Experience with single-dose daclizumab in the prevention of acute rejection in heart transplantation.

INTRODUCTION

Daclizumab is a monoclonal antibody that binds to the interleukin-2 receptor. It has been used as induction therapy in heart transplantation with two to five repeated administrations over several weeks. The objective of our study was to estimate the efficacy and safety of induction therapy with only one dose of daclizumab in a consecutive series of patients undergoing heart transplantation.

METHODS

Thirty-two consecutive heart transplants performed since July 2002, who received single-dose daclizumab as induction therapy, were compared with the 30 patients transplanted previously, who received OKT3. In both groups, maintenance immunosuppression included cyclosporine or tacrolimus, mycophenolate mofetil, and corticosteroids. Follow-up time was 1 year.

RESULTS

There were no baseline differences between the two groups regarding age, gender, or etiology. In the group treated with daclizumab there were more diabetics (43% versus 10%, P = .01) and the ischemia time was longer (192 versus 156 minutes, P = .03). During the first posttransplant year, 76% of patients treated with OKT3 and 55% of those treated with daclizumab presented acute rejection > or =3A; 20% and 25%, respectively, presented infections; and 5 (17%) patients in the OKT3 group and 2 (6%) in the group treated with daclizumab died. None of these differences was statistically significant.

CONCLUSIONS

Our experience suggests that induction therapy with a single-dose regimen of daclizumab seems to have an efficacy and safety profile similar to OKT3, and it is easier to administer and has a lower cost than other induction regimens.