Pharmacokinetics of monoclonal antibodies;Propriétés pharmacocinétiques des anticorps monoclonaux

Journal de Pharmacie Clinique

Volumn 21, Issue 4, 2002, Pages 271-277

  Leveque D ^a,b  

^a UNIVERSITY HOSPITAL OF STRASBOURG   (France)

^b UNIVERSITÉ DE STRASBOURG   (France)

Author keywords

Clinical pharmacokinetics; Monoclonal antibodies

Indexed keywords

ABCIXIMAB; ALEMTUZUMAB; BASILIXIMAB; DACLIZUMAB; GEMTUZUMAB OZOGAMICIN; IMMUNOGLOBULIN G; INFLIXIMAB; MONOCLONAL ANTIBODY; OKT 3; PALIVIZUMAB; RITUXIMAB; TRASTUZUMAB; ZENOPAX;

DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG INDICATION; HUMAN; NONHUMAN; PHARMACODYNAMICS; REVIEW; TISSUE DISTRIBUTION;

EID: 0036824526     PISSN: 02911981     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (69)

1. Köhler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975; 256: 495-7.
2. Rajewsky K. César Milstein (1927-2002). Nature 2002; 416: 806.
3. Ford CHJ, Casson AG. Antibody-mediated targeting in the treatment and diagnosis of cancer: an overview. Cancer Chemother Pharmacol 1986; 17: 197-208.
4. Dillman RO. Monoclonal antibodies for treating cancer. Ann Intern Med 1989; 111: 592-603.
5. Hughes D. Therapeutic antibodies make a come back. Drug Discov Today 1998; 3: 439-42.
6. Glennie MJ, Johnson PWM. Clinical trials of antibody therapy. Immunol Today 2000; 21: 403-10.
7. Breedveld FC. Therapeutic monoclonal antibodies. Lancet 2000; 355: 735-40.
8. Dillman RO. Monoclonal antibodies in the treatment of malignancy: basic concepts and recent developments. Cancer Invest 2001; 19: 833-41.
9. Pascual J, Marcén R, Ortuno J. Anti-interleukin-2 receptor antibodies: basiliximab and daclizumab. Nephrol Dial Transplant 2001; 16: 1756-60.
10. Drewe E, Powell RJ. Clinically useful monoclonal antibodies in treatment. J Clin Pathol 2002; 55: 81-5.
11. Schlom J. Antibodies in cancer therapy: basic principles of monoclonal antibodies. In: De Vita VT Jr, Hellman S, Rosenberg SA, eds. Biologic treatment of cancer. Philadelphie: JB Lippincott Company, 1991: 464-81.
12. Bowen AL, Zomas A, Emmett E, Matutes E, Dyer MJS, Catovsky D. Subcutaneous Campath-1H in fludarabine-resistant/relapsed chronic lymphocytic and B-prolymphocytic leukaemia. Br J Haematol 1997; 96: 617-9.
13. Epenetos AA, Snook D, Durbin H, Johnson PM, Taylor-Papadimitriou J. Limitations of radiolabeled monoclonal antibodies for localization of human neoplasms. Cancer Res 1986; 46: 3183-91.
14. Jayson GC, Zweit J, Jackson A, et al. Molecular imaging and biological evaluation of HuMV833 anti-VEGF antibody: implications for trial design of antiangiogenic antibodies. J Natl Cancer Inst 2002; 94: 1484-93.
15. Sands H, Jones PL Shah SA, Palme D, Vessella RL, Gallagher BM. Correlation of vascular permeability and blood flow with monoclonal antibody uptake by human Clouser and renal cell xenografts. Cancer Res 1988; 48: 188-93.
16. Jain RK. Transport of molecules in the tumor interstitium: a review. Cancer Res 1987; 47: 3039-51.
17. Fujimori K, Covell DG, Fletcher JE, Weinstein JN. Modeling analysis of the global and microscopic distribution of immunoglobulin G, F(ab′)2, and Fab in tumors. Cancer Res 1989; 49: 5656-63.
18. Van Osdol W, Fujimori K, Weinstein JN. An analysis of monoclonal antibody distribution in microscopic tumor nodules: consequences of a "binding site barrier". Cancer Res 1991; 51: 4776-84.
19. Juweid M, Neumann R, Paik C et al. Micropharmacology of monoclonal antibodies in solid tumors: direct experimental evidence for a binding site barrier. Cancer Res 1992; 52: 5144-53.
20. Saga T, Neumann RD, Heya T, et al. Targeting cancer micrometastases with monoclonal antibodies: a binding site barrier. Proc Natl Acad Sci USA 1995; 92: 8999-9003.
21. 125I-antibody therapy efficacy in multicell spheroids. Cancer Res 1992; 52: 4728-34.
22. Yokota T, Milenic DE, Whitlow M, Schlom J. Rapid tumor penetration of a single-chain Fv and comparison with other immunoglobulin forms. Cancer Res 1992; 52: 3402-8.
23. Buist MR, Kenemons P, den Hollander W, et al. Kinetics and tissue distribution of the radiolabeled chimeric monoclonal antibody MOV18 IgG and F(ab′)2 fragments in ovarian carcinoma patients. Cancer Res 1993; 53: 5413-8.
24. Lankelma J, Dekker H, Fernandez Luque R, et al. Doxorubicin gradients in human breast cancer. Clin Cancer Res 1999; 5: 1703-7.
25. Tunggal JK, Cowan DSM, Shaikh H, Tannock IF. Penetration of anticancer drugs through solid tissue: a factor that limits the effectiveness of chemotherapy for solid tumors. Clin Cancer Res 1999; 5: 1583-6.
26. Tannock IF, Lee CM, Tunggal JK, Cowan DSM, Egorin MJ. Limited penetration of anticancer drugs through tumor tissue: a potential cause of resistance of solid tumors to chemotherapy. Clin Cancer Res 2002; 8: 878-84.
27. Österborg A, Dyer MJS, Bunjes D, et al. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. J Clin Oncol 1997; 15: 1567-74.
28. Coiffier B, Lepage E, Brière J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 2002; 346: 235-42.
29. Fields ALA, Keller AM, Schwartzenberg L, et al. Edrecolomab (17-1A antibody) in combination with 5-fluorouracil based chemotherapy in the adjuvant treatment of stage III colon cancer: results of a randomised north american phase III study. Proc Am Soc Clin Oncol 2002; 21: 128a.
30. Witzig TE, Gordon LI, Cabanillas F, et al. Randomized controlled trial of Ytrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low grade, follicular, or transformed B-cell non Hodgkin's lymphoma. J Clin Oncol 2002; 20: 2453-63.
31. Sievers EL, Larson RA, Stadtmouer EA, et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 2001; 19: 3244-54.
32. Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliver Rev 2002; 54: 531-45.
33. Ghetie MA, Bright H, Vitetta ES. Homodimers but not monomers of Rituxan (chimeric anti-CD20) induce apoptosis in human B-lymphoma cells and synergize with a chemotherapeutic agent and on immunotoxin. Blood 2001; 97: 1392-8.
34. Spiridon CI, Ghetie MA, Uhr J, et al. Targeting multiples Her-2 epitopes with monoclonal antibodies results in improved antigrowth activity of a human breast cancer cell line in vitro and in vivo. Clin Cancer Res 2002; 8: 1720-30.
35. Wolff EA, Schreiber GJ, Cosand WL, Raff HV. Monoclonal antibody homodimers: enhanced antitumor activity in nude mice. Cancer Res 1993; 53: 2560-5.
36. Jain RK. Delivery of molecular medicine to solid tumors. Science 1996; 271: 1079-80.
37. Pestalozzi BC, Brignoli S. Trastuzumab in CSF. J Clin Oncol 2000; 18: 2350-1.
38. Ghetie V, Word ES. FcRn: the MHC class I-related receptor that is more than an IgG transporter. Immunol Today 2000; 18: 592-8.
39. Israel EJ, Taylor S, Wu Z, et al. Expression of the neonatal Fc receptor, FcRn, on human intestinal cells. Immunology 1997; 92: 69-74.
40. Kobayashi N, Suzuki Y, Tsuge T, Okumura K, Ra C, Tomino Y. FcRn-mediated transcytosis of immunoglobulin G in human renal proximal tubular epithelial cells. Am J Physiol Renal Physiol 2002; 282: F358-65.
41. Brambell FWR, Hemmings WA, Morris IG. A theoretical model of γ-globulin catabolism. Nature 1964; 203: 1352-5.
42. Junghans RP, Anderson CL. The protection receptor for IgG catabolism is the β2-microglobulin-containing neonatal intestinal transport receptor. Proc Natl Acad Sci USA 1996; 93: 5512-6.
43. Dickinson BL, Badizadegan K, Wu Z, et al. Bidirectional FcRn-dependent IgG transport in a polarized human intestinal epithelial cell line. J Clin Invest 1999; 104: 903-11.
44. McKeage K, Perry CM. Trastuzumab. Drugs 2002; 62: 209-43.
45. Kavanaugh A, StClair EW, McCune WJ, Braakman T, Lipsky P. Chimeric anti-tumor necrosis factor-α monoclonal antibody treatment of patients with rheumatoid arthritis receiving methotrexate therapy. J Rheumatol 2000; 27: 841-50.
46. Kleiman NS, Raizner AE, Jordan R, et al. Differential inhibition of platelet aggregation induced by adenosine diphosphate or a thrombin receptor-activating peptide in patients treated with bolus chimeric 7E3 Fab: implications for inhibition of the internal pool of GPIIb/IIIa receptors. J Am Coll Cardiol 1995; 26: 1665-71.
47. Abernethy DR, Pezzullo J, Mascelli MA, Frederick B, Kleiman NS, Freedman J. Pharmacodynamics of abciximab during angioplasty: comparison to healthy subjects. Clin Pharmacol Ther 2002; 71: 186-95.
48. Saez-Llorens X, Castano E, Null D, et al. Safety and pharmacokinetics of a intramuscular humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. Pediatr Infect Dis J 1998; 17: 787-91.
49. Vincenti F, Lantz M, Birnbaum J, et al. A phase I trial of humanized anti-interleukin 2 receptor antibody in renal transplantation. Transplantation 1997; 63: 33-8.
50. Vincenti F, Kirkman R, Light S, et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998; 338: 161-5.
51. Koch M, Niemeyer G, Patel I, Light S, Nashan B. Pharmacokinetics, pharmacodynamics and immunodynamics of daclizumab in a two-dose regimen in liver transplantation. Transplantation 2002; 73: 1640-6.
52. Haba T, Uchida K, Katayama A, et al. Pharmacokinetics and pharmacodynamics of a chimeric interleukin-2 receptor monoclonal antibody, basiliximab, in renal transplantation: a comparison between japanese and non-japanese patients. Transplant Proc 2001; 33: 3174-5.
53. Kovarik J, Wolf P, Cisterne JM, et al. Disposition of basiliximab, an interleukin-2 receptor monoclonal antibody, in recipients of mismatched cadaver renal allografts. Transplantation 1997; 64: 1701-5.
54. Kovarik JM, Kahan BD, Rajagopalan PR, et al. Population pharmacokinetics and exposure-response relationships for basiliximab in kidney transplantation. Transplantation 1999; 68: 1288-94.
55. Kovarik J, Breidenbach T, Gerbeau C, Korn A, Schmidt AG, Nashon B. Disposition and immunodynamics of basiliximab in liver allograft recipients. Clin Pharmacol Ther 1998; 64: 66-72.
56. Kovarik JM, Nashan B, Neuhaus P, Clavien PA, Gerbeau C, Hall ML, Korn A. A population pharmacokinetic screen to identify demographic-clinical covariates of basiliximab in liver transplantation. Clin Pharmacol Ther 2001; 69: 201-9.
57. Goldstein G, Norman DJ, Henell KR, Smith IL. Pharmacokinetic study of orthoclone OKT3 serum levels during treatment of acute renal allograft rejection. Transplantation 1988; 46: 587-9.
58. Baselga J, Tripathy D, Mendelsohn J, et al. Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 1996; 14: 737-44.
59. Tokuda Y, Watanabe T, Omuro Y, et al. Dose escalation and pharmacokinetic study of a humanized anti-HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. Br J Cancer 1999; 81: 1419-25.
60. Berinstein NL, Grillo-Lopez AJ, White CA, et al. Association of serum rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of reccurent low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 1998; 9: 995-1001.
61. Rebello P Cwynarski K, Varughese M, Eades A, Apperley JF, Hale G. Pharmacokinetics of Campath-1H in BMT patients. Cytotherapy 2001; 3: 261-7.
62. 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. J Clin Pharmacol 2001; 41: 1206-14.
63. St. Clair EW, Wagner CL, Fasanmade AA, et al. The relation of serum infliximab concentrations to clinical improvement in rheumatoid arthritis. Arthritis Rheum 2002; 46: 1451-9.
64. Igarashi T, Kobayashi Y, Oguro M, et al. Factors affecting toxicity, response and progression-free survival in relapsed patients with indolent B-cell lymphoma and mantle cell lymphoma treated with rituximab: a japanese phase II study. Ann Oncol 2002; 13: 928-43.
65. Meijer RT, Koopmans RP, Ten Berge UM, Schellekens PTA. Pharmacokinetics of murine anti-human CD3 antibodies in man are determined by the disappearance of target antigen. J Pharmacol Exp Ther 2002; 300: 346-53.
66. Schroeder TJ, Michael AT, First MR, et al. Variations in serum OKT3 concentration based upon age, sex, transplanted organ, treatment regimen, and antiOKT3 antibody status. Ther Drug Monit 1994; 16: 361-7.
67. Baker RJ, Kozoll D, Meyer KA. The use of surface area as a basis for establishing normal blood volume. Surg Gyn Obst 1957; 104: 183-9.
68. Davies 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. J Clin Oncol 1999; 17: 1851-7.
69. Harris KA, Washington CB, Lieberman G, Lu JF, Mass R, Bruno G. A population pharmacokinetic model for trastuzumab (Herceptin) and implications for clinical dosing. Proc Am Soc Clin Oncol 2002; 21: 123a.