VIDEO: Mitigating risks associated with JAK inhibitor use

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Recently the FDA issued warnings. And these warnings caused clinicians to take a pause. The FDA said that these drugs were associated with blood clots, with strokes, cardiovascular disease, and death. When you see the word "death," you're like, "Whoa, hold on."

So this was based on the oral surveillance data with tofacitinib. And what happened was that they compared patients who were already high risk. And these patients have had a cardiovascular risk factor. So it could be hypertension, diabetes; They were smokers over the age of 65. And then what they did was randomized them to receiving tofacitinib or adalimumab. And they found that there was a signal. And the signal was that patients on tofacitinib had higher rates of deep vein thrombosis, cardiovascular risks, as well as deaths, and cancers too. So then they went ahead and applied the warnings to tofacitinib, but they didn't stop there. The FDA went ahead and applied it to the whole class of drugs, which seemed a little bit unfair. And the question has always been like, is it the class of drugs that's increasing the risk of all of these cardiovascular risks? Or is it that adalimumab was protected?

So fast forward. At the American College of Rheumatology in 2021, so this was just a few months ago. What they did was there was a study that presented real-world data. And this was the STAR-RA study. And they went ahead and selected for high-risk patients, just like the oral surveillance trial did. So they selected patients who were over 65; They were smokers, had a history of heart attacks, or strokes. And they wanted to know, well, did these patients have a higher rate of major adverse cardiovascular events, MACE is what we call that, right? So they did find that yes, tofacitinib was associated, but they were able to define the demographics further. So the demographics include patients over the age of 65; males, smokers, or former smokers, as well as aspirin use. But I think aspirin use is just a surrogate for patients who are at high risk. So that includes diabetes, having uncontrolled hypertension, hyperlipidemia, or having the metabolic syndrome. So I think that aspirin in that context, not that people who take aspirin are at high risk for clots, but I think aspirin in that context were identifying patients who might be at high risk.

So how are clinicians interpreting this? So this is what I do in my practice is I do counsel patients on the risks. And if there is someone with several risk factors, I mean, I will try and see if there's other options, but sometimes there's not many options. Or maybe they failed the other options. And to me, uncontrolled inflammation is also really high risk for patients to develop a cardiovascular event. So you have to balance controlling inflammation versus possible risks or side effects of the drugs. So what I would do is I'll go ahead and prescribe it to these individuals, but then I really work hard to mitigate the other risks. So I'm telling them, "You gotta quit smoking period." "This is your quit date." I tell them, "You got to give up that cupcake, "put down that cookie. "Let's control your diabetes. "Take your blood pressure medicine, measure it, exercise." So these are all other tools that we have to mitigate cardiovascular risk. And I really want clinicians out there to enforce these. It's like, I know it's hard to do lifestyle changes, but lifestyle changes, how great is that? Very little side effects and it's cheap. Diet and exercise is cheap.