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This Article Full Text Full Text (PDF) Competing interests All Versions of this Article: gut.2005.089854v1 55/11/1568    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this link to a friend Similar articles in this journal Similar articles in PubMed Add article to my folders Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Van Assche, G Articles by Shames, R S Search for Related Content PubMed PubMed Citation Articles by Van Assche, G Articles by Shames, R S

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 Universitaire Ziekenhuizen Leuven, UZ Gasthuisberg, Leuven, Belgium
² Mayo Clinic, Rochester, MN, USA
³ Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
⁴ Atlanta Gastroenterology Associates, Atlanta, GA, USA
⁵ Drug Research Services, Metairie, LA, USA
⁶ Richmond GI Research Group, Richmond, VA, USA
⁷ McGuire Department of Veterans Affairs Medical Center, Richmond, VA, USA
⁸ Vancouver General Hospital, Vancouver, British Columbia, Canada
⁹ Gainesville Veterans Administration Medical Center and University of Florida, Gainesville, FL, USA
¹⁰ McGill University Health Centre, Montreal, Quebec, Canada
¹¹ Wisconsin Center for Advanced Research, Milwaukee, WI, USA
¹² Borland-Groover Clinic, Jacksonville, FL, USA
¹³ Cedars Sinai Medical Center, Los Angeles, CA, USA
¹⁴ PDL Biofarma, Fremont, California, USA, USA

Correspondence to:
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

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.

Abbreviations: IL-2, interleukin 2; UC, ulcerative colitis; FACS, fluorescence activated cell sorter

Keywords: ulcerative colitis; medical treatment; controlled trials; CD-25; daclizumab