Cargando…
A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients
BACKGROUND: Two prospective studies that were performed before the era of highly sensitive solid-phase assays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patients given polyclonal antibodies compared with those given anti-CD25 monoclonal antibodies. METHODS...
Autores principales: | , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7403559/ https://www.ncbi.nlm.nih.gov/pubmed/32775820 http://dx.doi.org/10.1016/j.ekir.2020.05.020 |
_version_ | 1783566966130212864 |
---|---|
author | Kamar, Nassim Lepage, Benoit Couzi, Lionel Albano, Laetitia Durrbach, Antoine Pernin, Vincent Esposito, Laure Hebral, Anne Laure Darres, Amandine Lequintrec, Moglie Cassuto, Elisabeth Merville, Pierre Congy, Nicolas Del Bello, Arnaud |
author_facet | Kamar, Nassim Lepage, Benoit Couzi, Lionel Albano, Laetitia Durrbach, Antoine Pernin, Vincent Esposito, Laure Hebral, Anne Laure Darres, Amandine Lequintrec, Moglie Cassuto, Elisabeth Merville, Pierre Congy, Nicolas Del Bello, Arnaud |
author_sort | Kamar, Nassim |
collection | PubMed |
description | BACKGROUND: Two prospective studies that were performed before the era of highly sensitive solid-phase assays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patients given polyclonal antibodies compared with those given anti-CD25 monoclonal antibodies. METHODS: This prospective pilot randomized French multicenter study aimed to compare anti–T-lymphocyte Ig (ATLG) (n = 32) and basiliximab (n = 27) in highly sensitized kidney-transplant patients without preformed donor-specific antibodies (pDSAs) as assessed by a Luminex Single-Antigen flow bead assay. Only patients with a calculated panel reactive antibody ≥50%, with at least 1 antibody with a mean fluorescence intensity ≥5000 and without a historical pDSA and without a pDSA on the day of transplantation were included. RESULTS: Treatment failure as defined by biopsy-proven acute rejection, patient lost to follow-up, graft loss, and death was observed in 18.8% (95% confidence interval [CI], 8.9%–37.1%) and 18.8% (95% CI, 8.9%–37.1%) in patients who received ATLG and 14.8% (95% CI, 5.8%–34.8%) and 28.2% (95% CI, 14.2%–51.2%) of patients who received basiliximab, respectively at 6 (P = 0.66) and 12 (P = 0.62) months post-transplantation. One T cell–mediated rejection was observed in ATLG-treated patients (3.1%). One antibody-mediated rejection due to a de novo donor-specific antibody (DSA) occurred in basiliximab-treated patients (3.7%). Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 groups. CONCLUSION: This pilot study indicates that in highly sensitized kidney-transplant patients without pDSAs, both ATLG and basiliximab can be used efficiently and safely. However, because of the lack of power, these results should be interpreted with caution. |
format | Online Article Text |
id | pubmed-7403559 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-74035592020-08-06 A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients Kamar, Nassim Lepage, Benoit Couzi, Lionel Albano, Laetitia Durrbach, Antoine Pernin, Vincent Esposito, Laure Hebral, Anne Laure Darres, Amandine Lequintrec, Moglie Cassuto, Elisabeth Merville, Pierre Congy, Nicolas Del Bello, Arnaud Kidney Int Rep Clinical Research BACKGROUND: Two prospective studies that were performed before the era of highly sensitive solid-phase assays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patients given polyclonal antibodies compared with those given anti-CD25 monoclonal antibodies. METHODS: This prospective pilot randomized French multicenter study aimed to compare anti–T-lymphocyte Ig (ATLG) (n = 32) and basiliximab (n = 27) in highly sensitized kidney-transplant patients without preformed donor-specific antibodies (pDSAs) as assessed by a Luminex Single-Antigen flow bead assay. Only patients with a calculated panel reactive antibody ≥50%, with at least 1 antibody with a mean fluorescence intensity ≥5000 and without a historical pDSA and without a pDSA on the day of transplantation were included. RESULTS: Treatment failure as defined by biopsy-proven acute rejection, patient lost to follow-up, graft loss, and death was observed in 18.8% (95% confidence interval [CI], 8.9%–37.1%) and 18.8% (95% CI, 8.9%–37.1%) in patients who received ATLG and 14.8% (95% CI, 5.8%–34.8%) and 28.2% (95% CI, 14.2%–51.2%) of patients who received basiliximab, respectively at 6 (P = 0.66) and 12 (P = 0.62) months post-transplantation. One T cell–mediated rejection was observed in ATLG-treated patients (3.1%). One antibody-mediated rejection due to a de novo donor-specific antibody (DSA) occurred in basiliximab-treated patients (3.7%). Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 groups. CONCLUSION: This pilot study indicates that in highly sensitized kidney-transplant patients without pDSAs, both ATLG and basiliximab can be used efficiently and safely. However, because of the lack of power, these results should be interpreted with caution. Elsevier 2020-06-02 /pmc/articles/PMC7403559/ /pubmed/32775820 http://dx.doi.org/10.1016/j.ekir.2020.05.020 Text en © 2020 International Society of Nephrology. Published by Elsevier Inc. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Clinical Research Kamar, Nassim Lepage, Benoit Couzi, Lionel Albano, Laetitia Durrbach, Antoine Pernin, Vincent Esposito, Laure Hebral, Anne Laure Darres, Amandine Lequintrec, Moglie Cassuto, Elisabeth Merville, Pierre Congy, Nicolas Del Bello, Arnaud A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients |
title | A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients |
title_full | A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients |
title_fullStr | A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients |
title_full_unstemmed | A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients |
title_short | A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients |
title_sort | randomized prospective study comparing anti–t-lymphocyte igs to basiliximab in highly sensitized kidney transplant patients |
topic | Clinical Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7403559/ https://www.ncbi.nlm.nih.gov/pubmed/32775820 http://dx.doi.org/10.1016/j.ekir.2020.05.020 |
work_keys_str_mv | AT kamarnassim arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT lepagebenoit arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT couzilionel arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT albanolaetitia arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT durrbachantoine arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT perninvincent arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT espositolaure arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT hebralannelaure arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT darresamandine arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT lequintrecmoglie arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT cassutoelisabeth arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT mervillepierre arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT congynicolas arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT delbelloarnaud arandomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT kamarnassim randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT lepagebenoit randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT couzilionel randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT albanolaetitia randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT durrbachantoine randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT perninvincent randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT espositolaure randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT hebralannelaure randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT darresamandine randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT lequintrecmoglie randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT cassutoelisabeth randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT mervillepierre randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT congynicolas randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients AT delbelloarnaud randomizedprospectivestudycomparingantitlymphocyteigstobasiliximabinhighlysensitizedkidneytransplantpatients |