IngentaConnect Efficacy and cardiovascular safety of daclizumab, mycophenolate m...

Abstract:

Abramowicz D, Vanrenterghem Y, Squifflet J-P, Kuypers D, Mourad M, Meurisse M, Wissing M. Efficacy and cardiovascular safety of daclizumab, mycophenolate mofetil, tacrolimus, and early steroid withdrawal in renal transplant recipients: a multicenter, prospective, pilot trial.

Clin Transplant 2005: 19: 475–482. © Blackwell Munksgaard, 2005 Abstract:

This single-arm, open-label, pilot study was designed to assess the efficacy and cardiovascular safety profile of daclizumab, a humanized monoclonal interleukin (IL)-2Rα antibody, in combination with mycophenolate mofetil (MMF), tacrolimus, and early corticosteroid withdrawal in renal transplant recipients. Seventy-nine renal allograft recipients were treated with daclizumab (1 mg/kg; five doses starting on the day before transplant and then every two weeks), MMF (1 g b.i.d.), tacrolimus (0.2 mg/kg/d), and low-dose prednisolone, which was withdrawn at day 150 after transplant. The rate of acute rejection was determined at 12 months. Lipid profile, oral glucose tolerance, and adverse events were monitored. Of the 76 patients eligible for analysis, eight (10.5%) developed biopsy-proven acute rejection (BPAR). Ten (13.2%) experienced clinical and/or BPAR. Corticosteroids were withdrawn completely in 91% of patients at 12 months. Graft and patient survival were 97.5% and 98.7% respectively. Mean total cholesterol and triglycerides were significantly lower at 12 months post-transplant than at baseline (201 ± 47.5 vs. 190.8 ± 43.6 mg/dL, p = 0.005 and 196.2 ± 133.2 vs. 144.5 ± 76.8 mg/dL, p < 0.001, respectively). Mean hemoglobin A_1c levels did not differ between baseline (5.54%) and 12 months (5.48%). New-onset post-transplant diabetes mellitus occurred in 6.6% of the non-diabetic transplanted patients. The proportion of patients with abnormal oral glucose tolerance test (OGTT) was 47% at 3 months and 39% at 12 months (p = NS). Daclizumab induction in combination with MMF, tacrolimus, and low-dose (followed by withdrawal) prednisolone appears to be effective and safe in patients receiving renal allografts. The regimen appears to be associated with a favorable cardiovascular profile.

Keywords: daclizumab; mycophenolate mofetil; renal transplant; steroid-free; tacrolimus

Document Type: Research article

DOI: 10.1111/j.1399-0012.2005.00369.x

Affiliations: 1: Nephrology and Renal Transplantation, ULB, Hôpital Erasme, Brussels, Belgium 2: Nephrology and Renal Transplantation, KU Leuven, UZ Gasthuisberg, Leuven, Belgium 3: Renal and Pancreatic Transplantation, UCL, St.-Luc, Brussels, Belgium 4: Renal Transplantation, CHU Sart-Tilman, Liège, Belgium

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