Avoidance of cyclosporine in renal transplantation: Effects of daclizumab,mycophenolate mofetil, and steroids

Cyclosporine (CsA) has been implicated in both acute and chronic graft dysf unction. The addition of humanized IL-2 receptor antibody daclizumab (DZB) to CsA-based immunosuppression decreases the rate of acute renal transplant rejection. Therefore, 45 patients were evaluated in an immunosuppressive p rotocol that included DZB, mycophenolate mofetil (MMF), and steroids withou t CsA. This was a prospective, nonrandomized, open-label trial of the effic acy and safety of the treatment. DZB was given intravenously at 2 mg/kg bef ore transplantation and then at 1 mg/kg every 2 wk for four doses, MMF was given orally at 3 g/d, and methylprednisolone/prednisone was given at 7 mg/ kg per day and tapered to 15 mg/d at 6 mo. CsA was added to the regimen whe n patients developed acute rejection episodes or adverse effects to steroid s or MMF; 49% of patients were spared CsA maintenance. Patients without CsA had lower serum creatinine at 6 mo and needed fewer medications to control BP. Incidence of biopsy proven rejections was 31% and occurred early (medi an, 10 d). These rejection episodes occurred earlier in cadaver transplants (median, 7 d) and later in living donor transplants (median, 62 days). Acu te rejections occurred at a higher frequency (46% versus 34%) and earlier ( 6.5 versus 15 d) in patients with delayed graft function compared with pati ents without delayed graft function. Most of the rejections were moderate a nd easily reversible. The actuarial 1-yr graft survival was 95% with 100% p atient survival.