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Daclizumab for Graft Versus Host disease

Posted Jun 24 2009 7:01pm

Daclizumab (trade name Zenapax) is a therapeutic humanized monoclonal antibody to the alpha subunit of the IL-2 receptor of T cells. It is used to prevent rejection in organ transplantation, especially in kidney transplants.Daclizumab reduces the incidence and severity of acute rejection in kidney transplantation without increasing the incidence of opportunistic infections.
This drug has been used to treat graft vs. Host Disease (GVHD) in stem cell as well as other types of transplants but most evidence is in the form of case reports and series.

It was studied in a clinical study: Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease, NCT00053976 . This was a randomized phase III trial to compare the effectiveness of methylprednisolone with or without daclizumab in treating patients who have acute graft-versus-host disease following donor bone marrow transplantation.   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 = .02). Overall survival at 1 year was also inferior in the combination arm (29% vs 60%; P = .002). Both relapse- and GVHD-related mortality contributed to the increased mortality in the combination group. It concluded: "The combination of corticosteroids and daclizumab should not be used as initial therapy of acute GVHD."

D T Teachey et al, Daclizumab for children with corticosteroid refractory graft-versus-host disease
Bone Marrow Transplantation (2006) 37, 95–99 2005

C H Hui et al, Daclizumab has poor efficacy in steroid-refractory severe acute graft-versus-host disease: a single centre experience with 12 allograft patientsBone Marrow Transplantation (2008) 41, 409–410;2007

Srinivasan, R, Chakrabarti, S, Walsh, T, et al. Improved survival in steroid-refractory acute graft versus host disease after non-myeloablative allogeneic transplantation using a daclizumab-based strategy with comprehensive infection prophylaxis. Br J Haematol 2004; 124:777.

Stephanie J. Lee, David Zahrieh, Edward Agura, Margaret L. MacMillan, Richard T. Maziarz, Philip L. McCarthy, Jr, Vincent T. Ho, Corey Cutler, Edwin P. Alyea, Joseph H. Antin, and Robert J. Soiffer
Effect of up-front daclizumab when combined with steroids for the treatment of acute graft-versus-host disease: results of a randomized trial Blood 104: 1559-1564;

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