BACKGROUND: An uncontrolled pilot study demonstrated that daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor ( @entity2902 ), might be effective for the treatment of active @entity31 . METHODS: A randomised, double blind, placebo controlled trial was conducted to evaluate the efficacy of daclizumab induction therapy in @entity1 with active @entity31 . A total of 159 @entity1 with moderate @entity31 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 @entity548 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 @entity1 receiving daclizumab 1 mg/kg (p = 0.11 v placebo) and 7% of @entity1 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 @entity1 receiving daclizumab 1 mg/kg (p = 0.04) and in 33% of @entity1 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 @entity1 compared with placebo treated @entity1 were @entity11266 (14.6%) and pyrexia (10.7%). CONCLUSION: @entity1 with moderate @entity31 who are treated with daclizumab are not more likely to be in remission or response at eight weeks than @entity1 treated with placebo.

Daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor ( @entity2902 ), for the treatment of moderately to severely active XXXX : a randomised, double blind, placebo controlled, dose ranging trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity11266 :: ('MESH:D009304', 'Disease') :: ['nasopharyngitis'] @entity548 :: ('MESH:D006470', 'Disease') :: ['endoscopy and rectal bleeding components'] @entity31 :: ('MESH:D003093', 'Disease') :: ['ulcerative colitis'] @entity2902 :: ('3559', 'Gene') :: ['CD25']
@entity31 :: (MESH:D003093,Disease) :: ['ulcerative colitis']
