Therapeutic benefit of blocking interleukin-6 activity with an anti-interleukin-6 receptor monoclonal antibody in rheumatoid arthritis: A randomized, double-blind, placebo-controlled, dose-escalation trial

Arthritis and Rheumatism

Volumn 46, Issue 12, 2002, Pages 3143-3150

  Choy, Ernest H S ^a,i   Isenberg, D A ^b   Garrood, T ^a   Farrow, S ^a   Ioannou, Y ^b   Bird, H ^c   Cheung, N ^d   Williams, B ^e   Hazleman, B ^f   Price, R ^g   Yoshizaki, K ^h   Nishimoto, N ^h   Kishimoto, T ^h   Panayi, G S ^a  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d QUEEN MARY S HOSPITAL   (United Kingdom)

^e UNIVERSITY HOSPITAL OF WALES   (United Kingdom)

^f ADDENBROOKE S HOSPITAL   (United Kingdom)

^g GREENWICH HOSPITAL   (United States)

^h OSAKA UNIVERSITY   (Japan)

ⁱ KING S COLLEGE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRHEUMATIC AGENT; C REACTIVE PROTEIN; HUMAN MONOCLONAL ANTIBODY; INTERLEUKIN 6 RECEPTOR; INTERLEUKIN 6 RECEPTOR MONOCLONAL ANTIBODY; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AGED; ANALYSIS OF VARIANCE; ARTICLE; BLOOD TOXICITY; BONE DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DIARRHEA; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG SAFETY; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; GASTROINTESTINAL SYMPTOM; HEART MUSCLE ISCHEMIA; HUMAN; INJECTION PAIN; LYMPHOCYTOTOXICITY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHEUMATOID ARTHRITIS; SCORING SYSTEM; SKIN DISEASE; SUBCUTANEOUS TISSUE; THORAX DISEASE; VASCULAR DISEASE;

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

EID: 0036899812     PISSN: 00043591     EISSN: None     Source Type: Journal    
DOI: 10.1002/art.10623     Document Type: Article

References (26)

1. Pincus T. Long-term outcome in rheumatoid arthritis. Br J Rheumatol 1995;34 Suppl 2:59-73.
2. Harris ED Jr. Management of rheumatoid arthritis. In: Kelley WN, Harris ED Jr, Ruddy S, Sledge CB, editors. Textbook of Rheumatology. Philadelphia: WB Saunders; 1993. p. 912.
3. Kishimoto T. Interleukin-6 and its receptor in autoimmunity. J Autoimmun 1992;5 Suppl A:123-32.
4. Guerne PA, Zuraw BL, Vaughan JH, Carson DA, Lotz M. Synovium as a source of interleukin 6 in vitro: Contribution to local and systemic manifestations of arthritis. J Clin Invest 1989;83: 585-92.
5. Hirano T, Matsuda T, Turner M, Miyasaka N, Buchan G, Tang B, et al. Excessive production of interleukin-6/B cell stimulatory factor-2 in rheumatoid arthritis. Eur J Immunol 1988;18:1797-801.
6. Houssiau FA, Devogelaer J-P, Van Damme J, Nagant de Deuxchaisnes C, 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.
7. Swaak AJ, van Rooyen A, Nieuwenhuis E, Aarden LA. Interleukin-6 (IL-6) in synovial fluid and serum of patients with rheumatic diseases. Scand J Rheumatol 1988;17:469-74.
8. Taga T, Kishimoto T. Gp130 and the interleukin-6 family of cytokines. Ann Rev Immunol 1997;15:797-819.
9. Dasgupta B, Corkill M, Kirkham B, Gibson T, Panayi G. Serial estimation of interleukin-6 as a measure of systemic disease in rheumatoid arthritis. J Rheumatol 1992;19:22-5.
10. Kotake S, Sato K, Kim KJ, Takahashi N, Udagawa N, Nakamura I, et al. Interleukin-6 and soluble interleukin-6 receptors in the synovial fluids from rheumatoid arthritis patients are responsible for osteoclast-like cell formation. J Bone Miner Res 1996;11: 88-95.
11. Watson J, Crilly A, Madhok R, Capell H, Sturrock R. IL-6 and soluble IL-2 receptor in rheumatoid arthritis patients treated with second line drugs. Biochem Soc Trans 1992;20:138S.
12. Wendling D, Racadot E, Wijdenes J. Treatment of severe rheumatoid arthritis by anti-interleukin-6 monoclonal antibody. J Rheumatol 1993;20:259-62.
13. Masahiko M, Kotoh M, Oda Y, Kumagai E, Takagi N, Tsunemi K, et al. Anti-IL-6 receptor antibody suppresses the onset of collagen arthritis in monkeys [abstract]. Arthritis Rheum 1997;40 Suppl 9:S133.
14. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
15. Boers M, Tugwell P, Felson DT, van Riel PL, Kirwan JR, Edmonds JP, et al. World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol Suppl 1994;41:86-9.
16. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
17. Prevoo MLL, van't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LBA, van Riel PLCM. Modified disease activity scores that include twenty-eight-joint counts: Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.
18. Nishimoto N, Maeda K, Kuritani T, Deguchi H, Sato B, Imai N, et al. Safety and efficacy of repetitive treatment with humanized anti-interleukin-6 receptor antibody (MRA) in rheumatoid arthritis (RA) [abstract]. Arthritis Rheum 2001;44 Suppl 9:S84.
19. Lipsky PE, van der Heijde DM, St. Clair EW, Furst DE, Breedveld FC, Kalden JR, et al, for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594-1602.
20. Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, et al. Etanercept therapy in rheumatoid arthritis: A randomized, controlled trial. Ann Intern Med 1999;130: 478-86.
21. Bresnihan B, Alvaro-Gracia JM, Cobby M, Doherty M, Domljan Z, Emery P, et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 1998;41:2196-204.
22. Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med 2001;344:907-16.
23. Papanicolaou DA, Wilder RL, Manolagas SC, Chrousos GP. The pathophysiologic roles of interleukin-6 in human disease. Ann Intern Med 1998;128:127-37.
24. Sinigaglia L, Nervetti A, Mela Q, Bianchi G, Del Puente A, Di Munno O, et al, for the Italian Study Group on Bone Mass in Rheumatoid Arthritis. A multicenter cross sectional study on bone mineral density in rheumatoid arthritis. J Rheumatol 2000;7: 2582-9.
25. 2 in mouse macrophages. J Leukocyte Biol 1993;54:329-35.
26. Brennan FM, Maini RN, Feldmann M. TNF alpha: A pivotal role in rheumatoid arthritis? Br J Rheumatol 1992;31:293-8.