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New Study Demonstrated ACTEMRA(R) (tocilizumab) Inhibited Progression of Joint Damage in Rheumatoid Arthritis Patients
Date:10/25/2008

bo infusions every four weeks plus methotrexate weekly. The study included nearly 1,200 patients from 137 sites in 15 countries, including the United States.

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. Four Phase III studies are completed and have reported meeting their primary endpoints. A fifth Phase III study, the LITHE study evaluating ACTEMRA in RA is an ongoing two-year study, which is expected to report complete data evaluating the effects of ACTEMRA on the inhibition of structural joint damage in 2009. ACTEMRA is currently under review in the United States and Europe.

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.

The serious adverse reactions reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver e
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SOURCE Hoffmann-La Roche Inc.
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