Tofacitinib

• Tofacitinib is used to treat Ulcerative Colitis in adults aged 18-65. It can help get your symptoms under control and keep them under control.
• Tofacitinib is not offered to adults over the age of 65 if other treatments are available.
• Tofacitinib is a tablet taken twice a day.
• Tofacitinib may be used if other medicines have not worked well to control your symptoms. It may also be used if you cannot take other medicines for Colitis.
• Tofacitinib can affect your immune system. You may be more likely to get an infection while you are taking tofacitinib. If you have any concerns about infections, talk to your IBD team.
• Tofacitinib should not be used if you are pregnant, planning on becoming pregnant, or breastfeeding. If you could get pregnant, you should use effective contraception while taking tofacitinib and for at least four weeks after stopping.
• You should not have any live vaccines while taking tofacitinib. It is safe to take non-live vaccines, like the yearly injected flu and COVID-19

Tofacitinib is used to treat adults with moderately to severely active Colitis. The aim of this treatment is to get your Colitis into remission. Remission is when you feel better because your Crohn's or Colitis is well-controlled. During this time, medical tests, such as blood tests or endoscopy, show your gut is less affected. Your symptoms, such as diarrhoea, abdominal pain or fatigue, will improve. However, some symptoms, like fatigue, may not go away completely. Keeping your Crohn’s or Colitis under control is good for your long-term health. It lowers your risk of complications and the need for surgery.

Your IBD team may suggest tofacitinib if you:

• Cannot have standard treatments or biologic medicines, or had to stop taking them due to side effects
• Did not respond well enough to standard treatments or biologic medicines
• Have stopped responding to standard treatments or biologic medicines

The order you try medicines in might differ, depending on the advice of your IBD team.

Standard treatments include 5-ASAs, steroids, azathioprine and mercaptopurine. Biologics include adalimumab, golimumab, infliximab, mirikizumab, risankizumab, ustekinumab and vedolizumab. Other treatments for Ulcerative Colitis include sphingosine-1-phosphate receptor modulators like ozanimod. and etrasimod, as well as other JAK inhibitors, such as filgotinib and upadacitinib.

Tofacitinib is a small molecule medicine. Molecules are chains of atoms, the basic building blocks that things are made of. The molecules that make up biologic medicines, such as infliximab, are larger. The immune system sometimes recognises these larger molecules as something harmful. If that happens, the body may produce antibodies. An antibody is a protein that is part of your natural defences. These antibodies prevent the medicine from working as well. Because tofacitinib is a small molecule treatment, antibodies are unlikely to form. This means that tofacitinib is less likely to lose effectiveness over time due to antibody formation. Read more in our information on biologics and other targeted medicines.

Tofacitinib is not usually offered to people with Colitis who are under 18 years old. This is because we do not know how safe it is for younger people, or how well it would work. Tofacitinib is also not usually recommended for people over 65 years old. This is because the risk of serious infections, heart attacks and certain cancers is higher. If you are over 65, tofacitinib may still be an option if other treatments are not suitable for you.

Finally, tofacitinib is not recommended if you have an increased risk of cancer or heart problems. It is also not recommended if you have a history of smoking. But it may still be offered if no other treatment is suitable.

There are lots of things to think about when you start a new medicine. Your IBD team will talk to you about your options. For new medicines, you might want to think about the aim of the treatment and what the pros and cons might be. Some things to think about include: 

• How you take it
• How well it works
• How quickly it works
• Possible side effects
• Whether you need ongoing tests or checks
• Other medicines you are taking
• Other conditions you have
• If you are planning to get pregnant or breastfeed in the next few years
• What happens if you do not take it

You could use our medicine tool to help you think about your options. Our appointment guide has a list of questions you might want to ask your IBD team. We also have information on other medicines or surgery for Crohn’s or Colitis.

At first, tofacitinib is used to get your Colitis symptoms under control. This is called induction treatment. Once your Colitis is under control, tofacitinib aims to keep it under control. This is called maintenance treatment.

Studies have shown that tofacitinib can be effective at managing Colitis. But it does not work for everyone.

Find out more about how we talk about the effectiveness of medicines.

Getting Colitis under control with tofacitinib

There have been two large trials that have looked at how well tofacitinib can get Colitis under control. These trials included adults with moderate to severely active Colitis. Everyone taking part in the trials had already been treated with medicines that had not worked or they had to stop because of serious side effects. The people in the trials did not include those who only had proctitis. Proctitis is inflammation that affects the rectum only.

The people in the trials were given tofacitinib or a placebo. A placebo is a substance that looks the same as the treatment but does not have any medicine in it. Across the two trials 234 people took a placebo and 905 people took tofacitinib.

After eight weeks of taking tofacitinib 10mg twice a day around 6 out of every 10 people (55 to 60%) noticed a positive difference. Around 2 out of every 10 people (17 to 19%) were in remission. Of the people who took placebo, around 1 out of every 20 people (4 to 8%) were in remission.

Keeping Colitis under control with tofacitinib

The people who found tofacitinib was effective after eight weeks were invited to take part in a third trial. This trial looked at how well tofacitinib keeps Colitis under control. Here, people who found tofacitinib effective either continued taking tofacitinib or were switched to a placebo. Of the people who took tofacitinib, some people continued taking 10mg twice a day while others took 5mg twice a day.

After 44 weeks of maintenance treatment with tofacitinib 5mg, around 5 out of every 10 people (51%) noticed a positive difference. Around 3 in every 10 people (34%) were in remission. Of the people who took placebo, around 1 out of every 10 people (11%) were in remission.

Your IBD team will check if tofacitinib is right for you. This will involve asking about any pre-existing conditions and having some tests.

Pre-existing conditions

Let your IBD team know if you have any of the following pre-existing conditions. Tofacitinib might not be right for you if you have:

Tuberculosis

Tell your IBD team if you have a history of tuberculosis, known as TB, or any recent exposure to people with TB. You should also let them know if you have recently travelled to an area with high levels of TB.

You should not be given tofacitinib if you have TB, whether it’s active or inactive. This will need to be treated before you start therapy. Most healthcare professionals now use a blood test to check for underlying or inactive TB, but you may be given a chest x-ray as well.

Infections

Let your IBD team know if you have a current infection or a history of infections. Tofacitinib should not be started if you have an infection. Taking tofacitinib with an infection could make it worse.

Signs of an infection include:

• A high temperature
• Flu-like symptoms
• Coughing and feeling tired or short of breath. This could be a sign of pneumonia.
• Peeing more than usual, or a burning feeling when you pee. This could be a sign of a urinary tract infection.
• A severe headache with a stiff neck. This can be a sign of meningitis. You might also be sensitive to light, feel sick, have a rash, be confused, or have seizures.
• Sore, red skin or a painful skin rash with blisters. This could be a sign of shingles.

Heart problems

Tofacitinib has been associated with an increased risk of heart problems. This includes heart attacks. If you already have heart problems, tofacitinib may make them worse. This risk increases with age and is higher if you smoke or have diabetes. Talk to your IBD team if you have:

• Heart problems, such as heart failure, coronary heart disease
• High cholesterol
• High blood pressure
• A history of fainting
• Have ever smoked
• Have diabetes

If you are at an increased risk of heart attacks, your IBD team may decide that tofacitinib is not right for you.

Blood clots

Tofacitinib may increase the risk of blood clots in the legs or lungs. A blood clot is also more likely to happen if you:

• Are over 60
• Are overweight
• Smoke
• Take the oral contraceptive pill or Hormonal Replacement Therapy, known as HRT
• Have cancer or heart failure
• Have varicose veins

Tofacitinib may not be right for you if you have a high risk of blood clots. Speak to your IBD team if you think you are at risk of blood clots.

Cancer

Anti-TNF medicines are another group of medicines used to treat Crohn’s and Colitis. They include adalimumab, golimumab, and infliximab. Compared to anti-TNF medicines, tofacitinib has been associated with an increased risk of cancer. See more in the section on side effects.

Tell your doctor if you have ever had any cancer or if you have ever smoked. If you are at increased risk of cancer, your IBD team may decide that tofacitinib is not right for you.

Liver problems

If you have severe liver problems, tofacitinib may not be right for you. If you have previously had hepatitis, tofacitinib may increase the risk of it coming back. Your doctor may do blood tests to monitor this.

Blood tests

Before starting tofacitinib, you will have some blood tests. They include:

• Full blood count
• Liver function tests
• Cholesterol

Read more about these blood tests in our information on tests and investigations.

Your IBD team may also want to check if you have been exposed to viral infections. This includes HIV, Hepatitis B and C, EBV, known as Epstein-Barr virus, and chicken pox, known as varicella. They will also screen for tuberculosis. This is to make sure tofacitinib is safe and right for you.

Vaccinations

Tofacitinib affects the immune system and can make you more susceptible to infections. To lower this risk, make sure you are up to date with vaccines before starting tofacitinib.

See our section on vaccinations for more.

Your IBD team will check how well tofacitinib is working. You may need to have a camera put into your mouth or bottom, called an endoscopy. You might also need a poo test, called a faecal calprotectin test. See our information on tests and investigations for more.

You can also expect to have:

• Full blood count blood tests. Tofacitinib can lower the number of white and red blood cells. Your blood count will be monitored to check this. These blood tests will happen four to eight weeks after starting tofacitinib. After this, they should happen three months after that. If your blood count is abnormal, you may have to pause treatment until it improves.
• Cholesterol levels. Tofacitinib can increase cholesterol levels. You will have a cholesterol test eight weeks after starting treatment to check for this.
• Liver function blood tests. Sometimes tofacitinib may cause raised levels of liver enzymes. You will have liver function blood tests now and then to look for this.

Your doctor will give you a Patient Alert Card. This contains important information about what to look out for. You should show this card to any doctor, dentist or healthcare professional that is treating you. Always carry this card with you while you are taking tofacitinib. You should also carry it for at least two months after stopping tofacitinib.

Infections

Tofacitinib affects the way your immune system works. This means you are more likely to get infections. Tell your GP or IBD team if you’re worried about an infection, or if an infection is slow to improve. Treatment with tofacitinib should be paused if you get a serious infection.

Staying up to date on your vaccinations can help reduce the risk of infections. This may include vaccinations for COVID-19, shingles, pneumonia and an annual flu vaccination. See the section on vaccinations for more.

You can find out about other things you can do to look after yourself on our immunosuppressant precautions page.

Skin cancer

Some types of skin cancer have been reported in people who take tofacitinib.

The NHS website has more information on staying safe in the sun.

Fractures

Some people taking tofacitinib may be at increased risk of fractures. This risk is higher in:

• Older people
• Women
• People taking steroids

If you have osteoporosis or are concerned about this risk discuss it with your IBD team. You can find out more in our information on bones.

All medicines can have side effects, but not everyone gets them. Having certain side effects might mean that tofacitinib is not right for you.

• Some side effects can happen right away. Others may happen after you have been taking tofacitinib for a while
• Some side effects are mild. Others may be more serious and could need treatment.
• Some side effects may go away on their own. Others may go away after you stop taking tofacitinib. Some may be long lasting.

Speak to your IBD team if you experience any side effects.

Possible serious side effects

Infections

If you take tofacitinib, you may get infections more easily. This is because tofacitinib affects your immune system. Infections might last longer or be more serious than usual. Sometimes, previous infections can reappear, such as tuberculosis.

Infections you may get include:

• Lung infections, such as pneumonia and bronchitis
• Infections of the nose or throat
• Sinus infections
• Urinary or bladder infections
• Flu

Up to 1 in 10 people may experience serious infections.

Our information on immunosuppressant precautions has tips on what you can do to reduce the risk of infection.  

Shingles

Taking tofacitinib increases the risk of shingles. Shingles is an infection caused by the varicella-zoster virus, which also causes chickenpox. It causes a rash that turns into itchy blisters. This rash is usually on your tummy and chest, but it can develop anywhere on your body. If you develop blister-like skin eruptions contact your GP or IBD team immediately.

Your consultant may recommend you have a shingles vaccination before starting tofacitinib. If you are over the age of 50 and taking tofacitinib you can get the shingles vaccine. Japanese or Korean people may be more likely to get shingles when taking tofacitinib.

Talk to your IBD team if you have any concerns about any new or ongoing symptoms.

Allergic reactions

Some people may be allergic to the ingredients in tofacitinib.

Cancer

Cancer can affect between 1 in 100 to 1 in 1,000 people taking tofacitinib. Compared to anti-TNF medicines, some studies show tofacitinib increases the risk of cancer. In particular, lung cancer and lymphoma (cancer of the lymphatic system). The risk of developing cancer is greater if you:

• Are 65 or older
• Currently smoke or used to smoke
• Have diabetes
• Have a history of heart problems, such as angina or a heart attack

Blood clots

There is an increased risk of developing blood clots if you take tofacitinib. This is thought to affect 1 in 100 to 1 in 1,000 people.

Ring 111 if you develop symptoms of a clot. These include:

• Swelling and pain of your legs or arms with reddened, warm skin
• Breathlessness, sharp chest or back pain and cough

Call 999 or go to A&E if:

• You’re struggling to breathe
• Someone has passed out

Heart attack

Heart attacks are thought to affect 1 in 100 to 1 in 1,000 people taking tofacitinib.

Call 999 or attend A&E if you have symptoms of a heart attack. These include:

• Severe chest pain or tightness, which may spread to arms, jaw, neck and back
• Shortness of breath
• Cold sweats
• Lightheadedness
• Sudden dizziness
• Feeling or being sick
• Coughing or wheezing

Common side effects

Common side effects can affect between 1 in 10 people to 1 in 100 people. These may include:

• Low levels of red and white blood cells
• Headache
• High blood pressure
• Cough
• Tummy pain
• Feeling or being sick
• Diarrhoea
• Indigestion
• Skin issues such as rashes and acne
• Muscle aches
• Swelling of the feet and hands

This is not a full list of side effects. For more information see the Patient Information Leaflet that comes with your medicine. You can also download the leaflet by searching for ‘tofacitinib’ on the Electronic Medicines Compendium or EMC. 

We encourage you to report any side effects to the Medicines and Healthcare Products Regulatory Agency, known as the MHRA. You can do this through the Yellow Card scheme online or by downloading the MHRA Yellow Card app at yellowcard.mhra.gov.uk. This helps collect important safety information about medicines. 

Tell your IBD team about any other medicines you are taking or thinking of taking. This means: 

• Prescribed medicines 
• Over-the-counter medicines 
• Multivitamins or supplements 
• Herbal, complementary or alternative therapies.
• Recreational drugs

There are some medicines known to interact with tofacitinib. Tell your IBD team if you take, or have recently taken:

• Anti-fungals such as fluconazole and ketoconazole, used to treat fungal infections
• Antibiotics such as rifampicin, used to treat bacterial infections
• Medicines that affect the immune system. This includes tacrolimus, ciclosporin, biologics, azathioprine and mercaptopurine
• Anti-epileptic medicines. This includes carbamazepine and phenytoin.
• St John’s Wort
• Warfarin

Your IBD team may need to make adjustments if you take these medicines. This could include reducing your dose or stopping tofacitinib.

Live vaccines

You should not have live vaccines if you take tofacitinib. Live vaccines contain weakened live strains of viruses or bacteria. If you take tofacitinib, the weakened virus could reproduce and cause a serious infection. In the UK, live vaccines include:

• Rotavirus vaccine: babies only 
• Measles, mumps and rubella vaccine, also known as the MMR vaccine – either as an individual vaccine or as the triple MMR vaccine 
• Nasal flu vaccine used in children: the injected flu vaccine used in adults is not live 
• Chicken pox vaccine, which is called varicella 
• BCG vaccine against tuberculosis, or TB 
• Yellow fever  vaccine
• Oral typhoid vaccine: the injected typhoid is not live 

If you have had a live vaccine, you may need to wait between two and four weeks before starting tofacitinib.

It may be safe to have live vaccines three months after stopping tofacitinib. You may be advised to wait longer.

If someone that you live with is due to have a live vaccine

There is a small risk that people who have received live vaccines could pass the virus to close contacts who are immunosuppressed. This could then cause an infection. ​ For most of the live vaccines used in the UK, the virus is not passed on to contacts. You can lower the risk by following simple precautions. This includes washing your hands after direct contact with the person who has had the vaccine, and before preparing food.

Non-live vaccines

It is safe to have non-live vaccines when you are taking tofacitinib.

Everyone with Colitis taking tofacitinib should have the yearly flu vaccine and COVID-19 vaccine. But, flu vaccines may not work as well in people taking tofacitinib. You may also be advised to have the pneumococcal vaccine.

Speak to your GP to arrange any vaccinations you might need. You can also talk to your IBD team if you’re concerned about the safety of any vaccines. If you need vaccinations for travel you may find our information on travel useful.

Tofacitinib should not be used if you are breastfeeding. This is because tofacitinib is passed into the breast milk. We do not know what effect this would have on a breast-feeding baby. So, to be safe, you should avoid breastfeeding while taking tofacitinib.

We have more information on breastfeeding in our postnatal care and breastfeeding resource. 

We follow strict processes to make sure our award-winning information is based on up-to-date evidence and is easy to understand. We produce it with patients, medical advisers and other professionals. It is not intended to replace advice from your own healthcare professional.

We hope that you’ve found this information helpful. Please email us at evidence@crohnsandcolitis.org.uk if:

• You have any comments or suggestions for improvements
• You would like more information about the evidence we use
• You would like details of any conflicts of interest

You can also write to us at Crohn’s & Colitis UK, 1 Bishop Square, Hatfield, AL10 9NE. Or you can contact us through our Helpline by calling 0300 222 5700.

We do not endorse any products mentioned in our information.