Tocilizumab

Supplementum: 1 / 2010 (Obsah)
Rubrika: Profily léčiv
Obor: Bolest, Osteologie
Autoři: MUDr. Heřman Mann
Autoři - působiště: Revmatologický ústav, Klinika revmatologie 1. LF UK, Praha
Citace: 1 Choy E. Inhibiting interleukin-6 in rheumatoid arthritis. Curr Rheumatol Rep 2008;10:413–7. 2 de Benedetti F, Martini A. Targeting the interleukin-6 receptor: a new treatment for systemic juvenile idiopathic arthritis? Arthritis Rheum 2005;52:687–93. 3 Tackey E, Lipsky PE, Illei GG. Rationale for interleukin-6 blockade in systemic lupus erythematosus. Lupus 2004;13:339–43. 4 Kishimoto T. The biology of interleukin-6. Blood 1989:74:1–10. 5 Nishimoto N, Yoshizaki K, Maeda K, et al. 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. J Rheumatol 2003;30:1426–35. 6 Oldfield V, Dhillon S, Plosker GL. Tocilizumab: a review of its use in the management of rheumatoid arthritis. Drugs 2009;69:609–32. 7 www.emea.europa.eu 8 Nishimoto N, Yoshizaki K, Maeda K, et al. 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. J Rheumatol 2003;30:1426–35. 9 Choy EH, Isenberg DA, Garood T, et al. 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 Rheum 2002;46:3143–50. 10 Nishimoto N, Yoshizaki K, Miyasaka N, et al. Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:1761–9. 11 Maini RN, Taylor PC, Szechinski J, et al. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum 2006;54:2817–29. 12 Nishimoto N, Hashimoto J, Miyasaka N, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis 2007;66:1162–7306. 13 Smolen JS, Beaulieu A, Rubbert-Roth A, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis: a double-blind, placebo-controlled, randomised trial. Lancet 2008;371:987–97. 14 Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease- -modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum 2008;58:2968–80. 15 Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis 2008;67:1516–23. 16 Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study. Ann Rheum Dis 2010;69:88–96. 17 Kremer JM, Fleischmann RM, Halland AM. Tocilizumab Inhibits Structural Joint Damage in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate. Abstract L14 ACR 2008. 18 Fleischmann R, Burgos-Vargas R, Ambs P, et al. LITHE: Tocilizumab inhibits radiographic progression and improves physical function in rheumatoid arthritis patients at 2 yrs with increasing clinical efficacy over time. Abstract 637 ACR 2009. 19 Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis 2009;68:1580–4. 20 Woo P, et al. Open label phase II trial of single, ascending doses of MRA in Caucasian children with severe systemic juvenile idiopathic arthritis: proof of principle of the efficacy of IL-6 receptor blockade in this type of arthritis and demonstration of prolonged clinical improvement. Arthritis Res Ther 2005; 7:1281–8. 21 Yokota S, et al. Therapeutic efficacy of humanized recombinant anti-interleukin-6 receptor antibody in children with systemic- -onset juvenile idiopathic arthritis. Arthritis Rheum 2005; 52:818–25. 22 Yokota S, et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet 2008;371:998–1006. 23 llei GG, Shirota Y, Yarboro CH, et al. Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study. Arthritis Rheum 2010;62:542–52. 24 Smolen JS, Beaulieu AD, Dikranian A, et al. Arthritis Rheum 2008;58:S784. 25 van Vollenhoven R, et al. EULAR 2009; Poster SAT0081. 26 van Vollenhoven R, et al. EULAR 2009; Poster SAT0111. 27 Genovese MC, Smolen JS, Emery P, et al. Lipid and Inflammatory Biomarker Profiles in Patients Receiving Tocilizumab for Rheumatoid Arthritis: Analysis of Five Phase 3 Clinical Trials. Arthritis Rheum 2008;58:S531–2. 28 www.fda.gov/ohrms/dockets/ac/acmenu.htm 29 Choy E, Sattar N. Interpreting lipid levels in the context of high-grade inflammatory states with a focus on rheumatoid arthritis: a challenge to conventional cardiovascular risk actions. Ann Rheum Dis 2009;68:460–9.

Souhrn

Navzdory významnému pokroku dosaženému v revmatologii díky biologické léčbě není možné dosáhnout uspokojivého terapeutického výsledku u všech nemocných, a proto je stále nutné hledat nové cíle zásahu do imunitních procesů. Jednou z možností je blokáda účinků interleukinu-6 (IL-6). IL-6 je prozánětlivý cytokin, který hraje klíčovou roli při rozvoji a udržování chronického zánětu a podílí se na patogenezi řady autoimunitních onemocnění.

Literatura

1 Choy E. Inhibiting interleukin-6 in rheumatoid arthritis. Curr Rheumatol Rep 2008;10:413–7. 2 de Benedetti F, Martini A. Targeting the interleukin-6 receptor: a new treatment for systemic juvenile idiopathic arthritis? Arthritis Rheum 2005;52:687–93. 3 Tackey E, Lipsky PE, Illei GG. Rationale for interleukin-6 blockade in systemic lupus erythematosus. Lupus 2004;13:339–43. 4 Kishimoto T. The biology of interleukin-6. Blood 1989:74:1–10. 5 Nishimoto N, Yoshizaki K, Maeda K, et al. 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. J Rheumatol 2003;30:1426–35. 6 Oldfield V, Dhillon S, Plosker GL. Tocilizumab: a review of its use in the management of rheumatoid arthritis. Drugs 2009;69:609–32. 7 www.emea.europa.eu 8 Nishimoto N, Yoshizaki K, Maeda K, et al. 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. J Rheumatol 2003;30:1426–35. 9 Choy EH, Isenberg DA, Garood T, et al. 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 Rheum 2002;46:3143–50.
10
Nishimoto N, Yoshizaki K, Miyasaka N, et al. Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:1761–9.
11
Maini RN, Taylor PC, Szechinski J, et al. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum 2006;54:2817–29.
12
Nishimoto N, Hashimoto J, Miyasaka N, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis 2007;66:1162–7306.
13
Smolen JS, Beaulieu A, Rubbert-Roth A, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis: a double-blind, placebo-controlled, randomised trial. Lancet 2008;371:987–97.
14
Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease- -modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum 2008;58:2968–80.
15
Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis 2008;67:1516–23.
16
Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study. Ann Rheum Dis 2010;69:88–96.
17
Kremer JM, Fleischmann RM, Halland AM. Tocilizumab Inhibits Structural Joint Damage in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate. Abstract L14 ACR 2008.
18
Fleischmann R, Burgos-Vargas R, Ambs P, et al. LITHE: Tocilizumab inhibits radiographic progression and improves physical function in rheumatoid arthritis patients at 2 yrs with increasing clinical efficacy over time. Abstract 637 ACR 2009.
19
Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis 2009;68:1580–4.
20
Woo P, et al. Open label phase II trial of single, ascending doses of MRA in Caucasian children with severe systemic juvenile idiopathic arthritis: proof of principle of the efficacy of IL-6 receptor blockade in this type of arthritis and demonstration of prolonged clinical improvement. Arthritis Res Ther 2005; 7:1281–8.
21
Yokota S, et al. Therapeutic efficacy of humanized recombinant anti-interleukin-6 receptor antibody in children with systemic- -onset juvenile idiopathic arthritis. Arthritis Rheum 2005; 52:818–25.
22
Yokota S, et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet 2008;371:998–1006.
23
llei GG, Shirota Y, Yarboro CH, et al. Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study. Arthritis Rheum 2010;62:542–52.
24
Smolen JS, Beaulieu AD, Dikranian A, et al. Arthritis Rheum 2008;58:S784.
25
van Vollenhoven R, et al. EULAR 2009; Poster SAT0081.
26
van Vollenhoven R, et al. EULAR 2009; Poster SAT0111.
27
Genovese MC, Smolen JS, Emery P, et al. Lipid and Inflammatory Biomarker Profiles in Patients Receiving Tocilizumab for Rheumatoid Arthritis: Analysis of Five Phase 3 Clinical Trials. Arthritis Rheum 2008;58:S531–2.
28
www.fda.gov/ohrms/dockets/ac/acmenu.htm
29
Choy E, Sattar N. Interpreting lipid levels in the context of high-grade inflammatory states with a focus on rheumatoid arthritis: a challenge to conventional cardiovascular risk actions. Ann Rheum Dis 2009;68:460–9.

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