Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis

European Journal of Clinical Pharmacology

Volumn 65, Issue 12, 2009, Pages 1211-1228

  Fasanmade, Adedigbo A ^a   Adedokun, Omoniyi J ^a   Ford, Joyce ^a   Hernandez, Danika ^a   Johanns, Jewel ^a   Hu, Chuanpu ^a   Davis, Hugh M ^a   Zhou, Honghui ^a  

^a CENTOCOR INC   (United States)

Author keywords

Immunomodulators albumin; Infliximab; Population pharmacokinetics; Ulcerative colitis

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; AZATHIOPRINE; CORTICOSTEROID DERIVATIVE; INFLIXIMAB; MERCAPTOPURINE; MESALAZINE; PLACEBO; SERUM ALBUMIN;

ADULT; AGED; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FEMALE; HUMAN; INDIVIDUALIZATION; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; POPULATION MODEL; PRIORITY JOURNAL; SEX DIFFERENCE; TREATMENT DURATION; ULCERATIVE COLITIS;

ADULT; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; BAYES THEOREM; COLITIS, ULCERATIVE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MODELS, BIOLOGICAL; PLACEBOS; SERUM ALBUMIN; SEVERITY OF ILLNESS INDEX; SEX FACTORS;

EID: 71249099165     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-009-0718-4     Document Type: Article

References (30)

1. Remicade (infliximab) for IV injection. Malvern, Pa: Centocor Ortho Biotech, Inc., April 2009 (package insert)
2. R Maini EW St Clair F Breedveld D Furst J Kalden M Weisman J Smolen P Emery G Harriman M Feldmann P Lipsky 1999 Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial Lancet 354 1932 1939 10.1016/S0140-6736(99)05246-0 1:CAS:528: DC%2BD3cXit1Oquw%3D%3D 10622295
3. AB Gottlieb S Masud R Ramamurthi A Abdulghani P Romano U Chaudhari LT Dooley A Fasanmade CL Wagner 2003 Pharmacodynamic and pharmacokinetic response to anti-tumor necrosis factor-α monoclonal antibody (infliximab) treatment of moderate to severe psoriasis vulgaris J Am Acad Dermatol 48 68 75 10.1067/mjd.2003.10 12522373 (Pubitemid 36091536)
4. D Ternant A Aubourg C Magdelaine-Beuzelin D Degenne H Watier L Picon G Paintaud 2008 Infliximab pharmacokinetics in inflammatory bowel disease patients Ther Drug Monit 30 523 529 1:CAS:528:DC%2BD1cXpsVCiu7c%3D 18641542
5. U Klotz A Teml M Schwab 2007 Clinical pharmacokinetics and use of infliximab Clin Pharmacokinet 46 645 660 10.2165/00003088-200746080-00002 1:CAS:528:DC%2BD2sXhtVKgs7%2FI 17655372 (Pubitemid 47204851)
6. A Fasanmade A Olson W Bao C Pendley H Davis L Mayer 2002 Relationship between infliximab pharmacokinetics and improvement in Crohn's disease Gastroenterology 122 4 Suppl 1 A617 A618
7. AA Fasanmade P Marsters E Munsanje MA Graham HM Davis S Van Deventer 2003 Infliximab pharmacokinetics and improvement in fistulizing Crohn's disease Gastroenterology 124 4 Suppl 1 A61 10.1016/S0016-5085(03)80303-7
8. St EW Clair CL Wagner AA Fasanmade B Wang T Schaible A Kavanaugh EC Keystone 2002 The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis Arthritis Rheum 46 1451 1459 10.1002/art.10302 (Pubitemid 34620190)
9. Z Xu K Seitz A Fasanmade J Ford P Williamson W Xu HM Davis H Zhou 2008 Population pharmacokinetics of infliximab in patients with ankylosing spondylitis J Clin Pharmacol 48 681 695 10.1177/0091270008316886 1:CAS:528:DC%2BD1cXns1Kitrk%3D 18401017 (Pubitemid 351713154)
10. Enbrel®-[etanercept] package insert; Thousand Oaks, Calif: Immunex Corporation; October 2005
11. WJ Sandborn SB Hanauer S Katz, et al. 2001 Etanercept for active Crohn's disease: A randomized, double-blind, placebo-controlled trial Gastroenterology 121 1088 1094 10.1053/gast.2001.28674 1:CAS:528:DC%2BD3MXpt1SrsLk%3D 11677200
12. D Tracey L Klareskog EH Sasso JG Salfeld PP Tak 2008 Tumor necrosis factor antagonist mechanisms of action: A comprehensive review Pharmacol Ther 117 244 279 10.1016/j.pharmthera.2007.10.001 1:CAS:528:DC%2BD1cXhtV2it74%3D 18155297
13. P Rutgeerts WJ Sandborn BG Feagan W Reinisch A Olson J Johanns S Travers D Rachmilewitz SB Hanauer GR Lichtenstein WJ de Villiers D Present BE Sands JF Colombel 2005 Infliximab for induction and maintenance therapy for ulcerative colitis N Engl J Med 353 2462 2476 10.1056/NEJMoa050516 1:CAS:528: DC%2BD2MXhtlShurjE 16339095 (Pubitemid 41770166)
14. KW Schroeder WJ Tremaine DM Ilstrup 1987 Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis: a randomized study N Engl J Med. 317 1625 1629 1:STN:280:DyaL1c%2FmsFOkuw%3D%3D 3317057
15. SB Hanauer CL Wagner M Bala L Mayer S Travers RH Diamond W Bao P Rutgeerts 2004 Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease Clin Gastroenterol Hepatol 2 542 553 10.1016/S1542-3565(04)00238-1 1:CAS:528:DC%2BD2cXmtl2gsb0%3D 15224278 (Pubitemid 38834038)
16. DW Cockroft MH Gault 1976 Prediction of creatinine clearance from serum creatinine Nephron 16 31 41 10.1159/000180580
17. Holford NH (2007) Wings for NONMEM, http://wfn.sourceforge.net
18. EN Jonsson MO Karlsson 1999 Xpose - an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM Comput Methods Programs Biomed 58 51 64 10.1016/S0169-2607(98)00067-4 1:STN:280: DyaK1M3htVShsw%3D%3D 10195646 (Pubitemid 29049052)
19. MO Karlsson RM Savic 2007 Diagnosing model diagnostics Clin Pharmacol Ther 82 17 20 10.1038/sj.clpt.6100241 1:STN:280:DC%2BD2szlvVakug%3D%3D 17571070 (Pubitemid 46944205)
20. EI Ette 1997 Stability and performance of a population pharmacokinetic model J Clin Pharmacol 37 486 495 1:CAS:528:DyaK2sXktlWisbk%3D 9208355
21. K Brendel E Comets C Laffont C Laveille F Mentre 2006 Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide Pharm Res 23 2036 2049 10.1007/s11095-006-9067-5 1:CAS:528:DC%2BD28XptVaitL4%3D 16906454
22. LK Roskos CG Davis GM Schwab 2004 The clinical pharmacology of therapeutic monoclonal antibodies Drug Dev Res 61 108 120 10.1002/ddr.10346 1:CAS:528:DC%2BD2cXms1Gmtr8%3D (Pubitemid 39043717)
23. Kuester K, Kloft C (2007) Pharmacokinetics and monoclonal antibodies. In: Meibohm B (ed) Pharmacokinetics and pharmacodynamics of biotech drugs: principles and case studies in drug development. Wiley-VCH, Weinheim, pp 45-92
24. MA Siddiqui JL Scott 2006 Infliximab: A review of its use in Crohn's disease and rheumatoid arthritis Drug 66 2179 2208
25. M Schwab U Klotz 2001 Pharmacokinetic Considerations in the Treatment of Inflammatory Bowel Disease Clin Pharmacokinet 40 723 751 10.2165/00003088- 200140100-00003 1:CAS:528:DC%2BD3MXosF2ktb8%3D 11707060
26. Cimzia (certolizumab) [prescribing information], UCB, Inc., Smyrna, GA, April 2008
27. Humira (adalimumab) [prescribing information], Abbott Laboratories, Abbott Park, IL, December 2008
28. CM Ng R Bruno D Combs B Davies 2005 Population pharmacokinetics of rituximab (Anti-CD20 Monoclonal Antibody) in rheumatoid arthritis patients during a phase II clinical trial J Clin Pharmacol 45 792 801 10.1177/0091270005277075 1:CAS:528:DC%2BD2MXmsFymtLY%3D 15951469 (Pubitemid 40875331)
29. I Nestorov R Zitnik T Ludden 2004 Population pharmacokinetic modeling of subcutaneously administered etanercept in patients with psoriasis J Pharmacokinet Pharmacodyn 31 463 490 10.1007/s10928-005-5912-0 1:CAS:528:DC%2BD2MXmtlWjs7g%3D 16222785 (Pubitemid 41175366)
30. J Kim WL Hayton JM Robinson CL Anderson 2007 Kinetics of FcRn-mediated recycling of IgG and albumin in human: Pathophysiology and therapeutic implications using a simplified mechanism-based model Clin Immunol 122 146 155 10.1016/j.clim.2006.09.001 1:CAS:528:DC%2BD2sXltFWgsg%3D%3D 17046328 (Pubitemid 46073892)