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

Van Assche, G.; Sandborn, W. J.; Feagan, B. G.; Salzberg, B. A.; Silvers, D.; Monroe, P. S.; Pandak, W. M.; Anderson, F. H.; Valentine, J. F.; Wild, G. E.; Geenen, D. J.; Sprague, R.; Targan, S. R.; Rutgeerts, P.; Vexier, V.; Young, D.; Shames, R. S.
November 2006
Gut;Nov2006, Vol. 55 Issue 11, p1568
Academic Journal
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.


Related Articles


    Steroid resistance in ulcerative colitis (UC) presents a difficult clinical challenge, with few available therapeutic options other than colectomy. Basiliximab is a chimeric monoclonal antibody to the interleukin-2 receptors. This has potential as new treatment for this condition. The article...

  • NICE gives positive signal to first biologic for UC.  // Gastrointestinal Nursing;Dec2014/Jan2015, Vol. 12 Issue 10, p2 

    The article reports on the positive draft guidance issued by Great Britain's National Institute for Health and Care Excellence (NICE) to Entyvio or vedolizumab, a biologic drug developed by Takeda for the maintenance treatment of patients with ulcerative colitis. The NICE will issue its final...

  • SURGICAL CURE OF ULCERATIVE COLITIS. Boehme, Earl J. // American Journal of Gastroenterology;Jul1960, Vol. 34 Issue 1, p74 

    Discusses the surgical treatments for ulcerative colitis. Reason for a fewer number of patients undergoing surgery for ulcerative colitis; Implication of steroid administration in ulcerative colitis with colonic bleeding; Regimen of treatment with ulcerative colitis patients during remission...

  • An Open-Labeled, Randomized Study Comparing Systemic Interferon-α-2A and Prednisolone Enemas in the Treatment of Left-Sided Ulcerative Colitis. Madsen, S. M.; Schlichting, P.; Davidsen, B.; Nielsen, O. H.; Federspiel, B.; Riis, P.; Munkholm, P. // American Journal of Gastroenterology;Jun2001, Vol. 96 Issue 6, p1807 

    OBJECTIVE: The aim of this study was to compare the treatment efficacies of subcutaneous interferon-α-2A (IFN-α- 2A) injections versus prednisolone enemas in active left-sided ulcerative colitis in an open-labeled, randomized study. METHODS: Sixteen ulcerative colitis patients...

  • A Prospective Randomized Observer-Blind 2-Year Trial of Azathioprine MonotherapyversusAzathioprine and Olsalazine for the Maintenance of Remission of Steroid-Dependent Ulcerative Colitis. Mantzaris, Gerassimos J.; Sfakianakis, Michael; Archavlis, Emmanuel; Petraki, Kalliopi; Christidou, Angeliki; Karagiannidis, Alexandros; Triadaphyllou, George // American Journal of Gastroenterology;Jun2004, Vol. 99 Issue 6, p1122 

    OBJECTIVE: The aim of this prospective study was to assess whether the coadministration of azathioprine (AZA) and olsalazine is superior to AZA monotherapy in maintaining remission of steroid-dependent ulcerative colitis (UC).METHODS: Patients with steroid-dependent UC in remission were...

  • Sulfasalazine: II. Some Notes on the Discovery and Development of Salazopyrin. Svartz, Nanna // American Journal of Gastroenterology;May1988, Vol. 83 Issue 5, p497 

    Provides information on the discovery and development of the sulfa drug salazopyrin. Efficacy of the drug in the treatment of ulcerative colitis; Allergic reactions that are frequent during treatment with all sulfa drugs; Pharmacology of salazopyrin.

  • Combined Therapy with 5-Aminosalicylic Acid Tablets and Enemas for Maintaining Remission in Ulcerative Colitis: A Randomized Double-Blind Study. D'Albasio, G.; Pacini, F.; Camarri, E.; Messori, A.; Trallori, G.; Bonanomi, A. G.; Bardazzi, G.; Milla, M.; Ferrero, S.; Biagini, M.; Quaranta, S.; Amorosi, A. // American Journal of Gastroenterology;Jul1997, Vol. 92 Issue 7, p1143 

    Objectives: To assess the efficacy of a combination of oral and topical 5-aminosalicylic acid (5-ASA) for the maintenance treatment of ulcerative colitis, we under-took a double-blind randomized clinical trial. Methods: Patients aged 18 to 65 yr (with disease extent greater than proctitis only)...

  • Novel treatment for UC at a discount.  // Gastrointestinal Nursing;Apr2015, Vol. 13 Issue 3, p12 

    The article reports that the National Institute for Health and Care Excellence has placed a condition on the use of Entyvio for the treatment of ulcerative colitis for manufacturers to offer a discount.

  • Golimumab approved for ulcerative colitis.  // WHO Drug Information;2013, Vol. 27 Issue 2, p115 

    The article reports on a 2013 decision that the U.S. Food and Drug Administration made to approve the drug golimumab to treat severe ulcerative colitis.


Read the Article


Sign out of this library

Other Topics