Population pharmacokinetic-pharmacodynamic-disease progression model for effects of anakinra in Lewis rats with collagen-induced arthritis

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 38, Issue 6, 2011, Pages 769-786

  Liu, Dongyang ^a   Lon, Hoi Kei ^a   DuBois, Debra C ^a   Almon, Richard R ^a   Jusko, William J ^a  

^a UNIVERSITY AT BUFFALO   (United States)

Author keywords

Anakinra; Pharmacodynamics; Pharmacokinetics; Population model; Rheumatoid arthritis

Indexed keywords

INTERLEUKIN 1BETA; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BOOTSTRAPPING; CONTROLLED STUDY; DISEASE COURSE; DISEASE MODEL; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFECT; DRUG ELIMINATION; ENZYME LINKED IMMUNOSORBENT ASSAY; FEEDBACK SYSTEM; GROWTH RATE; LEWIS RAT; MALE; NONHUMAN; PATHOGENESIS; PAW EDEMA; PHARMACODYNAMICS; POPULATION MODEL; PRIORITY JOURNAL; PROTEIN FUNCTION; RAT; RHEUMATOID ARTHRITIS;

ANIMALS; ANTIRHEUMATIC AGENTS; ARTHRITIS, EXPERIMENTAL; BODY WEIGHT; DISEASE PROGRESSION; DRUG EVALUATION, PRECLINICAL; EDEMA; HUMANS; INTERLEUKIN 1 RECEPTOR ANTAGONIST PROTEIN; MALE; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; RATS; RATS, INBRED LEW;

EID: 84855710205     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-011-9219-z     Document Type: Article

References (51)

1. Scott DL, Wolfe F, Huizinga TW (2010) Rheumatoid arthritis. Lancet 376:1094-1108
2. Klareskog L, Catrina AI, Paget S (2009) Rheumatoid arthritis. Lancet 373:659-672
3. Lipsky PE (2007) Why does rheumatoid arthritis involve the joints. N Engl J Med 356:2419-2420
4. Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP (2008) Tumor necrosis factor antagonist mechanisms of action: A comprehensive review. Pharmacol Ther 117:244-279
5. Smolen JS, Aletaha D, Koeller M, Weisman MH, Emery P (2007) New therapies for treatment of rheumatoid arthritis. Lancet 370:1861-1874 (Pubitemid 350180008)
6. Choy EH, Panayi GS (2001) Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med 344:907-916 (Pubitemid 32224400)
7. Dinarello CA (2011) Interleukin-1 in the pathogenesis and treatment of inflammatory diseases. Blood 117:3720-3732
8. Jacques C, Gosset M, Berenbaum F, Gabay C (2006) The role of IL-1 and IL-1Ra in joint inflammation and cartilage degradation. Vitam Horm 74:371-403
9. Dinarello CA (2011) A clinical perspective of IL-1beta as the gatekeeper of inflammation. Eur J Immunol 41:1203-1217
10. Molto A, Olive A (2010) Anti-IL-1 molecules: New comers and new indications. Joint Bone Spine 77:102-107
11. Cohen SB, Moreland LW, Cush JJ, Greenwald MW, Block S, Shergy WJ, Hanrahan PS, Kraishi MM, Patel A, Sun G, Bear MB (2004) A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. Ann Rheum Dis 63:1062-1068 (Pubitemid 39120355)
12. Wooley PH (2004) The usefulness and the limitations of animal models in identifying targets for therapy in arthritis. Best Pract Res Clin Rheumatol 18:47-58 (Pubitemid 38324658)
13. Hegen M, Keith JC Jr, Collins M, Nickerson-Nutter CL (2008) Utility of animal models for identification of potential therapeutics for rheumatoid arthritis. Ann Rheum Dis 67:1505-1515
14. Lalonde RL, Kowalski KG, Hutmacher MM, Ewy W, Nichols DJ, Milligan PA, Corrigan BW, Lockwood PA, Marshall SA, Benincosa LJ, Tensfeldt TG, Parivar K, Amantea M, Glue P, Koide H, Miller R (2007) Model-based drug development. Clin Pharmacol Ther 82:21-32 (Pubitemid 46950619)
15. Wang Y, Bhattaram AV, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV (2008) Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006. J Clin Pharmacol 48:146-156
16. Atkinson AJ Jr, Lalonde RL (2007) Introduction of quantitative methods in pharmacology and clinical pharmacology: A historical overview. Clin Pharmacol Ther 82:3-6 (Pubitemid 46944206)
17. Earp JC, Dubois DC, Molano DS, Pyszczynski NA, Almon RR, Jusko WJ (2008) Modeling corticosteroid effects in a rat model of rheumatoid arthritis II: Mechanistic pharmacodynamic model for dexamethasone effects in Lewis rats with collagen-induced arthritis. J Pharmacol Exp Ther 326:546-554
18. Earp JC, Dubois DC, Molano DS, Pyszczynski NA, Keller CE, Almon RR, Jusko WJ (2008) Modeling corticosteroid effects in a rat model of rheumatoid arthritis I: Mechanistic disease progression model for the time course of collagen-induced arthritis in Lewis rats. J Pharmacol Exp Ther 326:532-545
19. R&D Systems, Inc. Human IL-1ra/IL-1F3 Immunoassay. www.rndsystems.com/pdf/DRA00B.pdf
20. Yang BB, Baughman S, Sullivan JT (2003) Pharmacokinetics of anakinra in subjects with different levels of renal function. Clin Pharmacol Ther 74:85-94 (Pubitemid 36776180)
21. Chang DM, Chang SY, Yeh MK, Lai JH (2004) The pharmacokinetics of interleukin-1 receptor antagonist in Chinese subjects with rheumatoid arthritis. Pharmacol Res 50:371-376
22. Center for Drug Evaluation and Research, Food and Drug Administration (2001) Pharmacology review, application number: 103950/0. http://www.accessdata. fda.gov/drugsatfda-docs/nda/2001/103950-0-Kineret-Pharmr.PDF
23. Earp JC, Dubois DC, Almon RR, Jusko WJ (2009) Quantitative dynamic models of arthritis progression in the rat. Pharm Res 26:196-203
24. Lon HK, Liu D, Zhang Q, Dubois DC, Almon RR, Jusko WJ (2011) Pharmacokinetic-pharmacodynamic disease progression model for effect of etanercept in lewis rats with collagen-induced arthritis. Pharm Res 28:1622-1630
25. Holford N (2005) The visual predictive check-superiority to standard diagnostic (Rorschach) plots. www.page-meeting.org/?abstract=738
26. Shi J, Ludden TM, Melikian AP, Gastonguay MR, Hinderling PH (2001) Population pharmacokinetics and pharmacodynamics of sotalol in pediatric patients with supraventricular or ventricular tachyarrhythmia. J Pharmacokinet Pharmacodyn 28:555-575 (Pubitemid 34289543)
27. Efron B (1979) Bootstrap methods: Another look at the jackknife. Ann Statisit 7:1-26
28. Lindbom L, Ribbing J, Jonsson EN (2004) Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed 75:85-94 (Pubitemid 38798039)
29. Jain L, Woo S, Gardner ER, Dahut WL, Kohn EC, Kummar S, Mould DR, Giaccone G, Yarchoan R, Venitz J, Figg WD (2011) Population pharmacokinetic analysis of sorafenib in patients with solid tumors. Br J Clin Pharmacol 72:294-305
30. Nam JL, Winthrop KL, Van VRF, Pavelka K, Valesini G, Hensor EM, Worthy G, Landewe R, Smolen JS, Emery P, Buch MH (2010) Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: A systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis 69:976-986
31. Mertens M, Singh JA (2009) Anakinra for rheumatoid arthritis: A systematic review. J Rheumatol 36:1118-1125
32. Gueorguieva I, Clark SR, McMahon CJ, Scarth S, Rothwell NJ, Tyrrell PJ, Hopkins S, Rowland M (2008) Pharmacokinetic modelling of interleukin-1 receptor antagonist in plasma and cerebrospinal fluid of patients following subarachnoid haemorrhage. Br J Clin Pharmacol 65:317-325 (Pubitemid 351316912)
33. Kim DC, Reitz B, Carmichael DF, Bloedow DC (1995) Kidney as a major clearance organ for recombinant human interleukin-1 receptor antagonist. J Pharm Sci 84:575-580
34. Granowitz EV, Porat R, Mier JW, Pribble JP, Stiles DM, Bloedow DC, Catalano MA, Wolff SM, Dinarello CA (1992) Pharmacokinetics, safety and immunomodulatory effects of human recombinant interleukin-1 receptor antagonist in healthy humans. Cytokine 4:353-360
35. Zuurmond AM, Koudijs A, Van EB, Doornbos RP, Van MBC, Bastiaans JH, Penninks AH, Van BJH, Cnubben NH, Degroot J (2011) Integration of efficacy, pharmacokinetic and safety assessment of interleukin-1 receptor antagonist in a preclinical model of arthritis. Regul Toxicol Pharmacol 59:461-470
36. Wang W, Wang EQ, Balthasar JP (2008) Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 84:548-558
37. Lin JH (2009) Pharmacokinetics of biotech drugs: Peptides, proteins and monoclonal antibodies. Curr Drug Metab 10:661-691
38. Dirks NL, Meibohm B (2010) Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 49:633-659
39. Davies B, Morris T (1993) Physiological parameters in laboratory animals and humans. Pharm Res 10:1093-1095 (Pubitemid 23211439)
40. Giraudel JM, Diquelou A, Laroute V, Lees P, Toutain PL (2005) Pharmacokinetic/pharmacodynamic modelling of NSAIDs in a model of reversible inflammation in the cat. Br J Pharmacol 146:642-653 (Pubitemid 41573615)
41. Jeunesse EC, Bargues IA, Toutain CE, Lacroix MZ, Letellier IM, Giraudel JM, Toutain PL (2011) Paw inflammation model in dogs for preclinical PK/PD investigations of non steroidal anti-inflammatory drugs. J Pharmacol Exp Ther 338:548-558
42. Sun YN, Jusko WJ (1998) Transit compartments versus gamma distribution function to model signal transduction processes in pharmacodynamics. J Pharm Sci 87:732-737 (Pubitemid 28268573)
43. Mager DE, Jusko WJ (2001) Pharmacodynamic modeling of time-dependent transduction systems. Clin Pharmacol Ther 70:210-216 (Pubitemid 32868484)
44. Liu L, Paolo JD, Barbosa J, Rong H, Reif K, Wong H (2011) Anti-arthritis effect of a novel bruton's tyrosine kinase (BTK) inhibitor in rat collagen-induced arthritis and mechanism-based pharmacokinetic/ pharmacodynamic modeling: Relationships between inhibition of BTK phosphorylation and efficacy. J Pharmacol Exp Ther 338:154-163
45. Jusko WJ, Ko HC (1994) Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther 56:406-419 (Pubitemid 24339087)
46. Dayneka NL, Garg V, Jusko WJ (1993) Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokinet Biopharm 21:457-478 (Pubitemid 24025269)
47. Bendele A, McAbee T, Sennello G, Frazier J, Chlipala E, McCabe D (1999) Efficacy of sustained blood levels of interleukin-1 receptor antagonist in animal models of arthritis: Comparison of efficacy in animal models with human clinical data. Arthritis Rheum 42:498-506 (Pubitemid 29136098)
48. Schett G, Middleton S, Bolon B, Stolina M, Brown H, Zhu L, Pretorius J, Zack DJ, Kostenuik P, Feige U (2005) Additive bone-protective effects of anabolic treatment when used in conjunction with RANKL and tumor necrosis factor inhibition in two rat arthritis models. Arthritis Rheum 52:1604-1611 (Pubitemid 40663953)
49. D'Argenio DZ, Schumitzky A (1979) A program package for simulation and parameter estimation in pharmacokinetic systems. Comput Programs Biomed 9:115-134 (Pubitemid 9104986)
50. Zhang L, Beal SL, Sheiner LB (2003) Simultaneous vs. sequential analysis for population PK/PD data I: Best-case performance. J Pharmacokinet Pharmacodyn 30:387-404 (Pubitemid 38221931)
51. Zhang L, Beal SL, Sheiner LB (2003) Simultaneous vs. sequential analysis for population PK/PD data II: Robustness of methods. J Pharmacokinet Pharmacodyn 30:405-416 (Pubitemid 38221932)