Can daclizumab reduce acute rejection and improve long-term renal function in tacrolimus-based primary renal transplant recipients?
OBJECTIVE
To evaluate the efficacy and safety of a tacrolimus-based immunosuppressive regimen with and without induction therapy using daclizumab in first cadaveric renal transplant recipients.


METHODS
Since January 2001, we studied the effect of daclizumab in a non-randomized and prospective study of 36 sequential first cadaveric renal transplant recipients. They were compared with a historical control group of 21 sequential first cadaveric renal transplant recipients without induction therapy. All patients received tacrolimus, azathioprine and corticosteroids as concomitant immunosuppressive therapy. Daclizumab was given at 1 mg/kg infusion 2 h before transplantation and then every 14 days for four more doses. Outcomes measured included incidence of acute rejection, patient survival, graft survival, annualized change in creatinine clearance (CrCl), cardiovascular risk profile, infection and malignancy.


RESULTS
Fewer biopsy proven acute rejections were observed in the induction treatment group: 11.1% (4/36) versus 19% (4/21) but the rejection free survival was similar (P = 0.37). The patient survival and graft survival were comparable. The renal function was similar in both groups. There were also no significant difference in infection, malignancy and cardiovascular risk profile in both groups.


CONCLUSIONS
Adding daclizumab to a tacrolimus-based therapy is safe but cannot further improve clinical efficacy.
Cheung
Chi Yuen
CY
Department of Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong. simoncycheung@gmail.com
Liu
Yan Lun
YL
Wong
Kim Ming
KM
Chan
Hoi Wong
HW
Chan
Yiu Han
YH
Wong
Ho Sing
HS
Chak
Wai Leung
WL
Choi
Koon Shing
KS
Chau
Ka Foon
KF
Shek
Chi Chung
CC
Li
Chun Sang
CS
D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001379:Azathioprine / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000209:etiology; D003404:Creatinine / Q000378:metabolism; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000401:mortality / Q000503:physiopathology / Q000517:prevention & control*; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007668:Kidney / Q000187:drug effects* / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery; D016030:Kidney Transplantation / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000209:etiology; D009894:Opportunistic Infections / Q000209:etiology; D011446:Prospective Studies; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D003404:Creatinine; D000077561:Daclizumab; D001379:Azathioprine; D016559:Tacrolimus