Toxicity, pharmacokinetics, and dose-finding study of repetitive treatment with the humanized anti-interleukin 6 receptor antibody MRA in rheumatoid arthritis. Phase I/II clinical study

Journal of Rheumatology

Volumn 30, Issue 7, 2003, Pages 1426-1435

  Nishimoto, Norihiro ^a   Yoshizaki, Kazuyuki ^a   Maeda, Keiji ^b   Kuritani, Taro ^b   Deguchi, Hitoshi ^b   Sato, Bunzo ^b   Imai, Nobuyuki ^b   Suemura, Masaki ^a   Kakehi, Takahiro ^b   Takagi, Nobuhiro ^b   Kishimoto, Tadamitsu ^a  

^a OSAKA UNIVERSITY   (Japan)

^b Osaka University ^*

Author keywords

Humanized anti IL 6 receptor antibody; Interleukin 6; Rheumatoid arthritis; Therapy

Indexed keywords

ANTINUCLEAR ANTIBODY; C REACTIVE PROTEIN; DNA ANTIBODY; INTERLEUKIN 6 RECEPTOR; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY MRA; NONSTEROID ANTIINFLAMMATORY AGENT; PREDNISOLONE; RECEPTOR ANTIBODY; SERUM AMYLOID A; STEROID; UNCLASSIFIED DRUG;

ACUTE PHASE RESPONSE; ADULT; AGED; ALLERGY; ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; HUMAN; MALE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS;

ACUTE-PHASE REACTION; ADULT; AGED; ANTIBODIES, MONOCLONAL; ARTHRITIS, RHEUMATOID; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HALF-LIFE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; RECEPTORS, INTERLEUKIN-6; TREATMENT OUTCOME;

EID: 0038166958     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (39)

1. Nishimoto N, Kishimoto T, Yoshizaki K. Anti-interleukin 6 receptor antibody treatment in rheumatic disease. Ann Rheum Dis 2000;59 Suppl 1:i21-7.
2. Gabay C. IL-1 inhibitors: novel agents in the treatment of rheumatoid arthritis. Expert Opin Investig Drugs 2000;9:113-27.
3. Feldmann M, Brennan FM, Foxwell BM, Maini RN. The role of TNF alpha and IL-1 in rheumatoid arthritis. Curr Dir Autoimmun 2001;3:188-99.
4. Yoshizaki K, Nakagawa T, Kaieda T, Muraguchi A, Yamamura Y, Kishimoto T. Induction of proliferation and Ig production in human B leukemic cells by anti-immunoglobulins and T cell factors. J Immunol 1982;128:1296-301.
5. Ceuppens JL, Baroja ML, Lorre K, Van Damme J, Billiau A. Human T cell activation with phytohemagglutinin. The function of IL-6 as an accessory signal. J Immunol 1988;141:3868-74.
6. Lotz M, Jirik F, Kabouridis P, et al. B cell stimulating factor 2/interleukin 6 is a costimulant for human thymocytes and T lymphocytes. J Exp Med 1988;167:1253-8.
7. Hirano T, Taga T, Nakano N, et al. Purification to homogeneity and characterization of human B-cell differentiation factor (BCDF or BSFp-2). Proc Natl Acad Sci USA 1985;82:5490-4.
8. Andus T, Geiger T, Hirano T, et al. Recombinant human B cell stimulatory factor 2 (BSF-2/IFN-beta 2) regulates beta-fibrinogen and albumin mRNA levels in Fao-9 cells. FEBS Lett 1987; 221:18-22.
9. Gauldie J, Richards C, Harnish D, Lansdorp P, Baumann H. Interferon beta 2/B-cell stimulatory factor type 2 shares identity with monocyte-derived hepatocyte-stimulating factor and regulates the major acute phase protein response in liver cells. Proc Natl Acad Sci USA 1987;84:7251-5.
10. Castell JV, Gomez-Lechon MJ, David M, Hirano T, Kishimoto T, Heinrich PC. Recombinant human interleukin-6 (IL-6/BSF-2/HSF) regulates the synthesis of acute phase proteins in human hepatocytes. FEBS Lett 1988;232:347-50.
11. Isshiki H, Akira S, Sugita T, et al. Reciprocal expression of NF-IL6 and C/EBP in hepatocytes: possible involvement of NF-IL6 in acute phase protein gene expression. New Biol 1991;3:63-70.
12. Tamura T, Udagawa N, Takahashi N, et al. Soluble interleukin-6 receptor triggers osteoclast formation by interleukin 6. Proc Natl Acad Sci USA 1993;90:11924-8.
13. Ishibashi T, Kimura H, Uchida T, Kariyone S, Friese P, Burstein SA. Human interleukin 6 is a direct promoter of maturation of megakaryocytes in vitro. Proc Natl Acad Sci USA 1989;86:5953-7.
14. Ishibashi T, Kimura H, Shikama Y, et al. Interleukin-6 is a potent thrombopoietic factor in vivo in mice. Blood 1989;74:1241-4.
15. Hirano T, Matsuda T, Turner M, et al. Excessive production of interleukin 6/B cell stimulatory factor-2 in rheumatoid arthritis. Eur J Immunol 1988;18:1797-801.
16. Houssiau FA, Devogelaer JP, Van Damme J, de Deuxchaisnes CN, Van Snick J. Interleukin-6 in synovial fluid and serum of patients with rheumatoid arthritis and other inflammatory arthritides. Arthritis Rheum 1988;31:784-8.
17. Madhok R, Crilly A, Watson J, Capell HA. Serum interleukin 6 levels in rheumatoid arthritis: correlations with clinical and laboratory indices of disease activity. Ann Rheum Dis 1993; 52:232-4.
18. Wendling D, Racadot E, Wijdenes J. Treatment of severe rheumatoid arthritis by anti-interleukin 6 monoclonal antibody. J Rheumatol 1993;20:259-62.
19. Hibi M, Murakami M, Saito M, Hirano T, Taga T, Kishimoto T. Molecular cloning and expression of an IL-6 signal transducer, gp130. Cell 1990;63:1149-57.
20. Murakami M, Hibi M, Nakagawa N, et al. IL-6-induced homodimerization of gp130 and associated activation of a tyrosine kinase. Science 1993;260:1808-10.
21. Mihara M, Kotoh M, Nishimoto N, et al. Humanized antibody to human interleukin-6 receptor inhibits the development of collagen arthritis in cynomolgus monkeys. Clin Immunol 2001;98:319-26.
22. Matsuno H, Sawai T, Nezuka T, et al. Treatment of rheumatoid synovitis with anti-reshaping human interleukin-6 receptor monoclonal antibody: use of rheumatoid arthritis tissue implants in the SCID mouse model. Arthritis Rheum 1998;41:2014-21.
23. Yoshizaki K, Nishimoto N, Mihara M, Kishimoto T. Therapy of rheumatoid arthritis by blocking IL-6 signal transduction with a humanized anti-IL-6 receptor antibody. Springer Semin Immunopathol 1998;20:247-59.
24. Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. JAMA 1949;140:1443-53.
25. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
26. van Gameren MM, Willemse PH, Mulder NH, et al. Effects of recombinant human interleukin-6 in cancer patients: a phase I-II study. Blood 1994;84:1434-41.
27. Veldhuis GJ, Willemse PH, Sleijfer DT, et al. Toxicity and efficacy of escalating dosages of recombinant human interleukin-6 after chemotherapy in patients with breast cancer or non-small-cell lung cancer. J Clin Oncol 1995;13:2585-93.
28. Ettinger WH, Varma VK, Sorci-Thomas M, et al. Cytokines decrease apolipoprotein accumulation in medium from Hep G2 cells. Arterioscler Thromb 1994;14:8-13.
29. Wallenius V, Wallenius K, Ahren B, et al. Interleukin-6-deficient mice develop mature-onset obesity. Nat Med 2002;8:75-9.
30. Argiles JM, Lopez-Soriano FJ. The role of cytokines in cancer cachexia. Med Res Rev 1999;19:223-48.
31. Elliott MJ, Maini RN, Feldmann M, et al. Treatment of rheumatoid arthritis with chimeric monoclonal antibodies to tumor necrosis factor alpha. Arthritis Rheum 1993;36:1681-90.
32. Lipsky PE, van der Heijde DM, St. Clair EW, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. ATTRACT Study Group. N Engl J Med 2000;343:1594-602.
33. Bresnihan B, Alvaro-Gracia JM, Cobby M. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 1998;41:2196-204.
34. Moreland LW, Schiff MH, Baumgartner SW. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 1999;130:478-86.
35. Charles P, Elliott MJ, Davis D, et al. Regulation of cytokines, cytokine inhibitors, and acute-phase proteins following anti-TNF-alpha therapy in rheumatoid arthritis. J Immunol 1999;163:1521-8.
36. Gillmore JD, Lovat LB, Persey MR, Pepys MB, Hawkins PN. Amyloid load and clinical outcome in AA amyloidosis in relation to circulating concentration of serum amyloid A protein. Lancet 2001;358:4-5.
37. Martel-Pelletier J, Welsch DJ, Pelletier JP. Metalloproteases and inhibitors in arthritic diseases. Best Pract Res Clin Rheumatol 2001;15:805-29.
38. Migita K, Kawabe Y, Tominaga M, Origuchi T, Aoyagi T, Eguchi K. Serum amyloid A protein induces production of matrix metalloproteinases by human synovial fibroblasts. Lab Invest 1998;78:535-9.
39. Xing Z, Gauldie J, Cox G, et al. IL-6 is an antiinflammatory cytokine required for controlling local or systemic acute inflammatory responses. J Clin Invest 1998;101:311-20.