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Title: A pilot study on the use of the humanized anti-interleukin-2 receptor antibody daclizumab in active ulcerative colitis
Authors: Van Assche, Gert ×
Dalle, Ignace
Noman, Maja
Aerden, Isolde
Swijsen, Caroline
Asnong, Katrien
Maes, Bart
Ceuppens, Jan
Geboes, Karel
Rutgeerts, Paul #
Issue Date: Feb-2003
Series Title: American Journal of Gastroenterology vol:98 issue:2 pages:369-76
Abstract: OBJECTIVES: Medical therapy of refractory ulcerative colitis (UC) is associated with long-term side effects of cyclosporine and steroids. Because cyclosporine acts by inhibiting interleukin-2 (IL-2) production, we studied the efficacy and safety of humanized anti-IL2 receptor (CD25) antibodies daclizumab for refractory UC in an open label pilot study. METHODS: Ten patients with chronically active UC received daclizumab, 1 mg/kg i.v. twice with a 4-wk interval. Clinical, endoscopic, and histological evaluation was scored at regular intervals. CD25 immunohistochemistry was followed in mucosal biopsies. The primary study endpoint was clinical improvement at wk 8. RESULTS: Nine of 10 patients completed the study. The median clinical activity score decreased from a median of 8 (95% CI = 7.2-9.2) at baseline to 3.5 (95% CI = 1.4-4.9) at wk 8 (p < 0.005). Endoscopic scores were significantly decreased at wk 8 (wk 0: 8, 95% CI = 6.3-8.5; wk 8: 5.0, 95% CI = 2.6-6.3; p < 0.01). Mucosal biopsies showed a significant decrease in CD25+ cells, and there was a trend toward lower histology scores at wk 8. Quality of life as assessed by the Inflammatory Bowel Disease Questionnaire increased after therapy (baseline: 131, 95% CI = 119-178; wk 8: 169; 95% CI = 124-216, p < 0.05). Nausea was most frequently reported as an adverse event, but always in patients that were concomitantly started on azathioprine. CONCLUSIONS: The anti-IL-2R antibody daclizumab was safe and well tolerated in acute UC. Patients experienced clinical benefit along with signs of endoscopic improvement, but further controlled trials are needed to determine the therapeutic benefit of this compound.
ISSN: 0002-9270
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Translational Research in GastroIntestinal Disorders
Laboratory of Nephrology
Laboratory of Clinical Immunology
Translational Cell & Tissue Research
× corresponding author
# (joint) last author

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