Renal transplantation using belatacept without maintenance steroids or calcineurin inhibitors

American Journal of Transplantation

Volumn 14, Issue 5, 2014, Pages 1142-1151

  Kirk, A D ^a   Guasch, A ^a   Xu, H ^a   Cheeseman, J ^a   Mead, S I ^a   Ghali, A ^a   Mehta, A K ^a   Wu, D ^a   Gebel, H ^a   Bray, R ^a   Horan, J ^a   Kean, L S ^a   Larsen, C P ^a   Pearson, T C ^a  

^a EMORY UNIVERSITY   (United States)

Author keywords

Alemtuzumab; belatacept; costimulation; immunosuppressive regimens; minimization withdrawal; sirolimus

Indexed keywords

ALEMTUZUMAB; BELATACEPT; CALCINEURIN INHIBITOR; CREATININE; DIPHENHYDRAMINE; INFLIXIMAB; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PARACETAMOL; PREDNISONE; RAPAMYCIN; STEROID; ABATACEPT; ANTIBODY CONJUGATE; CORTICOSTEROID; IMMUNOSUPPRESSIVE AGENT;

ADULT; AGED; ARTICLE; BONE MARROW; CLINICAL ARTICLE; CREATININE BLOOD LEVEL; DRUG EFFECT; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GRAFT RECIPIENT; HUMAN; HUMAN TISSUE; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY ALLOGRAFT REJECTION; KIDNEY DONOR; KIDNEY TRANSPLANTATION; MAINTENANCE THERAPY; MALE; MONOTHERAPY; PATIENT SELECTION; PRIORITY JOURNAL; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TREATMENT DURATION; ULCERATIVE COLITIS; WEANING; DISEASE MANAGEMENT; DRUG EFFECTS; FLOW CYTOMETRY; GRAFT REJECTION; GRAFT SURVIVAL; KIDNEY FAILURE, CHRONIC; MIDDLE AGED; POSTOPERATIVE COMPLICATIONS; PROGNOSIS; YOUNG ADULT;

ADRENAL CORTEX HORMONES; ADULT; AGED; CALCINEURIN INHIBITORS; DISEASE MANAGEMENT; FEMALE; FLOW CYTOMETRY; FOLLOW-UP STUDIES; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOCONJUGATES; IMMUNOSUPPRESSIVE AGENTS; KIDNEY FAILURE, CHRONIC; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; POSTOPERATIVE COMPLICATIONS; PROGNOSIS; SIROLIMUS; YOUNG ADULT;

EID: 84898960416     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/ajt.12712     Document Type: Article

References (42)

1. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry or Transplant Recipients (SRTR). OPTN/SRTR 2010; Annual Data Report. Department of Health and Human Services, Health and Services Administration, Healthcare Systems Bureau, Division of Transplantation. Am J Transplant 2012; 12: S1-S154.
2. Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant 2009; 9: S1-S155.
3. Lamb KE, Lodhi S, Meier-Kriesche HU., Long-term renal allograft survival in the United States: A critical reappraisal. Am J Transplant 2011; 11: 450-462.
4. Larsen CP, Pearson TC, Adams AB, et al. Rational development of LEA29Y (belatacept), a high-affinity variant of CTLA4-Ig with potent immunosuppressive properties. Am J Transplant 2005; 5: 443-453.
5. Vincenti F, Larsen C, Durrbach A, et al. Costimulation blockade with belatacept in renal transplantation. N Engl J Med 2005; 353: 770-781.
6. Larsen CP, Knechtle SJ, Adams A, Pearson T, Kirk AD., A new look at blockade of T-cell co-stimulation: A therapeutic strategy for long-term maintenance immunosuppression. Am J Transplant 2006; 6: 876-883.
7. Vincenti F, Charpentier B, Vanrenterghem Y, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant 2010; 10: 535-546.
8. Durrbach A, Pestana JM, Pearson T, et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant 2010; 10: 547-557.
9. Vanrenterghem Y, Bresnahan B, Campistol J, et al. Belatacept-based regimens are associated with improved cardiovascular and metabolic risk factors compared with cyclosporine in kidney transplant recipients (BENEFIT and BENEFIT-EXT studies). Transplantation 2011; 91: 976-983.
10. Li Y, Li XC, Zheng XX, Wells AD, Turka LA, Strom TB., Blocking both signal 1 and signal 2 of T-cell activation prevents apoptosis of alloreactive T cells and induction of peripheral allograft tolerance. Nat Med 1999; 5: 1298-1302.
11. Wells AD, Li XC, Li Y, et al. Requirement for T-cell apoptosis in the induction of peripheral transplantation tolerance. Nat Med 1999; 5: 1303-1307.
12. Gao W, Lu Y, El Essawy B, Oukka M, Kuchroo VK, Strom TB., Contrasting effects of cyclosporine and rapamycin in de novo generation of alloantigen-specific regulatory T cells. Am J Transplant 2007; 7: 1722-1732.
13. Vincenti F, Larsen CP, Alberu J, et al. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant 2012; 12: 210-217.
14. Pestana JO, Grinyo JM, Vanrenterghem Y, et al. Three-year outcomes from BENEFIT-EXT: A phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant 2012; 12: 630-639.
15. Belatacept package insert. Available at: http://packageinserts.bms.com/ pi/pi-nulojix.pdf. Accessed September 19, 2013.
16. Trambley J, Bingaman AW, Lin A, et al. Asialo GM1(+) CD8(+) T cells play a critical role in costimulation blockade-resistant allograft rejection. J Clin Invest 1999; 104: 1715-1722.
17. Ford ML, Koehn BH, Wagener ME, et al. Antigen-specific precursor frequency impacts T cell proliferation, differentiation, and requirement for costimulation. J Exp Med 2007; 204: 299-309.
18. Ford ML, Larsen CP., Overcoming the memory barrier in tolerance induction: Molecular mimicry and functional heterogeneity among pathogen-specific T-cell populations. Curr Opin Organ Transplant 2010; 15: 405-410.
19. Ford ML, Wagener ME, Hanna SS, Pearson TC, Kirk AD, Larsen CP., A critical precursor frequency of donor-reactive CD4 + T cell help is required for CD8 + T cell-mediated CD28/CD154-independent rejection. J Immunol 2008; 180: 7203-7211.
20. Larsen CP, Elwood ET, Alexander DZ, et al. Long-term acceptance of skin and cardiac allografts after blocking CD40 and CD28 pathways. Nature 1996; 381: 434-438.
21. Szczech LA, Berlin JA, Aradhye S, Grossman RA, Feldman HI., Effect of anti-lymphocyte induction therapy on renal allograft survival: A meta-analysis. J Am Soc Nephrol 1997; 8: 1771-1777.
22. Szczech LA, Berlin JA, Feldman HI., The effect of antilymphocyte induction therapy on renal allograft survival. A meta-analysis of individual patient-level data. Anti-Lymphocyte Antibody Induction Therapy Study Group. Ann Intern Med 1998; 128: 817-826.
23. Swanson SJ, Hale DA, Mannon RB, et al. Kidney transplantation with rabbit antithymocyte globulin induction and sirolimus monotherapy. Lancet 2002; 360: 1662-1664.
24. Kirk AD, Hale DA, Mannon RB, et al. Results from a human renal allograft tolerance trial evaluating the humanized CD52-specific monoclonal antibody Campath-1H. Transplantation 2003; 76: 120-129.
25. Knechtle SJ, Pirsch JD, Fechner JH Jr, et al. Campath-1H induction plus rapamycin monotherapy for renal transplantation: Results of a pilot study. Am J Transplant 2003; 3: 722-730.
26. Padley D, editor. Standards for cellular product services. 4th ed. Bethesda, MD: American Association of Blood Banks, 2009.
27. Solez K, Colvin RB, Racusen LC, et al. Banff 07 classification of renal allograft pathology: Updates and future directions. Am Journal Transplant 2008; 8: 753-760.
28. Pei R, Wang G, Tarsitani C, et al. Simultaneous HLA Class I and Class II antibodies screening with flow cytometry. Hum Immunol 1998; 59: 313-322.
29. Bray RA, Tarsitani C, Gebel HM, Lee J-H., Clinical cytometry and progress in HLA antibody detection. Methods Cell Biol 2011; 103: 285-310.
30. Pearl JP, Parris J, Hale DA, et al. Immunocompetent T-cells with a memory-like phenotype are the dominant cell type following antibody-mediated T-cell depletion. Am J Transplant 2005; 5: 465-474.
31. Sallusto F, Lenig D, Förster R, Lipp M, Lanzavecchia A., Two subsets of memory T lymphocytes with distinct homing potentials and effector functions. Nature 1999; 401: 708-712.
32. Newell KA, Asare A, Kirk AD, et al. Identification of a B cell signature associated with renal transplant tolerance in humans. J Clin Invest 2010; 120: 1836-1847.
33. Li XC, Turka LA., An update on regulatory T cells in transplant tolerance and rejection. Nat Rev Nephrol 2010; 6: 577-583.
34. Lo DJ, Weaver TA, Stempora L, et al. Selective targeting of human alloresponsive CD8 + effector memory T cells based on CD2 expression. Am J Transplant 2011; 11: 22-33.
35. Nankivell BJ, Gruenewald SM, Allen RD, Chapman JR., Predicting glomerular filtration rate after kidney transplantation. Transplantation 1995; 59: 1683-1689.
36. Adams AB, Pearson TC, Larsen CP., Heterologous immunity: An overlooked barrier to tolerance. Immunol Rev 2003; 196: 147-160.
37. Lin H, Bolling SF, Linsley PS, et al. Long-term acceptance of major histocompatibility complex mismatched cardiac allografts induced by CTLA4Ig plus donor-specific transfusion. J Exp Med 1993; 178: 1801-1806.
38. Xu H, Perez SD, Cheeseman J, Mehta AK, Kirk AD., The allo- and viral-specific immunosuppressive effect of belatacept, but not tacrolimus, attenuates with progressive T cell maturation. Am J Transplant, 2014; 14: 319-332.
39. Wu Z, Bensinger SJ, Zhang J, et al. Homeostatic proliferation is a barrier to transplantation tolerance. Nat Med 2004; 10: 87-92.
40. Suwelack B, Malyar V, Koch M, Sester M, Sommerer C., The influence of immunosuppressive agents on BK virus risk following kidney transplantation, and implications for choice of regimen. Transplant Rev 2012; 26: 201-211.
41. Ferguson R, Grinyõ J, Vincenti F, et al. Immunosuppression with belatacept-based, corticosteroid-avoiding regimens in de novo kidney transplant recipients. Am J Transplant 2011; 11: 66-76.
42. Ciancio G, Sageshima J, Akpinar E, et al. A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab. Transplantation 2013; 96: 800-806.