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:	Jun Tao, Li Sun, Zijie Wang, Hao Chen, Zhijian Han, Hengcheng Zhang, Haiwei Yang, Zhengkai Huang, Shuang Fei, Xiaobin Ju, Ruoyun Tan, Min Gu
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	Iguratimod randomized clinical trial biopsy-proven acute rejection donor-specific antibody (DSA) kidney transplantation Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/e756b7d5b8ea4e82ad4976baa6ce9473
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spelling	oai:doaj.org-article:e756b7d5b8ea4e82ad4976baa6ce94732021-11-30T13:12:40ZEfficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study1664-322410.3389/fimmu.2021.738392https://doaj.org/article/e756b7d5b8ea4e82ad4976baa6ce94732021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fimmu.2021.738392/fullhttps://doaj.org/toc/1664-3224Iguratimod (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.Jun TaoLi SunZijie WangHao ChenZhijian HanHengcheng ZhangHaiwei YangZhengkai HuangShuang FeiXiaobin JuRuoyun TanMin GuFrontiers Media S.A.articleIguratimodrandomized clinical trialbiopsy-proven acute rejectiondonor-specific antibody (DSA)kidney transplantationImmunologic diseases. AllergyRC581-607ENFrontiers in Immunology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Iguratimod randomized clinical trial biopsy-proven acute rejection donor-specific antibody (DSA) kidney transplantation Immunologic diseases. Allergy RC581-607
spellingShingle	Iguratimod randomized clinical trial biopsy-proven acute rejection donor-specific antibody (DSA) kidney transplantation Immunologic diseases. Allergy RC581-607 Jun Tao Li Sun Zijie Wang Hao Chen Zhijian Han Hengcheng Zhang Haiwei Yang Zhengkai Huang Shuang Fei Xiaobin Ju Ruoyun Tan Min Gu Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study
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.
format	article
author	Jun Tao Li Sun Zijie Wang Hao Chen Zhijian Han Hengcheng Zhang Haiwei Yang Zhengkai Huang Shuang Fei Xiaobin Ju Ruoyun Tan Min Gu
author_facet	Jun Tao Li Sun Zijie Wang Hao Chen Zhijian Han Hengcheng Zhang Haiwei Yang Zhengkai Huang Shuang Fei Xiaobin Ju Ruoyun Tan Min Gu
author_sort	Jun Tao
title	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_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_sort	efficacy and safety of iguratimod supplement to the standard immunosuppressive regimen in highly mismatched renal transplant recipients: a pilot study
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/e756b7d5b8ea4e82ad4976baa6ce9473
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Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study

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