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Daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), for the treatment of moderately to severely active ulcerative colitis: a randomised, double blind, placebo controlled, dose ranging trial
  1. G Van Assche1,
  2. W J Sandborn2,
  3. B G Feagan3,
  4. B A Salzberg4,
  5. D Silvers5,
  6. P S Monroe6,
  7. W M Pandak7,
  8. F H Anderson8,
  9. J F Valentine9,
  10. G E Wild10,
  11. D J Geenen11,
  12. R Sprague12,
  13. S R Targan13,
  14. P Rutgeerts1,
  15. V Vexler14,
  16. D Young14,
  17. R S Shames14
  1. 1Universitaire Ziekenhuizen Leuven, UZ Gasthuisberg, Leuven, Belgium
  2. 2Mayo Clinic, Rochester, MN, USA
  3. 3Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
  4. 4Atlanta Gastroenterology Associates, Atlanta, GA, USA
  5. 5Drug Research Services, Metairie, LA, USA
  6. 6Richmond GI Research Group, Richmond, VA, USA
  7. 7McGuire Department of Veterans Affairs Medical Center, Richmond, VA, USA
  8. 8Vancouver General Hospital, Vancouver, British Columbia, Canada
  9. 9Gainesville Veterans Administration Medical Center and University of Florida, Gainesville, FL, USA
  10. 10McGill University Health Centre, Montreal, Quebec, Canada
  11. 11Wisconsin Center for Advanced Research, Milwaukee, WI, USA
  12. 12Borland-Groover Clinic, Jacksonville, FL, USA
  13. 13Cedars Sinai Medical Center, Los Angeles, CA, USA
  14. 14PDL Biofarma, Fremont, California, USA, USA
  1. Correspondence to:
    Dr G Van Assche
    Universitaire Ziekenhuizen Leuven, Inwendige Geneeskunde, UZ Gasthuisberg, Herestraat 49-B–3000, Leuven, Belgium; gert.vanassche{at}uz.kuleuven.ac.be

Abstract

Background: An uncontrolled pilot study demonstrated that daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), might be effective for the treatment of active ulcerative colitis.

Methods: A randomised, double blind, placebo controlled trial was conducted to evaluate the efficacy of daclizumab induction therapy in patients with active ulcerative colitis. A total of 159 patients with moderate ulcerative colitis were randomised to receive induction therapy with daclizumab 1 mg/kg intravenously at weeks 0 and 4, or 2 mg/kg intravenously at weeks 0, 2, 4, and 6, or placebo. The primary end point was induction of remission at week 8. Remission was defined as a Mayo score of 0 on both endoscopy and rectal bleeding components and a score of 0 or 1 on stool frequency and physician’s global assessment components. Response was defined as a decrease from baseline in the Mayo score of at least 3 points.

Results: Two per cent of patients receiving daclizumab 1 mg/kg (p = 0.11 v placebo) and 7% of patients receiving 2 mg/kg (p = 0.73) were in remission at week 8, compared with 10% of those who received placebo. Response occurred at week 8 in 25% of patients receiving daclizumab 1 mg/kg (p = 0.04) and in 33% of patients receiving 2 mg/kg (p = 0.30) versus 44% of those receiving placebo. Daclizumab was well tolerated. The most frequently reported adverse events in daclizumab treated patients compared with placebo treated patients were nasopharyngitis (14.6%) and pyrexia (10.7%).

Conclusion: Patients with moderate ulcerative colitis who are treated with daclizumab are not more likely to be in remission or response at eight weeks than patients treated with placebo.

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Footnotes

  • Published online first 7 April 2006

  • Financial support was received from Protein Design Labs, Fremont, California, USA.

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