Actemra (ocilizumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved May 2013

Specific Treatments:

Polyarticular Juvenile Idiopathic Arthritis

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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

FDA Approval
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.

Literature References

Imagawa T, Yokota S, Mori M, Miyamae T, Takei S, Imanaka H, Nerome Y, Iwata N, Murata T, Miyoshi M, Nishimoto N, Kishimoto T Safety and efficacy of tocilizumab, an anti-IL-6-receptor monoclonal antibody, in patients with polyarticular-course juvenile idiopathic arthritis. Modern Rheumatology 2012 Feb;22(1):109-15

Additional Information

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