TUESDAY, Aug. 23 (HealthDay News) -- An extensive review of
research investigating injectable drugs to treat psoriasis -- an
autoimmune disorder triggering itchy, red skin patches -- indicates
the medications are not linked to higher heart risks.
But, the study authors said a lack of complete information from
drug makers impeded their ability to assess potential dangers noted
in earlier research.
With the additional information, "it would have been a much more
robust statistical analysis," said study author Dr. Caitriona Ryan,
a dermatology resident at Baylor Research Institute in Dallas. "We
could have adjusted for all the risk factors."
Researchers evaluated 22 randomized, controlled experiments
involving more than 10,000 patients to determine if the rates of
major adverse cardiovascular events -- including heart attack,
stroke or cardiac death -- were affected by use of two types of
so-called biologic psoriasis drugs. These drugs are injected
systemically in some patients with moderate or advanced
Some preliminary reports suggested an "excess" number of
cardiovascular events linked to one drug type, IL-12/23 antibodies
known by the brand names Stelara and Ozespa, and a small number of
such events from the anti-tumor necrosis factor alpha (TNF-a) drugs
Humira, Enbrel and Remicade. However, this study found no such
Ryan said the jury is ultimately still out on the cardiac safety
of the biologic medications because drug manufacturers, who
sponsored prior research, wouldn't release patient-level data
associated with the medications, including patient demographics and
prior known cardiac risk factors.
The short length of most randomized trials also discouraged an
analysis of long-term side effects or other problems stemming from
the drugs, she said.
The study is published in the Aug. 24/31 issue of the
Journal of the American Medical Association.
As many as 7.5 million Americans have psoriasis, according to
the National Psoriasis Foundation, with the most common form,
plaque psoriasis, appearing as raised, red patches covered with
silvery scales. Lesions can occur on any area of the body, and
about 10 percent of sufferers also cope with a related form of
Some research over the past decade has linked autoimmune
diseases such as psoriasis with chronic systemic inflammation and a
subsequent increase in cardiovascular risks, the scientists
During studies of Stelara and Ozespa, 10 of the 3,179 patients
treated with those therapies had a major cardiovascular event,
compared with none of the 1,474 patients treated with a placebo. In
studies of Humira, Enbrel and Remicade, one of the 3,858 patients
receiving those medications had a major cardiovascular event,
compared to one of the 1,812 treated with a placebo.
"More than anything, the big conclusion of our study was this data was not powered to tell the risks," Ryan said.
Dr. Jerry Bagel, a spokesman for the National Psoriasis
Foundation, said he doesn't prescribe Stelara as a first-line
treatment for patients who have existing cardiovascular risk
"It's just logic here . . . there may be some risk here, so let's not take risk where risk doesn't need to be amplified," said Bagel, also director of the Psoriasis Treatment Center of Central New Jersey and an associate clinical professor of dermatology at Columbia University in New York City.
Learn more about psoriasis from the
National Psoriasis Foundation.
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