The effect of Daclizumab in a high-risk renal transplant population

Introduction: African-American (AA) renal transplant recipients have a high er incidence of acute rejection when compared to Caucasian renal transplant recipients. This higher rejection rate holds true even with the addition o f several of the newer immunosuppressive agents (e.g. mycophenolate mofetil (MMF) and Rapamycin). Acute rejection rates among Hispanic (H) renal trans plant recipients are higher in some settings, while lower or the same as in Caucasians in other settings. IL-2 receptor antibodies have been shown to decrease rejection rates when added to a regimen of cyclosporine (CsA), aza thioprine and prednisone. Limited data are available on these agents in con junction with triple CsA, MMF and prednisone therapy, particularly in highe r risk group patients. We studied the effect of the addition of the IL-2 re ceptor antibody Daclizumab to a CsA, MMF, prednisone regimen in a group of African-American and high-risk Hispanic renal transplant recipients. Methods: This was a non-randomized, prospective study. A total of 49 renal transplant recipients (29 African-American and 20 Hispanic) were studied an d followed. A simultaneous cohort of 56 (31 African-American and 25 Hispani c) renal transplant recipients receiving CsA, MMF and prednisone with no st andard induction agent served as the control group. The study cohort receiv ed the same regimen with the addition of Daclizumab at 1 mg/kg for five dos es over 10 wk. Multivariate analysis was performed to isolate independent f actors influencing the study's results. Results: A total of 56 patients in the control group and 49 patients in the Daclizumab group received an average follow-up of 17.1 +/- 6.9 and 12.7 +/ - 5.1 months, respectively. Acute rejection rates were lower in the Daclizu mab group as compared to the control group 26.4% versus 49.3% per patient y ears, respectively. A total of eight recurrent rejections in 6 patients occ urred in the control group and none in the Daclizumab arm. Craft loss at th is follow-up was no different between the groups. Conclusion: The addition of Daclizumab to a regimen of CsA, MMF and prednis one decreases acute rejection episodes in a high-risk group of African-Amer ican and Hispanic renal transplant recipients.