutics},
  title        = {Clinical trial: colectomy after rescue therapy in ulcerative colitis-3-year follow-up of the Swedish-Danish controlled infliximab study},
  url          = {http://dx.doi.org/10.1111/j.1365-2036.2010.04435.x},
  doi          = {10.1111/j.1365-2036.2010.04435.x},
  volume       = {32},
  year         = {2010},
}