Pharmacokinetic Properties of Infliximab in Children and Adults with Crohn's Disease: A Retrospective Analysis of Data from 2 Phase III Clinical Trials

Clinical Therapeutics

Volumn 33, Issue 7, 2011, Pages 946-964

  Fasanmade, Adedigbo A ^a   Adedokun, Omoniyi J ^a   Blank, Marion ^a   Zhou, Honghui ^a   Davis, Hugh M ^a  

^a CENTOCOR INC   (United States)

Author keywords

Crohn's disease; Infliximab; Monoclonal antibody; Pediatric; Population pharmacokinetics; Tumor necrosis factor

Indexed keywords

ACETYLSALICYLIC ACID; AZATHIOPRINE; CORTICOSTEROID; INFLIXIMAB; MERCAPTOPURINE; METHOTREXATE; PLACEBO;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AGED; ARTICLE; BODY WEIGHT; CHILD; COMPARTMENT MODEL; CONTROLLED STUDY; CROHN DISEASE; DISEASE ACTIVITY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; FEMALE; HUMAN; IMMUNE RESPONSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; SCHOOL CHILD; SEX RATIO;

ADOLESCENT; ADULT; AGE FACTORS; AGED; ANTIBODIES, MONOCLONAL; CHILD; CLINICAL TRIALS, PHASE III AS TOPIC; CROHN DISEASE; GASTROINTESTINAL AGENTS; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; RETROSPECTIVE STUDIES; TISSUE DISTRIBUTION; TUMOR NECROSIS FACTOR-ALPHA; YOUNG ADULT;

EID: 79960283949     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.06.002     Document Type: Article

References (48)

1. Maini R.N., Breedveld F.C., Kalden J.R., 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, 41:1552-1563.
2. St Clair E.W., van der Heijde D.M., Smolen J.S., et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004, 50:3432-3443.
3. van der Heijde D., Dijkmans B., Geusens P., et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005, 52:582-591.
4. Antoni C., Kruefer G.G., de Vlam K., et al. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis 2005, 64:1150-1157.
5. Reich K., Nestle F.O., Papp K., et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005, 366:1367-1374.
6. Menter A., Feldman S.R., Weinstein G.D., et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007, 56:31.e1-31.e15.
7. Gottlieb A.B., Evans R., Li S., et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. Am Acad Dermatol 2004, 51:534-542.
8. Targen S.R., Hanauer S.B., van Deventer S.J.H., et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn's disease. N Engl J Med 1997, 337:1029-1035.
9. Hanauer S.B., Feagan B.G., Lichtenstein G.R., et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomized trial. Lancet 2002, 359:1541-1549.
10. Present D.H., Rutgeerts P., Targan S., et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999, 340:1398-1405.
11. Sands B.E., Anderson F.H., Bernstein C.N., et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004, 350:876-885.
12. Rutgeerts P., Sandborn W.J., Feagan B.G., et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005, 353:2462-2476.
13. Hyams J., Crandall W., Kugathasan S., et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children. Gastroenterology 2007, 132:863-873.
14. Lichtenstein G.R., Feagan B.G., Cohen R.D., et al. serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastroenterol Hepatol 2006, 4:621-630.
15. Kotlyar D.S., Osterman M.T., Diamond R.H., et al. A systematic review of factors that contribute to hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2011, 9:36-41.e1.
16. Xu Z., Seitz K., Fasanmade A., et al. Population pharmacokinetics of infliximab in patients with ankylosing spondylitis. J Clin Pharmacol 2008, 48:681-695.
17. Ternant D., Aubourg A., Magdelaine-Beuzelin C., et al. Infliximab pharmacokinetics in inflammatory bowel disease patients. Ther Drug Monit 2008, 30:523-529.
18. Fasanmade A.A., Adedokun O.J., Ford J., et al. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol 2009, 65:1211-1228.
19. Fasanmade A., Olson A., Bao W., et al. Relationship between infliximab pharmacokinetics and improvement in Crohn's disease. Gastroenterology 2002, 122(Suppl 1):A-617-A-618. Abstract.
20. Fasanmade A.A., Marsters P., Munsanje E., et al. Infliximab pharmacokinetics and improvement in fistulizing Crohn's disease. Gastroenterology 2003, 124(Suppl 1):A-61. Abstract.
21. St.Clair E.W., Wagner C.L., Fasanmade A.A., et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis. Arthritis Rheum 2002, 46:1451-1459.
22. Gottlieb A.B., Masud S., Ramamurthi R., et al. Pharmacodynamic and pharmacokinetic response to anti-tumor necrosis factor-α monoclonal antibody (infliximab) treatment of moderate to severe psoriasis vulgaris. J Am Acad Dermatol 2003, 48:68-75.
23. Fasanmade A.A., Adedokun O.J., Olson A., et al. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Therapeut 2010, 48:297-308.
24. Kearns G.L., Abdel-Rahman S.M., Alander S.W., et al. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med 2003, 349:1157-1167.
25. Mahmood I., Tammara V. A comparison of two sparse sampling population pharmacokinetic approaches for the estimation of pharmacokinetic parameters in children. Int J Clin Pharmacol Ther 2004, 42:240-245.
26. Braun J., Brandt J., Listing J., et al. Treatment of active ankylosing spondylitis with infliximab: a randomized controlled multicentre trial. Lancet 2002, 359:1187-1193.
27. Hanauer S.B., Wagner C.L., Bala M., et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol 2004, 2:542-553.
28. Holford N.H. Wings for NONMEM Accessed February 11, 2007. http://wfn.sourceforge.net.
29. Jonsson E.N., Karlsson M.O. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed 1999, 58:51-64.
30. Boeckmann A.J., Sheiner L.B., Beal S.L. NONMEM Users Guide, Part V, Introductory Guide 1994, NONMEM Project Group, UCSF.
31. Karlsson M.O., Sheiner L.B. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993, 21:735-750.
32. Jonsson N.E., Karlsson M.O., Milligan P.A. Graphical displays for modeling population data. Pharmacometrics: The Science of Quantitative Pharmacology 2007, 183-222. John Wiley & Sons, Hoboken, NJ. E.I. Ette, P.J. Williams (Eds.).
33. Cleveland W.S., Devlin S.J. Locally weighted regression: an approach to regression analysis by local fitting. J Am Stat Assoc 1988, 83:596-610.
34. Mandema J.W., Verotta D., Sheiner L.B. Building population pharmacokinetic-dynamic models. I. Models for covariate effects. J Pharmacokinet Biopharmaceut 1992, 20:511-528.
35. Ette E.I. Stability and performance of a population pharmacokinetic model. J Clin Pharmacol 1997, 37:486-495.
36. Karlsson M.O., Savic R.M. Diagnosing model diagnostics. Clin Pharmacol Ther 2007, 82:17-20.
37. Klein R.J., Proctor S.E., Boudreault M.A., et al. Healthy people 2010 criteria for data suppression Accessed November 26, 2010. http://%20www.cdc.gov/nchs/data/statnt/statnt24.pdf.
38. Montgomery D.C., Peck E.A., Vining G.G. Introduction to Linear Regression Analysis 2001, 339. John Wiley & Sons, Inc, New York, NY. 3rd ed.
39. West G.B., Brown J.H., Enquist B.J. A general model for the origin of allometric scaling laws in biology. Science 1997, 276:122-126.
40. Wade K.C., Wu D., Kaufman D.A., et al. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother 2008, 52:4043-4049.
41. de Wildt S.N., de Hoog M., Vinks A.A., et al. Population pharmacokinetics and metabolism of midazolam in pediatric intensive care patients. Crit Care Med 2003, 31:1952-1958.
42. Gregoire N., Desfrere L., Roze J.-C., et al. Population pharmacokinetic analysis of ibuprofen enantiomers in preterm newborn infants. J Clin Pharmacol 2008, 48:1460-1468.
43. Roskos L.K., Davis C.G., Schwab G.M. The clinical pharmacology of therapeutic monoclonal antibodies. Drug Dev Res 2004, 61:108-120.
44. Kuester K., Kloft C. Pharmacokinetics and monoclonal antibodies. Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug Development 2006, 45-92. Wiley-VCH, Weinheim, Germany. B. Meibohm (Ed.).
45. Siddiqui M.A., Scott J.L. Infliximab: A review of its use in Crohn's disease and rheumatoid arthritis. Drugs 2005, 65:2179-2208.
46. Kim J., Hayton W.L., Robinson J.M., Anderson C.L. Kinetics of FcRn-mediated recycling of IgG and albumin in human: pathophysiology and therapeutic implications using a simplified mechanism-based model. Clin Immunol 2007, 122:146-155.
47. Klotz U., Teml A., Schwab M. Clinical pharmacokinetics and use of infliximab. Clin Pharmacokinet 2007, 46:645-660.
48. Fasanmade A.A., Zhu Y.W., Wagner C., et al. Population pharmacokinetics of single dose infliximab in patients with Crohn's disease. J Clin Pharmacol Ther 2002, 71:P66.