Actemra (tocilizumab) is a humanized anti IL-6 receptor monoclonal antibody. It binds specifically to IL-6 receptors. IL-6 is a pro-inflammatory cytokine produced by a variety of cell types, including T- and B-cells, lymphocytes, monocytes and fibroblasts.
Actemra is specifically indicated for the treatment of active systemic juvenile idiopathic arthritis in patients two years of age and older.
Actemra is supplied as a solution for intravenous infusion. The recommended dose for patients with systemic juvenile idiopathic arthritis is as follows:
patients less than 30 kg weight: 12 mg per kg once every two weeks as a 60-minute single intravenous drip infusion
patients at or above 30 kg weight: 8 mg per kg once every two weeks as a 60-minute single intravenous drip infusion.
The FDA approval of Actemra for systemic juvenile idiopathic arthritis was based on a 12-week randomized, double blind, placebo-controlled, parallel group, two-arm study. The subjects (n=75) received Actemra infusions every two weeks at either 8 mg per kg for patients at or above 30 kg or 12 mg per kg for patients less than 30 kg or placebo infusions every two weeks (n=37). The primary endpoint was the proportion of subjects with at least 30% improvement in JIA ACR core set (JIA ACR30 response) at Week 12 and absence of fever. The primary endpoint was reached by 85% of the Actemra arm and 24% of the placebo arm. Secondary endpoints, including JIA ACR 50 and JIA ACR 70 were also reached.
Adverse events associated with the use of Actemra may include, but are not limited to, the following:
Actemra is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1 (gamma 1, kappa) subclass. Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T 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 Mar 22;371(9617):998-1006
Yokota S, Miyamae T, Imagawa T, Katakura S, Kurosawa R, Mori M Clinical study of tocilizumab in children with systemic-onset juvenile idiopathic arthritis. Clinical Reviews in Allergy & Immunology 2005 Jun;28(3):231-8
For additional information regarding Actemra or systemic juvenile idiopathic arthritis, please visit the Actemra web page.