A newer rheumatoid arthritis drug may increase the risk of cardiovascular disease and cancer, compared to older drugs, according to a new study published in the New England Journal of Medicine .the research was mandated by the US Food and Drug Administration, following safety signals about the drug specifically that it was found to increase in lipid levels and incidence of cancers. As a result of the study, the FDA is now requiring warning labels about other medications known as Janus kinase (JAK) inhibitors, indicating that they may cause serious heart-related events, cancer, blood clots, and death. The three JAK inhibitors affected by the new warning have all been approved to treat rheumatoid arthritis (RA), a chronic inflammatory condition in which the body attacks its own joints, causing pain, swelling, and joint damage. It is also approved to treat and ulcerative colitis—two more autoimmune conditions. The new Boxed Warning for JAK inhibitors also comes with the recommendation that doctors only approve them if patients haven't responded to, or cannot tolerate, other medications known as tumor necrosis factor (TNF) blockers, about the new research linking JAK inhibitors, to cardiovascular disease and cancer—and what that means for those who may be on the drugs, or may need it in the future. Trial participants were split into three groups: Group one (1,455 patients) received at 5 milligrams (mg) twice a day, group two (1,456 patients) received at 10 mg twice a day, and group three (1,451 patients) received a TNF blocker or inhibitor, the patients for a median of four years. Over that period of time, they found that incidences of both major adverse cardiac events (MACE) and cancers (excluding skin cancers) were higher with the combined doses than with TNF blockers. Specifically: 98 patients (3.4%) who took either dose had a MACE, compared to 37 patients (2.5%) who received a TNF blocker; and 122 patients (4.2%) who took developed cancer, compared to 42 patients (2.9%) who received a TNF blocker. The FDA has also required health care providers to consider the risks and benefits of these JAK inhibitors before beginning or continuing therapy—primarily in patients who have cardiovascular risk factors or a history of cancer. JAK inhibitors are now also recommended as a final approach, if patients "have had an inadequate response or intolerance to one or more TNF blockers," the FDA says. JAK inhibitors are an extremely common medication used to treat rheumatoid arthritis or other autoimmune conditions, Michael George, MD, an assistant professor of medicine in rheumatology at Penn Medicine, tells Health.
For those already taking Xeljanz or another JAK inhibitor, Dr. George says it's worth talking to your doctor about whether the medication is still right for you, especially if you have other risk factors for cardiovascular disease or cancer. "For people who have not tried a TNF inhibitor or other rheumatoid arthritis therapies before, trying to switch treatment is a consideration, especially for people at high risk of possible JAK inhibitor side effects," he says. "There are many patients with rheumatoid arthritis whose disease is not well controlled even with a TNF inhibitor or other biologic," says Dr. George. "JAK inhibitors can be very effective in treating rheumatoid arthritis for some patients, even when other medications have not worked. In many cases, the benefits of the medication may outweigh the possible risks."
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