Exposure-effect population model of inolimomab, a monoclonal antibody administered in first-line treatment for acute graft-versus-host disease

Clinical Pharmacokinetics

Volumn 46, Issue 5, 2007, Pages 417-432

  Dartois, Céline ^a,b   Freyer, Gilles ^a,b,c   Michallet, Mauricette ^d   Hénin, Emilie ^a,b   You, Benoît ^a,b,c   Darlavoix, Isabelle ^e   Vermot Desroches, Claudine ^e   Tranchand, Brigitte ^a,b,f   Girard, Pascal ^a,b  

^a UNIVERSITÉ CLAUDE BERNARD LYON 1   (France)

^b UNIVERSITÉ DE LYON   (France)

^c CENTRE HOSPITALIER LYON SUD   (France)

^d EDOUARD HERRIOT HOSPITAL   (France)

^e OPi SA   (France)

^f CENTRE LÉON BÉRARD   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; CYCLOSPORIN; INOLIMOMAB; METHOTREXATE; METHYLPREDNISOLONE;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG ELIMINATION; DRUG EXPOSURE; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; GRAFT VERSUS HOST REACTION; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROPHYLAXIS; REPEATED DRUG DOSE; SCORING SYSTEM;

EID: 34247552314     PISSN: 03125963     EISSN: 03125963     Source Type: Journal    
DOI: 10.2165/00003088-200746050-00004     Document Type: Article

References (39)

1. Storb R. Allogeneic hematopoietic stem cell transplantation - yesterday, today, and tomorrow. Exp Hematol 2003 Jan; 31 (1): 1-10
2. Ferrara JL, Deeg HJ. Graft-versus-host disease. N Engl J Med 1991 Mar 7; 324 (10): 667-74
3. Storb R, Pepe M, Deeg HJ, et al. Long-term follow-up of a controlled trial comparing a combination of methotrexate plus cyclosporine with cyclosporine alone for prophylaxis of graft-versus-host disease in patients administered HLA-identical marrow grafts for leukemia. Blood 1992 Jul 15; 80 (2): 560-1
4. Keever CA, Small TN, Flomenberg N, et al. Immune reconstitution following bone marrow transplantation: comparison of recipients of T-cell depleted marrow with recipients of conventional marrow grafts. Blood 1989 Apr; 73 (5): 1340-50
5. Ruutu T, Niederwieser D, Gratwohl A, et al. A survey of the prophylaxis and treatment of acute GVHD in Europe: a report of the European Group for Blood and Marrow, Transplantation (EBMT). Chronic Leukaemia Working Party of the EBMT. Bone Marrow Transplant 1997 Apr; 19 (8): 759-64
6. Martin PJ, Schoch G, Fisher L, et al. A retrospective analysis of therapy for acute graft-versus-host disease: secondary treatment. Blood 1991 Apr 15; 77 (8): 1821-8
7. Weisdorf D, Haake R, Blazar B, et al. Treatment of moderate/severe acute graft-versus-host disease after allogeneic bone marrow transplantation: an analysis of clinical risk features and outcome. Blood 1990 Feb 15; 75 (4): 1024-30
8. Ross WA. Treatment of gastrointestinal acute graft-versus-host disease. Curr Treat Options Gastroenterol 2005 Jun; 8 (3): 249-58
9. Akpek G, Lee SM, Anders V, et al. A high-dose pulse steroid regimen for controlling active chronic graft-versus-host disease. Biol Blood Marrow Transplant 2001; 7 (9): 495-502
10. Mollee P, Morton AJ, Irving I, et al. Combination therapy with tacrolimus and anti-thymocyte globulin for the treatment of steroid-resistant acute graft-versus-host disease developing during cyclosporine prophylaxis. Br J Haematol 2001 Apr; 113 (1): 217-23
11. Curtis RE, Travis LB, Rowlings PA, et al. Risk of lymphoproliferative disorders after bone marrow transplantation: a multi-institutional study. Blood 1999 Oct 1; 94 (7): 2208-16
12. Micallef IN, Chhanabhai M, Gascoyne RD, et al. Lymphoproliferative disorders following allogeneic bone marrow transplantation: the Vancouver experience. Bone Marrow Transplant 1998 Nov; 22 (10): 981-7
13. Hertenstein B, Stefanic M, Sandherr M, et al. Treatment of steroid-resistant acute graft-vs-host disease after allogeneic marrow transplantation with anti-interleukin-2 receptor antibody (BT563). Transplant Proc 1994 Dec; 26 (6): 3114-6
14. Herbelin C, Stephan JL, Donadieu J, et al. Treatment of steroid-resistant acute graft-versus-host disease with an anti-IL-2-receptor monoclonal antibody (BT 563) in children who received T cell-depleted, partially matched, related bone marrow transplants. Bone Marrow Transplant 1994 May; 13 (5): 563-9
15. Cuthbert RJ, Phillips GL, Barnett MJ, et al. Anti-interleukin-2 receptor monoclonal antibody (BT 563) in the treatment of severe acute GVHD refractory to systemic corticosteroid therapy. Bone Marrow Transplant 1992 Nov; 10 (5): 451-5
16. Herve P, Bordigoni P, Cahn JY, et al. Use of monoclonal antibodies in vivo as a therapeutic strategy for acute GvHD in matched and mismatched bone marrow transplantation. Transplant Proc 1991 Feb; 23 (1 Pt 2): 1692-4
17. Herve P, Wijdenes J, Bergerat JP, et al. Treatment of corticosteroid resistant acute graft-versus-host disease by in vivo administration of anti-interleukin-2 receptor monoclonal antibody (B-B10). Blood 1990 Feb 15; 75 (4): 1017-23
18. Glucksberg H, Storb R, Fefer A, et al. Clinical manifestations of graft-versus-host disease in human recipients of marrow from HL-A-matched sibling donors. Transplantation 1974 Oct; 18 (4): 295-304
19. Thomas ED, Storb R, Clift RA, et al. Bone-marrow transplantation (second of two parts). N Engl J Med 1975 Apr 24; 292 (17): 895-902
20. Rowlings PA, Przepiorka D, Klein JP, et al. IBMTR severity index for grading acute graft-versus-host disease: retrospective comparison with Glucksberg grade. Br J Haematol 1997 Jun; 97 (4): 855-64
21. Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In: Macleod CM, editor. Evaluation of chemotherapeutic agents. New York: Columbia University Press, 1949: 199-205
22. Boeckmann AJ, Sheiner L, Beal SL. NONMEM Project Group. NONMEM user's guides. San Francisco (CA): University of California, 1998
23. Ette EI, Ludden TM. Population pharmacokinetic modeling: the importance of informative graphics. Pharm Res 1995 Dec; 12 (12): 1845-55
24. Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services. Guidance for industry: population pharmacokinetics [online]. Rockville (MD): Center for Drug Evaluation and Research, 1999. Available from URL: http://www.fda.gov/cder/guidance/1852fnl.pdf [Accessed 2007 Mar 12]
25. Wade JR, Edholm M, Salmonson T. A guide for reporting the results of population pharmacokinetic analyses: a Swedish perspective. AAPS PharmSci 2005 Oct; 7 (2): 45
26. Agresti A. Modelling ordered categorical data: recent advances and future challenges. Stat Med 1999 Sep 15; 18 (17-18): 2191-207
27. Duffull SB, Chabaud S, Nony P, et al. A pharmacokinetic simulation model for ivabradine in healthy volunteers. Eur J Pharm Sci 2000; 10 (4): 285-94
28. Yano Y, Beal SL, Sheiner LB. Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J Pharmacokinet Pharmacodyn 2001 Apr; 28 (2): 171-92
29. Rubin DB. Bayesianly justifiable and relevant frequency calculations for the applied statistician. Ann Stat 1984; 12: 1151-72
30. Shiiki T, Hashimoto Y, Inui K. Simulation for population pharmacodynamic analysis of dose-ranging trials: usefulness of the mixture model analysis for detecting nonresponders. Pharm Res 2002 Jun; 19 (6): 909-13
31. Cahn JY, Bordigoni P, Tiberghien P, et al. Treatment of acute graft-versus-host disease with methylprednisolone and cyclosporine with or without an anti-interleukin-2 receptor monoclonal antibody: a multicenter phase III study. Transplantation 1995 Nov 15; 60 (9): 939-42
32. Bay JO, Dhedin N, Goerner M, et al. Inolimomab in steroid-refractory acute graft-versus-host disease following allogeneic hematopoietic stem cell transplantation: retrospective analysis and comparison with other interleukin-2 receptor antibodies. Transplantation 2005 Sep 27; 80 (6): 782-8
33. Martin P, Bleyzac N, Souillet G, et al. Relationship between CsA trough blood concentration and severity of acute graft-versus-host disease after paediatric stem cell transplantation Pharfrom matched-sibling or unrelated donors. Bone Marrow Transplant 2003 Oct; 32 (8): 777-84
34. Andersson BS, Thall PF, Madden T, et al. Busulfan systemic exposure relative to regimen-related toxicity and acute graft-versus-host disease: defining a therapeutic window for i.v. BuCy2 in chronic myelogenous leukemia. Biol Blood Marrow Transplant 2002; 8 (9): 477-85
35. Jacobson P, Rogosheske J, Barker JN, et al. Relationship of mycophenolic acid exposure to clinical outcome after hematopoietic cell transplantation. Clin Pharmacol Ther 2005 Nov; 78 (5): 486-500
36. Beal SL, Sheiner LB, NONMEM Project Group. NONMEM user's guide: part VII. Conditional estimation methods. San Francisco (CA): University of California, 1998
37. Frey N, Laveille C, Paraire M, et al. Population PKPD modelling of the long-term hypoglycaemic effect of gliclazide given as a once-a-day modified release (MR) formulation. Br J Clin Pharmacol 2003 Feb; 55 (2): 147-57
38. Zingmark PH, Ekblom M, Odergren T, et al. Population pharmacokinetics of clomethiazole and its effect on the natural course of sedation in acute stroke patients. Br J Clin Pharmacol 2003 Aug; 56 (2): 173-83
39. Karlsson MO, Molnar V, Bergh J, et al. A general model for time-dissociated pharmacokinetic-pharmacodynamic relationship exemplified by paclitaxel myelosuppression. Clin Pharmacol Ther 1998 Jan; 63 (1): 11-25