General Information

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 approved for patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.

Actemra is supplied as a solution for intravenous administration. Actemra may be used alone or in combination with methotrexate. The recommended dose of for PJIA patients is once every 4 weeks as a 60-minute single intravenous drip infusion: patients less than 30 kg weight: 10 mg per kg; patients at or above 30 kg weight: 8 mg per kg.

Clinical Results

The FDA approval of Actemra for polyarticular juvenile idiopathic arthritis (PJIA) was based on CHERISH, a phase III trial. The trial consisted of an open label phase, followed by a randomized double-blind placebo-controlled withdrawal phase. The study demonstrated that subjects treated with Actemra experienced clinically meaningful improvement in signs and symptoms of PJIA. A total of 91% of subjects taking Actemra plus MTX and 83% taking Actemra alone achieved an ACR 30 response at week 16 compared to baseline. In the randomized double-blind placebo-controlled withdrawal phase of the trial, Actemra-treated patients experienced significantly fewer disease flares compared to placebo-treated patients (26% vs. 48%).

Side Effects

Adverse effects associated with the use of Actemra may include, but are not limited to, the following:

• upper respiratory tract infections
• nasopharyngitis
• headache
• hypertension
• increased ALT

Mechanism of Action

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.

Additional Information

For additional information regarding Actemra or polyarticular-course juvenile idiopathic arthritis, please visit the Actemra web page.