According to American researchers, although a review of published studies reveals that a new and highly effective class of psoriasis drugs does not appear to raise the risk of heart problems, the studies may not have been big enough to detect rare cases.
Abbott Laboratories pulled its U.S. and European marketing applications for one of the drugs in January, known as briakinumab due to concerns raised by U.S. regulators. The drug is part of a new class of treatments known as anti-IL-12/23 agents that have been shown to be highly effective at treating psoriasis, an autoimmune disease marked by well-defined patches of red raised skin. 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 arthritis.
Patients with severe psoriasis are already at increased risk of heart attacks, and doctors are worried the new treatments may increase this risk. Abbott's decision also raised concerns about Johnson & Johnson's Stelara or ustekinumb, the first drug in the class to win marketing approval.
Caitriona Ryan of the Baylor Research Institute in Dallas, whose study appears in the Journal of the American Medical Association on Tuesday said, “We're concerned about the apparent excess in cardiovascular events.” The team analyzed data from 22 randomized clinical trials of anti-IL-12/23 and anti-TNF drugs to treat chronic plaque psoriasis, the most common form of psoriasis.
Ryan's team found that during the active portion of the clinical trials they reviewed, 10 out of the more than 3,179 patients who were treated with anti-IL-12/23 had a major cardiac event, such as a heart attack, stroke or death related to heart disease, compared with no heart problems in the 1,474 patients treated with a placebo. Among patients treated with the older anti-TNF drugs, only 1 of the 3,858 patients had a major cardiac problem compared with 1 of the 1,812 patients treated with placebo.
Ryan said that although the study did not show a statistically significant increase in heart problems, it was likely not large enough to detect these rare events.
Dr. Christopher Ritchlin, a rheumatologist at the University of Rochester Medical Center, who has seen the findings but was not involved with the study, said the analysis does not ease his concerns about drugs in this class. “There are some safety signals you are seeing in the treatment groups that are not in the placebo groups. I'm not saying there is a definite association, but there is smoke here,” he 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 factors. “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.
What is needed, Ryan said, is some form of regulatory oversight of drugs after they win marketing approval, beyond the current system in which individual companies submit reports to the U.S. Food and Drug Administration. “We have to find a way of being able to systematically gather safety data for these agents after they are on the market,” Ryan said.
The authors concluded, “Until more definitive data become available, we believe that dermatologists should exercise heightened vigilance for cardiovascular risk factors when initiating anti-IL-12/23 agents in psoriasis patients.”
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