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Previous Volume 338:161-165 January 15, 1998 Number 3 Next

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ABSTRACT

Background Monoclonal antibodies that block the high-affinity interleukin-2 receptor expressed on alloantigen-reactive T lymphocytes may cause selective immunosuppression. Daclizumab is a genetically engineered human IgG1 monoclonal antibody that binds specifically to the chain of the interleukin-2 receptor and may thus reduce the risk of rejection after renal transplantation.

Methods We administered daclizumab (1.0 mg per kilogram of body weight) or placebo intravenously before transplantation and once every other week afterward, for a total of five doses, to 260 patients receiving first cadaveric kidney grafts and immunosuppressive therapy with cyclosporine, azathioprine, and prednisone. The patients were followed at regular intervals for 12 months. The primary end point was the incidence of biopsy-confirmed acute rejection within six months after transplantation.

Results Of the 126 patients given daclizumab, 28 (22 percent) had biopsy-confirmed episodes of acute rejection, as compared with 47 of the 134 patients (35 percent) who received placebo (P = 0.03). Graft survival at 12 months was 95 percent in the daclizumab-treated patients, as compared with 90 percent in the patients given placebo (P = 0.08). The patients given daclizumab did not have any adverse reactions to the drug, and at six months, there were no significant differences between the two groups with respect to infectious complications or cancers. The serum half-life of daclizumab was 20 days, and its administration resulted in prolonged saturation of interleukin-2 receptors on circulating lymphocytes.

Conclusions Daclizumab reduces the frequency of acute rejection in kidney-transplant recipients.

Source Information

From the University of California, San Francisco (F.V.); Brigham and Women's Hospital, Boston (R.K.); Hoffmann–LaRoche, Nutley, N.J. (S.L.); Ohio State University, Columbus (G.B.); Indiana University, Indianapolis (M.P.); the University of Alberta, Edmonton, Alta., Canada (P.H.); Emory University, Atlanta (J.N.); the University of California, Los Angeles (A.W.); Malmö University Hospital, Malmö, Sweden (H.E.); the University of Alabama, Birmingham (R.G.); Sahlgrenska Hospital, Gothenburg, Sweden (L.B.); and Johns Hopkins University, Baltimore (J.B.).

Address reprint requests to Dr. Vincenti at the Transplant Service, University of California, San Francisco, 505 Parnassus Ave., Rm. M884, Box 0116, San Francisco, CA 94143-0116.

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Daclizumab to Prevent Acute Rejection in Renal Transplantation
Abramowicz D., Vincenti F., The Daclizumab Triple Therapy Study Group
Extract | Full Text  
N Engl J Med 1998; 338:1700-1701, Jun 4, 1998. Correspondence

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