Deaths Reported Among Rheumatoid Arthritis Patients Treated With Actemra

Among Actemra users, there have been 15 reported deaths and 221 cases of serious side effects. Chugai Pharmaceutical (the Japanese unit of Roche Holding AG) reports that 4,915 rheumatoid arthritis patients received Actemra intravenously between April 2006 and February 2009. Japan was the first country to approve the drug for rheumatoid arthritis. Actemra is not yet approved in the U.S.

In November 2007, Roche submitted a biologics license application to the U.S. FDA seeking approval for Actemra to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of Actemra, but the FDA has requested more information from Roche before it grants final approval.

Actemra inhibits the interleukin-6 receptor, thereby blocking interleukin-6 (a cytokine known to play a role in immune and inflammatory responses). The drug is not a TNF blocker like Enbrel, Remicade, and Humira.

Related Resources:

• Actemra (Tocilizumab) - What You Should Know
• Cytokines and Inflammation
• TNF-alpha Blockers - What You Need to Know
• 10 Things You Should Know About Rheumatoid Arthritis

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