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Previous Volume 353:770-781 August 25, 2005 Number 8 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Ingelfinger, J. R. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Renal transplantation is the standard of care for patients with end-stage renal disease. Although maintenance immunosuppression with calcineurin inhibitors yields excellent one-year survival, it is associated over the long term with high rates of death and graft loss, owing in part to the adverse renal, cardiovascular, and metabolic effects of these agents. The use of potentially less toxic agents, such as belatacept, a selective blocker of T-cell activation, may improve outcomes.

Methods We randomly assigned renal-transplant recipients to receive an intensive or a less-intensive regimen of belatacept or cyclosporine. All patients received induction therapy with basiliximab, mycophenolate mofetil, and corticosteroids. The primary objective was to demonstrate the noninferiority of belatacept over cyclosporine in the incidence of acute rejection at six months (with an upper bound of the 95 percent confidence interval around the treatment difference of less than 20 percent).

Results At six months, the incidence of acute rejection was similar among the groups: 7 percent for intensive belatacept, 6 percent for less-intensive belatacept, and 8 percent for cyclosporine. At 12 months, the glomerular filtration rate was significantly higher with both intensive and less-intensive belatacept than it was with cyclosporine (66.3, 62.1, and 53.5 ml per minute per 1.73 m², respectively), and chronic allograft nephropathy was less common with both regimens of belatacept than with cyclosporine (29 percent, 20 percent, and 44 percent, respectively). Lipid levels and blood-pressure values were similar or slightly lower in the belatacept groups, despite the greater use of lipid-lowering and antihypertensive medications in the cyclosporine group.

Conclusions Belatacept, an investigational selective costimulation blocker, did not appear to be inferior to cyclosporine as a means of preventing acute rejection after renal transplantation. Belatacept may preserve the glomerular filtration rate and reduce the rate of chronic allograft nephropathy.

Source Information

From the University of California, San Francisco, San Francisco (F.V.); the Emory Transplant Center and Department of Surgery, Emory University School of Medicine, Atlanta (C.L.); the Nephrology Unit, INSERM Unité 542, Le Kremlin Bicêtre Hospital, Le Kremlin Bicêtre, France (A.D., B.C.); the Department of Surgery, Division of Transplantation, Vienna General Hospital, Medical University of Vienna, Vienna (T.W.); Klinik für Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover, Germany (B.N.); the Nephrology Unit, Hotel Dieu Hospital, Nantes, France (G.B.); Service de Néphrologie et de Transplantation, Hôpital Henri-Mondor, Créteil, France (P.L.); the Department of Medicine, Universitat de Barcelona, Hospital Universitari de Bellvitge, Barcelona (J.G.); the Departments of Medicine (P.F.H.) and Laboratory Medicine and Pathology (K.S.), University of Alberta, Edmonton, Alta., Canada; and Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, N.J. (D.H., E.L., W.Z., K.N.).

Drs. Vincenti and Larsen contributed equally to the article.

Address reprint requests to Dr. Larsen at Emory University, Rm. 5105 WMB, 1639 Pierce Dr., Atlanta, GA 30322, or at clarsen{at}emory.org.

Full Text of this Article

Related Letters:

Costimulation Blockade with Belatacept in Renal Transplantation
Dharnidharka V. R., Vincenti F.
Extract | Full Text | PDF  
N Engl J Med 2005; 353:2085-2086, Nov 10, 2005. Correspondence

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