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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Frontiers Media S.A.
2021-11-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2021.738392/full |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-14T08:37:11Z |
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| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-12-14T08:37:11Z |
| publishDate | 2021-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj.art-e756b7d5b8ea4e82ad4976baa6ce94732022-12-21T23:09:23ZengFrontiers Media S.A.Frontiers in Immunology1664-32242021-11-011210.3389/fimmu.2021.738392738392Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot StudyJun Tao0Li Sun1Zijie Wang2Hao Chen3Zhijian Han4Hengcheng Zhang5Haiwei Yang6Zhengkai Huang7Shuang Fei8Xiaobin Ju9Ruoyun Tan10Min Gu11Department of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaTransplantation Research Center, Renal Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, United StatesDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaIguratimod (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.https://www.frontiersin.org/articles/10.3389/fimmu.2021.738392/fullIguratimodrandomized clinical trialbiopsy-proven acute rejectiondonor-specific antibody (DSA)kidney transplantation |
| spellingShingle | 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 Frontiers in Immunology Iguratimod randomized clinical trial biopsy-proven acute rejection donor-specific antibody (DSA) kidney transplantation |
| 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 | Iguratimod randomized clinical trial biopsy-proven acute rejection donor-specific antibody (DSA) kidney transplantation |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2021.738392/full |
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