title: Pilot study of rapid steroid elimination with alemtuzumab induction therapy in kidney and pancreas transplantation.
abstract: This study evaluates our initial experience using alemtuzumab induction with rapid corticosteroid elimination in kidney (KTX) and pancreas transplant (PTX) patients. Data were collected retrospectively for all patients who received single-dose alemtuzumab (30 mg IV intraoperatively) with steroid pretreatment and a control group who received alternate day rabbit antithymocyte globulin (rATG) induction with a steroid-based regimen. Patients in both groups received tacrolimus (TAC) and mycophenolate mofetil (MMF). There were 16 patients in each group, including 9 deceased donor KTXs, 5 living donor KTXs, 1 simultaneous K-PTX, and 1 sequential PTX after KTX. Demographic, immunologic, and transplant characteristics were similar between groups. Nine patients (56%) in the alemtuzumab group compared to five (25%) in the control group developed neutropenia requiring MMF or valganciclovir dose reduction (or both). Absolute lymphocyte counts at 3 months were 340 +/- 200/mm3 and 890 +/- 544/ mm3 in the alemtuzumab and control groups, respectively (P = .001). There were two biopsy-proven acute rejection episodes (12.5%) in each group, and no difference in the incidence of infection. Creatinine clearance at 6 months was 58 mL/min in each group. Patient and kidney graft survival rates were both 94% in the alemtuzumab group (one death from cardiac arrest), compared with 100% patient and kidney graft survival rates in the control group (P = NS), with a mean follow-up of 9 and 11 months, respectively. The results of this pilot study suggest that similar short-term outcomes can be achieved using a rapid steroid elimination protocol with alemtuzumab induction therapy compared to rATG with steroids in patients receiving TAC and MMF maintenance therapy.
authors.affiliation: Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1095, USA. asundber@wfubmc.edu
authors.forename: A K
authors.initials: AK
authors.lastname: Sundberg
authors.forename: J A
authors.initials: JA
authors.lastname: Roskopf
authors.forename: E L
authors.initials: EL
authors.lastname: Hartmann
authors.forename: A C
authors.initials: AC
authors.lastname: Farney
authors.forename: M S
authors.initials: MS
authors.lastname: Rohr
authors.forename: R J
authors.initials: RJ
authors.lastname: Stratta
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007239:Infections / Q000453:epidemiology; D016030:Kidney Transplantation / Q000276:immunology*; D007958:Leukocyte Count; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D016035:Pancreas Transplantation / Q000276:immunology*; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology; D014019:Tissue Donors / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab