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Clazakizumab (Anti-IL-6) Induces Foxp3+ Tregs in Highly HLA Sensitized Patients Desensitized for HLAi Transplantation (NCT03380962)

S. C. Jordan, S. Ge, N. Ammerman, M. Toyoda, E. Huang, A. Peng, R. Najjar, S. Sethi, S. Williamson, C. Myers, K. Lim, J. Choi, A. Vo

Cedars Sinai Medical Ctr, West Hollywood, CA

Meeting: 2020 American Transplant Congress

Abstract number: D-087

Keywords: HLA antibodies, Kidney transplantation, Sensitization

Session Information

Date: Saturday, May 30, 2020

Session Name: Poster Session D: Kidney Immunosuppression: Desensitization

Session Time: 3:15pm-4:00pm

 Presentation Time: 3:30pm-4:00pm

Location: Virtual

Related Abstracts
  • Evaluation of the Safety and Tolerability of Clazakizumab® (Anti-IL-6 Monoclonal) as a Desensitization Agent in Highly-HLA Sensitized ESRD Patients (nct03380962)
  • Evaluation of the Safety and Tolerability of Clazakizumab® as a Desensitization Agent in Highly-HLA Sensitized ESRD Patients (NCT03380962): 12m Follow-Up

*Purpose: Interleukin-6 is an important inflammatory cytokine. In addition, it acts as a growth factor for B-cells, plasma cells and Th17 cells, inhibiting FoxP3+ Treg cells. These considerations suggest IL-6 may be an important target to reduce inflammation and Th17 mediated inflammation in kidney allografts.

*Methods: Clazakizumab (Vitaeris Inc.) is a humanized monoclonal antibody aimed at the cytokine IL-6. As part of a phase I/II trial of clazakizumab for desensitization, HLA sensitized patients received anti-IL-6, 25mg SC monthly X 6 doses with monitoring of HLA antibody levels and Tregs. Patients were treated pre- and post-transplant with anti-IL-6. Transplanted patients received monthly claza 25mg SC starting 5-7 days post-transplant for 12M. Tregs were determined by flow cytometry as CD4+,CD25+,CD127dim,FoxP3+ cell populations in CD4+ cells. Determinations were made at baseline, at transplantation and day 180 post-transplant.

*Results: Nine patients were transplanted. All patients had previous transplants; 78% had cPRA 99-100%, 67% were B-cell FCMX+ and class II DSA+ @ time of transplant. Mean MFI for HLA cI & cII were: pre-desensitization vs. post claza: cI 13062±3123 vs. 8585±4597 (p=0.05) and cII 13519±2966 vs. 8344±4836 (p =0.03). All DSA+ patients were negative by day 180 post-transplant. Mean Treg values at baseline v. at transplant did not differ (3.2+1.09% v.3.5+1.75%,p=NS). However, were significantly different at day 180 post-transplant (3.2+1.09% v.3.5+1.75% v. 12.6+9.3%, p=0.008)(Figure 1).

*Conclusions: Clazakizumab desensitization reduced HLA cI/cII antibodies and allowed 9/10 highly sensitized patients to receive transplants. In addition, a dramatic increase in Treg cells at day 180 post-transplant was seen while patients were still on anti-IL-6 therapy suggesting that anti-IL-6 may deviate CD4+ T-cell responses to a Treg profile. This may have therapeutic implications for modifying baseline immunosuppression post-transplant.

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To cite this abstract in AMA style:

Jordan SC, Ge S, Ammerman N, Toyoda M, Huang E, Peng A, Najjar R, Sethi S, Williamson S, Myers C, Lim K, Choi J, Vo A. Clazakizumab (Anti-IL-6) Induces Foxp3+ Tregs in Highly HLA Sensitized Patients Desensitized for HLAi Transplantation (NCT03380962) [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/clazakizumab-anti-il-6-induces-foxp3-tregs-in-highly-hla-sensitized-patients-desensitized-for-hlai-transplantation-nct03380962/. Accessed March 7, 2021.

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