In a new study, researchers found a newer pill against rheumatoid arthritis (RA) carries higher risks of heart attack, stroke and cancer than older RA drugs, a new clinical trial confirms.
The study was mandated by the U.S. Food and Drug Administration after earlier safety signals about the drug, called tofacitinib (Xeljanz).
In the study, the team examined nearly 4,400 patients age 50 and older who had at least one risk factor for heart disease or stroke, such as high blood pressure or diabetes.
All had failed to get adequate relief from a standard RA drug, methotrexate. They were randomly assigned to start either tofacitinib or a TNF inhibitor.
Over the next four years, tofacitinib patients were one-third more likely to suffer a heart attack or stroke than those on a TNF blocker.
Their risk of developing cancer, meanwhile, was 48% higher: Just over 4% of tofacitinib patients developed cancer, versus 3% of TNF inhibitor patients.
There are numerous RA medications that can slow the progression of joint damage by targeting parts of the immune response.
TNF inhibitors are among them, and include drugs like etanercept (Enbrel) and adalimumab (Humira).
JAK inhibitors—tofacitinib, baricitinib (Olumiant) and upadacitinib (Rinvoq)—are relatively newer RA therapies. Unlike TNF inhibitors, which are injected or infused, they are taken orally.
In response to the findings, the FDA has changed the labeling of the medication, as well as two others in the same drug class, known as JAK inhibitors.
The drugs are now required to carry warnings about the increased risks.
The FDA is also advising doctors to prescribe JAK inhibitors only after a patient has tried and failed at least one TNF inhibitor—an older class of RA medication.
Patients need to talk to their doctor about what it means for them. People already on JAK inhibitors may feel the benefits outweigh any risks.
If you care about heart health, please read studies that fat in milk and cheese linked to lower risk of heart disease, and antioxidant drug that could help prevent heart attacks and strokes.
For more information about health, please see recent studies about combo therapy that could cut risk of heart attack and stroke by half, and results showing that her pain seemed muscular. It was actually a heart attack.
The study is published in the New England Journal of Medicine, and was conducted by Steven Ytterberg et al.
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