Research progress of the clinical pharmacokinetics of etanercept and its biosimilars

Chinese Journal of New Drugs

Volumn 22, Issue 24, 2013, Pages 2896-2902

  Ma, Ying ^a   Wang, Ting ^b   Ma, Yi Ming ^b   Lin, Bi Rong ^a  

^a Shanghai Allist Pharmaceut Co Inc   (China)

^b National Engineering Research Center of Antibody Medicine   (China)

Author keywords

Biosimilar; Etanercept; Pharmacokinetics; Research progress

Indexed keywords

BIOSIMILAR AGENT; ETANERCEPT; METHOTREXATE;

AGE; BODY SURFACE; BODY WEIGHT; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG INDICATION; HEART FAILURE; HUMAN; KIDNEY DISEASE; PHARMACOKINETICS; REVIEW;

EID: 84892523977     PISSN: 10033734     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (40)

1. WEINBLATT M E, KREMER J M, BANKHURST A D, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate[J]. N Engl J Med, 1999, 340(4): 253-259.
2. MORELAND L W, SCHIFF M H, BAUMGARTNER S W, et al. Etanercept therapy in rheumatoid arthritis. a randomized, controlled trial[J]. Ann Intern Med, 1999, 130(6): 478-486.
3. CALIN A, DIJKMANS B A, EMERY P, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis[J]. Ann Rheum Dis, 2004, 63(12): 1594-1600.
4. DAVIS J C J, Van Der Heijde D, BRAUN J, et al. Recombinant human tumor necrosis factor (etanercept) for treating ankylosing spondylitis: a randomized controlled trial[J]. Arthritis Rheum, 2003, 48(11): 3230-3236.
5. 2009, 18(19): 1846-1850.
6. PAPP K A, TYRING S, LAHFA M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction[J]. Br J Dermatol, 2005, 152(6): 1304-1312.
7. VENDER R, LYNDE C, GILBERT M. Etanercept improves quality of life outcomes and treatment satisfaction in patients with moderate to severe plaque psoriasis in clinical practice[J]. J Cutan Med Surg, 2012, 16(6): 407-416.
8. STRAND V, SHARP V, KOENIG A S. Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment[J]. Ann Rheum Dis, 2012, 71(7): 1143-1150.
9. MORI M, TAKEI S, IMAGAWA T, et al. Etanercept in the treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory polyarticular course juvenile idiopathic arthritis: experience from Japanese clinical trials[J]. Mod Rheumatol, 2011, 21(6): 572-578.
10. PRINCE F H, TWILT M, JANSEN-WIJNGAARDEN N C, et al. Effectiveness of a once weekly double dose of etanercept in patients with juvenile idiopathic arthritis: a clinical study[J]. Ann Rheum Dis, 2007, 66(5): 704-705.
11. FDA. Guidance for Industry Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product[EB/OL]. (2012-02-09). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation /Guidances/ucm290967.htm.
12. KORTH-BRADLEY J M, RUBIN A S, HANNA R K, et al. The pharmacokinetics of etanercept in healthy volunteers[J]. Ann Pharmacother, 2000, 34(2): 161-164.
13. YI S, KIM S E, PARK M K, et al. Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed Etanercept (Enbrel) a double-blind, single-dose, crossover study in healthy volunteers[J]. Biodrugs, 2012, 26(3): 177-184.
14. GU N, YI S, KIM T E, et al. Comparative pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg): a randomized, open-label, single-dose, two-Sequence, crossover study in healthy Korean male volunteers[J]. Clin Ther, 2011, 33(12): 2029-2037.
15. SULLIVAN J T, NI L, SHEELO C, et al. Bioequivalence of liquid and reconstituted lyophilized etanercept subcutaneous injections[J]. J Clin Pharmacol, 2006, 46(6): 654-661.
16. GRANSTEIN R D. New treatments for psoriasis[J]. N Engl J Med, 2001, 345(4): 284-287.
17. WOOLEY P H, DUTCHER J, WIDMER M B, et al. Influence of a recombinant human soluble tumor necrosis factor receptor FC fusion protein on type II collagen-induced arthritis in mice[J]. J Immunol, 1993, 151(11): 6602-6607.
18. reg; (etanrecept) pharmacokinetics in patients with rheumatoid arthritis[J]. Arthritis Rheum, 2000, 43(Suppl): S229.
19. KEYSTONE E C, SCHIFF M H, KREMER J M, et al. Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis results of a multicenter, randomized, double-blind, placebo-controlled Trial[J]. Arthritis Rheum, 2004, 50(2): 353-363.
20. Van Der Heijde D, Da Silva J C, DOUGADOS M, et al. Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis[J]. Ann Rheum Dis, 2006, 65(12): 1572-1577.
21. NESTOROV I, ZITNIK R, DEVRIES T, et al. Pharmacokinetics of subcutaneously administered etanercept in subjects with psoriasis[J]. Br J Clin Pharmacol, 2006, 62(4): 435-445.
22. ELEWSKI B, LEONARDI C, GOTTLIEB A B, et al. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis[J]. Br J Dermatol, 2007, 156(1): 138-142.
23. reg (etanercept)[EB/OL]. (2012-12-10). http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
24. 2005.
25. 2010: 53-55.
26. DON B R, SPIN G, NESTOROV I, et al. The pharmacokinetics of etanercept in patients with end-stage renal disease on haemodialysis[J]. J Pharm Pharmacol, 2005, 57(11): 1407-1413.
27. SORAN O, FELDMAN A M, SCHNEIDER V M, et al. The pharmacokinetics of etanercept in patients with heart failure[J]. Br J Clin Pharmacol, 2001, 51(2): 191-192.
28. ZHOU H, BUCKWALTER M, BONI J, et al. Population-based pharmacokinetics of the soluble TNFr etanercept: a clinical study in 43 patients with ankylosing spondylitis compared with post hoc data from patients with rheumatoid arthritis[J]. Int J Clin Pharmacol Ther, 2004, 42(5): 267-276.
29. OSTENSEN M, EIGENMANN G O. Etanercept in breast milk[J]. J Rheumatol, 2004, 31(5): 1017-1018.
30. ROMÃO VC, CANHÃO H, FONSECA J E. Old drugs, old problems: where do we stand in prediction of rheumatoid arthritis responsiveness to methotrexate and other synthetic DMARDs?[J]. BMC Medicine, 2013, 11: 17.
31. JARVIS B, FAULDS D. Etanercept, a review of its use in rheumatoid arthritis[J]. Drugs, 1999, 57(6): 945-966.
32. ZHOU H, MAYER P R, WAJDULA J, et al. Unaltered etanercept pharmacokinetics with concurrent methotrexate in patients with rheumatoid arthritis[J]. J Clin Pharmacol, 2004, 44(11): 1235-1243.
33. GENOVESE M, COHEN S, MORELAND L, et al. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate[J]. Arthritis Rheum, 2004, 50(5): 1412-1419.
34. http://www.celgenpharm.com/products.asp?id=1.
35. ZHOU H, PARKSV, PATAT A, et al. Absence of a clinically relevant interaction between etanercept and digoxin[J]. J Clin Pharmacol, 2004, 44(11): 1244-1251.
36. ZHOU H, PATATA, PARKS V, et al. Absence of a pharmacokinetic interaction between etanercept and warfarin[J]. J Clin Pharmacol, 2004, 44(5): 543-550.
37. 2005: 132-133.
38. LEE H, KIMKO H, ROGGE M, et al. Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis[J]. Clin Pharmacol Ther, 2003, 73(4): 348-365.
39. YIM D S, ZHOU H, BUCKWALTER M, et al. Population pharmacokinetic analysis and simulation of the timeconcentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis[J]. J Clin Pharmacol, 2005, 45(3): 246-256.
40. FANG Y, LI L J, WANG R, et al. Population pharmacokinetics of rhTNFR-Fc in healthy Chinese volunteers and in Chinese patients with Ankylosing spondylitis[J]. Acta Pharmacol Sin, 2010, 31(11): 1500-1507.