Rheumatoid arthritis (RA) is a challenging autoimmune disease. For reasons that remain mysterious, people with RA are the victims of an assault by their own immune system. Bones and joints are especially vulnerable, but the whole body can be affected. Flareups can come and then go without obvious cause. Patients may become desperate for relief but treatment is complicated and expensive. One immune modulating oral medication is tofacitinib (Xeljanz). This drug was first approved for treating RA in 2012, and there was a lot of excitement. Xeljanz was the first in a new category of powerful anti-inflammatory medications called JAK (Janus kinase) inhibitors. A longer acting version, Xeljanz XR got an FDA green light in 2016. Some have called it a breakthrough for severe arthritis. Others warn about serious Xeljanz XR side effects.
Have You Seen the Xeljanz XR Commercial?
Pfizer has spent hundreds of millions of dollars advertising Xeljanz. One television commercial advertising Xeljanz XR is very sophisticated. It starts with a close up of a phonograph needle in a groove of a record. Of course, you have to be over 40 to even know what the device is.
The voice-over says:
Needle. Essential for vinyl, but maybe not for people with rheumatoid arthritis. Because there are options. Like an unjection. Xeljanz XR, a once daily pill for adults with moderate to severe RA for whom methotrexate did not work well.”
Wait for it…The Xeljanz XR Side Effects!
As with so many prescription drug commercials on TV you have an attractive couple. This one adds a cute kid and an even cuter dog. And of course everyone is having a great time.
That doesn’t change when the announcer starts to share the side effects:
Xeljanz XR can lower your ability to fight infection, including tuberculosis. Serious, sometimes fatal infections, lymphoma and other cancers have happened. Don’t start Xeljanz XR if you have an infection. Tears in the stomach or intestines, low blood cell count and higher liver tests and higher cholesterol levels have happened…”
The announcer tells the viewer that her doctor should perform liver and other blood tests during treatment and warns about fungal infections. People are supposed to tell their physician if they are “prone to infections.” While the scary side effects about infections and cancer are mentioned, the people in the video are smiling, dancing and enjoying the old-fashioned vinyl record player.
How Does Xeljanz Work?
This drug is called a JAK inhibitor. JAK is short for janus kinase, an enzyme involved in the inflammatory process. The TV commercial is right about the “unjection” appeal of Xeljanz. “Biologics” for RA such as adalimumab (Humira), etanercept (Enbrel), golimumab (Simponi) and infliximab (Remicade) are injected. These TNF (tissue necrosis factor) blockers also affect the immune system. Like the JAK inhibitor Xeljanz, the TNF blockers reduce inflammation in the joints.
What the New Research Shows:
When the FDA first approved Xeljanz for rheumatoid arthritis, it required Pfizer to conduct research on the drug’s safety. The study compared tofacitinib to the older arthritis medicines.
It took a long time for this study to be completed. Remember, the drug was first marketed in 2012.
Early Results Were Not Encouraging:
The FDA got an early peek at the data last year, and it didn’t much like what it saw. People taking Xeljanz were more susceptible to cardiovascular complications like blood clots, heart attacks and strokes. In addition, they were more likely to be diagnosed with cancer.
The agency wrote:
“We are requiring revisions to the BOXED WARNING, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death…In addition, to ensure the benefits of these three medicines outweigh the risks in patients who receive them, we are limiting all approved uses to certain patients who have not responded or cannot tolerate one or more TNF blockers.”
Final Results Put Patients in a Bind:
Now the results of the study have been published (New England Journal of Medicine, Jan. 27, 2022). People taking Xeljanz were more susceptible to “major adverse cardiovascular events” and cancers compared to those taking a TNF blocker, either etanercept (Enbrel) or adalimumab (Humira).
This puts patients in a terrible bind.
One reader is quite happy with Xeljanz:
“I started taking Xeljanz in May of 2014, and it has worked great since. It is like I don’t have RA at all unless I get an occasional flare. I am praying it continues to work for me. It is very expensive, but my insurance covers it, and I also have a co-pay card.”
Another reader is scared:
“My doctor wants me to start Xeljanz, but I am terrified. I’m used to some side effects, but liver and bowel problems are my worst fears.
“I have psoriatic arthritis and have tried most treatments without much success. I am getting help with medication costs through Pfizer, which is a blessing. Still, I can’t make myself start the medication.”
Although the study just published in The New England Journal of Medicine focused on Xeljanz, the FDA considers the serious adverse reactions to be a “class effect.” That means that drugs such as upadacitinib (Rinvoq) and baricitinib (Olumiant) are also under a cloud.
If there is a moral to this story, it is that serious complications may not show up until years after the Food and Drug Administration approves a medication. Read on to learn about other side effects beyond cardiovascular problems and cancer that have the FDA concerned.
Xeljanz XR Side Effects:
Powerful immune modulating drugs like Xeljanz work by targeting proteins within the immune system. When you mess with mother nature, there are bound to be consequences. The body may not be able to resist infections the way it normally does. People with latent hepatitis B or tuberculosis may experience a reactivation of the infection.
The Food and Drug Administration requires a special black box warning in the prescribing information for Xeljanz XR:
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
“Patients treated with XELJANZ/XELJANZ XR are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
“If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled.
Reported infections include:
“Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ/XELJANZ XR use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ/XELJANZ XR use.
Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
“The risks and benefits of treatment with XELJANZ/XELJANZ XR should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
“Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ/XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
“Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications”
Other Xeljanz XR Side Effects:
- Upper respiratory tract infections, nasal congestion, sore throat, colds, sinus infections
- Urinary tract infections
- Blood disorders
- Headache, insomnia
- Elevated liver enzymes
- Digestive upset, diarrhea, tears or perforations of the stomach or intestinal tract
- Signs of kidney damage
- Lung disease
- Increases in LDL cholesterol levels
- Skin cancer (non melanoma)
One Big Drawback of Xeljanz XR: Price!
The last time we checked, the cost of a month’s supply of Xeljanz XR was well over $5,000. We suspect that some insurance companies object when a doctor writes a prescription for this medication. They may even refuse to pay. Although the original Xeljanz is substantially less expensive from Canadian online pharmacies, a month’s supply is still around $2,000. That is beyond the reach of many patients with RA.
What’s Your Experience?
Share your experience with Xeljanz XR, both positive or negative. Other visitors to this web site would like to know how you have fared on this drug. Did your insurance company pay for it?