title: Daclizumab versus antithymocyte globulin in high-immunological-risk renal transplant recipients.
abstract: Nondepleting anti-CD25 monoclonal antibodies (daclizumab) and depleting polyclonal antithymocyte globulin (Thymoglobulin) both prevent acute rejection, but these therapies have not been directly compared in a high-risk, HLA-sensitized renal transplant population. We randomly assigned 227 patients, who were about to receive a kidney graft from a deceased donor, to either Thymoglobulin or daclizumab if they met one of the following risk factors: current panel reactive antibodies (PRA) >30%; peak PRA >50%; loss of a first kidney graft from rejection within 2 yr of transplantation; or two or three previous grafts. Maintenance immunosuppression comprised tacrolimus, mycophenolate mofetil, and steroids. Compared with the daclizumab group, patients treated with Thymoglobulin had a lower incidence of both biopsy-proven acute rejection (15.0% versus 27.2%; P = 0.016) and steroid-resistant rejection (2.7% versus 14.9%; P = 0.002) at one year. One-year graft and patient survival rates were similar between the two groups. In a comparison of rejectors and nonrejectors, overall graft survival was significantly higher in the rejection-free group (87.2% versus 75.0%; P = 0.037). In conclusion, among high-immunological-risk renal transplant recipients, Thymoglobulin is superior to daclizumab for the prevention of biopsy-proven acute rejection, but there is no significant benefit to one-year graft or patient survival.
authors.affiliation: Service de Néphrologie, Hôpital Calmette, Lille, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Noël
authors.forename: Daniel
authors.initials: D
authors.lastname: Abramowicz
authors.forename: Dominique
authors.initials: D
authors.lastname: Durand
authors.forename: Georges
authors.initials: G
authors.lastname: Mourad
authors.forename: Philippe
authors.initials: P
authors.lastname: Lang
authors.forename: Michèle
authors.initials: M
authors.lastname: Kessler
authors.forename: Bernard
authors.initials: B
authors.lastname: Charpentier
authors.forename: Guy
authors.initials: G
authors.lastname: Touchard
authors.forename: François
authors.initials: F
authors.lastname: Berthoux
authors.forename: Pierre
authors.initials: P
authors.lastname: Merville
authors.forename: Nacera
authors.initials: N
authors.lastname: Ouali
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Squifflet
authors.forename: François
authors.initials: F
authors.lastname: Bayle
authors.forename: Karl Martin
authors.initials: KM
authors.lastname: Wissing
authors.forename: Marc
authors.initials: M
authors.lastname: Hazzan
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum / Q000627:therapeutic use*; D001706:Biopsy; D000077561:Daclizumab; D005260:Female; D006084:Graft Rejection / Q000473:pathology / Q000517:prevention & control*; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007668:Kidney / Q000473:pathology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab