Early Steroid Withdrawal with a Sirolimus - and Mycophenolate-Based Calcineurin Inhibitor Minimization Regimen: Long-Term Results

2012 ◽  
Vol 94 (10S) ◽  
pp. 979
Author(s):  
D. J. Conti ◽  
B. J. Conti ◽  
R. Dellehunt ◽  
N. Chandolias ◽  
N. Siparsky ◽  
...  
2003 ◽  
Vol 16 (6) ◽  
pp. 434-441 ◽  
Author(s):  
Lisa M. McDevitt

The evolution of immunosuppression in organ transplantation has resulted in decreasing rates of rejection and improved allograft survival. The current successes, however, comes at the price of intense drug monitoring, frequent adverse affects, and long-term toxicity. New immunosuppressive agents offer the hope for decreased toxicity and improved long-term results. This article highlights those novel agents that are currently in late-stage clinical studies including new calcineurin inhibitor analogs and formulations, mycophenolate acid sodium, everolimus, FK-778, FTY720, and various monoclonal antibodies. The diverse mechanisms of action of these agents, coupled with promising efficacy and adverse effect profiles, may land each of them a unique niche for immunosuppression in organ transplantation.


2008 ◽  
Vol 86 (Supplement) ◽  
pp. 325
Author(s):  
M Gallichio ◽  
O Elbahloul ◽  
J Jaber ◽  
D Cont

2006 ◽  
Vol 13 (5) ◽  
pp. 502-508 ◽  
Author(s):  
HIROAKI SHIMMURA ◽  
KAZUNARI TANABE ◽  
HIDEKI ISHIDA ◽  
NAOSHI MIYAMOTO ◽  
TADAHIKO TOKUMOTO ◽  
...  

2011 ◽  
Vol 11 (11) ◽  
pp. 1832-1836 ◽  
Author(s):  
Alexandre B. Libório ◽  
Talita R. Mendoza ◽  
Ronaldo M. Esmeraldo ◽  
Maria Luiza M.B. Oliveira ◽  
Fernando J.V. Nogueira Paes ◽  
...  

Author(s):  
Dixon Kaufman ◽  
E. Steve Woodle ◽  
Adele Shields ◽  
John Leone ◽  
Arthur Matas ◽  
...  

Immunosuppressive therapy in kidney transplantation is associated with numerous toxicities. CD28-mediated T cell costimulation blockade using belatacept may reduce long-term nephrotoxicity, compared with calcineurin inhibitor-based immunosuppression. The efficacy and safety of simultaneous calcineurin inhibitor avoidance and rapid steroid withdrawal were tested in a randomized, prospective, multi-center study. MethodsAll kidney transplants were performed using rapid steroid withdrawal immunosuppression. Recipients were randomized to 1:1:1 to receive belatacept with alemtuzumab induction, belatacept with rabbit antithymocyte globulin (rATG) induction, or tacrolimus with rATG induction. The composite endpoint consisted of death, kidney allograft loss, or an MDRD calculated eGFR of <45 ml/min/1.73m2 at 2 years. ResultsThe composite endpoint was observed for 11/107 (10%) participants assigned to belatacept/alemtuzumab, 13/104 (13%) assigned to belatacept /rATG, and 21/105 (21%) assigned to tacrolimus/rATG (belatacept/alemtuzumab vs tacrolimus/rATG p = 0.99: belatacept/rATG vs tacrolimus/rATG p = 0.66). Patient and graft survival rates were similar between all groups. eGFR <45 ml/min/1.73m2 was observed for 9/107 (8%) participants assigned to belatacept/alemtuzuab, 8/104 (8%) participants assigned to belatacept/rATG, and 20/105 (19%) participants assigned to tacrolimus/rATG (p<0.05 for each belatacept group vs tacrolimus/rATG). Biopsy-proven acute rejection was observed for 20/107 (19%) participants assigned to belatacept/alemtuzuab, 26/104 (25%) participants assigned to belatacept/rATG, and 7/105 (7%) participants assigned to tacrolimus/rATG (belatacept/alemtuzumab vs tacrolimus/rATG p = 0.006: belatacept/rATG vs tacrolimus/rATG p < 0.001). Gastrointestinal and neurologic adverse events were less frequent with belatacept versus calcineurin based immunosuppression. ConclusionsOverall two-year outcomes were similar comparing maintenance immunosuppression based on belatacept versus tacrolimus, each protocol with rapid steroid withdrawal. The incidence of eGFR <45 ml/min/1.73m2 was significantly lower but the incidence of biopsy proven acute rejection significantly higher with belatacept compared with tacrolimus.


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