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On Monday, September 1, the United States Food and Drug Administration (FDA) announced that Xeljanz (tofacitinib), Xeljanz XR, Oluminant (baricitinib) and Rinvoq (upadacitinib) to be accompanied by new and updated warnings regarding an increased risk of disease. cardiac. related events such as heart attack or stroke, cancer, blood clots and death.
All three drugs are JAK inhibitors and are approved for rheumatoid arthritis (RA) alone or in combination; Xeljanz and Xeljanz XR are also approved for psoriatic arthritis (RP) and ulcerative colitis, and Xeljanz oral solution is approved to treat polyarticular juvenile idiopathic arthritis (JIA).
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Xeljanz, Xeljanz XR, Oluminant and Rinvoq already had a warning, but the FDA will now require these to be revised to include information on the risks of serious cardiovascular events, malignancy, thrombosis and death. Additionally, the FDA restricts all approved uses of these drugs to patients who have had an inadequate response or who cannot tolerate one or more TNF blockers.
How JAK Inhibitors Treat Disease
These drugs decrease the activity of the immune system by blocking certain enzymes that cause inflammation. In addition to the risk of major adverse events, common side effects of these JAK inhibitors include upper respiratory tract infections such as colds and sinus infections, bronchitis, headache, cough, hypertension. blood pressure, rash, nausea and shingles.
Do not stop taking JAK inhibitor medicines without talking to your doctor.
If you are taking tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Oluminant) or upadacitinib (Rinvoq) it is very important that you not stop them without first consulting your provider, says Jonathan Greer, MD, rheumatologist with Arthritis & Rheumatology Associates in Palm Beach, Fla. and medical adviser to arthritis advocacy organization CreakyJoints.
“In my opinion, these are great drugs that have helped us manage our rheumatoid arthritis (RA) patients and put people into remission where it was not possible otherwise,” says Dr. Greer.
New warnings are based on further review of the safety study
The FDA’s decision was based on a review of a large randomized safety clinical trial that compared Xeljanz to tumor necrosis factor (TNF) inhibitors, such as Humira (adalimumab) or Enbrel (etanercept), in people patients with rheumatoid arthritis who were also taking methotrexate.
This warning is an update to a previous alert issued by the FDA that was based on earlier interim results; These found an increased risk of blood clots only at the higher dose of 10 milligrams (mg) twice daily of tofacitinib, but the final trial results also showed an increased risk at the lower dose.
There are a few things to keep in mind when reviewing these results, which continue to be reviewed, says Greer. “This review is a look back over 10 years; it was not a controlled study, and it only included a subset of patients, men over 50 who had at least one cardiovascular risk factor. These results may not be generalizable to other populations, such as women or people without these risk factors, ”he says.
It’s also important to note that there was no placebo control in this review, and so it doesn’t tell us what would happen to these people if they weren’t taking any type of medicine to control their RA, Greer says. “We know from previous studies that patients who are not treated for RA have the same mortality as people with three-vessel coronary artery disease. They die sooner without treatment for RA because the disease itself increases the risk of heart attack and stroke, ”he says.
The idea that rheumatoid arthritis might not be treated for fear of possible side effects is a terrible thing to consider, he adds.
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Other JAK inhibitors are included in the new warning
Due to the mechanism of action (the way the drug works in the body) is the same for Oluminant and Rinvoq, the FDA considers these drugs to pose similar risks to those seen with Xeljanz, and they will also carry the additional warning. , according to the ad.
Greer finds the decision to include these drugs questionable. “Even though these drugs belong to the same class, they are very different molecules, and they have somewhat different targets for controlling the immune system,” he says.
The results found for Xeljanz may not be generalizable to these other drugs, says Greer. “I think we have to be careful not to overinterpret these results as a class effect of all drugs,” he says.
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Jakafi (ruxolitinib) and Inrebic (fedratinib), also JAK inhibitors, are not required to do the same safety updates because these drugs are not indicated for the treatment of arthritis and other inflammatory conditions, according to the agency.
What does the black box warning mean?
The warning is intended to alert doctors so that they can carefully weigh the benefits of the drugs against any potential serious adverse event. It is also used to warn doctors to be especially careful when prescribing the medicine to people with certain risk factors, or to place restrictions on when and how the medicine can be used.
What does the new warning mean for people who take these drugs?
Before prescribing or continuing patients on these drugs, a doctor will assess the risk of heart events, cancer, blood clots, and death with all potential benefits. Physicians should especially consider the risks of medications in people who smoke or have smoked in the past, who have cardiovascular risk factors, who develop a malignant tumor, who have a known malignant tumor (other than skin cancer other than successfully treated melanoma), as these people may be at a higher risk of one of the adverse events.
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Finally, Xeljanz, Xeljanz XR, Oluminant and Rinvoq should only be prescribed to people who have had an inadequate response or intolerance to one or more anti-TNF agents.
Talk to your doctor if you are taking any of the JAK inhibitors included in the warning
According to an article published in American family physician, physicians are required to provide patients with relevant risk information with a drug warning box before prescribing.
Greer plans to discuss the risks and benefits of these drugs with patients, as with any drug he prescribes. “I plan to continue using these drugs for rheumatoid arthritis patients who are in remission, are doing well and haven’t found other drugs that have helped them,” said Greer.
If you and your doctor decide that one of these medicines is the right choice for your treatment, you will also discuss the importance of seeing an emergency doctor if you have signs and symptoms of a heart attack, ‘have a stroke or blood clot.
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