Daclizumab prevents acute rejection and improves patient survival post transplantation: 1 year pooled analysis

Daclizumab is a genetically engineered human IgG1 monoclonal antibody speci fic for the a chain of the IL-2 receptor. A pooled analysis of two randomiz ed, double-blind studies was performed on the efficacy and safety of dacliz umab in renal transplantation, given in addition to standard immunosuppress ion. Patients receiving their first cadaveric renal allograft were randomiz ed to receive 5 doses of daclizumab (n = 267) or placebo (n = 268), startin g pre-operatively. Acute rejection at 1 year occurred less frequently with daclizumab (n = 74, 27.7 %) than with placebo (n = 116, 43.3 %) (P = 0.0001 ), Fewer patients treated with daclizumab required anti-lymphocyte therapy for acute rejection (7.9 % vs. 15.3 %; P = 0.005). Mean cumulative doses of corticosteroids were lower with daclizumab (4133 mg) than with placebo (45 62 mg). One year graft survival was 91.4% with daclizumab, compared with 86 .6% on placebo (P = 0.065), with patient survival of 98.5% and 95.1% for da clizumab and placebo respectively (P = 0.022). Daclizumab was well tolerate d. No increase in infectious episodes or lymphoproliferative disorders was observed with daclizumab. The incidence of cytomegalovirus infections was s imilar with daclizumab and placebo (15% vs. 17.5%). Therapy with daclizumab significantly reduces acute rejection in renal transplantation and improve s patient survival without any increase in morbidity.