Reaching Remission From Moderate to Severe Ulcerative Colitis (UC) With Xeljanz

7 min read

Xeljanz is an oral medication for the treatment of adults with moderate to severe ulcerative colitis (UC) who have not had a positive response to other treatments for UC, specifically TNF blockers. Examples of TNF blockers include Remicade and Humira. UC is an inflammatory bowel disease (IBD). The main symptom is diarrhea that can have blood in it. Other symptoms of UC include stomach pain or cramps, sudden urges for a bowel movement, and weight loss.

UC causes irritation, inflammation, and ulcers in the lining of your large intestine (colon). UC is classified as mild, moderate, or severe, depending on your symptoms. Xeljanz is approved for moderate or severe types of UC.

The active ingredient in Xeljanz is tofacitinib. It is a Janus kinase (JAK) inhibitor. JAKs are enzymes that transmit signals in the body that influence immune cell function. Xeljanz works to adjust the signaling pathway of JAKs. This prevents inflammation and helps with UC. 

Xeljanz comes in two dosage types for UC. It comes as Xeljanz 5-milligram and 10-milligram tablets, and then Xeljanz XR (extended release) 11-milligram and 22-milligram tablets. Regardless of the tablet type, you take it by mouth with or without food. 

Xeljanz. You will start with 10 milligrams by mouth twice a day for at least 8 weeks. At this point, your health care provider will evaluate your symptoms. If you are in remission of your symptoms, you will start on Xeljanz at 5 milligrams twice a day. If you are still having symptoms, your health care provider may choose to continue Xeljanz at 10 milligrams twice a day for up to 16 weeks. 

Xeljanz XR. You will start with 22 milligrams by mouth once a day for at least 8 weeks. At this point, your health care provider will evaluate your symptoms. If you are in remission of your symptoms, you will start on Xeljanz XR at 11 milligrams once a day. If you are still having symptoms, your health care provider may choose to continue Xeljanz XR at 22 milligrams once daily for up to 16 weeks.

If you have moderate or severe kidney or liver issues, your dose will be different. If you are taking certain medications with drug interactions like ketoconazole or fluconazole, your dose will also be different. 

For UC, two early studies were done to see if 10 milligrams of Xeljanz twice a day was effective, compared to a placebo containing no medicine. The people in the studies did not know if they were getting Xeljanz or the placebo. 

Both studies included people 18 years and older who had moderate to severe UC for at least 4 months. People were required to have been unsuccessful or unable to tolerate at least one other drug for the treatment of UC – oral or IV steroids, adalimumab (Humira), azathioprine, infliximab (Remicade), or mercaptopurine.

Most people in the studies were male (49%-63%). The average age of people in the studies was 40 to 41 years.

People in the studies who took Xeljanz during the early 8-week period had significantly higher rates of remission than those who took the placebo. In the first study, over 18% of people who took Xeljanz reached remission, compared to only 8% who took the placebo. In the second study, close to 17% of people reached remission who took Xeljanz, vs. almost 4% in the placebo group. 

Similarly, during an extension study, where people in the early trial were monitored for 52 weeks, those who took Xeljanz had a higher rate of remission than those who took the placebo.

And a long-term study, where people were monitored for 36 months (3 years), showed 68% of people had remission of their symptoms while taking 5 milligrams of Xeljanz twice a day. At the end of the study, about 50% of people were still in remission. 

Your results may differ from what was seen in clinical studies.

Studies have shown that Xeljanz can start working as quickly as 3 days. But for some people, it may take up to 8 weeks or longer. Tell your health care provider if your UC symptoms do not improve. Consider keeping a symptoms diary to keep track of when you have bowel movements and their consistency. This can help you and your health care provider find out how well your medicines are working for you.

The most common side effects of Xeljanz include certain types of infections, changes in cholesterol levels, headaches, changes in muscle enzymes, rashes, and diarrhea.

Infections. The most commonly reported infections were nasopharyngitis (the common cold), upper respiratory tract infections, and shingles infections (herpes zoster). Signs of a common cold or an upper respiratory tract infection include a fever, coughing, and a sore throat. Signs of shingles include pain, burning or tingling of the skin, and a painful rash with blisters. To reduce your risk of getting an infection, make sure you are up to date with your vaccines. You should use good hygiene practices, such as disinfecting surfaces, washing your hands, and avoiding touching your face. You should also avoid being in close contact with someone you know is sick and avoid large crowds. Call your health care provider right away if you think you might have an infection.

Cholesterol levels. Xeljanz can increase your cholesterol levels. Your health care provider will monitor your cholesterol with a simple blood test about 4-8 weeks after you start the medicine. The way you live your life can also help your cholesterol. Do your best to exercise and eat a heart-healthy diet to help your cholesterol. 

Headaches. Headaches come in multiple forms, but they typically include pain in the head or face. If you get headaches while taking Xeljanz, talk to your health care provider about which treatment might be the best for you. 

These are not all of the possible side effects of Xeljanz. Talk with your health care provider if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).

Several medicines can interact with Xeljanz. This may increase the risk of side effects from it or can cause it to not work as well.

Inhibitors of cytochrome P450 3A4 (CYP3A4). Cytochrome P450 3A4 is an enzyme that processes and removes some medicines from the body. Taking CYP3A4 inhibitors (medicines that block the activity of CYP3A4) could increase the amount of Xeljanz in your body, which may lead to excessive or dangerous side effects. An example of a drug that can interact in this way is ketoconazole. 

Inducers of cytochrome P450 3A4 (CYP3A4). Taking CYP3A4 inducers (medicines that increase the activity of CYP3A4) could decrease the amount of Xeljanz in your body, causing it to work less well or not work at all. An example of a drug that interacts in this way is rifampin. 

Ask your pharmacist or other health care provider if any of your medicines are CYP3A4 inhibitors or inducers.

Drugs that decrease your immune system. Azathioprine, cyclosporine, and tacrolimus are examples of medications that can decrease your immune system and increase your chances of having an infection. These medications should not be taken with Xeljanz. 

Other medications that can interact with Xeljanz. Fluconazole, an antifungal medication, can interact with Xeljanz to increase the amount in your body, which may lead to excessive or dangerous side effects. 

Live vaccinations. Live vaccinations should be avoided while taking Xeljanz This is because the vaccination may not be as effective and can risk infection. Your health care provider will review your vaccination record before you start Xeljanz and recommend any vaccinations at that time. 

This is not a complete list of medicines that may interact with Xeljanz. Tell your health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions. Do not start or stop other medicines without talking to your health care provider.

Xeljanz requires a prescription from a health care provider. Your primary care provider or gastroenterologist may prescribe it. Xeljanz is considered a specialty drug. Check with your insurance company to see if there is a specific pharmacy you need to use to fill the prescription. You can also check with your local pharmacy to see if they can get the medication for you or if they have a local specialty pharmacy location they can refer you to. 

Xeljanz offers financial services to help you with medication costs. There is a copay card available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out about all the financial services at https://www.xeljanz.com/savings-and-support/#co-pay-savings-program

For questions about cost, insurance coverage, or any other questions related to Xeljanz, you can also contact the drugmaker at 844-935-5269.