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Prepublished online as a Blood First Edition Paper on July 18, 2002; DOI 10.1182/blood-2002-03-0985. This Article Full Text Full Text (PDF) All Versions of this Article: 2002-03-0985v1 100/10/3479    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map 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 Antin, J. H. Articles by Ferrara, J. L.M. Search for Related Content PubMed PubMed Citation Articles by Antin, J. H. Articles by Ferrara, J. L.M. Related Collections Transplantation Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 15 November 2002, Vol. 100, No. 10, pp. 3479-3482 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS Interleukin-1 blockade does not prevent acute graft-versus-host disease: results of a randomized, double-blind, placebo-controlled trial of interleukin-1 receptor antagonist in allogeneic bone marrow transplantation Joseph H. Antin, Daniel Weisdorf, Donna Neuberg, Roberta Nicklow, Shawn Clouthier, Stephanie J. Lee, Edwin Alyea, Carol McGarigle, Bruce R. Blazar, Stephen Sonis, Robert J. Soiffer, and James L.M. Ferrara From the Department of Medical Oncology and Biostatistical Science, Dana-Farber Cancer Institute, Departments of Medicine and Surgery, Brigham and Women's Hospital, Boston, MA; Departments of Medicine and Pediatrics, Blood and Marrow Transplant Program, University of Minnesota, Minneapolis, MN. Acute graft-versus-host disease (GVHD) is thought to derive from direct T-cell injury of target tissues through perforin/granzyme, Fas/FasL interactions, and the effects of inflammatory cytokines. Animal models and some clinical trials support the notion that inhibition of inflammatory mediators such as interleukin-1 (IL-1), tumor necrosis factor , and interferon  may ameliorate or prevent GVHD. We hypothesized that blockade of IL-1 during the period of initial T-cell activation would reduce the risk of severe GVHD. We tested this hypothesis in a double-blind, placebo-controlled randomized trial of recombinant human IL-1 receptor antagonist (IL-1Ra) in 186 patients undergoing allogeneic stem cell transplantation. Randomization was stratified by degree of histocompatibility and stem cell source. All patients were conditioned with cyclophosphamide and total body irradiation. GVHD prevention consisted of cyclosporine and methotrexate in all patients. Recombinant human IL-1Ra or saline placebo was given from day 4 to day +10. Randomization was stratified according to GVHD risk. The 2 groups were well-matched for pretreatment characteristics. Moderate to severe GVHD (grades B-D) developed in 57 (61%) of 94 patients receiving IL-1Ra and in 51 (59%) of 86 patients on placebo (P = .88). There was no difference in hematologic recovery, transplantation-related toxicity, event-free survival, or overall survival. We conclude that blockade of IL-1 using IL-1Ra during conditioning and 10 days immediately after transplantation is not sufficient to reduce GVHD or toxicity or to improve survival. © 2002 by The American Society of Hematology.   CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: G. Socie and B. R. Blazar Acute graft-versus-host disease: from the bench to the bedside Blood, November 12, 2009; 114(20): 4327 - 4336. [Abstract] [Full Text] [PDF] D E Furst, E C Keystone, B Kirkham, R Fleischmann, P Mease, F C Breedveld, J S Smolen, J R Kalden, G R Burmester, J Braun, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2008 Ann Rheum Dis, December 1, 2008; 67(Suppl_3): iii2 - iii25. [Full Text] [PDF] G. A. Yanik, V. T. Ho, J. E. Levine, E. S. White, T. Braun, J. H. Antin, J. Whitfield, J. Custer, D. Jones, J. L. M. Ferrara, et al. 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