A network meta-analysis of the efficacy of belatacept, cyclosporine and tacrolimus for immunosuppression therapy in adult renal transplant recipients

Current Medical Research and Opinion

Volumn 30, Issue 8, 2014, Pages 1473-1487

  Goring, Sarah M ^a   Levy, Adrian R ^a,b   Ghement, Isabella ^c   Kalsekar, Anupama ^d   Eyawo, Oghenowede ^e   L'Italien, Gilbert J ^d,f   Kasiske, Bertram ^g  

^a ICON PLC   (United Kingdom)

^b DALHOUSIE UNIVERSITY   (Canada)

^c Ghement Statistical Consulting Company   (Canada)

^d BRISTOL MYERS SQUIBB   (United States)

^e SIMON FRASER UNIVERSITY   (Canada)

^f YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g HENNEPIN COUNTY MEDICAL CENTER   (United States)

Author keywords

Belatacept; Cyclosporine; Immunosuppression; Kidney transplantation; Meta analysis; Tacrolimus

Indexed keywords

BELATACEPT; CYCLOSPORIN; TACROLIMUS; ABATACEPT; ANTIBODY CONJUGATE; IMMUNOSUPPRESSIVE AGENT;

ACUTE GRAFT REJECTION; ARTICLE; DRUG EFFICACY; GLOMERULUS FILTRATION RATE; GRAFT FAILURE; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY FUNCTION; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; META ANALYSIS; MORTALITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECIPIENT; SOLITARY KIDNEY; SYSTEMATIC REVIEW; ADULT; BAYES THEOREM; COMPARATIVE STUDY; DRUG COMBINATION; GRAFT REJECTION; GRAFT SURVIVAL; PROCEDURES; TREATMENT OUTCOME;

ADULT; BAYES THEOREM; CYCLOSPORINE; DRUG THERAPY, COMBINATION; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOCONJUGATES; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; TACROLIMUS; TREATMENT OUTCOME;

EID: 84904860499     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2014.898140     Document Type: Article

References (58)

1. Abecassis M, Bartlett ST, Collins AJ, et al. Kidney transplantation as primary therapy for end-stage renal disease: a National Kidney Foundation/Kidney Disease Outcomes Quality Initiative (NKF/KDOQITM) conference. Clin J Am Soc Nephrol 2008;3:471-80
2. Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med 1999;341:1725-30
3. Webster AC, Taylor RRS, Chapman JR, Craig JC. Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients. Cochrane Database of Systematic Reviews 2005;(4): CD003961. doi: 10.1002/14651858.CD003961.pub2
4. Annual Report of the U.S. Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients: Transplant Data 1999- 2008. Rockland, MD: Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation, 2010
5. Chang SH, Russ GR, Chadban SJ, et al. Trends in adult post-kidney transplant immunosuppressive use in Australia, 1991-2005. Nephrology (Carlton) 2008;13:171-6
6. Vincenti F, Larsen C, Durrbach A, et al. Costimulation blockade with belatacept in renal transplantation. N Engl J Med 2005;353:770-81
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: 535-46
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;10:547-57
9. Hoaglin DC, Hawkins N, Jansen JP, et al. Conducting Indirect- treatmentcomparison and network-meta-analysis studies: report of the ISPOR task force on indirect treatment comparisons good research practices - part 2. Value Health 2011;14:429-437
10. Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR task force on indirect treatment comparisons good research practices: part 1. Value Health 2011;14:417-28
11. Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Stat Med 2004;23:3105-24
12. Egger M, Davey SG, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34
13. Borenstein M, Hedges LV, Higgins JPT, et al. Introduction to Meta-Analysis. West Sussex, United Kingdom: Wiley, 2009
14. Zintzaras E, Koufakis T, Ziakas PD, et al. A meta-analysis of genotypes and haplotypes of methylenetetrahydrofolate reductase gene polymorphisms in acute lymphoblastic leukemia. Eur J Epidemiol 2006;21:501-10
15. Thompson SG, Higgins JP. How should meta-regression analyses be undertaken and interpreted? Stat Med 2002;21:1559-73
16. Dias S, Sutton AJ, Ades AE, et al. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making 2013;33:607-17
17. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999;130:461-70
18. Cockroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41
19. Abou-Jaoude MM, Najm R, Shaheen J, et al. Tacrolimus (FK506) versus cyclosporine microemulsion (neoral) as maintenance immunosuppression therapy in kidney transplant recipients. Transplant Proc 2005;37:3025-8
20. Charpentier B, Rostaing L, Berthoux F, et al. A three-arm study comparing immediate tacrolimus therapy with antithymocyte globulin induction therapy followed by tacrolimus or cyclosporine A in adult renal transplant recipients. Transplantation 2003;75:844-51
21. Cheung CY, Wong KM, Chan HW, et al. Paired kidney analysis of tacrolimus and cyclosporine microemulsion-based therapy in Chinese cadaveric renal transplant recipients. Transplant International 2006;19:657-66
22. Vincenti F, Friman S, Scheuermann E, et al. Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus. Am J Transplant 2007;6:1506-14
23. Ekberg H, Tedesco-Silva H, Demirbas A, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 2007;357:2562-75
24. Hardinger KL, Bohl DL, Schnitzler MA, et al. A randomized, prospective, pharmacoeconomic trial of tacrolimus versus cyclosporine in combination with thymoglobulin in renal transplant recipients. Transplantation 2005;80: 41-6
25. Hernandez D, Miquel R, Porrini E, et al. Randomized controlled study comparing reduced calcineurin inhibitors exposure versus standard cyclosporinebased immunosuppression. Transplantation 2007;84:706-14
26. Kumar MSA, Saeed MI, Ranganna K, et al. Comparison of four different immunosuppression protocols without long-term steroid therapy in kidney recipients monitored by surveillance biopsy: Five-year outcomes. Transplant Immunology 2008;20:32-42
27. Liu B, Lin ZB, Ming CS, et al. Randomized trial of tacrolimus in combination with mycophenolate mofetil versus cyclosporine with mycophenolate mofetil in cadaveric renal transplant recipients with delayed graft function. Transplant Proc 2003;35:87-8
28. Rowshani AT, Scholten EM, Bemelman F, et al. No difference in degree of interstitial sirius red-stained area in serial biopsies from area under concentration-over-time curves-guided cyclosporine versus tacrolimustreated renal transplant recipients at one year. J Am Soc Nephrol 2006;17: 305-12
29. Vincenti F, Laskow DA, Neylan JF, et al. One-year follow-up of an open-label trial of FK506 for primary kidney transplantation: a report of the U.S. Multicenter FK506 Kidney Transplant group. Transplantation 1996;61:1576-81
30. Egfjord M, Ladefoged J, Olgaard K. Similar frequency of acute rejection, graft and patient survival in quadruple therapy with tacrolimus versus cyclosporin in combination with prednisone, mycophenolate mofetil, and ATGAM after renal allotransplantation [abstract]. XIXth International Congress of the Transplantation Society; 25-30 August 2002, Miami, USA
31. El Haggan W, Barthe N, Vendrely B, et al. One year evolution of bone mineral density in kidney transplant recipients receiving tacrolimus versus cyclosporine. Transplant Proc 2002;34:1817-18
32. Toz H, Sen S, Sezis M, et al. Comparison of tacrolimus and cyclosporin in renal transplantation by the protocol biopsies. Transplantation Proceedings 2004;36:134-6
33. Yang HC, Holman MJ, Langhoff E, et al. Tacrolimus/'low-dose' mycophenolate mofetil versus microemulsion cyclosporine/'low-dose' mycophenolate mofetil after kidney transplantation - 1-year follow-up of a prospective, randomized clinical trial. Transplant Proc 1999;31:1121-4
34. Yu L, Wang Y, Fu SJ, et al. Clinical experience with Prograf (tacrolimus, FK 506) in Chinese patients after renal transplantation. Transplant Proc 2000;32:1709-10
35. Van Duijnhoven EM, Christiaans MH, Boots JM, et al. Glucose metabolism in the first 3 years after renal transplantation in patients receiving tacrolimus versus cyclosporine-based immunosuppression. J Am Soc Nephrol 2002;13:213-20
36. Tsinalis D, Binet I, Dickenmann M, et al. Cost of medical care after renal transplantation comparing cyclosporine-mycophenolate to tacrolimus- azathioprine - a randomised controlled study [abstract]. XVIII International Congress of the Transplantation Society; 27 August-1 September 2000, Rome, Italy
37. Busque S, Shoker A, Landsberg D, et al. Canadian multicentre trial of tacrolimus/azathioprine/steroids versus tacrolimus/mycophenolate mofetil/steroids versus neoral/mycophenolate mofetil/steroids in renal transplantation. Transplant Proc 2001;33:1266-7
38. Campos HH, Abbud FM. One-year follow-up of a Brazilian randomized multicenter study comparing tacrolimus versus cyclosporine in kidney transplantation. Transplant Proc 2002;34:1656-8
39. Margreiter R. Efficacy and safety of tacrolimus compared with ciclosporin microemulsion in renal transplantation: a randomised multicentre study. Lancet 2002;359:741-6
40. Mayer AD, Dmitrewski J, Squifflet JP, et al. Multicenter randomized trial comparing tacrolimus (FK506) and cyclosporine in the prevention of renal allograft rejection: a report of the European Tacrolimus Multicenter Renal Study Group. Transplantation 1997;64:436-43
41. Murphy GJ, Waller JR, Sandford RS, et al. Randomized clinical trial of the effect of microemulsion cyclosporin and tacrolimus on renal allograft fibrosis. Br J Surg 2003;90:680-6
42. Radermacher J, Meiners M, Bramlage C, et al. Pronounced renal vasoconstriction and systemic hypertension in renal transplant patients treated with cyclosporin A versus FK 506. Transpl Int 1998;11:3-10
43. Heering P, Ivens K, Aker S, et al. Distal tubular acidosis induced by FK506. Clinical Transplantation 1998;12:465-71
44. Wang XH, Tang XD, Xu D. Tacrolimus vs CyA neoral in combination with MMF and steroids after cadaveric renal transplantation. Transplant Proc 2000;32:1702-3
45. Vacher-Coponat H, Moal V, Indreies M, et al. A randomized trial with steroids and antithymocyte globulins comparing cyclosporine/azathioprine versus tacrolimus/mycophenolate mofetil (CATM2) in renal transplantation. Transplantation 2012;93:437-43
46. Hardinger KL, Koch MJ, Bohl DJ, et al. BK-virus and the impact of pre-emptive immunosuppression reduction: 5-year results. Am J Transplant 2010;10: 407-15
47. Rostaing L, Vincenti F, Grinyo J, et al. Long-term belatacept exposure maintains efficacy and safety at 5 years: results from the long-term extension of the BENEFIT study. Am J Transplant 2013;13:2875-83
48. Charpentier B, Medina Pestana JO, Del CR, et al. Long-term exposure to belatacept in recipients of extended criteria donor kidneys. Am J Transplant 2013;13:2884-91
49. Hariharan S, McBride MA, Cherikh WS, et al. Post-transplant renal function in the first year predicts long-term kidney transplant survival. Kidney Int 2002;62:311-18
50. Grinyo J, Charpentier B, Pestana JM, et al. An integrated safety profile analysis of belatacept in kidney transplant recipients. Transplantation 2010;90:1521-7
51. Almeida CC, Silveira MR, de Araujo VE, et al. Safety of immunosuppressive drugs used as maintenance therapy in kidney transplantation: a systematic review and meta-analysis. Pharmaceuticals (Basel) 2013;6:1170-94
52. Sharif A, Shabir S, Chand S, et al. Meta-analysis of calcineurin- inhibitorsparing regimens in kidney transplantation. J Am Soc Nephrol 2011;22(11):2107-18
53. Thorlund K, Thabane L, Mills EJ. Modelling heterogeneity variances in multiple treatment comparison meta-analysis - are informative priors the better solution? BMC Med Res Methodol 2013;13:2
54. Ferguson R, Grinyo J, Vincenti F, et al. Immunosuppression with belataceptbased, corticosteroid-avoiding regimens in de novo kidney transplant recipients. Am J Transplant 2011;11:66-76
55. Rostaing L, Massari P, Garcia VD, et al. Switching from calcineurin inhibitorbased regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol 2011;6:430-9
56. Schena FP, Pascoe MD, Alberu J, et al. Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial. Transplantation 2009;87:233-42
57. Sutton A, Ades AE, Cooper N, et al. Use of indirect and mixed treatment comparisons for technology assessment. Pharmacoeconomics 2008;26:753-67
58. Chen K-H, Tsai M-K, Lai I-R, et al. Favorable results of concomitant tacrolimus and sirolimus therapy in Taiwanese renal transplant recipients at 12 months. J Formos Med Assoc 2008;107:533-9