A randomized trial of alemtuzumab versus antithymocyte globulin induction in renal and pancreas transplantation.
BACKGROUND.: Alemtuzumab and rabbit antithymocyte globulin (rATG) are commonly used for induction of immunsuppression for kidney and pancreas transplantation, but the two agents have not been compared directly. METHODS.: We conducted a prospective randomized single-center trial comparing alemtuzumab and rATG induction in adult kidney and pancreas transplantation in patients treated with similar maintenance immunosuppression. RESULTS.: Between February 1, 2005, and September 1, 2007, 222 patients randomly received either alemtuzumab (n=113) or rATG (n=109) induction; 180 (81%) underwent kidney alone, 38 (17%) simultaneous pancreas-kidney, and 4 (2%) pancreas after kidney transplants. Of 180 kidney-alone transplants, 152 (84%) were from deceased donors, including 61 (34%) from expanded criteria donors. Retransplantation, human leukocyte antigen match, antibody titer, expanded criteria donors, race, cytomegalovirus status, delayed graft function, and immunologic risks were similar between the two induction groups. With a median follow-up of 2 years (minimum 1 year), overall patient, kidney, and pancreas graft survival rates were 96%, 89%, and 90%, respectively. Survival, initial length of stay, and maintenance immunosuppression (including early steroid elimination) were similar between alemtuzumab and rATG groups, but biopsy-proven acute rejection (BPAR) episodes occurred in 16 (14%) alemtuzumab patients compared with 28 (26%) rATG patients (P=0.02). Late BPAR (>12 months after transplant) occurred in 1 (8%) alemtuzumab patient and 3 (11%) rATG patients (P=NS). Infections and malignancy were similar between the two induction arms. CONCLUSION.: Alemtuzumab and rATG induction therapies were equally safe, but alemtuzumab was associated with less BPAR.
Farney
Alan C
AC
Department of General Surgery, Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157, USA. afarney@wfubmc.edu
Doares
William
W
Rogers
Jeffrey
J
Singh
Rajinder
R
Hartmann
Erica
E
Hart
Lois
L
Ashcraft
Elizabeth
E
Reeves-Daniels
Amber
A
Gautreaux
Michael
M
Iskandar
Samy S
SS
Moore
Phillip
P
Adams
Patricia L
PL
Stratta
Robert J
RJ
D000328:Adult; D000074323:Alemtuzumab; D000818:Animals; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000627:therapeutic use*; D000961:Antilymphocyte Serum / Q000627:therapeutic use*; D005260:Female; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology* / Q000401:mortality / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016035:Pancreas Transplantation / Q000009:adverse effects / Q000276:immunology* / Q000401:mortality / Q000502:physiology; D011446:Prospective Studies; D011817:Rabbits; D013256:Steroids / Q000627:therapeutic use; D015996:Survival Rate; D013601:T-Lymphocytes / Q000276:immunology
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D013256:Steroids; D000074323:Alemtuzumab