Study finds no major heart risk in new psoriasis drugs… or does it?

What are we to make of the recent analysis in The Journal of The American Medical Association (JAMA) about the “Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events”?

Some of that depends on what you read. Here’s a selection of headlines from major news outlets:

So, is it “no major risk”, “no risk”, “not clear”, or “may not”? What is the truth?

Reading beyond just the headline, all the articles echoed the Reuters lead:

“A new, highly effective class of psoriasis drugs did not appear to raise the risk of heart problems in a review of published studies, but the analysis may not have been big enough to detect rare cases, U.S. researchers said.”

For the most part, the articles also quoted one or more doctors (from dermatologists to rheumatologists) to the effect that because of the study’s shortcomings, they’ll need more information to ease their concerns about the risk of Anti-TNF drugs in the study, which included Abbott’s Humira or adalimumab, Pfizer’s Enbrel or etanercept and Johnson & Johnson’s Remicade or infliximab.

In other words, the real take away from this analysis isn’t about the new psoriasis drugs: it’s about the shortcomings of the clinical trials, which lasted at most 12 weeks, even though psoriasis sufferers may take a biologic for years.

As quoted in CNN, the study’s lead author, Caitriona Ryan, said,

“Unfortunately, the way clinical trials are designed at the moment, they’re powered for efficacy, [not] safety,” Ryan says. “To be able to show there’s an increase in heart attack or strokes, you’re going to have to look at lots, lots more patients.”

And according to US News,

“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.”

What do you think? Are clinical trials designed for efficacy, as opposed to safety, as Ryan asserts? And whether they are or not, can a 12 week trial possibly be long enough to judge the long-term impact of a powerful drug like an Anti-TNF biologic?

Posted on August 24, 2011, in Psoriasis and tagged , , , , , , , , , , , , , . Bookmark the permalink. Leave a comment.

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