Population pharmacokinetics-pharmacodynamics of alemtuzumab (Campath®) in patients with chronic lymphocytic leukaemia and its link to treatment response

British Journal of Clinical Pharmacology

Volumn 64, Issue 3, 2007, Pages 278-291

  Mould, D R ^a   Baumann, A ^c   Kuhlmann, J ^c   Keating, M J ^d   Weitman, S ^b   Hillmen, P ^e   Brettman, L R ^f   Reif, S ^c   Bonate, P L ^a,b  

^a Projections Research   (United States)

^b GENZYME CORPORATION   (United States)

^c BAYER PHARMA AG   (Germany)

^d UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^e UNIVERSITY OF LEEDS   (United Kingdom)

^f Dynogen Pharmaceuticals   (United States)

Author keywords

Exposure response; Indirect response model; Logistic regression; Model validation; Nonlinear pharmacokinetics; NONMEM

Indexed keywords

ALEMTUZUMAB;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; CONCENTRATION (PARAMETERS); DRUG ELIMINATION; DRUG EXPOSURE; FEMALE; HUMAN; LEUKOCYTE COUNT; LOGISTIC REGRESSION ANALYSIS; MALE; MULTICENTER STUDY; PHARMACOLOGICAL PARAMETERS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT RESPONSE;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, NEOPLASM; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; IMMUNOGLOBULIN G; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; LEUKOCYTE COUNT; LOGISTIC MODELS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS;

EID: 34548028700     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2007.02914.x     Document Type: Article

References (32)

1. Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, Albitar M, Brettman L, Santabarbara P, Wacker B, Rai KR. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood 2002 99 : 3554 61.
2. Moreau T, Coles A, Wing M, Thorpe J, Miller D, Moseley I, Issacs J, Hale G, Clayton D, Scolding N, Waldmann H, Compston A. CAMPATH-IH in multiple sclerosis. Mult Sclerosis 1996 1 : 357 65.
3. Knechtle SJ. Present experience with Campath-1H in organ transplantation and its potential use in pediatric recipients. Pediatr Tranplant 2004 8 : 106 12.
4. Isaacs JD, Manna VK, Rapson N, Bulpitt KJ, Hazleman BL, Matteson EL, St Clair EW, Schnitzer TJ, Johnston JM. CAMPATH-1H in rheumatoid arthritis - an intravenous dose-ranging study. Br J Rheumatol 1996 35 : 231 40.
5. Hale G, Rebello P, Brettman LR, Fegan C, Kennedy B, Kimby Leach M, Lundin J, Mellstedt H, Moreton P, Rawstron AC, Waldmann H, Osterberg A, Hillmen P. Blood concentrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or subcutaneous routes of administration. Blood 2004 104 : 948 55.
6. Morris EC, Rebello P, Thomson KJ, Peggs KS, Kyriakou C, Goldstone AH, Mackinnon S, Hale G. Pharmacokinetics of alemtuzumab used for in vivo and in vitro T-cell depletion in allogeneic transplantations: relevance for early adoptive immunotherapy and infectious complications. Blood 2003 102 : 404 6.
7. Rebello P, Cwynarski K, Varughese M, Eades A, Apperley JF, Hale G. Pharmacokinetics of CAMPATH-1H in BMT patients. Cytotherapy 2001 3 : 261 7.
8. 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.
9. Joshi A. Antibody Pharmacokinetics. Presented at the Annual Meeting of the American Assocation of Pharmaceutical Scientists, Salt Lake City UT, 27 October 2003.
10. Rebello P, Hale G. Pharmacokinetics of CAMPATH-1H: assay development and validation. J Immunol Meth 2002 1 : 285 302.
11. Wahlby U, Jonsson EN, Karlsson MO. Assessment of actual significance levels for covariate effects in NONMEM. J Pharmcokin Pharmacodyn 2001 28 : 231 52.
12. Dayneka NL, Garg V, Jusko WJ. Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokin Biopharm 1993 21 : 457 78.
13. Sharma A, Ebling WF, Jusko WJ. Precursor-dependent indirect pharmacodynamic response model for tolerance and rebound phenomena. J Pharm Sci 1998 87 : 1577 84.
14. Yano Y, Beal SL, Sheiner LB. Evaluating pharmacokinetic/pharmacodynamic models using the predictive check. J Pharmacokinet Pharmacodyn 2001 28 : 171 92.
15. Cheson BD, Bennett JM, Grever M, Kay N, Keating MJ, O'Brien S, Rai KR. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996 87 : 4990 7.
16. Stokes M, Davis CS, Koch GG. Categorical Data Analysis Using the SAS System. Cary, NC : SAS Institute 2000.
17. Hooker A, Staatz CE, Karlsson MO. Conditional weighted residuals, an improved diagnostic for the FO/FOCE methods. 2006 Abstr. 1001 : 15.
18. Jusko WJ, Ko HC. Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther 1994 56 : 406 19.
19. 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.
20. Peters RH. The Ecological Implications of Body Size. Cambridge : Cambridge University Press 1983.
21. Perotti B, Doshi S, Chen D, Gayko U, Leonard JP, Wegener WA, Goldenberg DM, Cesano A. Pharmacokinetics of epratuzumab administered as a single agent or in combination with rituximab in patients with B-cell NHL. Proc Am Soc Clin Oncol 2003 22 (Abstr. 2311) : 575.
22. Maloney DG, Grillo-Lopez AJ, Bodkin DJ, White CA, Liles T-M, Royston I, Varns C, Rosenberg J, Levy R. IDEC-C2B8: Results of a Phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J Clin Oncol 1997 15 : 3266 74.
23. Carpenter PA, Appelbaum FR, Corey L, Deeg HJ, Doney K, Gooley T, Krueger J, Martin P, Pavlovic S, Sanders J, Slattery J, Levitt D, Storb R, Woolfrey A, Anasetti C. A humanized non-FcR-binding anti-CD3 antibody, visilizumab, for treatment of steroid-refractory acute graft-versus-host disease. Blood 2002 99 : 2712 9.
24. Dowell JA, Korth-Bradley J, Liu HL, 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 : 1206 14.
25. Mould DR, Davis CB, Minthorn EA, Kwow KC, Elliot MJ, Luggen ME, Totoritis MC. A population pharmacokinetic-pharmacodynamic analysis of single doses of clenoliximab in patients with rheumatoid arthritis. Clin Pharmacol Ther 1999 66 : 246 57.
26. ® (trastuzumab). Product label. South San Francisco : Genentech 2001.
27. ® (rituximab). Product label. South San Francisco : Genentech 2002.
28. Graff J, Klinkhardt U, Westrup D, Kirchmaier CM, Breddin HK, Harder S. Pharmacodynamic characterization of the interaction between the glycoprotein IIb/IIIa inhibitor YM337 and unfractionated heparin and aspirin in humans. Br J Clin Pharmacol 2003 56 : 321 6.
29. Lee H, Kimko HC, Rogge M, Wang D, Nestorov I, Peck CC. Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis. Clin Pharmacol Ther 2003 73 : 348 65.
30. Mould DR, Nieforth KA, Patel IH. The Population Pharmacokinetics and Pharmacodynamics of Humanized Anti-TAC. King of Prussia, PA : East Coast Nonmen User's Group 1995.
31. Chow FS, Benincosa LJ, Sheth SB, Wilson D, Davis CB, Minthorn EA, Jusko WJ. Pharmacokinetic and pharmacodynamic modeling of humanized anti-factor IX antibody (SB 249417) in humans. Clin Pharmacol Ther 2002 71 : 235 45.
32. Montillo M, Tedeschi A, Miqueleiz S, Veronese S, Cairoli R, Intropido L, Ricci F, Colosimo A, Scarpati B, Montagna M, Nichelatti M, Regazzi M, Morra E. Alemtuzumab as consolidation after a response to fludarabine is effective in purging residual disease in patients with chronic lymphocytic leukemia. J Clin Oncol 2006 24 : 2337 42.