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Blood, 1 September 2004, Vol. 104, No. 5, pp. 1559-1564. Prepublished online as a Blood First Edition Paper on May 11, 2004; DOI 10.1182/blood-2004-03-0854. This Article Full Text (PDF) All Versions of this Article: 2004-03-0854v1 104/5/1559    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Lee, S. J Articles by Soiffer, R. J Search for Related Content PubMed PubMed Citation Articles by Lee, S. J Articles by Soiffer, R. J Related Collections Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted March 5, 2004 Accepted April 19, 2004 Effect of up-front daclizumab when combined with steroids for the treatment of acute graft-vs.-host disease: results of a randomized trial Stephanie J Lee*, David Zahrieh, Edward Agura, Margaret L MacMillan, Richard T Maziarz, Philip L McCarthy, Vincent T Ho, Corey Cutler, Edwin P Alyea, Joseph H Antin, and Robert J Soiffer Adult Oncology, Dana-Farber Cancer Institute, Boston, MA, USA Biostatistics, Dana-Farber Cancer Institute, Boston, MA, USA Baylor University Medical Center, Dallas, TX, USA University of Minnesota, Minneapolis, MN, USA Oregon Health & Science University, Portland, OR, USA Roswell Park Cancer Institute, Buffalo, NY, USA * Corresponding author; email: stephanie_lee{at}dfci.harvard.edu. The standard initial therapy for acute graft-versus-host disease (GVHD) is corticosteroids. Daclizumab (Zenapax®) is a humanized monoclonal antibody against the IL-2 receptor expressed on activated T lymphocytes. Because of daclizumab[[rad]]s favorable toxicity profile and response rate in steroid resistant GVHD, a multi-center, double-blinded, randomized study of corticosteroids with or without daclizumab for initial treatment of acute GVHD was conducted. A total of 102 evaluable subjects of the targeted 166 were enrolled at five participating sites. Methylprednisolone at a dose of 2 mg/kg or equivalent daily was given in conjunction with daclizumab 1 mg/kg or placebo on study days 1, 4, 8 and weekly as long as clinically indicated. The groups were balanced for clinical characteristics. GVHD response rates by study day 42 were similar (53% vs. 51%, p=0.85). The study was halted after a planned interim analysis showed a significantly worse 100-day survival in the group receiving corticosteroids plus daclizumab (77% vs. 94%, p=0.02). Overall survival at one year was also inferior in the combination arm (29% vs. 60%, p=0.002). Both relapse and GVHD-related mortality contributed to the increased mortality in the combination group. The combination of corticosteroids and daclizumab should not be used as initial therapy of acute GVHD. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: GVHD therapy: the best-laid schemes... Krishna V. Komanduri and Richard E. Champlin Blood 2004 104: 1240-1241. [Full Text] [PDF] This article has been cited by other articles: Y. Xie, M. Wu, R. Song, J. Ma, Y. Shi, W. Qin, and Y. Jin A glucocorticoid amplifies IL-2-induced selective expansion of CD4+CD25+FOXP3+ regulatory T cells in vivo and suppresses graft-versus-host disease after allogeneic lymphocyte transplantation Acta Biochim Biophys Sin, September 1, 2009; 41(9): 781 - 791. [Abstract] [Full Text] [PDF] A. M. Alousi, D. J. Weisdorf, B. R. Logan, J. Bolanos-Meade, S. Carter, N. DiFronzo, M. Pasquini, S. C. Goldstein, V. T. Ho, B. Hayes-Lattin, et al. Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network Blood, July 16, 2009; 114(3): 511 - 517. [Abstract] [Full Text] [PDF] A. Gratwohl At last, an "ointment" for gastrointestinal GVHD? Blood, May 15, 2007; 109(10): 4117 - 4117. [Full Text] [PDF] H. J. Deeg How I treat refractory acute GVHD Blood, May 15, 2007; 109(10): 4119 - 4126. [Abstract] [Full Text] [PDF] D. Weisdorf GVHD The Nuts and Bolts Hematology, January 1, 2007; 2007(1): 62 - 67. [Abstract] [Full Text] [PDF] M. T. Van Lint, G. Milone, S. Leotta, C. Uderzo, R. Scime, S. Dallorso, A. Locasciulli, S. Guidi, N. Mordini, S. Sica, et al. Treatment of acute graft-versus-host disease with prednisolone: significant survival advantage for day +5 responders and no advantage for nonresponders receiving anti-thymocyte globulin Blood, May 15, 2006; 107(10): 4177 - 4181. [Abstract] [Full Text] [PDF] B. Knoechel, J. Lohr, E. Kahn, J. A. Bluestone, and A. K. Abbas Sequential development of interleukin 2-dependent effector and regulatory T cells in response to endogenous systemic antigen J. Exp. Med., November 21, 2005; 202(10): 1375 - 1386. [Abstract] [Full Text] [PDF] T. Kober, J. Bohlius, S. Trelle, and A. Engert Second Biannual Report of the Cochrane Haematological Malignancies Group J Natl Cancer Inst, April 6, 2005; 97(7): E1 - E. [Full Text] T. Iwasaki Recent Advances in the Treatment of Graft-Versus-Host Disease Clin. Med. Res., November 1, 2004; 2(4): 243 - 252. [Abstract] [Full Text] [PDF]

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