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Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study

Iguratimod (IGU) can mitigate the symptoms of rheumatoid arthritis through its anti-inflammatory effects. The objective of this study was to investigate the clinical efficacy and safety of IGU in highly HLA-mismatched renal transplant recipients, in combination with standard immunosuppressive regime...

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Autores principales: Tao, Jun, Sun, Li, Wang, Zijie, Chen, Hao, Han, Zhijian, Zhang, Hengcheng, Yang, Haiwei, Huang, Zhengkai, Fei, Shuang, Ju, Xiaobin, Tan, Ruoyun, Gu, Min
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8650225/
https://www.ncbi.nlm.nih.gov/pubmed/34887851
http://dx.doi.org/10.3389/fimmu.2021.738392
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author Tao, Jun
Sun, Li
Wang, Zijie
Chen, Hao
Han, Zhijian
Zhang, Hengcheng
Yang, Haiwei
Huang, Zhengkai
Fei, Shuang
Ju, Xiaobin
Tan, Ruoyun
Gu, Min
author_facet Tao, Jun
Sun, Li
Wang, Zijie
Chen, Hao
Han, Zhijian
Zhang, Hengcheng
Yang, Haiwei
Huang, Zhengkai
Fei, Shuang
Ju, Xiaobin
Tan, Ruoyun
Gu, Min
author_sort Tao, Jun
collection PubMed
description Iguratimod (IGU) can mitigate the symptoms of rheumatoid arthritis through its anti-inflammatory effects. The objective of this study was to investigate the clinical efficacy and safety of IGU in highly HLA-mismatched renal transplant recipients, in combination with standard immunosuppressive regimen. This pilot study was designed as an open-label, blank-control, randomized clinical trial on patients recruited from a single transplant center in China. Patients who met the inclusion criteria were randomized to the IGU (n=27) and blank control (n=27) groups. IGU was administrated with the conventional triple immunosuppressive protocol for 52 weeks after kidney transplantation. The incidence of biopsy-proven acute rejection rate was 14.8% (4/27) in the IGU group and 29.6% (8/27) in the control group, P = 0.19. The clinical rejection rate was also substantially reduced in the IGU group (3.7% vs. 18.5%, P = 0.08). De novo donor-specific antibody also showed a decline trend in the IGU group after 52 weeks. The graft function and incidence of adverse events were similar between the two groups. In addition, IGU intervention significantly decreased the number of NK cells throughout the follow-up. In conclusion, our study has shown the possibility that IGU could reduce the allograft rejection rate and de novo DSA with appreciable safety in combination with conventional immunosuppressants. Formal clinical trials were warranted based on current findings.
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spelling pubmed-86502252021-12-08 Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study Tao, Jun Sun, Li Wang, Zijie Chen, Hao Han, Zhijian Zhang, Hengcheng Yang, Haiwei Huang, Zhengkai Fei, Shuang Ju, Xiaobin Tan, Ruoyun Gu, Min Front Immunol Immunology Iguratimod (IGU) can mitigate the symptoms of rheumatoid arthritis through its anti-inflammatory effects. The objective of this study was to investigate the clinical efficacy and safety of IGU in highly HLA-mismatched renal transplant recipients, in combination with standard immunosuppressive regimen. This pilot study was designed as an open-label, blank-control, randomized clinical trial on patients recruited from a single transplant center in China. Patients who met the inclusion criteria were randomized to the IGU (n=27) and blank control (n=27) groups. IGU was administrated with the conventional triple immunosuppressive protocol for 52 weeks after kidney transplantation. The incidence of biopsy-proven acute rejection rate was 14.8% (4/27) in the IGU group and 29.6% (8/27) in the control group, P = 0.19. The clinical rejection rate was also substantially reduced in the IGU group (3.7% vs. 18.5%, P = 0.08). De novo donor-specific antibody also showed a decline trend in the IGU group after 52 weeks. The graft function and incidence of adverse events were similar between the two groups. In addition, IGU intervention significantly decreased the number of NK cells throughout the follow-up. In conclusion, our study has shown the possibility that IGU could reduce the allograft rejection rate and de novo DSA with appreciable safety in combination with conventional immunosuppressants. Formal clinical trials were warranted based on current findings. Frontiers Media S.A. 2021-11-23 /pmc/articles/PMC8650225/ /pubmed/34887851 http://dx.doi.org/10.3389/fimmu.2021.738392 Text en Copyright © 2021 Tao, Sun, Wang, Chen, Han, Zhang, Yang, Huang, Fei, Ju, Tan and Gu https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Immunology
Tao, Jun
Sun, Li
Wang, Zijie
Chen, Hao
Han, Zhijian
Zhang, Hengcheng
Yang, Haiwei
Huang, Zhengkai
Fei, Shuang
Ju, Xiaobin
Tan, Ruoyun
Gu, Min
Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study
title Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study
title_full Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study
title_fullStr Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study
title_full_unstemmed Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study
title_short Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study
title_sort efficacy and safety of iguratimod supplement to the standard immunosuppressive regimen in highly mismatched renal transplant recipients: a pilot study
topic Immunology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8650225/
https://www.ncbi.nlm.nih.gov/pubmed/34887851
http://dx.doi.org/10.3389/fimmu.2021.738392
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