Long-term belatacept exposure maintains efficacy and safety at 5 years: Results from the long-term extension of the BENEFIT study

American Journal of Transplantation

Volumn 13, Issue 11, 2013, Pages 2875-2883

  Rostaing, L ^a,b   Vincenti, F ^c   Grinyo J ^d   Rice, K M ^e   Bresnahan, B ^f   Steinberg, S ^g   Gang, S ^h   Gaite, L E ⁱ   Moal, M C ^j   Mondragon Ramirez G A ^k   Kothari, J ^l   Pupim, L ^m   Larsen, C P ⁿ  

^a TOULOUSE UNIVERSITY HOSPITAL   (France)

^b INSERM   (France)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^e BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^f MEDICAL COLLEGE OF WISCONSIN   (United States)

^g SHARP MEMORIAL HOSPITAL   (United States)

^h MULJIBHAI PATEL UROLOGICAL HOSPITAL   (India)

ⁱ Clinica de Urologia y Nefrologia   (Argentina)

^j SERVICE DE RHUMATOLOGIE   (France)

^k Instituto Mexicano de Transplantes   (Mexico)

^l P D HINDUJA NATIONAL HOSPITAL   (India)

^m BRISTOL MYERS SQUIBB   (United States)

ⁿ EMORY UNIVERSITY   (United States)

more..

Author keywords

Belatacept; cyclosporine A; kidney; renal function

Indexed keywords

BASILIXIMAB; BELATACEPT; CORTICOSTEROID; CYCLOSPORIN A; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER;

ADULT; AGED; ARTICLE; BASAL CELL CARCINOMA; BOWEN DISEASE; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEVER; GASTROINTESTINAL DISEASE; GLOMERULUS FILTRATION RATE; HEART DISEASE; HERPES SIMPLEX; HERPES ZOSTER; HUMAN; KIDNEY DISEASE; LONG TERM EXPOSURE; LUNG TUBERCULOSIS; MALE; MENTAL DISEASE; METABOLIC DISORDER; MORTALITY; MULTICENTER STUDY; MYCOSIS; NEOPLASM; NEUROLOGIC DISEASE; ONYCHOMYCOSIS; PHASE 3 CLINICAL TRIAL; PNEUMONIA; POLYOMAVIRUS INFECTION; POSTTRANSPLANT LYMPHOPROLIFERATIVE DISEASE; PRIORITY JOURNAL; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; SQUAMOUS CELL CARCINOMA; THRUSH; TINEA VERSICOLOR; URINARY TRACT INFECTION; VASCULAR DISEASE; VIRUS INFECTION;

BELATACEPT; CYCLOSPORINE A; KIDNEY; RENAL FUNCTION;

ADULT; COHORT STUDIES; CYCLOSPORINE; FEMALE; FOLLOW-UP STUDIES; GLOMERULAR FILTRATION RATE; GRAFT REJECTION; HUMANS; IMMUNOCONJUGATES; IMMUNOSUPPRESSIVE AGENTS; INTERNATIONAL AGENCIES; KIDNEY FAILURE, CHRONIC; KIDNEY FUNCTION TESTS; KIDNEY TRANSPLANTATION; LYMPHOPROLIFERATIVE DISORDERS; MALE; POSTOPERATIVE COMPLICATIONS; PROGNOSIS; SAFETY; TIME FACTORS;

EID: 84886791910     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/ajt.12460     Document Type: Article

References (26)

1. United Network for Organ Sharing Renal Transplant Registry 1999-2008. Available at: http://optn.transplant.hrsa.gov/ar2009/chapter-iii-AR-cd.htm?cp= 4#7. Accessed May 7, 2013.
2. Lamb KE, Lodhi S, Meier-Kriesche H-U., Long-term renal allograft survival in the United States: A critical reappraisal. Am J Transplant 2011; 11: 450-462.
3. Naesens M, Kuypers DRJ, Sarwal M., Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol 2009; 4: 481-508.
4. Lanese DM, Conger JD., Effects of endothelin receptor antagonist on cyclosporin-induced vasoconstriction in isolated rat renal arterioles. J Clin Invest 1993; 91: 2144-2149.
5. 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.
6. Durrbach A, Pestana JM, Vincenti F, 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.
7. 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.
8. Pestana JOM, 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.
9. Larsen CP, Alberu J, Massari P, et al. 4-year results from the long-term extension of the belatacept BENEFIT study. Oral presentation at: Annual Meeting of the American Transplant Congress; 2012; June 2-6; Boston, MA.
10. Florman S, Durrbach A, Grinyo J, et al. 4-year results from the long-term extension of the belatacept BENEFIT-EXT study. Oral presentation at: Annual Meeting of the American Transplant Congress; 2012; June 2-6; Boston, MA.
11. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: A new prediction equation. Ann Intern Med 1999; 130: 461-470.
12. Levey AS, Coresh J, Greene T, et al. Expressing the MDRD study equation for estimating GFR with IDMS traceable (gold standard) serum creatinine values. J Am Soc Nephrol 2005; 16: 69A.
13. Larsen CP, Grinyo J, Medina-Pestana J, et al. Belatacept-based regimens versus a cyclosporine A-based regimen in kidney transplant recipients: 2-year results from the BENEFIT and BENEFIT-EXT studies. Transplantation 2010; 90: 1528-1535.
14. Everly MJ, Everly JJ, Arend LJ, et al. Reducing de novo donor-specific antibody levels during acute rejection diminishes renal allograft loss. Am J Transplant 2009; 9: 1063-1071.
15. Wu J, Li H, Huang H, et al. Slope of changes in renal function in the first year post-transplantation and one-yr estimated glomerular filtration rate together predict long-term renal allograft survival. Clin Transplant 2010; 24: 862-868.
16. Lenihan CR, O'Kelly P, Mohan P, et al. MDRD-estimated GFR at one year post-renal transplant is a predictor of long-term graft function. Ren Fail 2008; 30: 345-352.
17. Kasiske BL, Israni AK, Snyder JJ, et al. The relationship between kidney function and long-term graft survival after kidney transplant. Am J Kidney Dis 2011; 57: 466-475.
18. Schnitzler MA, Lentine KL, Axelrod D, et al. Use of 12-month renal function and baseline clinical factors to predict long-term graft survival: Application to BENEFIT and BENEFIT-EXT trials. Transplantation 2012; 93: 172-181.
19. Schnitzler MA, Johnston K, Axelrod D, Gheorghian A, Lentine KL., Associations of renal function at 1-year after kidney transplantation with subsequent return to dialysis, mortality, and healthcare costs. Transplantation 2011; 91: 1347-1356.
20. Gheorghian A, Schnitzler MA, Axelrod DA, Kalsekar A, L'Italien G, Lentine KL., The implications of acute rejection and reduced allograft function on health care expenditures in contemporary US kidney transplantation. Transplantation 2012; 94: 241-249.
21. Fellstrom B, Jardine AG, Soveri I, et al. Renal dysfunction as a risk factor for mortality and cardiovascular disease in renal transplantation: Experience from the Assessment of Lescol in Renal Transplantation trial. Transplantation 2005; 79: 1160-1163.
22. Meier-Kriesche HU, Baliga R, Kaplan B., Decreased renal function is a strong risk factor for cardiovascular death after renal transplantation. Transplantation 2003; 75: 1291-1295.
23. 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.
24. Saini SD, Schoenfeld P, Kaulback K, Dubinsky MC., Effect of medication dosing frequency on adherence in chronic diseases. Am J Manag Care 2009; 15: e22-e33.
25. Reginster JY, Rabenda V, Neuprez A., Adherence, patient preference and dosing frequency: Understanding the relationship. Bone 2006; 38: S2-S6.
26. Kramer BK, Montagnino G, Del Castillo D, et al. Efficacy and safety of tacrolimus compared with cyclosporin A microemulsion in renal transplantation: 2 year follow-up results. Nephrol Dial Transplant 2005; 20: 968-973.