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Clinical Trial
. 2003 Jul;52(7):998-1002.
doi: 10.1136/gut.52.7.998.

Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial

C S J Probert  1 , S D Hearing, S Schreiber, T Kühbacher, S Ghosh, I D R Arnott, A Forbes
Affiliations
Clinical Trial

Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial

C S J Probert et al. Gut. 2003 Jul.

Abstract

Background: Tumour necrosis factor production is increased in the mucosa of patients with active ulcerative colitis. The benefits of infliximab in Crohn's disease are established. We investigated its efficacy in ulcerative colitis.

Methods: We conducted a randomised placebo controlled trial of infliximab (5 mg/kg) in the treatment of glucocorticoid resistant ulcerative colitis. Infusions were given at weeks 0 and 2. Disease activity and quality of life were recorded over eight weeks of follow up. Remission was defined as an ulcerative colitis symptom score (UCSS) of < or =2 and/or Baron score of 0 at week 6. Patients not in remission were offered open label infliximab 10 mg/kg and reviewed two weeks later.

Results: After two weeks, there was no statistically significant difference between the infliximab and placebo groups in the proportion of patients with a Baron score of 0 (13% (3/23) v 5% (1/19) (95% confidence interval (CI) -9% to 24%); p=0.74). After six weeks, remission (UCSS < or =2) rates were 39% (9/23) versus 30% (6/20) (95% CI -19 to 34%; p=0.76). The median improvement in UCSS was 3 for the infliximab group and 2.5 for the placebo group (p=0.82, Mann-Whitney U test). A Baron score of 0 was likely in either group (26% (6/23) v 30% (6/20) (95% CI -30% to 23%); p=0.96). Improvement in the IBDQ and EuroQol was not significantly different between the groups (p=0.22 and 0.3, respectively, Mann-Whitney U test). Twenty eligible patients were given open labelled infusions. Remission was achieved in 3/11 (27%) patients initially treated with infliximab and in 1/9 (11%) patients treated with placebo.

Conclusion: These data do not support the use of infliximab in the management of moderately active glucocorticoid resistant ulcerative colitis.

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References

    1. Travis SPL, Farrant JM, Nolan DJ, et al. Predicting outcome in severe ulcerative colitis. Gut 1996;38:905–10. - PMC - PubMed
    1. Hearing SD, Norman M, Probert CSJ, et al. Predicting therapeutic outcome in severe ulcerative colitis by measuring in vitro steroid sensitivity of proliferating peripheral blood lymphocyte. Gut 1999;45:382–8. - PMC - PubMed
    1. Sandborn WJ. Cyclosporine in ulcerative colitis: state of the art. Acta Gastroenterol Belg 2001;64:201–4. - PubMed
    1. Lichtiger S, Present DH, Kornbluth A, et al. Cyclosporine in severe ulcerative colitis refractory to steroid therapy. N Engl J Med 1994;330:1841–5. - PubMed
    1. Hyde GM, Thillainayagam AV, Jewell DP. Intravenous cyclosporin as rescue therapy in severe ulcerative colitis: time for a reappraisal? Eur J Gastroenterol Hepatol 1998;10:411–13. - PubMed

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