Gastroenterology
Volume 128, Issue 7 , Pages 1805-1811 , June 2005

Infliximab as Rescue Therapy in Severe to Moderately Severe Ulcerative Colitis: A Randomized, Placebo-Controlled Study

  • Gunnar Järnerot

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Örebro University Hospital, Örebro, Sweden
    • Corresponding Author InformationAddress requests for reprints to: Gunnar Järnerot, MD, PhD, FRCP, Department of Medicine, Division of Gastroenterology, Örebro University Hospital, S-701 85 Örebro, Sweden.
  • ,
  • Erik Hertervig

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Lund University Hospital, Lund, Sweden
  • ,
  • Ingalill Friis-Liby

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Sahlgrenska University Hospital, Gothenburg, Sweden
  • ,
  • Lars Blomquist

      Affiliations

    • Department of Gastroenterology and Hepatology, Karolinska University Hospital, Stockholm, Sweden
  • ,
  • Per Karlén

      Affiliations

    • Department of Medicine, Division of Gastroenterology, South Hospital, Stockholm, Sweden
  • ,
  • Christer Grännö

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Ryhov Hospital, Jönköping, Sweden
  • ,
  • Mogens Vilien

      Affiliations

    • Department of Medicine, Division of Gastroenterology, West Zealand Hospital, Slagelse, Denmark
  • ,
  • Magnus Ström

      Affiliations

    • Department of Molecular and Clinical Medicine, Division of Gastroenterology and Hepatology, Faculty of Health Sciences, Linköping, Sweden
  • ,
  • Åke Danielsson

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Umeå University Hospital, Umeå, Sweden
  • ,
  • Hans Verbaan

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Malmö General University Hospital, Malmö, Sweden
  • ,
  • Per M. Hellström

      Affiliations

    • Department of Gastroenterology and Hepatology, Karolinska University Hospital, Stockholm, Sweden
  • ,
  • Anders Magnuson

      Affiliations

    • Unit of Statistics and Epidemiology, Centre for Clinical Research, Örebro University Hospital, Örebro, Sweden
  • ,
  • Bengt Curman

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Örebro University Hospital, Örebro, Sweden

Received 9 November 2004 ,Accepted 23 February 2005.

References 

  1. Truelove SC , Jewell DP . Intensive intravenous regimen for severe attacks of ulcerative colitis . Lancet . 1974;1:1067–1070
  2. Järnerot G , Rolny P , Sandberg-Gertzén H . Intensive intravenous treatment of ulcerative colitis . Gastroenterology . 1985;89:1005–1013
  3. Lichtiger S, Present DH, Kornbluth A, Gelernt I, Bauer J, Galler G, et al. Cyclosporine in severe ulcerative colitis refractory to steroid therapy . N Engl J Med . 1994;330:1841–1845
  4. Sandborn WJ . A critical review of cyclosporine therapy in inflammatory bowel disease . Inflamm Bowel Dis . 1995;1:48–63
  5. Blomberg B , Järnerot G . Clinical evaluation and management of acute severe colitis . Inflamm Bowel Dis . 2000;6:214–227
  6. Arts J, D’Haens G, Zeegers M, van Assche G, Hiele M, D’Hoore A, et al. Long-term outcome of treatment with intravenous cyclosporin in patients with severe ulcerative colitis . Inflamm Bowel Dis . 2004;10:73–78
  7. Sandborn WJ , Hanauer SB . Antitumor necrosis factor therapy for inflammatory bowel disease (a review of agents, pharmacology, clinical results, and safety) . Inflamm Bowel Dis . 1999;5:119–133
  8. Braegger CP , Nicholls S , Murch SH , Stephens S , MacDonald TT . Tumor necrosis factor alpha in stool as a marker of intestinal inflammation . Lancet . 1992;339:89–91
  9. Nielsen OH, Gionchetti P, Ainsworth M, Vainer B, Campieri M, Borregaard N, et al. Rectal dialysate and faecal concentrations of neutrophil gelatinase-associated lipocalin interleukin-8, and tumor necrosis factor-α in ulcerative colitis . Am J Gastroenterol . 1999;94:2923–2928
  10. Murch SH , Braegger CP , Walker-Smith JA , MacDonald TT . Location of tumor necrosis factor α by immunochemistry in chronic inflammatory bowel disease . Gut . 1993;34:1705–1709
  11. Woywodt A, Ludwig D, Neustock P, Kruse A, Schwerting K, Jantschek G, et al. Mucosal cytokine expression, cellular markers and adhesion molecules in inflammatory bowel disease . Eur J Gastroenterol Hepatol . 1999;11:267–276
  12. Noguchi M , Hiwatashi N , Lin Z , Toyota T . Secretion imbalance between tumor necrosis factor and its inhibition in inflammatory bowel disease . Gut . 1998;43:203–209
  13. Sands BE, Tremaine WJ, Sandborn WJ, Rutgeerts PJ, Hanauer SB, Mayer L, et al. Infliximab in the treatment of severe, steroid-refractory ulcerative colitis (a pilot study) . Inflamm Bowel Dis . 2001;7:83–88
  14. Chey WY , Hussain A , Ryan C , Potter GD , Shah A . Infliximab for refractory ulcerative colitis . Am J Gastroenterol . 2001;96:2373–2381
  15. Kohu A , Prantera C , Pera A , Cosintino R , Sostegni R , Daperno M . Anti-tumor necrosis factor alpha (infliximab) in the treatment of severe ulcerative colitis (result of an open study on 13 patients) . Dig Liver Dis . 2003;34:626–630
  16. Järnerot G , Blomberg B , Bohr J , Curman B , Sandberg-Gertzén H . Infliximab (Remicade) as rescue therapy in acute corticosteroid-resistant ulcerative colitis . Scand J Gastroenterol . 2001;36(Suppl):233; :08.
  17. Seo M , Okada M , Yao T , Ueki M , Arima S , Okumura M . An index of disease activity in patients with ulcerative colitis . Am J Gastroenterol . 1992;87:971–976
  18. Lindgren SC , Flood LM , Kilander AF , Löfberg R , Persson TB , Sjödahl RI . Early predictors of glucosteroid treatment failure in severe and moderately severe attacks of ulcerative colitis . Eur J Gastroenterol Hepatol . 1998;10:831–835
  19. Carbonnel F, Lavergne A, Lémann M, Bitoun A, Valleur P, Hautefeuille P, et al. Colonoscopy of acute colitis. A safe and reliable tool for assessment of severity . Dig Dis Sci . 1994;39:1550–1557
  20. Pocock SJ . Clinical trials (a practical approach) . Chichester: Wiley; 1983; 147–155
  21. Probert CSJ, Hearing SD, Schreiber S, Kühbacher T, Ghosh S, Arnott IDR, et al. Infliximab in moderately severe glucocorticoid resistant ulcerative colitis (a randomised controlled trial) . Gut . 2003;52:998–1002
  22. Carbonnel F, Gargouri D, Lémann M, Beaugerie L, Cattan S, Cosnes J, et al. Predictive factors of outcome of intensive intravenous treatment for attacks of ulcerative colitis . Aliment Pharmacol Ther . 2000;14:273–279
  23. Colombel J-F, Loftus EV, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, et al. The safety profile of infliximab in patients with Crohn’s disease (the Mayo Clinic experience in 500 patients) . Gastroenterology . 2004;126:19–31
  24. Ljung T, Karlén P, Schmidt D, Hellström PM, Lapidus A, Janczewska I, et al. Infliximab in inflammatory bowel disease (clinical outcome in a population based cohort from Stockholm County) . Gut . 2004;53:849–853
  25. Marchal L, D’Haens G, van Assche G, Vermeire S, Noman M, Ferrante M, et al. The risk of post-operative complications associated with infliximab therapy for Crohn’s disease (a controlled cohort study) . Aliment Pharmacol Ther . 2004;19:749–754
  26. Travis SPL, Farrant JM, Ricketts C, Nolan DJ, Mortensen NM, Kettlewell MGN, et al. Predicting outcome in severe ulcerative colitis . Gut . 1996;38:905–910

 Supported by the Swedish Federation of County Councils, Örebro County Research Foundation, Schering-Plough AB, Sweden, Clinical Research Centre, Örebro University Hospital, the Medical Research Council of Southeast Sweden, Foundation of Medical Science Region 3, Denmark (Grant 2-47-19-02), and participating hospitals (infliximab/placebo).

PII: S0016-5085(05)00384-7

doi: 10.1053/j.gastro.2005.03.003

Gastroenterology
Volume 128, Issue 7 , Pages 1805-1811 , June 2005