title: Daclizumab Versus Rabbit Antithymocyte Globulin in High-Risk Renal Transplants: Five-Year Follow-up of a Randomized Study.
abstract: We previously reported a randomized controlled trial in which 227 de novo deceased-donor kidney transplant recipients were randomized to rabbit antithymocyte (rATG, Thymoglobulin) or daclizumab if they were considered to be at high immunological risk, defined as high panel reactive antibodies (PRA), loss of a first kidney graft through rejection within 2 years of transplantation, or third or fourth transplantation. Patients treated with rATG had lower incidences of biopsy-proven acute rejection (BPAR) and steroid-resistant rejection at 1 year. Patients were followed to 5 years posttransplant in an observational study; findings are described here. Treatment with rATG was associated with a lower rate of BPAR at 5 years (14.2% vs. 26.0% with daclizumab; p = 0.035). Only one rATG-treated patient (0.9%) and one daclizumab-treated patient (1.0%) developed BPAR after 1 year. Five-year graft and patient survival rates, and renal function, were similar between the two groups. Overall graft survival at 5 years was significantly higher in patients without BPAR (81.0% vs. 54.8%; p < 0.001). In conclusion, rATG is superior to daclizumab for the prevention of BPAR among high-immunological-risk renal transplant recipients. Overall graft survival at 5 years was approximately 70% with either induction therapy, which compares favorably to low-risk cohorts.
authors.affiliation: Dienst Néphrologie, Universitair Ziekenhuis Antwerpen, Edegem, Belgium.
authors.forename: R
authors.initials: R
authors.lastname: Hellemans
authors.affiliation: Service de N, é, phrologie, Hôpital, Lille, France.
authors.forename: M
authors.initials: M
authors.lastname: Hazzan
authors.affiliation: Service de Néphrologie-HTA-Dialyse-Transplantation, CHU-Toulouse Rangueil, Toulouse, France.
authors.forename: D
authors.initials: D
authors.lastname: Durand
authors.affiliation: Département de Néphrologie et Transplantation, CHRU-Hôpital Lapeyronie, Montpellier, France.
authors.forename: G
authors.initials: G
authors.lastname: Mourad
authors.affiliation: Service de Néphrologie, Hôpital Henri Mondor, Créteil, France.
authors.forename: P
authors.initials: P
authors.lastname: Lang
authors.affiliation: Département de Néphrologie, Hôpital Universitaire de Nancy, Nancy, France.
authors.forename: M
authors.initials: M
authors.lastname: Kessler
authors.affiliation: Service de Néphrologie, CHRU de Bicêtre, Bicêtre, France.
authors.forename: B
authors.initials: B
authors.lastname: Charpentier
authors.affiliation: Service de Néphrologie-Transplantation, CHU de Poitiers, Hôpital Jean-Bernard, Poitiers, France.
authors.forename: G
authors.initials: G
authors.lastname: Touchard
authors.affiliation: Service de Néphrologie, CHRU-Hôpital Nord, Saint-Etienne, France.
authors.forename: F
authors.initials: F
authors.lastname: Berthoux
authors.affiliation: Service de Néphrologie, Hôpital Pellegrin, Bordeaux, France.
authors.forename: P
authors.initials: P
authors.lastname: Merville
authors.affiliation: Service de Néphrologie A, Hôpital Tenon, Paris, France.
authors.forename: N
authors.initials: N
authors.lastname: Ouali
authors.affiliation: Cliniques Universitaires St Luc, Brussels, and Department of Abdominal Transplantation, CHU Sart Tilman, Liege, Belgium.
authors.forename: J-P
authors.initials: JP
authors.lastname: Squifflet
authors.affiliation: Service de Néphrologie, CHU de Grenoble, Grenoble, France.
authors.forename: F
authors.initials: F
authors.lastname: Bayle
authors.affiliation: Dienst Nefrologie, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: K M
authors.initials: KM
authors.lastname: Wissing
authors.affiliation: Service de N, é, phrologie, Hôpital, Lille, France.
authors.forename: C
authors.initials: C
authors.lastname: Noël
authors.affiliation: Dienst Néphrologie, Universitair Ziekenhuis Antwerpen, Edegem, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Abramowicz
mesh_terms: D000328:Adult; D000818:Animals; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011817:Rabbits; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D000077561:Daclizumab; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D007074:Immunoglobulin G / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000601:surgery; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D011183:Postoperative Complications; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum; D000077561:Daclizumab; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents
keywords: Immunosuppressant; clinical research/practice; fusion proteins and monoclonal antibodies: basiliximab/daclizumab; graft survival; immunosuppressant; kidney transplantation/nephrology; polyclonal preparations: rabbit antithymocyte globulin