Rabbit antithymocyte globulin versus basiliximab in renal transplantation.
BACKGROUND
Induction therapy reduces the frequency of acute rejection and delayed graft function after transplantation. A rabbit antithymocyte polyclonal antibody or basiliximab, an interleukin-2 receptor monoclonal antibody, is most commonly used for induction.


METHODS
In this prospective, randomized, international study, we compared short courses of antithymocyte globulin and basiliximab in patients at high risk for acute rejection or delayed graft function who received a renal transplant from a deceased donor. Patients taking cyclosporine, mycophenolate mofetil, and prednisone were randomly assigned to receive either rabbit antithymocyte globulin (1.5 mg per kilogram of body weight daily, 141 patients) during transplantation (day 0) and on days 1 through 4 or basiliximab (20 mg, 137 patients) on days 0 and 4. The primary end point was a composite of acute rejection, delayed graft function, graft loss, and death.


RESULTS
At 12 months, the incidence of the composite end point was similar in the two groups (P=0.34). The antithymocyte globulin group, as compared with the basiliximab group, had lower incidences of acute rejection (15.6% vs. 25.5%, P=0.02) and of acute rejection that required treatment with antibody (1.4% vs. 8.0%, P=0.005). The antithymocyte globulin group and the basiliximab group had similar incidences of graft loss (9.2% and 10.2%, respectively), delayed graft function (40.4% and 44.5%), and death (4.3% and 4.4%). Though the incidences of all adverse events, serious adverse events, and cancers were also similar between the two groups, patients receiving antithymocyte globulin had a greater incidence of infection (85.8% vs. 75.2%, P=0.03) but a lower incidence of cytomegalovirus disease (7.8% vs. 17.5%, P=0.02).


CONCLUSIONS
Among patients at high risk for acute rejection or delayed graft function who received a renal transplant from a deceased donor, induction therapy consisting of a 5-day course of antithymocyte globulin, as compared with basiliximab, reduced the incidence and severity of acute rejection but not the incidence of delayed graft function. Patient and graft survival were similar in the two groups. (ClinicalTrials.gov number, NCT00235300 [ClinicalTrials.gov].).
Brennan
Daniel C
DC
Renal Division, Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, MO 63110, USA. dbrennan@wustl.edu
Daller
John A
JA
Lake
Kathleen D
KD
Cibrik
Diane
D
Del Castillo
Domingo
D
D000208:Acute Disease; D000818:Animals; D019072:Antibiotic Prophylaxis; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000961:Antilymphocyte Serum / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D001772:Blood Cell Count; D002102:Cadaver; D051799:Delayed Graft Function / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011817:Rabbits; D015375:Receptors, Interleukin-2 / Q000037:antagonists & inhibitors; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*
D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; D006454:Hemoglobins; D007166:Immunosuppressive Agents; D015375:Receptors, Interleukin-2; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab