Population pharmacokinetics of rhTNFR-Fc in healthy Chinese volunteers and in Chinese patients with Ankylosing spondylitis

Acta Pharmacologica Sinica

Volumn 31, Issue 11, 2010, Pages 1500-1507

  Fang, Yi ^a,b   Li, Lu Jin ^c   Wang, Rui ^d   Huang, Feng ^d   Song, Hai Feng ^e   Tang, Zhong Ming ^e   Li, Yu Zhen ^b   Guan, Hua Shi ^a   Zheng, Qing Shan ^c  

^a OCEAN UNIVERSITY OF CHINA   (China)

^b PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

^c SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

^d CHINESE PLA GENERAL HOSPITAL   (China)

^e BEIJING INSTITUTE OF RADIATION MEDICINE   (China)

Author keywords

ankylosing spondylitis; fusion protein; population pharmacokinetics; tumor necrosis factor receptor

Indexed keywords

ETANERCEPT;

ADULT; ANKYLOSING SPONDYLITIS; ARTICLE; CHINESE; CLINICAL ARTICLE; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISTRIBUTION; FEMALE; HUMAN; MALE; SEX DIFFERENCE; SINGLE DRUG DOSE; TREATMENT OUTCOME;

ABSORPTION; ADULT; ANTIRHEUMATIC AGENTS; CHINA; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; IMMUNOGLOBULIN G; INJECTIONS, SUBCUTANEOUS; MALE; RECEPTORS, TUMOR NECROSIS FACTOR; RECOMBINANT FUSION PROTEINS; SEX CHARACTERISTICS; SPONDYLITIS, ANKYLOSING; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 78149403810     PISSN: 16714083     EISSN: 17457254     Source Type: Journal    
DOI: 10.1038/aps.2010.113     Document Type: Article

References (20)

1. Ng SC, Liao Z, Yu DT, Chan ES, Zhao L, Gu J. Epidemiology of spondyloarthritis in the People's Republic of China: review of the literature and commentary. Semin Arthritis Rheum 2007; 37: 39-47.
2. Gran JT, Skomsvoll JF. The outcome of ankylosing spondylitis: a study of 100 patients. Br J Rheumatol 1997; 36: 766-71.
3. Khalessi AA, Oh BC, Wang MY. Medical management of ankylosing spondylitis. Neurosurg Focus 2008; 24: E4.
4. Kalden JR. Emerging role of anti-tumor necrosis factor therapy in rheumatic diseases. Arthritis Res 2002; 4: S34-40.
5. Camussi G, Albano E, Tetta C, Bussolino F. The molecular action of tumor necrosis factor-alpha. Eur J Biochem 1991; 202: 3-14.
6. Crew MD, Effros RB, Walford RL, Zeller E, Cheroutre H, Brahn E. Transgenic mice expressing a truncated Peromyscus leucopus TNFalpha gene manifest an arthritis resembling ankylosing spondylitis. J Interferon Cytokine Res 1998; 18: 219-25.
7. Bal A, Unlu E, Bahar G, Aydog E, Eksioglu E, Yorgancioglu R. Comparison of serum IL-1 beta, sIL-2R, IL-6, and TNF-alpha levels with disease activity parameters in ankylosing spondylitis. Clin Rheumatol 2007; 26: 211-5.
8. Braun J, Bollow M, Neure L, Seipelt E, Seyrekbasan F, Herbst H, et al. Use of immunohistologic and in situ hybridization techniques in the examination of sacroiliac joint biopsy specimens from patients with ankylosing spondylitis. Arthritis Rheum 1995; 38: 499-505.
9. Francois RJ, Neure L, Sieper J, Braun J. Immunohistological examination of open sacroiliac biopsies of patients with ankylosing spondylitis: detection of tumour necrosis factor alpha in two patients with early disease and transforming growth factor beta in three more advanced cases. Ann Rheum Dis 2006; 65: 713-20.
10. Amgen-Wyeth Enbrel Prescribing Information. United States 2009.
11. Braun J, Sieper J, Breban M, Collantes-Estevez E, Davis J, Inman R, et al. Anti-tumour necrosis factor alpha therapy for ankylosing spondylitis: international experience. Ann Rheum Dis 2002; 61: iii51-60.
12. Brandt J, Khariouzov A, Listing J, Haibel H, Sorensen H Grassnickel L, 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: 1667-75.
13. Davis JC, Van Der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum 2003; 48: 3230-6.
14. Baraliakos X, Davis J, Tsuji W, Braun J. Magnetic resonance imaging examinations of the spine in patients with ankylosing spondylitis before and after therapy with the tumor necrosis factor alpha receptor fusion protein etanercept. Arthritis Rheum 2005; 52: 1216-23.
15. Brandt J, Listing J, Haibel H, Sorensen H, Schwebig A, Rudwaleit M, et al. Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis. Rheumatology (Oxford) 2005; 44: 342-8.
16. Korth-Bradley JM, Rubin AS, Hanna RK, Simcoe DK, Lebsack ME. The pharmacokinetics of etanercept in healthy volunteers. Ann Pharmacother 2000; 34: 161-4.
17. Zhou H. Clinical pharmacokinetics of etanercept: a fully humanized soluble recombinant tumor necrosis factor receptor fusion protein. J Clin Pharmacol 2005; 45: 490-7.
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: 348-65.
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: 246-56.
20. Kawai S, Sekino H, Yamashita N, Tsuchiwata S, Liu H, Korth-Bradley JM. The comparability of etanercept pharmacokinetics in healthy Japanese and American subjects. J Clin Pharmacol 2006; 46: 418-23.