HEART TRANSPLANTATION Anti-CD25 Therapy Impairs Donor-Specific Th1 and Th2 Cytokine- Producing Peripheral Blood Cells After Clinical Heart Transplantation N.M. van Besouw, A.H.M.M. Balk, M. van Vliet, P.H. van der Meide, A.P.W.M. Maat, T. van Gelder, C.C. Baan, and W. Weimar R EJECTION episodes after transplantation are associ- ated with increased levels of intragraft IL-2, CD25 mRNA expression and protein production. 1–3 The target of the Anti-CD25 mAbs is the -chain of the IL-2R complex (CD25); these antibodies are used to prevent acute rejec- tion after organ transplantation. 4 Alloactivated T cells express the IL-2 receptor complex (CD25) and secrete Th1 and Th2 cytokines. Thus, blockade of the IL-2 signalling pathway may affect other cytokine systems as well (e.g., down-regulating Th2 cytokines) and may impair graft ac- ceptance. In a pilot study, we determined the effect of treatment with daclizumab (a humanized anti-CD25mAb) on donor- specific IFN-(Th1) and IL-4 (Th2) producing cells in peripheral blood by Elispot-assay in the first 4 months after heart transplantation; at that time no circulating CD3 + CD25 + cells were detected by flowcytometry. PATIENTS AND METHODS Patients were treated with cyclosporine (CsA), prednisone, 1.5 g twice daily mycophenolate mofetil (MMF), and five doses of daclizumab 1.0 mg/kg IV or matching placebo every 2 weeks starting at the time of heart transplantation. We tested PBMC from 9 patients treated with anti-CD25 mAbs and 10 patients treated with placebo for the frequency of IFN- and IL-4 producing cells by Elispot (U-CyTech, Utrecht, The Netherlands). We stimulated 1 10 5 (IL-4: 2 10 5 ) PBMC with 1 10 5 (IL-4: 2 10 5 ) irradiated donor spleen cells. After 40 hours of incubation, the nonadherent cells were transferred to the Elispot plate precoated with anti-human IFN-or IL-4 mAb. Within the Elispot plate the cells were incubated for 5 or 18 hours, respec- tively, to allow spot formation. RESULTS AND DISCUSSION After stimulation with irradiated donor spleen cells, we found significant numbers of IFN-–producing cells in all patients from the placebo group; only 5 out of 9 patients treated with anti-CD25 mAbs had significant numbers ( 50/10 6 PBMC) of donor-specific IFN-–producing cells in peripheral blood (Fischer’s Exact test; P = .03). The median number of donor-specific IFN-–producing cells was 245/10 6 PBMC (range, 50 to 870) in the placebo group and 230/10 6 PBMC (range, 0 to 1560) in the group of patients treated with anti-CD25 mAb therapy. In addition, all patients treated with placebo had donor-specific IL-4 –producing cells (0/10 6 PBMC), while during anti-CD25 mAb therapy 5 out of 9 patients had no IL-4 –producing cells after donor stimu- lation (Fisher’s Exact test; P = .01). The median number of donor-specific IL-4 –producing cells was 63/10 6 PBMC (range, 5 to 295) in the placebo group and 0/10 6 PBMC (range, 0 to 225) in the group of patients treated with anti-CD25 mAb therapy (Mann-Whitney test, P = .09). From the Departments of Internal Medicine (N.M.v.B., M.v.V., T.V.G., C.C.B., W.W.), Cardiology (A.H.M.M.B.), and Thoracic Surgery (A.P.W.M.M.), University Hospital Rotterdam-Dijkzigt, Rotterdam, and U-CyTech (P.H.v.d.M.), Utrecht, The Nether- lands. Supported by grant NHS99064 from the Netherlands Heart Foundation. Address reprint requests to Dr N.M. van Besouw, University Hospital Rotterdam-Dijkzigt, Department of Internal Medicine- Transplantation, Room Ee559, P.O. Box 2040, 3000 CA Rotter- dam, The Netherlands. E-mail: vanbesouw@inw1.azr.nl 0041-1345/02/$–see front matter © 2002 by Elsevier Science Inc. PII S0041-1345(02)03498-X 360 Park Avenue South, New York, NY 10010-1710 2942 Transplantation Proceedings, 34, 2942–2943 (2002)