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Volumn 6, Issue JAN, 2015, Pages

Prediction of the pharmacokinetics, pharmacodynamics, and efficacy of a monoclonal antibody, using a physiologically based pharmacokinetic FcRn model

Author keywords

Efalizumab; FcRn model; Monoclonal antibodies; PBPK models; PBPK PD

Indexed keywords

EFALIZUMAB; FC RECEPTOR; LYMPHOCYTE FUNCTION ASSOCIATED ANTIGEN 1;

EID: 84926681388     PISSN: None     EISSN: 16643224     Source Type: Journal    
DOI: 10.3389/fimmu.2014.00670     Document Type: Article
Times cited : (17)

References (24)
  • 1
    • 29144457336 scopus 로고    scopus 로고
    • A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn)
    • Ferl GZ, Wu AM, Distefano JJ III. A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn). Ann Biomed Eng (2005) 33:1640-52. doi: 10.1007/s10439-005-7410-3
    • (2005) Ann Biomed Eng , vol.33 , pp. 1640-1652
    • Ferl, G.Z.1    Wu, A.M.2    Distefano, J.J.3
  • 2
    • 34748877223 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
    • Garg A, Balthasar JP. Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J Pharmacokinet Pharmacodyn (2007) 34:687-709. doi:10.1007/s10928-007-9065-1
    • (2007) J Pharmacokinet Pharmacodyn , vol.34 , pp. 687-709
    • Garg, A.1    Balthasar, J.P.2
  • 3
    • 76649094549 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic model for T84.66: a monoclonal anti-CEA antibody
    • Urva SR, Yang VC, Balthasar JP. Physiologically based pharmacokinetic model for T84.66: a monoclonal anti-CEA antibody. J Pharm Sci (2010) 99:1582-600. doi:10.1002/jps.21918
    • (2010) J Pharm Sci , vol.99 , pp. 1582-1600
    • Urva, S.R.1    Yang, V.C.2    Balthasar, J.P.3
  • 4
    • 84869147336 scopus 로고    scopus 로고
    • Evaluation of a catenary PBPK model for predicting the in vivo disposition of mAbs engineered for high-affinity binding to FcRn
    • Chen Y, Balthasar JP. Evaluation of a catenary PBPK model for predicting the in vivo disposition of mAbs engineered for high-affinity binding to FcRn. AAPS J (2012) 14:850-9. doi:10.1208/s12248-012-9395-9
    • (2012) AAPS J , vol.14 , pp. 850-859
    • Chen, Y.1    Balthasar, J.P.2
  • 5
    • 84861480783 scopus 로고    scopus 로고
    • Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human
    • Shah DK, Betts AM. Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human. J Pharmacokinet Pharmacodyn (2012) 39:67-86. doi:10.1007/s10928-011-9232-2
    • (2012) J Pharmacokinet Pharmacodyn , vol.39 , pp. 67-86
    • Shah, D.K.1    Betts, A.M.2
  • 6
    • 84897578766 scopus 로고    scopus 로고
    • Monoclonal antibody disposition: a simplified PBPK model and its implications for the derivation and interpretation of classical compartment models
    • Fronton L, Pilari S, Huisinga W. Monoclonal antibody disposition: a simplified PBPK model and its implications for the derivation and interpretation of classical compartment models. J Pharmacokinet Pharmacodyn (2014) 41:87-107. doi:10.1007/s10928-014-9349-1
    • (2014) J Pharmacokinet Pharmacodyn , vol.41 , pp. 87-107
    • Fronton, L.1    Pilari, S.2    Huisinga, W.3
  • 7
    • 77956388219 scopus 로고    scopus 로고
    • Population pharmacokinetics of therapeutic monoclonal antibodies
    • Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet (2010) 49:633-59. doi:10.2165/11535960-000000000-00000
    • (2010) Clin Pharmacokinet , vol.49 , pp. 633-659
    • Dirks, N.L.1    Meibohm, B.2
  • 8
    • 77954472838 scopus 로고    scopus 로고
    • Clinical pharmacokinetics of therapeutic monoclonal antibodies
    • Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet (2010) 49:493-507. doi:10.2165/11531280-000000000-00000
    • (2010) Clin Pharmacokinet , vol.49 , pp. 493-507
    • Keizer, R.J.1    Huitema, A.D.2    Schellens, J.H.3    Beijnen, J.H.4
  • 9
    • 75149145545 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development
    • Mould DR, Green B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs (2010) 24:23-39. doi:10.2165/11530560-000000000-00000
    • (2010) BioDrugs , vol.24 , pp. 23-39
    • Mould, D.R.1    Green, B.2
  • 10
    • 84856120429 scopus 로고    scopus 로고
    • Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development?
    • Deng R, Jin F, Prabhu S, Iyer S. Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin Drug Metab Toxicol (2012) 8:141-60. doi:10.1517/17425255.2012.643868
    • (2012) Expert Opin Drug Metab Toxicol , vol.8 , pp. 141-160
    • Deng, R.1    Jin, F.2    Prabhu, S.3    Iyer, S.4
  • 11
    • 84877057389 scopus 로고    scopus 로고
    • Pharmacokinetics, pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies
    • Dostalek M, Gardner I, Gurbaxani BM, Rose RH, Chetty M. Pharmacokinetics, pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies. Clin Pharmacokinet (2013) 52:83-124. doi:10.1007/s40262-012-0027-4
    • (2013) Clin Pharmacokinet , vol.52 , pp. 83-124
    • Dostalek, M.1    Gardner, I.2    Gurbaxani, B.M.3    Rose, R.H.4    Chetty, M.5
  • 12
    • 0033506984 scopus 로고    scopus 로고
    • Population pharmacokinetics and pharmacodynamics of the anti-CD11a antibody hu1124 in human subjects with psoriasis
    • Bauer RJ, Dedrick RL, White ML, Murray MJ, Garovoy MR. Population pharmacokinetics and pharmacodynamics of the anti-CD11a antibody hu1124 in human subjects with psoriasis. J Pharmacokinet Biopharm (1999) 27:397-420. doi:10.1023/A:1020917122093
    • (1999) J Pharmacokinet Biopharm , vol.27 , pp. 397-420
    • Bauer, R.J.1    Dedrick, R.L.2    White, M.L.3    Murray, M.J.4    Garovoy, M.R.5
  • 13
    • 33644901293 scopus 로고    scopus 로고
    • Efalizumab: a review of events reported during clinical trials and side effects
    • Scheinfeld N. Efalizumab: a review of events reported during clinical trials and side effects. Expert Opin Drug Saf (2006) 5:197-209. doi:10.1517/14740338.5.2.197
    • (2006) Expert Opin Drug Saf , vol.5 , pp. 197-209
    • Scheinfeld, N.1
  • 14
    • 12944283147 scopus 로고    scopus 로고
    • Effects of administration of a single dose of a humanized monoclonal antibody to CD11a on the immunobiology and clinical activity of psoriasis
    • Gottlieb A, Krueger JG, Bright R, Ling M, Lebwohl M, Kang S, et al. Effects of administration of a single dose of a humanized monoclonal antibody to CD11a on the immunobiology and clinical activity of psoriasis. J Am Acad Dermatol (2000) 42:428-35. doi:10.1016/S0190-9622(00)90214-7
    • (2000) J Am Acad Dermatol , vol.42 , pp. 428-435
    • Gottlieb, A.1    Krueger, J.G.2    Bright, R.3    Ling, M.4    Lebwohl, M.5    Kang, S.6
  • 15
    • 0036578664 scopus 로고    scopus 로고
    • Psoriasis as a model for T-cell-mediated disease: immunobiologic and clinical effects of treatment with multiple doses of efalizumab, an anti-CD11a antibody
    • Gottlieb AB, Krueger JG, Wittkowski K, Dedrick R, Walicke PA, Garovoy M. Psoriasis as a model for T-cell-mediated disease: immunobiologic and clinical effects of treatment with multiple doses of efalizumab, an anti-CD11a antibody. Arch Dermatol (2002) 138:591-600. doi:10.1001/archderm.138.5.591
    • (2002) Arch Dermatol , vol.138 , pp. 591-600
    • Gottlieb, A.B.1    Krueger, J.G.2    Wittkowski, K.3    Dedrick, R.4    Walicke, P.A.5    Garovoy, M.6
  • 16
    • 0346515709 scopus 로고    scopus 로고
    • Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial
    • Gordon KB, Papp KA, Hamilton TK, Walicke PA, Dummer W, Li N, et al. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA (2003) 290:3073-80. doi:10.1001/jama.290.23.3073
    • (2003) JAMA , vol.290 , pp. 3073-3080
    • Gordon, K.B.1    Papp, K.A.2    Hamilton, T.K.3    Walicke, P.A.4    Dummer, W.5    Li, N.6
  • 17
    • 20144389380 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of multiple weekly subcutaneous efalizumab doses in patients with plaque psoriasis
    • Mortensen DL, Walicke PA, Wang X, Kwon P, Kuebler P, Gottlieb AB, et al. Pharmacokinetics and pharmacodynamics of multiple weekly subcutaneous efalizumab doses in patients with plaque psoriasis. J Clin Pharmacol (2005) 45:286-98. doi:10.1177/0091270004270260
    • (2005) J Clin Pharmacol , vol.45 , pp. 286-298
    • Mortensen, D.L.1    Walicke, P.A.2    Wang, X.3    Kwon, P.4    Kuebler, P.5    Gottlieb, A.B.6
  • 18
    • 23744475396 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic-efficacy analysis of efalizumab in patients with moderate to severe psoriasis
    • Ng CM, Joshi A, Dedrick RL, Garovoy MR, Bauer RJ. Pharmacokinetic-pharmacodynamic-efficacy analysis of efalizumab in patients with moderate to severe psoriasis. Pharm Res (2005) 22:1088-100. doi:10.1007/s11095-005-5642-4
    • (2005) Pharm Res , vol.22 , pp. 1088-1100
    • Ng, C.M.1    Joshi, A.2    Dedrick, R.L.3    Garovoy, M.R.4    Bauer, R.J.5
  • 19
    • 77952853543 scopus 로고    scopus 로고
    • Efalizumab in the treatment of psoriasis
    • Boehncke WH. Efalizumab in the treatment of psoriasis. Biologics Targets and Therapy (2007) 1(3):301-9.
    • (2007) Biologics Targets and Therapy , vol.1 , Issue.3 , pp. 301-309
    • Boehncke, W.H.1
  • 20
    • 70449720511 scopus 로고    scopus 로고
    • Dynamics of target-mediated drug disposition
    • Peletier LA, Gabrielsson J. Dynamics of target-mediated drug disposition. Eur J Pharm Sci (2009) 38:445-64. doi:10.1016/j.ejps.2009.09.007
    • (2009) Eur J Pharm Sci , vol.38 , pp. 445-464
    • Peletier, L.A.1    Gabrielsson, J.2
  • 21
    • 77949884124 scopus 로고    scopus 로고
    • Importance of neonatal FcR in regulating the serum half-life of therapeutic proteins containing the Fc domain of human IgG1: a comparative study of the affinity of monoclonal antibodies and Fc-fusion proteins to human neonatal FcR
    • Suzuki T, Ishii-Watabe A, Tada M, Kobayashi T, Kanayasu-Toyoda T, Kawanishi T, et al. Importance of neonatal FcR in regulating the serum half-life of therapeutic proteins containing the Fc domain of human IgG1: a comparative study of the affinity of monoclonal antibodies and Fc-fusion proteins to human neonatal FcR. J Immunol (2010) 184:1968-76. doi:10.4049/jimmunol.0903296
    • (2010) J Immunol , vol.184 , pp. 1968-1976
    • Suzuki, T.1    Ishii-Watabe, A.2    Tada, M.3    Kobayashi, T.4    Kanayasu-Toyoda, T.5    Kawanishi, T.6
  • 22
    • 84908356716 scopus 로고    scopus 로고
    • Simulation of monoclonal antibody pharmacokinetics in humans using a minimal physiologically based model
    • Li L, Gardner I, Dostalek M, Jamei M. Simulation of monoclonal antibody pharmacokinetics in humans using a minimal physiologically based model. AAPS J (2014) 16(5):1097-109. doi:10.1208/s12248-014-9640-5
    • (2014) AAPS J , vol.16 , Issue.5 , pp. 1097-1109
    • Li, L.1    Gardner, I.2    Dostalek, M.3    Jamei, M.4
  • 23
    • 57749111624 scopus 로고    scopus 로고
    • Approximations of the target-mediated drug disposition model and identifiability of model parameters
    • Gibiansky L, Gibiansky E, Kakkar T, Ma P. Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn (2008) 35:573-91. doi:10.1007/s10928-008-9102-8
    • (2008) J Pharmacokinet Pharmacodyn , vol.35 , pp. 573-591
    • Gibiansky, L.1    Gibiansky, E.2    Kakkar, T.3    Ma, P.4
  • 24
    • 33745786419 scopus 로고    scopus 로고
    • Disease progression and pharmacodynamics in Parkinson disease-evidence for functional protection with levodopa and other treatments
    • Holford NH, Chan PL, Nutt JG, Kieburtz K, Shoulson I. Disease progression and pharmacodynamics in Parkinson disease-evidence for functional protection with levodopa and other treatments. J Pharmacokinet Pharmacodyn (2006) 33:281-311. doi:10.1007/s10928-006-9012-6
    • (2006) J Pharmacokinet Pharmacodyn , vol.33 , pp. 281-311
    • Holford, N.H.1    Chan, P.L.2    Nutt, J.G.3    Kieburtz, K.4    Shoulson, I.5


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