FDA Approves New Drug for Moderate to Severe
Rheumatoid Arthritis
Actemra’s recommended use is limited to patients who
have failed other approved therapies because of serious safety concerns
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Jan. 12, 2010 - The U.S. Food and Drug
Administration has approved Actemra (tocilizumab) to treat adults with
moderate to severe rheumatoid arthritis who have not adequately
responded to or cannot tolerate other approved drug classes for
rheumatoid arthritis. The majority of America’s 1.3 million RA patients
are senior citizens with the average age for all RA victims being 66.8
years.
Actemra’s recommended use is limited to patients
who have failed other approved therapies because of serious safety
concerns that were noted in clinical studies. These safety concerns
include elevated liver enzymes, elevated Low-density lipoprotein (LDL)
or bad cholesterol, hypertension, and gastrointestinal perforations.
“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,” said Bob Rappaport, M.D., director of the Division of
Analgesics, Anesthetics and Rheumatology Products in the FDA’s Center
for Drug Evaluation and Research.
The FDA is requiring the sponsor to conduct a
post-marketing clinical trial to further evaluate the long-term safety
of Actemra. Specifically, the FDA wants to evaluate the impact of
elevated LDL cholesterol and blood pressure seen in some patients in
shorter-term trials on the cardiovascular health of patients treated
with Actemra.
In addition, a Risk Evaluation and Mitigation
Strategy (REMS) will require the drug sponsor to implement a
Communication Plan for physicians informing them how to appropriately
monitor their patients for liver and/or gastrointestinal side effects.
The REMS will include a Medication Guide to ensure that patients are
informed of the benefits and risks of Actemra.
Actemra works by blocking the action of
interleukin-6, an immune system protein that is overabundant in people
with rheumatoid arthritis.
The effectiveness and safety of Actemra was
determined in five clinical trials in adult patients with active
rheumatoid arthritis. In all of the trials, patients treated with
Actemra experienced greater improvement in their tender or swollen
joints than patients treated with a placebo.
The most common adverse reactions in clinical
trials were upper respiratory tract infections, headache, inflammation
of the nose or nasal passage, high blood pressure and increased liver
enzymes. Elevations in the LDL or bad cholesterol were also seen in some
patients, some of whom required the addition of lipid lowering agents.
Patients treated with Actemra are at increased risk
for developing serious infections. Most patients who developed these
infections in clinical trials were also taking other drugs that suppress
the immune system such as methotrexate or corticosteroids.
Actemra is marketed by San Francisco-based
Genentech Inc., a subsidiary of the Roche Group.
About Rheumatoid Arthritis
Also called: RA
Rheumatoid
arthritis (RA) is a form of
arthritis that causes pain, swelling, stiffness and loss of function in
your joints. It can affect any joint but is common in the wrist and
fingers. More women than men get rheumatoid arthritis. It often starts
between ages 25 and 55. You might have the disease for only a short
time, or symptoms might come and go. The severe form can last a
lifetime.
Rheumatoid arthritis is different
from
osteoarthritis, the common
arthritis that often comes with older age. RA can affect body parts
besides joints, such as your eyes, mouth and lungs. RA is an
autoimmune disease, which means
the arthritis results from your immune system attacking your body's own
tissues.
No one knows what causes rheumatoid
arthritis. Genes, environment and hormones might contribute. Treatments
include medicine, lifestyle changes and surgery. These can slow or stop
joint damage and reduce pain and swelling.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
>>
More information at MedlinePlus
