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A review of published studies suggests that a new, effective class of psoriasis drugs may not raise the risk of heart problems, but researchers say the analysis is likely too small to detect rare cases, Reuters reports.
Dallas - A review of published studies suggests that a new, effective class of psoriasis drugs may not raise the risk of heart problems, but researchers say the analysis is likely too small to detect rare cases, Reuters reports.
In January, Abbott Laboratories pulled its U.S. and European marketing applications for one of the drugs, 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 in treating psoriasis. Patients with severe psoriasis are already at increased risk of heart attacks, and new treatments that may increase that risk are worrisome.
Abbott’s move also raised concerns about Johnson & Johnson’s Stelara (ustekinumab), the first drug in the class to win marketing approval.
Acting on that concern, researchers from the Baylor Research Institute in Dallas analyzed data from 22 randomized clinical trials of anti-IL-12/23 and anti-TNF drugs to treat chronic plaque psoriasis. Anti-TNF drugs in the study included Abbott’s Humira (adalimumab), Pfizer’s Enbrel (etanercept) and Johnson & Johnson’s Remicade (infliximab).
Investigators 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, compared with no heart problems in the 1,474 patients treated with placebo. Among patients treated with the older anti-TNF drugs, only one of the 3,858 patients had a major cardiac problem compared with one of the 1,812 patients treated with placebo.
Study leader Caitriona Ryan, M.D., a dermatology resident at Baylor Research Institute, told Reuters that although the study did not show a statistically significant increase in heart problems, the review probably was not large enough to detect these rare events. She said the analysis exposes flaws in some clinical trials, which are designed to show differences in the effectiveness of drugs but not to identify rare safety problems.
What is needed, Dr. Ryan told Reuters, is some form of regulatory oversight of drugs after they win marketing approval, beyond the current system, under which individual companies submit reports to the 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,” she said.
The study appears in the Journal of the American Medical Association.