Abstract
Extracorporeal photopheresis (ECP) is an accepted treatment option for acute and chronic rejection after solid organ transplantation but the mode of action is not fully elucidated. In a randomized controlled trial that investigates the addition of prophylactic use of ECP to a tacrolimus-based immunosuppressive regimen after lung transplantation, a comprehensive phenotypic immune monitoring is performed to assess the immunomodulatory effects of ECP. To date, 40 (from a calculated sample size of 62) end-stage chronic obstructive pulmonary disease (COPD) patients underwent bilateral lung transplantation and were randomized into 2 treatment arms - the control group received standard triple immunosuppression consisting of tacrolimus, mycophenolate mofetil and steroids while the second group additionally received 16 ECP treatments in the first three months after surgery. For monitoring a comprehensive set of leukocyte subsets such as regulatory T cells (CD4+CD25+FoxP3+ Tregs) polychromatic flow cytometry analysis was performed on fresh whole blood samples using validated, standardized, lyophilized monoclonal antibody panels (DuraClone). Samples were acquired before and 3 months after transplantation, when the last ECP treatment was performed, as well as 6 months after transplantation. Statistical analysis was conducted by using a two-tailed paired and unpaired t-test. From 40 double lung transplanted patients, 32 patients have reached their three-month-visit and 28 patients their 6-months-visit. No significant difference in the frequency of Tregs was found between both groups at baseline (p=0.425). At 3 months, Tregs have significantly decreased in the control group (p=0.009) while in the ECP-treated group no significant decline was seen (p=0.141). Six months after transplantation the frequency of Tregs was significantly decreased in both groups when compared to baseline (p=0.043 in control; p=0.030 in ECP-treated). Preliminary data from this interim analysis of double lung transplanted patients receiving ECP as prophylactic treatment provide evidence that during ECP treatments the post-transplant decline in Treg frequency seen with standard immunosuppression is prevented.
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