Humira, Remicade May Increase Shingles Risk - Study
February 17 2009 - 4:30PM
Dow Jones News
Rheumatoid arthritis patients being treated with Humira or
Remicade may have an increased risk of developing shingles,
according to a new study released Tuesday.
Humira, marketed by Abbott Laboratories (ABT) and Remicade, by a
unit of Johnson & Johnson (JNJ), are approved to treat
rheumatoid arthritis, Crohn's disease, psoriasis and other
inflammatory diseases. They both block a protein known as tumor
necrosis factor-alpha. People with certain diseases have too much
TNF-alpha in their bodies which causes the immune system to attack
healthy parts of the body. The drugs can also lower the body's
ability to fight infections and the drugs' labels warn of such
risks.
According to a study by German researchers that will appear in
the Feb. 18 edition of the Journal of the American Medical
Association, patients on Remicade or Humira had a small increased
risk of developing shingles, a painful infection characterized by
blisters on the skin.
Researchers, led by those at the German Rheumatism Research
Center, Berlin, looked at the association of various rheumatoid
arthritis treatments, including TNF-blockers, and the risk of
developing shingles, also known as herpes zoster, among 5,040
patients. The patients were enrolled in a German biologics register
between May 2001 and December 2006 when they started treatment with
a biologic agent such as Humira or Enbrel, another TNF-blocker by
Amgen Inc. (AMGN) and Wyeth (WYE) that works in a different manner
than Humira or Remicade. Most patients were followed for three
years.
Of the 5,040 patients, researchers identified 86 cases of
shingles in 82 people. Thirty nine of the cases were associated
with patients on Remicade or Humira, while 23 cases were associated
with patients on Enbrel and 24 with other rheumatoid arthritis
treatments. In real terms, patients on Remicade or Humira had a
shingles rate of 11.1 per 1,000 patient years.
According to an accompanying editorial written by two doctors at
the University of Alabama in Birmingham, the shingles rate for the
U.S. population as a whole is 3.5 per 1,000 patient years. They
said the rate seen in the study for Remicade and Humira "appears to
induce a risk similar to that observed in populations older than 80
years." They wrote that the drugs have "revolutionized" the
treatment of rheumatoid arthritis and other conditions.
Brian Kenney, a spokesman for Centocor, the J&J unit that
makes Remicade, said the company would keep an eye on
post-marketing reports of shingles, but noted the drug's label
already mentions reports of shingles. Humira also lists shingles as
an adverse reaction that was seen in clinical trials.
Researchers said doctors should monitor patients on Humira or
Remicade for "early signs and symptoms" of shingles. Doctors also
said patients who hadn't yet started treatment with Remicade or
Humira could consider being vaccinated against shingles.
Shingles is caused by the same virus that causes chicken pox,
which afflicted most children in the U.S. until routine vaccination
against chicken pox started in 1995.
After the chicken-pox infection has run its course, the virus
remains dormant in people and can reactivate and turn into
shingles. The condition is most common in people older than age 60,
and the severity increases with age. People with rheumatoid
arthritis also have an increased risk of developing shingles.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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