On January 11, 2010 the Food and Drug Administration (FDA) approved Genentech Inc.’s Actemra (tocilizumab), a drug used to treat adults with average or severe active rheumatoid arthritis and patients two years of age and older who suffer from active juvenile idiopathic arthritis (SJIA). Patients with rheumatoid arthritis have an amplified amount of interleukin-6, a protein of the immune system. Actemra helps to alleviate the swollen joints and ease the pain experienced by such patients by blocking the harmful exploits of this protein. The drug was tested in five rheumatoid arthritis clinical trials to determine its safety and efficacy in adult patients with active rheumatoid arthritis. Actemra proved to better treat the patients’ symptoms than did a placebo in every one of the trials.

Actemra bears the risks of an increase in liver enzymes, elevated low-density lipoprotein (LDL), hypertension and gastrointestinal damage, and is therefore only to be used by patients whose symptoms have not responded well to other available tumor necrosis factor antagonist drugs. Dr. Bob Rappaport, director of the Division of Analgesics, Anasthetics and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research warned, “physicians and patients need to be aware of the risk of serious adverse effects of Actemra and make informed decisions regarding its benefits and risks in the treatment of individual patients.”

For continued evaluation of the safety, efficiency and long-term effects of Actemra, the FDA is mandating that a post-marketing clinical trial be conducted. Other possible side effects of Actemra include headache, upper respiratory tract infection, low platelet count, low neutrophil count, hepatitis B infection becoming an active infection, nervous system complications and inflammation of the nose or nasal passage. Patients who simultaneously take immunosuppressant drugs such as methotrexate or corticosteroids are at risk of developing serious infections such as tuberculosis and infections caused by bacteria or fungi. Since Actemra works on the immune system, there is an increased risk of developing certain cancers.

Financial assistance is offered to those who take Actemra. Consult your healthcare provider and find out if Actemra is right for you. It is important to consider the risks with your healthcare provider before taking Actemra.

You can also check out the other RA Clinical Trials currently enrolling here:

Rheumatoid Arthritis – Vestavia Hills, AL – #35216 (age 18-75)

Rheumatoid Arthritis – Vestavia Hills, AL – #35216 (age 75+)