Actemra

Tocilizumab is known as RoACTEMRA in the EU and Mexico and as ACTEMRA in other countries.

ACTEMRA is the first humanised monoclonal antibody that targets and inhibits the human interleukin-6 (IL-6) receptor and represents a novel mechanism of action to treat rheumatoid arthritis (RA). ACTEMRA inhibits the actions of IL-6, a key pro-inflammatory cytokine that also affects a variety of tissues and organ systems in the body.^{1, 2} Clinical studies have shown that treatment of RA patients with ACTEMRA has beneficial effects not only on joint inflammation and damage but also on some of the systemic pathologies associated with RA, such as anaemia and fatigue.³

Based on the results of randomised, controlled, Phase III clinical trials, ACTEMRA in combination with methotrexate (MTX) was approved by the European Medicines Agency (EMEA) in January 2009 for the treatment of adult patients with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, ACTEMRA can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.^3,4

This section contains detailed scientific and medical information on ACTEMRA, including the mechanisms of action, dosage and administration details and safety and efficacy information from key clinical trials.

References:

1. Madhok R, et al. Ann Rheum Dis 1993; 52:232-234.

2. Naka T, et al. Arthritis Res 2002; 4(Suppl 3):S233–S242.

3. RoACTEMRA® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. January 2009.

4. RoACTEMRA® EU Commission Approval. Accessed January 2009. http://ec.europa.eu/enterprise/pharmaceuticals/register/