Integrated population pharmacokinetics of etanercept in healthy subjects and in patients with rheumatoid arthritis and ankylosing spondylitis

Journal of Clinical Pharmacology

Volumn 51, Issue 6, 2011, Pages 864-875

  Zhou, Simon Y ^a,e   Shu, Cathye ^b   Korth Bradley, Joan ^b   Raible, Donald ^c   Palmisano, Maria ^a   Wadjula, Joseph ^a   Fatenejad, Saeed ^a   Bjornsson, Thorir ^d  

^a PFIZER INC   (United States)

^b Cephalon Inc   (United States)

^c MEDIMMUNE   (United States)

^d Saint   (United States)

^e Saint ^*  (United States)

Author keywords

biostatistics clinical trials; biotechnology; Clinical pharmacology; clinical research; clinical trials; pharmacokinectics and drug metabolism; rheumatology immunology

Indexed keywords

ETANERCEPT;

ADULT; AGE; ANKYLOSING SPONDYLITIS; ARTICLE; BIOEQUIVALENCE; BODY WEIGHT; CLINICAL ASSESSMENT; COMPUTER PROGRAM; CONTROLLED STUDY; DISEASE CLASSIFICATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG MEGADOSE; FEMALE; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MALE; NORMAL HUMAN; PSORIASIS; RHEUMATOID ARTHRITIS;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ARTHRITIS, RHEUMATOID; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; FEMALE; HUMANS; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MODELS, STATISTICAL; RECEPTORS, TUMOR NECROSIS FACTOR; SPONDYLITIS, ANKYLOSING;

EID: 79955806736     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010375961     Document Type: Article

References (24)

1. van der Heijde D, Klareskog L, Landewé R, et al. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007 ; 56: 3928-3939 (Pubitemid 350262318)
2. Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999 ; 340: 253-259 (Pubitemid 29063266)
3. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis [comment] [erratum appears in N Engl J Med. 2001;344:240]. N Engl J Med. 2000 ; 343: 1586-1593 (Pubitemid 32162981)
4. Moreland LW, Baumgartner SW, Schiff MH, et al. Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein [comment]. N Engl J Med. 1997 ; 337: 141-147 (Pubitemid 27306284)
5. Moreland LW, Schiff MH, Baumgartner SW, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Int Med. 1999 ; 130: 478-486 (Pubitemid 29135800)
6. Brandt J, Khariouzov A, Listing J, et al. Six-month results of a double-blind, placebo-controlled trial of etanercept treatment in patients with active ankylosing spondylitis. Arthritis Rheum. 2003 ; 48: 1667-1675 (Pubitemid 36682375)
7. Davis JC, van der Heijde D, Braun J, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum. 2003 ; 48: 3230-3236 (Pubitemid 37409337)
8. Calin A, Dijkmans BA, Emery P, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis. 2004 ; 63: 1594-1600 (Pubitemid 39573687)
9. Mease PJ, Goffe BS, Metz J, VanderStoep A, Finck B, Burge DJ. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 2000 ; 356: 385-390 (Pubitemid 30487495)
10. Mease PJ. Etanercept, a TNF antagonist for treatment for psoriatic arthritis and psoriasis. Skin Therapy Lett. 2003 ; 8: 1-4
11. Mease PJ, Kivitz AJ, Burch FX, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 2004 ; 50: 2264-2272 (Pubitemid 38924405)
12. Papp KA, Tyring S, Lahfa M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005 ; 152: 1304-1312 (Pubitemid 40933433)
13. Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003 ; 349: 2014-2022 (Pubitemid 37448924)
14. Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol. 2003 ; 139: 1627-1632 (Pubitemid 37523083)
15. Korth-Bradley JM, Rubin AS, Hanna RK, Simcoe DK, Lebsack ME. The pharmacokinetics of etanercept in healthy volunteers. Ann Pharmacother. 2000 ; 34: 161-164 (Pubitemid 30082972)
16. Sullivan JT, Ni L, Sheelo C, Salfi M, Pelosis PM. Bioequivalence of liquid and reconstituted lyophilized etanercept subcutaneous injections. J Clin Pharmacol. 2006 ; 46: 654-661
17. 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. Int J Clin Pharmacol Ther. 2004 ; 42: 267-276 (Pubitemid 38679015)
18. Lee H, Kimko HC, Rogge M, Wang D, Nestorov I, Peck CC. Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis. Clin Pharmacol Ther. 2003 ; 73: 348-365 (Pubitemid 36403595)
19. Yim DS, Zhou H, Buckwalter M, Nestorov I, Peck CC, Lee H. Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis. J Clin Pharmacol. 2005 ; 45: 246-256 (Pubitemid 40490422)
20. Nestorov I, Zitnik R, Ludden T. Population pharmacokinetic modeling of subcutaneously administered etanercept in patients with psoriasis. J Pharmacokinet Pharmacodyn. 2004 ; 31: 463-490 (Pubitemid 41175366)
21. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther. 2007 ; 82: 17-20 (Pubitemid 46944205)
22. Dixon D, Goldberg R, Schneiderman N, Delamater A. Gender differences in TNF-levels among obese vs nonobese Latino children. Eur J Clin Nutr. 2004 ; 53: 696-699 (Pubitemid 38500142)
23. Bradley JR. TNF-mediated inflammatory disease. J Pathol. 2007 ; 214: 149-160 (Pubitemid 351160153)
24. HayGlassa KT, et al. Ethnicity plays a role in differential human toll-like receptor responsiveness. J Allergy Clin Immunol. 2007 ; 119: S147 - S148