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Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients
Date:5/24/2009

t-modified Sharp score, compared with 67 percent of patients treated with placebo plus methotrexate.

ACTEMRA was generally well tolerated; the most common adverse events reported most frequently in the ACTEMRA arms of the LITHE study were serious infections.

About ACTEMRA(R) (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody being studied for the treatment of RA. Studies demonstrate that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, relieves both inflammation of the joints and certain systemic effects of RA. The extensive clinical development program conducted by Roche includes five Phase III clinical studies and has enrolled more than 4,000 patients in 41 countries, including the United States. The five Phase III studies are completed and have reported meeting their primary endpoints. ACTEMRA is currently under review by the FDA in the United States.

ACTEMRA is part of a co-development agreement between Roche and Chugai Pharmaceutical Co. In June 2005, ACTEMRA was launched by Chugai in Japan as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. ACTEMRA (known as RoACTEMRA in Europe), was also recently approved in the European Union, Switzerland and India.

The serious adverse events reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in patients; these increases were generally mild and
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SOURCE Roche
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