title: A randomized trial of alemtuzumab versus antithymocyte globulin induction in renal and pancreas transplantation.
abstract: 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.
authors.affiliation: Department of General Surgery, Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157, USA. afarney@wfubmc.edu
authors.forename: Alan C
authors.initials: AC
authors.lastname: Farney
authors.forename: William
authors.initials: W
authors.lastname: Doares
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Rogers
authors.forename: Rajinder
authors.initials: R
authors.lastname: Singh
authors.forename: Erica
authors.initials: E
authors.lastname: Hartmann
authors.forename: Lois
authors.initials: L
authors.lastname: Hart
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ashcraft
authors.forename: Amber
authors.initials: A
authors.lastname: Reeves-Daniels
authors.forename: Michael
authors.initials: M
authors.lastname: Gautreaux
authors.forename: Samy S
authors.initials: SS
authors.lastname: Iskandar
authors.forename: Phillip
authors.initials: P
authors.lastname: Moore
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Adams
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Stratta
mesh_terms: 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
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D013256:Steroids; D000074323:Alemtuzumab