Pharmacokinetics and concentration–effect relationships of therapeutic monoclonal antibodies and fusion proteins

Bibliography

• KOHLER G, MILSTEIN C: Continuous cultures of fused cells secreting antibody of predefined specificity. Nature (1975) 256(5517):495–497.
   PubMed Web of Science ®Google Scholar
• KHAZAELI MB, CONRY RIVI, LOBUGLIO AF: Human immune response to monoclonal antibodies. J. Immunother. (1994) 15(1):42–52. et al.: Pharmacokinetics and immune response of 131I-chimeric mouse/human B72.3 (human gamma 4) monoclonal antibody in humans. Cancer Res. (1991)
   Google Scholar
• KHAZAELI MB, SALEH MN, LIU TP et al.: Pharmacokinetics and immune response of 131I-chimeric mouse/human B72.3 (human gamma 4) monoclonal antibody in humans. Cancer Res. (1991) 51(20):5461–5466.
   Google Scholar
• BREED VELD FC: Therapeutic monoclonal antibodies. Lancet (2000) 355(9205):735–740. OWEN CE: Anti-immunoglobulin E therapy for asthma. Pulm. Pharmacol Ther. (2002) 15(5):417–424. VAISHNAW AK, TENHOOR CN: Pharmacokinetics, biologic activity, and tolerability of alefacept by intravenous and intramuscular administration. Pharmacokinet. Pharmacodyn. (2002) 29(5–6):415–426.
   Google Scholar
• ECONOMIDES AN, CARPENTER LR, RUDGE JS et al.: Cytokine traps: multicomponent, high-affinity blockers of cytokine action. Nat. Med. (2003 (1):47–52.
   Google Scholar
• OWEN CE: Anti-immunoglobulin E therapy for asthma. Pulm. Pharmacol. Ther. (2002) 15(5):417–424.
   PubMed Web of Science ®Google Scholar
• VAISHNAW AK, TENHOOR CN: Pharmacokinetics, biologic activity, and tolerability of alefacept by intravenous and intramuscular administration. J. Pharmacokinet. Pharmacodyn. (2002) 29(5-6):415–426.
   PubMed Web of Science ®Google Scholar
• KORTH-BRADLEY JM, RUBIN AS, HANNA RIC, SIMCOE DK, LEBSACK ME: The pharmacokinetics of etanercept in healthy volunteers. Ann. Pharmacother. (2000) 34(2):161–164.
   PubMed Web of Science ®Google Scholar
• LOBO ED, HANSEN RJ, BALTHASAR JP: Antibody pharmacokinetics and pharmacodynamics. Pharm. ScL (2004) 93(11):2645–2668. J. RUBENSTEIN JL, COMBS D, ROSENBERG J et al.: Rituximab therapy for CNS lymphomas: targeting the leptomeningeal compartment. Blood (2003) 101(2):466–468.
   Google Scholar
• CRAGG MS, MORGAN SM, CHAN HT et al.: Complement-mediated lysis by anti-CD20 mAb correlates with segregation into lipid rafts. Blood (2003) 101(3):1045–1052.
   PubMed Web of Science ®Google Scholar
• MCLAUGHLIN P: Rituximab: perspective on single agent experience, and future directions in combination trials. Grit. Rev Oncol Hematol (2001) 40(1):3–16.
   PubMed Web of Science ®Google Scholar
• SCHEIDHAUER K, WOLF I, BAUMGARTL HJ et al.: Biodistribution and kinetics of (131)1-labelled anti-CD20 MAB IDEC-C2B8 (rituximab) in relapsed non-Hodgkin's lymphoma. Eur. I Nucl. Med. Mol Imaging (2002) 29(10):1276–1282.
   PubMed Web of Science ®Google Scholar
• REFF ME, HEARD C: A review of modifications to recombinant antibodies: attempt to increase efficacy in oncology applications. Crit. Rev Oncol Hematol (2001) 40(1):25–35.
   PubMed Web of Science ®Google Scholar
• VEREL I, HEIDER KH, SIEGMUND M et al.: Tumor targeting properties of monoclonal antibodies with different affinity for target antigen CD44V6 in nude mice bearing head-and-neck cancer xenografts. Int. J. Cancer (2002) 99(3)396–402.
   Google Scholar
• ADAMS GP, SCHIER R, MARSHALL K et al.: Increased affinity leads to improved selective tumor delivery of single-chain Fy antibodies. Cancer Res. (1998) 58(3)485–490.
   Google Scholar
• ADAMS GP, SCHIER R, MCCALL AM et al.: High affinity restricts the localization and tumor penetration of single-chain fv antibody molecules. Cancer Res. (2001) 61(12):4750–4755.
   PubMed Web of Science ®Google Scholar
• COFFEY GP, STEFANICH E, PALMIERI S et al.: hi vitro internalization, intracellular transport, and clearance of an anti-CD1 la antibody (Raptiva) by human Pharinacol Exp. Ther. (2004) 310(3)896–904.
   Google Scholar
• DAMLE NK: Tumour-targeted chemotherapy with immunoconjugates of calicheamicin. Expert Opin. Biol. Ther. (2004) 4(9):1445–1452.
   PubMed Web of Science ®Google Scholar
• MORELL A, TERRY WD, WALDMANN TA: Metabolic properties of IgG subclasses in man. J. Glitz Invest. (1970) 49(4):673–680.
   PubMed Web of Science ®Google Scholar
• JUNGHANS RP: Finally! The Brambell receptor (FcRB). Mediator of transmission of immunity and protection from catabolism for IgG. Iminunol Res. (1997) 16(1):29–57.
   Google Scholar
• ISRAEL EJ, WILSKER DF, HAYES KC,SCHOENFELD D, SIMISTER NE: Increased clearance of IgG in mice that lack beta 2-microglobulin: possible protective role of FcRn. Immunology (1996) 89(4):573–578.
   PubMed Web of Science ®Google Scholar
• RAULET DH: MHC class I-deficient mice.Adv. Iminunol (1994) 55:381–421.
   PubMed Web of Science ®Google Scholar
• ROOPENIAN DC, CHRISTIANSON GJ, SPROULE TJ et al.: The MHC class I-like IgG receptor controls perinatal IgG transport, IgG homeostasis, and fate of IgG-Fc-coupled drugs../. Iminunol (2003) 170(7):3528–3533.
   Google Scholar
• FIRAN M, BAWDON R, RADU C et al: The MHC class I-related receptor, FcRn, plays an essential role in the maternofetal transfer of gamma-globulin in humans. Int. Iminunol (2001) 13(8):993–1002.
   PubMed Web of Science ®Google Scholar
• GHETIE V, WARD ES: FcRn: the MHC class I-related receptor that is more than an IgG transporter. Iminunol Today (1997) 18(12):592–598.
   PubMed Web of Science ®Google Scholar
• KOBAYASHI N, SUZUKI Y, TSUGE T et al.: FcRn-mediated transcytosis of immunoglobulin G in human renal proximal tubular epithelial cells. Am. J. Physiol Rena] Physiol (2002) 282(2):F358–F365.
   Google Scholar
• POPOV S, HUBBARD JG, KIM J et al: The stoichiometry and affinity of the interaction of murine Fc fragments with the MHC class I-related receptor, FcRn. Mol. Immunol (1996) 33(6):521–530.
   PubMed Web of Science ®Google Scholar
• WARD ES, ZHOU J, GHETIE V, OBER RJ: Evidence to support the cellular mechanism involved in serum IgG homeostasis in humans. Int. Immunol (2003) 15(2):187–195.
   PubMed Web of Science ®Google Scholar
• OBER RJ, MARTINEZ C, VACCARO C, ZHOU J, WARD ES: Visualizing the site and dynamics of IgG salvage by the MHC class I-related receptor, FcRn. ./. Immunol (2004) 172(4):2021–2029.
   PubMed Web of Science ®Google Scholar
• OBER RJ, RADU CG, GHETIE V, WARD ES: Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. Int. Immunol (2001) 13(12):1551–1559.
   PubMed Web of Science ®Google Scholar
• SCHROR K, WEBER AA: Comparative pharmacology of GP IIb/IIIa antagonists. J. Thromb. Thrombolysis (2003) 15(2):71–80.
   PubMed Web of Science ®Google Scholar
• HINTON PR, JOHLFS MG, XIONG JM et al.: Engineered human IgG antibodies with longer serum half-lives in primates. J. Biol. Chem. (2004) 279(8):6213–6216.
   PubMed Web of Science ®Google Scholar
• HORNICK JL, SHARIFI J, KHAWLI LA et al.: Single amino acid substitution in the Fc region of chimeric TNT-3 antibody accelerates clearance and improves immunoscintigraphy of solid tumors. J. Nucl. Med. (2000) 41(2):355–362.
   PubMed Web of Science ®Google Scholar
• LEE H, KIMKO HC, ROGGE M et al: Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis. Glitz Pharmacol Ther. (2003) 73(4):348–365.
   Web of Science ®Google Scholar
• ZIA-AMIRHOSSEINI P, MINTHORN E, BENINCOSA LJ et al: Pharmacokinetics and pharmacodynamics of SB-240563, a humanized monoclonal antibody directed to human interleukin-5, in monkeys. Pharmacol Exp. Ther. (1999) 291(3):1060–1067.
   PubMed Web of Science ®Google Scholar
• ZAJA F, VIANELLI N, SPEROTTO A et al.: B-cell compartment as the selective target for the treatment of immune thrombocytopenias. Haematologica (2003) 88(5):538–546.
   PubMedGoogle Scholar
• COLNOT DR, ROOS JC, DE BREE R et al.: Safety, biodistribution, pharmacokinetics, and immunogenicity of 99mTc-labeled humanized monoclonal antibody BIWA 4 (bivatuzumab) in patients with squamous cell carcinoma of the head and neck. Cancer Immunol Immunother. (2003) 52(9):576–582.
   Google Scholar
• KLOFT C, GRAEFE EU, TANSWELL P et al.: Population pharmacokinetics of sibrotuzumab, a novel therapeutic monoclonal antibody, in cancer patients. Invest. New Drugs (2004) 22(1):39–52.
   PubMed Web of Science ®Google Scholar
• MOULD DR, DAVIS CB, MINTHORN EA et al.: A population pharmacokinetic-pharmacodynamic analysis of single doses of clenoliximab in patients with rheumatoid arthritis. Clin. Pharmacol Ther. (1999) 66(3):246–257.
   PubMed Web of Science ®Google Scholar
• SHARMA A, DAVIS CB, TOBIA LA et al: Comparative pharmacodynamics of keliximab and clenoliximab in transgenic mice bearing human CD4../. Pharmacol Exp. Ther. (2000) 293(1):33–41.
   Google Scholar
• REBELLO P, CWYNARSKI K, VARUGHESE M et al: Pharmacokinetics of CAMPATH-1H in BMT patients. Cytotherapy (2001) 3(4):261–267.
   PubMed Web of Science ®Google Scholar
• OLSEN NJ, STEIN CM: New drugs for rheumatoid arthritis. N Engl. I Med. (2004) 350(21):2167–2179.
   PubMed Web of Science ®Google Scholar
• MAINI RN, BREEDVELD FC, KALDEN JR et al.: Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. (1998) 41(9):1552–1563.
   PubMed Web of Science ®Google Scholar
• BAERT F, NOMAN M, VERMEIRE S et al: Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Eng]..1. Med. (2003) 348(7):601–608.
   Google Scholar
• DAVIS TA, WHITE CA, GRILLO-LOPEZ AJ et al: Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma: results of a Phase II trial of rituximab. Glitz Oncol (1999) 17(6):1851–1857.
   PubMed Web of Science ®Google Scholar
• WOLBINK GJ, VOSKUYL A, LEMS W et al: Relation between serum trough infliximab levels, pre- treatment CRP levels and clinical response to infliximab treatment in rheumatoid arthritis. Ann. Rheum. Dis. (2005) 64(5):704–707.
   PubMed Web of Science ®Google Scholar
• MAGER DE, MASCELLI MA, KLEIMAN, FITZGERALD DJ, ABERNETHY DR: Simultaneous modeling of abciximab plasma concentrations and ex vivo pharmacodynamics in patients undergoing coronary angioplasty. ./. Pharmacol Exp. Ther. (2003) 307(3):969–976.
   PubMed Web of Science ®Google Scholar
• STEPHENS S, EMTAGE S, VETTERLEIN 0 et al: Comprehensive pharmacokinetics of a humanized antibody and analysis of residual anti-idiotypic responses. Immunology (1995) 85(4):668–674.
   PubMed Web of Science ®Google Scholar
• BASELGA J, PFISTER D, COOPER MR et al.: Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. Clin. Oncol (2000) 18(4):904–914.
   Web of Science ®Google Scholar
• MALONEY DG, GRILLO-LOPEZ AJ, BODKIN DJ et al: IDEC-C2B8: results of a Phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J. Clin. Oncol (1997) 15(10):3266–3274.
   PubMed Web of Science ®Google Scholar
• BERINSTEIN NL, GRILLO-LOPEZ AJ, WHITE CA et al.: Association of serum rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Ann. Oncol (1998) 9(9):995–1001.
   PubMed Web of Science ®Google Scholar
• ST CLAIR EW, WAGNER CL, FASANMADE AA et al.: The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. (2002) 46(6):1451–1459.
   PubMed Web of Science ®Google Scholar
• RASTETTER W, MOLINA A, WHITE CA: Rituximab: expanding role in therapy for lymphomas and autoimmune diseases. Ann. Rev Med. (2004) 55:477–503.
   PubMed Web of Science ®Google Scholar
• MCLAUGHLIN P, GRILLO-LOPEZ AJ, LINK BK et al: Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J. Clin. Oncol. (1998) 16(8):2825–2833.
   PubMed Web of Science ®Google Scholar
• HALE G, REBELLO P, BRETTMAN LR et al: Blood concentrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or subcutaneous routes of administration. Blood (2004)104(4):948–955.
   PubMed Web of Science ®Google Scholar
• JUSKO WJ, KO HC: Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin. Pharmacol Ther. (1994) 56(4):406–419.
   PubMed Web of Science ®Google Scholar
• KOVARIK J, BREIDENBACH T, GERBEAU C et al.: Disposition and immunodynamics of basiliximab in liver allograft recipients. Clin. Pharmacol Ther. (1998) 64(1):66–72.
   PubMed Web of Science ®Google Scholar
• MENTRE F, KOVARIK J, GERBEAU C: Constructing a prediction interval for time to reach a threshold concentration based on a population pharmacokinetic analysis: an application to basiliximab in renal transplantation. J. Pharmacokinet. Biopharm. (1999) 27(2):213–230.
   PubMedGoogle Scholar
• KOVARIK JM, MOORE R, WOLF P et al.: Screening for basiliximab exposure-response relationships in renal allotransplantation. Clin. Transplant. (1999) 13(1 Pt 1):32–38.
   Google Scholar
• CARTRON G, WATIER H, GOLAY J, SOLAL-CELIGNY P: From the bench to the bedside: ways to improve rituximab efficacy. Blood (2004) 104(9):2635–2642.
   PubMed Web of Science ®Google Scholar
• CARTRON G, DACHEUX L, SALLES G et al: Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcgammaRIlla gene. Blood (2002) 99(3):754–758.
   PubMed Web of Science ®Google Scholar
• KOENE HR, KLEIJER M, ALGRA J et al: Fc gammaRIIIa-158V/F polymorphism influences the binding of IgG by natural killer cell Fc gammaRIIIa, independently of the Fc gammaRIIIa-48L/R/H phenotype. Blood (1997) 90(3):1109–1114.
   PubMed Web of Science ®Google Scholar
• WENG WK, LEVY R: Two immunoglobulin G fragment C receptor polymorphisms independently predict response to rituximab in patients with follicular lymphoma. ./. Clin. Oncol (2003) 21(20:3940–3947.
   PubMedGoogle Scholar
• FARAG SS, FLINN IW, MODALI R et al: Fc gamma RIIIa and Fc gamma Rila polymorphisms do not predict response to rituximab in B-cell chronic lymphocytic leukemia. Blood (2004) 103(4):1472–1474.
   PubMed Web of Science ®Google Scholar
• LIN TS, FLINN IW, MODALI R et al: FCGR3A and FCGR2A polymorphisms may not correlate with response to alemtuzumab in chronic lymphocytic leukemia. Blood (2005) 105(1):289–291.
   PubMed Web of Science ®Google Scholar
• DALLOZZO S, TARTAS S, PAINTAUD G et al: Rituximab-dependent cytotoxicity by natural killer cells: influence of FCGR3A polymorphism on the concentration-effect relationship. Cancer Res. (2004) 64(13):4664–4669.
   PubMed Web of Science ®Google Scholar
• ANOLIK JH, CAMPBELL D, FELGAR RE et al.: The relationship of FcgammaRIIIa genotype to degree of B cell depletion by rituximab in the treatment of systemic lupus erythematosus. Arthritis Rheum. (2003) 48(2):455–459.
   PubMed Web of Science ®Google Scholar
• LOUIS E, EL GHOUL Z, VERMEIRE S et al: Association between polymorphism in IgG Fc receptor Ma coding gene and biological response to infliximab in Crohn's disease. Ailment. Pharmacol Ther. (2004) 19(5):511–519.
   PubMed Web of Science ®Google Scholar
• MIESCHER S, SPYCHER MO, AMSTUTZ H et al.: A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes. Blood (2004) 103(11):4028–4035.
   PubMed Web of Science ®Google Scholar
• VAN DER POL WL, JANSEN MD, SLUITER WJ et al: Evidence for non-random distribution of Fcgamma receptor genotype combinations. Immunogenetics (2003) 55(4):240–246.
   PubMed Web of Science ®Google Scholar
• URQUIDI-MACDONALD M, MAGER DE, MASCELLI MA et al: Abciximab pharmacodynamic model with neural networks used to integrate sources of patient variability. Clin. Pharmacol Ther. (2004) 75(1):60–69.
   PubMed Web of Science ®Google Scholar
• WEISMAN MH, MORELAND LW FURST DE et al: Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study. Ther. (2003) 25(6):1700–1721.
   PubMed Web of Science ®Google Scholar
• KOVARIK JM, NASHAN B, NEUHAUS P et al: A population pharmacokinetic screen to identify demographic-clinical covariates of basiliximab in liver transplantation. Clin. Pharmacol Ther. (2001) 69(4):201–209.
   PubMed Web of Science ®Google Scholar
• THOMAS SM, GRANDIS JR: Pharmacokinetic and pharmacodynamic properties of EGFR inhibitors under clinical investigation. Cancer Treat. Rev (2004) 30(3):255–268.
   PubMed Web of Science ®Google Scholar
• VINCENTI F, NASHAN B, LIGHT S: Daclizumab: outcome of Phase III trials and mechanism of action. Double Therapy and the Triple Therapy Study Groups. Transplant. Proc. (1998) 30(5):2155–2158.
   Google Scholar
• DOWELL JA, KORTH-BRADLEY J, LIU H, KING SP, BERGER MS: Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse.' Clin. Pharmacol (2001) 41(10:1206–1214.
   Google Scholar
• WISEMAN GA, KORNMEHL E, LEIGH B et al: Radiation dosimetry results and safety correlations from 90Y-ibritumomab tiuxetan radioimmunotherapy for relapsed or refractory non-Hodgkin's lymphoma: combined data from 4 clinical trials. J. Nucl. Med. (2003) 44(3):465–474.
   PubMed Web of Science ®Google Scholar
• HOOKS MA, WADE CS, MILLIKAN WJ Jr: Muromonab CD-3: a review of its pharmacology, pharmacokinetics, and clinical use in transplantation. Pharmacotherapy (1991) 11(1):26–37.
   PubMed Web of Science ®Google Scholar
• BANG LM, PLOSKER GL: Omalizumab: a review of its use in the management of allergic asthma. Treat. Respir: Med. (2004) 3(3):183–199.
   PubMedGoogle Scholar
• SUBRAMANIAN KN, WEISMAN LE, RHODES T et al.: Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. MEDI-493 Study Group. Pediatr. Infect. Dis. J. (1998) 17(2):110–115.
   Google Scholar
• MALONEY DG, LILES TM, CZERWINSKI DK et al.: Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B- cell lymphoma. Blood (1994) 84 (8) :2457–2466.
   PubMed Web of Science ®Google Scholar
• LEYLAND-JONES B, GELMON K, AYOUB JP et al: Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel.Oncol (2003)21(20:3965–3971.
   Google Scholar