Calcineurin inhibitor- and steroid-free immunosuppression in pancreas-kidney and solitary pancreas transplantation.
BACKGROUND
Calcineurin inhibitors and steroids are standard immunosuppressants in solid organ transplantation, but (long-term) side effects are harmful to the recipient and the graft. The authors present a novel strategy for posttransplant immunosuppression that combines a depleting antibody with an antimetabolite, avoiding calcineurin inhibitors and steroids.


METHODS
In a prospective, nonrandomized, observational cohort study, 75 pancreas-kidney and solitary pancreas recipients received alemtuzumab (4 doses for induction and up to 12 doses within the first year) and mycophenolate mofetil (> or = 2 g/day) for induction and maintenance therapy. Minimum follow-up was 6 months. We compared the results with a historical group of 266 consecutive pancreas recipients on Thymoglobulin (induction) and tacrolimus (maintenance).


RESULTS
Differences in patient and graft survival rates between the study and control groups at 6 months were not statistically significant. However, the incidence of a first reversible rejection episode was significantly higher for simultaneous pancreas-kidney recipients in the study (vs. control) group. We noted a trend toward higher modification of renal disease levels at 6 months posttransplant in the study (vs. control) groups.


CONCLUSIONS
The combination of alemtuzumab and mycophenolate mofetil was associated with an acceptable rejection rate, a good safety profile, and good (graft and native) kidney function; it eliminated undesired calcineurin inhibitor- and steroid-related side effects. Longer follow-up is warranted before expanded application can be recommended.
Gruessner
Rainer W G
RW
Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA. grues001@umn.edu
Kandaswamy
Raja
R
Humar
Abhinav
A
Gruessner
Angelika C
AC
Sutherland
David E R
DE
D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000627:therapeutic use; D065095:Calcineurin Inhibitors; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000145:classification / Q000627:therapeutic use*; D007239:Infections / Q000453:epidemiology; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D016035:Pancreas Transplantation / Q000276:immunology* / Q000401:mortality; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology; D012189:Retrospective Studies; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab