Therapeutic protein drug-drug interactions: Navigating the knowledge gaps-highlights from the 2012 AAPS NBC roundtable and IQ Consortium/FDA workshop

AAPS Journal

Volumn 15, Issue 4, 2013, Pages 933-940

  Kenny, Jane R ^a   Liu, Maggie M ^b   Chow, Andrew T ^c   Earp, Justin C ^d   Evers, Raymond ^e   Slatter, J Greg ^f   Wang, Diane D ^g   Zhang, Lei ^d   Zhou, Honghui ^h  

^a GENENTECH INC   (United States)

^b Pharmaceutical Practice Group   (United States)

^c AMGEN INC   (United States)

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

^f AMGEN INC   (United States)

^g PFIZER INC   (United States)

^h JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

cytochrome P450s; drug drug interactions; pro inflammatory cytokines; small molecule; therapeutic protein

Indexed keywords

C REACTIVE PROTEIN; CYCLOSPORIN; CYTOCHROME P450 3A4; GAMMA INTERFERON; INTERLEUKIN 1BETA; INTERLEUKIN 23; INTERLEUKIN 6; OKT 3; SIMVASTATIN; TOCILIZUMAB;

BILIARY EXCRETION; CONFERENCE PAPER; CYTOKINE RELEASE; DRUG CLEARANCE; DRUG EFFICACY; DRUG INTERACTION; DRUG PROTEIN INTERACTION; HUMAN; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; LIVER METABOLISM; PRACTICE GUIDELINE; PROTEIN BLOOD LEVEL; PROTEIN EXPRESSION; URINARY EXCRETION;

ANIMALS; BIOMEDICAL RESEARCH; BIOTECHNOLOGY; CALIFORNIA; DRUG INDUSTRY; DRUG INTERACTIONS; EDUCATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84882775632     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9495-1     Document Type: Conference Paper

References (44)

1. Morgan ET. Impact of infectious and inflammatory disease on cytochrome P450-mediated drug metabolism and pharmacokinetics. Clin Pharmacol Ther. 2009;85(4):434-8.
2. Schmitt C, Kuhn B, Zhang X, Kivitz AJ, Grange S. Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2011;89(5):735-40.
3. Girish S, Martin SW, Peterson MC, Zhang LK, Zhao H, Balthasar J, et al. AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development. AAPS J. 2011;13(3):405-16.
4. Huang SM, Zhao H, Lee JI, Reynolds K, Zhang L, Temple R, et al. Therapeutic protein-drug interactions and implications for drug development. Clin Pharmacol Ther. 2010;87(4):497-503.
5. Slatter JG, Wienkers LC, Dickmann LJ. Drug interactions of cytokines and anticytokine therapeutic proteins. In: Zhou H, Meibohm B, editor. Drug interactions of therapeutic proteins: Wiley; 2013. chapter 13 p. 215-238.
6. Dallas S, Sensenhauser C, Batheja A, Singer M, Markowska M, Zakszewski C, et al. De-risking bio-therapeutics for possible drug interactions using cryopreserved human hepatocytes. Curr Drug Metab. 2012;13:923-9.
7. Dickmann LJ, Patel SK, Rock DA, Wienkers LC, Slatter JG. Effects of interleukin-6 (IL-6) and an anti-IL-6 monoclonal antibody on drug-metabolizing enzymes in human hepatocyte culture. Drug Metab Dispos. 2011;39(8):1415-22.
8. Dickmann LJ, Patel SK, Wienkers LC, Slatter JG. Effects of interleukin 1beta (IL-1beta) and IL-1beta/interleukin 6 (IL-6) combinations on drug metabolizing enzymes in human hepatocyte culture. Curr Drug Metab. 2012;13(7):930-7.
9. Dallas SC, Souvik; Sensenhauser, Carlo; Batheja, Ameesha; Singer, Monica; Silva, Jose. Interleukins-12 and -23 do not alter expression or activity of multiple CYP enzymes in cryopreserved human hepatocytes. Drug Metab Dispos. 2013;41:689-93.
10. Yang KH, Lee MG. Effects of endotoxin derived from Escherichia coli lipopolysaccharide on the pharmacokinetics of drugs. Arch Pharm Res. 2008;31(9):1073-86.
11. Ashino T, Arima Y, Shioda S, Iwakura Y, Numazawa S, Yoshida T. Effect of interleukin-6 neutralization on CYP3A11 and metallothionein-1/2 expressions in arthritic mouse liver. Eur J Pharmacol. 2007;558(1-3):199-207.
12. Ling S, Jamali F. The effect of infliximab on hepatic cytochrome P450 and pharmacokinetics of verapamil in rats with pre-adjuvant arthritis: a drug-disease and drug-drug interaction. Basic Clin Pharmacol Toxicol. 2009;105(1):24-9.
13. Dickmann LJ, McBride HJ, Patel SK, Miner K, Wienkers LC, Slatter JG. Murine collagen antibody induced arthritis (CAIA) and primary mouse hepatocyte culture as models to study cytochrome P450 suppression. Biochem Pharmacol. 2012;83(12):1682-9.
14. Taub R. Liver regeneration: from myth to mechanism. Nat Rev Mol Cell Biol. 2004;5(10):836-47.
15. Rhodes B, Furnrohr BG, Vyse TJ. C-reactive protein in rheumatology: biology and genetics. Nat Rev Rheumatol. 2011;7(5):282-9.
16. Yang X, Zhang B, Molony C, Chudin E, Hao K, Zhu J, et al. Systematic genetic and genomic analysis of cytochrome P450 enzyme activities in human liver. Genome Res. 2010;20(8):1020-36.
17. Chen YL, Le Vraux V, Leneveu A, Dreyfus F, Stheneur A, Florentin I, et al. Acute-phase response, interleukin-6, and alteration of cyclosporine pharmacokinetics. Clin Pharmacol Ther. 1994;55(6):649-60.
18. Rivory LP, Slaviero KA, Clarke SJ. Hepatic cytochrome P450 3A drug metabolism is reduced in cancer patients who have an acute-phase response. Br J Cancer. 2002;87(3):277-80.
19. Frye RF, Schneider VM, Frye CS, Feldman AM. Plasma levels of TNF-alpha and IL-6 are inversely related to cytochrome P450-dependent drug metabolism in patients with congestive heart failure. J Card Fail. 2002;8(5):315-9.
20. Haas CE, Kaufman DC, Jones CE, Burstein AH, Reiss W. Cytochrome P450 3A4 activity after surgical stress. Crit Care Med. 2003;31(5):1338-46.
21. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Davis D, Macfarlane JD, 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(9):1552-63.
22. Abbott Laboratories. Humira® US Prescribing Information. 2011. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/ 125057s0276lbl.pdf. Accessed 20 May 2013.
23. Janssen Biotech Inc. Simponi® US prescribing information. 2011. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/ 125289s0064lbl.pdf. Accessed 20 May 2013.
24. UCB Inc. Cimzia® US prescribing information. 2012. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/125160s0174lbl.pdf. Accessed 20 May 2013.
25. Zhou H, Mayer PR, Wajdula J, Fatenejad S. Unaltered etanercept pharmacokinetics with concurrent methotrexate in patients with rheumatoid arthritis. J Clin Pharmacol. 2004;44(11):1235-43.
26. Vasquez EM, Pollak R. OKT3 therapy increases cyclosporine blood levels. Clin Transplant. 1997;11(1):38-41.
27. Strehlau J, Pape L, Offner G, Nashan B, Ehrich JH. Interleukin-2 receptor antibody-induced alterations of ciclosporin dose requirements in paediatric transplant recipients. Lancet. 2000;356(9238):1327-8.
28. Chatenoud L, Ferran C, Legendre C, Thouard I, Merite S, Reuter A, et al. In vivo cell activation following OKT3 administration. Systemic cytokine release and modulation by corticosteroids. Transplantation. 1990;49(4):697-702.
29. Tinel M, Robin MA, Doostzadeh J, Maratrat M, Ballet F, Fardel N, et al. The interleukin-2 receptor down-regulates the expression of cytochrome P450 in cultured rat hepatocytes. Gastroenterology. 1995;109(5):1589-99.
30. Thal C, el Kahwaji J, Loeper J, Tinel M, Doostzadeh J, Labbe G, et al. Administration of high doses of human recombinant interleukin-2 decreases the expression of several cytochromes P-450 in the rat. J Pharmacol Exp Ther. 1994;268(1):515-21.
31. Sunman JA, Hawke RL, LeCluyse EL, Kashuba AD. Kupffer cell-mediated IL-2 suppression of CYP3A activity in human hepatocytes. Drug Metab Dispos. 2004;32(3):359-63.
32. Elkahwaji J, Robin MA, Berson A, Tinel M, Letteron P, Labbe G, et al. Decrease in hepatic cytochrome P450 after interleukin-2 immunotherapy. Biochem Pharmacol. 1999;57(8):951-4.
33. Piscitelli SC, Vogel S, Figg WD, Raje S, Forrest A, Metcalf JA, et al. Alteration in indinavir clearance during interleukin-2 infusions in patients infected with the human immunodeficiency virus. Pharmacotherapy. 1998;18(6):1212-6.
34. Machavaram KK, Almond LM, Rostami-Hodjegan A, Gardner I, Jamei M, Tay S, et al. A physiologically-based pharmacokinetic modelling approach to predict disease-drug interactions: suppression of CYP3A by IL-6. Clin Pharmacol Ther. 2013. doi: 10.1038/clpt.2013.79.
35. Abuqayyas L, Balthasar JP. Pharmacokinetic mAb-mAb interaction: anti-VEGF mAb decreases the distribution of anti-CEA mAb into colorectal tumor xenografts. AAPS J. 2012;14(3):445-55.
36. Sheiner LB, Rosenberg B, Marathe VV. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm. 1977;5(5):445-79.
37. FDA. Drug interaction studies - study design, data analysis, implications for dosing, and labeling recommendations. Draft Guidance for Industry. 2012. Available from: http:// www.fda.gov/ Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/ ucm064982. htm. Accessed 20 May 2013.
38. Hu C, Zhang J, Zhou H. Confirmatory analysis for phase III population pharmacokinetics. Pharm Stat. 2011;10(1):14-26.
39. Hu C, Zhou H. An improved approach for confirmatory phase III population pharmacokinetic analysis. J Clin Pharmacol. 2008;48(7):812-22.
40. Duan JZ. Applications of population pharmacokinetics in current drug labelling. J Clin Pharm Ther. 2007;32(1):57-79.
41. Zhou H. Population-based assessments of clinical drug-drug interactions: qualitative indices or quantitative measures? J Clin Pharmacol. 2006;46(11):1268-89.
42. Grimm SW, Einolf HJ, Hall SD, He K, Lim H-K, Ling K-HJ, et al. The conduct of in vitro studies to address time-dependent inhibition of drug-metabolizing enzymes: a perspective of the Pharmaceutical Research and Manufacturers of America. Drug Metab Dispos. 2009;37:1355-70.
43. Chu V, Einolf HJ, Evers R, Kumar G, Moore D, Ripp S, et al. In vitro and in vivo induction of cytochrome P450: a survey of the current practices and recommendations: a Pharmaceutical Research and Manufacturers of America perspective. Drug Metab Dispos. 2009;37:1339-54.
44. EMA. Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins. 2007. Available from: http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500003029.pdf. Accessed 20 May 2013.