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Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation

This report describes the results of 2 international randomized trials (total of 508 kidney transplant recipients). The primary objective was to assess the noninferiority of rabbit anti‐thymocyte globulin (rATG, Thymoglobulin(®)) versus interleukin‐2 receptor antagonists (IL2RAs) for the quadruple e...

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Autores principales: Alloway, Rita R., Woodle, E. Steve, Abramowicz, Daniel, Segev, Dorry L., Castan, Remi, Ilsley, Jillian N., Jeschke, Kari, Somerville, Kenneth Troy, Brennan, Daniel C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767488/
https://www.ncbi.nlm.nih.gov/pubmed/30838775
http://dx.doi.org/10.1111/ajt.15342
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author Alloway, Rita R.
Woodle, E. Steve
Abramowicz, Daniel
Segev, Dorry L.
Castan, Remi
Ilsley, Jillian N.
Jeschke, Kari
Somerville, Kenneth Troy
Brennan, Daniel C.
author_facet Alloway, Rita R.
Woodle, E. Steve
Abramowicz, Daniel
Segev, Dorry L.
Castan, Remi
Ilsley, Jillian N.
Jeschke, Kari
Somerville, Kenneth Troy
Brennan, Daniel C.
author_sort Alloway, Rita R.
collection PubMed
description This report describes the results of 2 international randomized trials (total of 508 kidney transplant recipients). The primary objective was to assess the noninferiority of rabbit anti‐thymocyte globulin (rATG, Thymoglobulin(®)) versus interleukin‐2 receptor antagonists (IL2RAs) for the quadruple endpoint (treatment failure defined as biopsy‐proven acute rejection, graft loss, death, or loss to follow‐up) to serve as the pivotal data for United States (US) regulatory approval of rATG. The pooled analysis provided an incidence of treatment failure of 25.1% in the rATG and 36.0% in the IL2RA treatment groups, an absolute difference of −10.9% (95% confidence interval [CI] −18.8% to −2.9%) supporting noninferiority (noninferiority margin was 10%) and superiority of rATG to IL2RA. In a meta‐analysis of 7 trials comparing rATG with an IL2RA, the difference in the proportion of patients with BPAR at 12 months was −4.8% (95% CI −8.6% to −0.9%) in favor of rATG. In conclusion, a rigorous reanalysis of patient‐level data from 2 prior randomized, controlled trials comparing rATG versus IL‐2R monoclonal antibodies provided support for regulatory approval for rATG for induction therapy in renal transplant, making it the first T cell–depleting therapy approved for the prophylaxis of acute rejection in patients receiving a kidney transplant in the United States.
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spelling pubmed-67674882019-10-03 Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation Alloway, Rita R. Woodle, E. Steve Abramowicz, Daniel Segev, Dorry L. Castan, Remi Ilsley, Jillian N. Jeschke, Kari Somerville, Kenneth Troy Brennan, Daniel C. Am J Transplant ORIGINAL ARTICLES This report describes the results of 2 international randomized trials (total of 508 kidney transplant recipients). The primary objective was to assess the noninferiority of rabbit anti‐thymocyte globulin (rATG, Thymoglobulin(®)) versus interleukin‐2 receptor antagonists (IL2RAs) for the quadruple endpoint (treatment failure defined as biopsy‐proven acute rejection, graft loss, death, or loss to follow‐up) to serve as the pivotal data for United States (US) regulatory approval of rATG. The pooled analysis provided an incidence of treatment failure of 25.1% in the rATG and 36.0% in the IL2RA treatment groups, an absolute difference of −10.9% (95% confidence interval [CI] −18.8% to −2.9%) supporting noninferiority (noninferiority margin was 10%) and superiority of rATG to IL2RA. In a meta‐analysis of 7 trials comparing rATG with an IL2RA, the difference in the proportion of patients with BPAR at 12 months was −4.8% (95% CI −8.6% to −0.9%) in favor of rATG. In conclusion, a rigorous reanalysis of patient‐level data from 2 prior randomized, controlled trials comparing rATG versus IL‐2R monoclonal antibodies provided support for regulatory approval for rATG for induction therapy in renal transplant, making it the first T cell–depleting therapy approved for the prophylaxis of acute rejection in patients receiving a kidney transplant in the United States. John Wiley and Sons Inc. 2019-04-03 2019-08 /pmc/articles/PMC6767488/ /pubmed/30838775 http://dx.doi.org/10.1111/ajt.15342 Text en © 2019 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle ORIGINAL ARTICLES
Alloway, Rita R.
Woodle, E. Steve
Abramowicz, Daniel
Segev, Dorry L.
Castan, Remi
Ilsley, Jillian N.
Jeschke, Kari
Somerville, Kenneth Troy
Brennan, Daniel C.
Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation
title Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation
title_full Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation
title_fullStr Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation
title_full_unstemmed Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation
title_short Rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation
title_sort rabbit anti‐thymocyte globulin for the prevention of acute rejection in kidney transplantation
topic ORIGINAL ARTICLES
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767488/
https://www.ncbi.nlm.nih.gov/pubmed/30838775
http://dx.doi.org/10.1111/ajt.15342
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