Time-varying belatacept exposure and its relationship to efficacy/safety responses in kidney-transplant recipients

Clinical Pharmacology and Therapeutics

Volumn 92, Issue 2, 2012, Pages 251-257

  Zhou, Z ^a   Shen, J ^a   Hong, Y ^a   Kaul, S ^a   Pfister, M ^a   Roy, A ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BELATACEPT;

ACUTE GRAFT REJECTION; ADULT; ARTICLE; BODY WEIGHT; DIABETES MELLITUS; DIALYSIS; DRUG CLEARANCE; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; GRAFT RECIPIENT; HUMAN; KIDNEY FUNCTION; KIDNEY TRANSPLANTATION; LIVER FUNCTION; PRIORITY JOURNAL;

CLINICAL TRIALS AS TOPIC; GRAFT REJECTION; HUMANS; IMMUNOCONJUGATES; IMMUNOSUPPRESSIVE AGENTS; KAPLAN-MEIER ESTIMATE; KIDNEY; KIDNEY TRANSPLANTATION; MODELS, THEORETICAL; TIME FACTORS;

EID: 84864127871     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2012.84     Document Type: Article

References (16)

1. Latek, R. et al. Assessment of belatacept-mediated costimulation blockade through evaluation of CD80/86-receptor saturation. Transplantation 87, 926-933 (2009).
2. Halloran, P.F. Immunosuppressive drugs for kidney transplantation. N. Engl. J. Med. 351, 2715-2729 (2004). (Pubitemid 39665325)
3. Vincenti, F. et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am. J. Transplant. 10, 535-546 (2010).
4. Vincenti, F. et al. Three-year outcomes from BENEFIT, a randomized, activecontrolled, parallel-group study in adult kidney transplant recipients. Am. J. Transplant. 12, 210-217 (2012).
5. Durrbach, A. et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am. J. Transplant. 10, 547-557 (2010).
6. Larsen, C.P. 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 90, 1528-1535 (2010).
7. G riny? J. et al. An integrated safety profile analysis of belatacept in kidney transplant recipients. Transplantation 90, 1521-1527 (2010).
8. Roy, A., Mould, D.R., Wang, X.F., Tay, L., Raymond, R. & Pfister, M. Modeling and simulation of abatacept exposure and interleukin-6 response in support of recommended doses for rheumatoid arthritis. J. Clin. Pharmacol. 47, 1408-1420 (2007). (Pubitemid 47624599)
9. Bichet, D.G. Pathogenesis of edematous states. Clin. Invest. Med. 12, 316-322 (1989). (Pubitemid 19277674)
10. Zhou Z., Wang X., Pfister M., Roy A. Feasibility of characterizing time and concentration dependent binary response data by time-to-event analysis. American Conference on Pharmacometrics (October 2009) Mashantucket CT, Oct 4-9, 2009.
11. Chang, S.H., Coates, P.T. & McDonald, S.P. Effects of body mass index at transplant on outcomes of kidney transplantation. Transplantation 84, 981-987 (2007). (Pubitemid 350287379)
12. Hariharan, S., Kasiske, B., Matas, A., Cohen, A., Harmon, W. & Rabb, H. Surrogate markers for long-term renal allograft survival. Am. J. Transplant. 4, 1179-1183 (2004). (Pubitemid 38868612)
13. S chiff, J., Cole, E. & Cantarovich, M. Therapeutic monitoring of calcineurin inhibitors for the nephrologist. Clin. J. Am. Soc. Nephrol. 2, 374-384 (2007).
14. Nulojix Prescribing Information (2011) 〈http://www.accessdata.fda. gov/drugsatfda-docs/label/2011/125288s0000lbl.pdf〉. Accessed 14 June 2012.
15. S hen J. et al. Pharmacokinetics, pharmacodynamics, and immunogenicity of belatacept in renal transplant recipients. Presented at the XXIII International Congress of the Transplantation Society, Vancouver, Canada, 15-19 August Abstract 1870.
16. Wlby, U., Thomson, A.H., Milligan, P.A. & Karlsson, M.O. Models for timevarying covariates in population pharmacokinetic-pharmacodynamic analysis. Br. J. Clin. Pharmacol. 58, 367-377 (2004). (Pubitemid 39312460)