The brand name for upadacitinib is Rinvoq.

Upadacitinib is a type of medicine called a Janus kinase (JAK) inhibitor. JAKs are proteins that play a part in activating your immune response. This helps you fight infections. But it can also cause inflammation.

Upadacitinib works by blocking the effects of JAKs. This reduces gut inflammation. Like many other treatments for Crohn’s and Colitis, it also alters your immune system. This can sometimes cause unwanted effects.

Upadacitinib is used to treat adults who have moderate to severely active Crohn's or Ulcerative Colitis. It aims to get your condition under control and keep it under control.

Upadacitinib can only be prescribed by a specialist in a hospital.

If you have Ulcerative Colitis your IBD team might suggest it for you if:

• Standard treatments or biologic medicines have not worked or
• Standard treatments or biologic medicines have stopped working or
• You had to stop standard treatments or biologic medicines because you had bad side effects

If you have Crohn’s, your IBD team might suggest it for you if:

• Biologic medicines have not worked or
• Biologic medicines have stopped working or
• You had to stop biologic medicine because you had bad side effects or
• Biologic medicines called TNF-alpha inhibitors (adalimumab or infliximab) are not suitable for you

If you live in Scotland, you might also be offered upadacitinib for Crohn’s if standard treatments have not worked, have stopped working or had bad side effects.

Standard treatments include aminosalicylates (5-ASAs), oral steroids or immunosuppressants like azathioprine, mercaptopurine or methotrexate. Biologic medicines include infliximab, adalimumab, golimumab, vedolizumab and ustekinumab.

There are lots of things to think about when you start a new treatment. Your IBD team will discuss your options with you. They might give you a choice of different treatments. You should consider the potential benefits, possible risks, and the goals of your treatment together. Things to consider include:

• How you take it
• How often you take it
• How effective it is
• How quickly it’s likely to work
• How long it’s likely to keep working
• Side effects you might get
• Whether you need ongoing tests or checks
• Other medicines you’re on

Our Appointment guide includes a list of questions you might want to ask. It can help you focus on what matters most to you. We also have information on other medicines or surgery for Crohn’s or Colitis that you might find helpful.

Upadacitinib can be effective at improving symptoms and keeping your condition under control. But it does not work for everyone.

Induction treatment and maintenance treatment

At first, the aim of upadacitinib treatment is to reduce the inflammation in your gut and get your condition under control. This is called induction treatment. Once your condition is under control, upadacitinib treatment aims to keep it under control. This is called maintenance treatment.

Some clinical trials look at how well a medicine works as induction treatment. Some look at how well it works as maintenance treatment. Some look at how well it works for both. We do not always have the same information for different medicines or different conditions.

Upadacitinib for Ulcerative Colitis

For Ulcerative Colitis, we have information about how well upadacitinib works for induction treatment and maintenance treatment separately.

Getting Ulcerative Colitis under control with upadacitinib

The table below shows how well the recommended dose of upadacitinib gets Ulcerative Colitis under control after 8 weeks of treatment.

Click to enlarge

More people had their Ulcerative Colitis under control after taking upadacitinib for 8 weeks compared with people who had not been taking upadacitinib (placebo). But not everyone responds to upadacitinib.

People taking the recommended dose of upadacitinib were also less likely than people taking placebo to have:

• An urgent need to go for a poo
• Tummy (abdominal) pain
• Bleeding from their bottom
• Diarrhoea
• Fatigue

Keeping Ulcerative Colitis under control with upadacitinib

In clinical trials of upadacitinib, people who got their Ulcerative Colitis under control after 8 weeks of treatment either carried on taking upadacitinib or switched to placebo for maintenance treatment. For maintenance treatment, the trial looked at how well upadacitinib kept Ulcerative Colitis under control after another 52 weeks of treatment. So people had over a year of treatment in total.

The table below shows how well upadacitinib keeps Ulcerative Colitis completely under control in people who respond to induction treatment.

Click to enlarge

More people taking upadacitinib kept their Ulcerative Colitis under control than people who were not taking upadacitinib (placebo). This included people who had not responded to biologic medicines in the past. But not everyone carried on responding to upadacitinib.

How does upadacitinib compare to other medicines?

There have not been any clinical trials that compared upadacitinib directly to other medicines for Ulcerative Colitis. But there has been an analysis of lots of clinical trials that compared biologic medicines, JAK inhibitors or ozanimod to dummy treatment (placebo). This analysis let the researchers compare the different medicines indirectly.

The analysis found that upadacitinib was better than the other medicines at getting Ulcerative Colitis under control. But it was more likely than other medicines to cause side effects.

Upadacitinib for Crohn's

For Crohn’s, we have information about how well upadacitinib works for induction treatment and maintenance treatment separately.

Getting Crohn’s under control with upadacitinib

The table below shows how well upadacitinib gets Crohn’s under control after 12 weeks of treatment.

Click to enlarge

More people had their Crohn’s under control after taking upadacitinib for 12 weeks compared with people who had not been taking upadacitinib (placebo). But not everyone responded to upadacitinib.

People taking upadacitinib were also more likely than people taking placebo to have improvements in:

• Diarrhoea
• Tummy (abdominal) pain
• Fatigue
• Quality of life

For some people, symptoms started to improve within a few days of treatment.

Keeping Crohn’s under control with upadacitinib

In clinical trials of upadacitinib, people who responded to 12 weeks of upadacitinib treatment either carried on taking upadacitinib or switched to placebo for maintenance treatment. For maintenance treatment, the trial looked at how well upadacitinib kept Crohn's under control after another 52 weeks of treatment.

The table below shows how well upadacitinib keeps Crohn’s completely under control in people whose Crohn’s is completely under control after induction treatment.

Click to enlarge

More people taking upadacitinib kept their Crohn’s under control than people who were not taking upadacitinib (placebo). This included people who had not responded to biologic medicines in the past. But not everyone carried on responding to upadacitinib.

How does upadacitinib compare to other medicines?

There have not been any clinical trials that compared upadacitinib directly to other medicines for Crohn’s. But there has been an analysis of lots of clinical trials that compared upadacitinib or biologic medicines to dummy treatment (placebo). This analysis let the researchers compare the different medicines indirectly.

The analysis found that upadacitinib 45mg was the third best medicine, after infliximab and risankizumab, at getting Crohn’s under control. But upadacitinib 30mg was the best at keeping it under control. It’s important to know that this analysis was carried out before the full clinical trial results for upadacitinib were available, which may change the conclusions.

Everyone responds differently to a new medicine. Some people taking upadacitinib start to feel better within a few days of starting treatment. Many people start feeling better between 2 and 8 weeks. But some people might not feel better at all.

• If you have Ulcerative Colitis and it has not improved within 8 weeks, your IBD team might suggest carrying on at the starting dose for another 8 weeks instead of dropping to a lower dose. If you still do not respond, you will probably need to stop upadacitinib and try a different treatment option.
• If you have Crohn’s and it has not improved within 12 weeks, your IBD team might suggest taking upadacitinib 30mg daily for another 12 weeks instead of dropping to 15mg daily. In clinical trials, about half the people who did not respond to the first 12 weeks of treatment responded after another 12 weeks. If you still do not respond after this, you will probably need to stop upadacitinib and try a different treatment option.

Upadacitinib is a tablet that you take once a day. The tablets come in 15mg, 30mg or 45mg doses.

Try to take the tablet at a similar time each day. Swallow it whole with a drink of water. Do not split, crush or chew the tablet because it could change how much medicine gets into your body.

You can take upadacitinib with or without food. But you should avoid foods or drinks containing grapefruit while you are on upadacitinib because they affect how your body deals with upadacitinib.

If you miss a dose, take it when you remember later that day. But if you miss a whole day, do not take a double-dose to make up for it – just skip the missed dose.

The dosage is different depending on whether you have Ulcerative Colitis or Crohn’s.

For Ulcerative Colitis

Most people start at a dose of 45mg once a day for 8 weeks. You might start on a lower dose if you have serious kidney disease or you’re taking medicines that could interact with upadacitinib. Your IBD team will tell you what dose is suitable for you.

After 8 weeks:

• If you’ve responded to treatment, you drop down to 15mg or 30mg once a day. The aim is to take the lowest dose that keeps your condition under control. In people over 65 and people who are at an increased risk of having a heart attack, a stroke, a blood clot or cancer, the recommended dose for long-term treatment is 15mg once a day.
• If you have not responded to treatment, you may carry on taking 45mg once a day for another 8 weeks. If you respond to this, you drop down to 15mg or 30mg once a day. If you do not respond, you will probably need to stop upadacitinib and try a different treatment option.

For Crohn’s

Most people start at a dose of 45mg once a day for 12 weeks. You might start on a lower dose if you have serious kidney disease or you’re taking medicines that could interact with upadacitinib. Your IBD team will tell you what dose is suitable for you.

After 12 weeks:

• If you’ve responded to treatment, you drop down to 15mg or 30mg once a day. The aim is to take the lowest dose that keeps your condition under control. If going down to 15mg does not work well, you may be able to go back up to 30mg.
• In people over 65 and people who are at an increased risk of having a heart attack, a stroke, a blood clot or cancer, the recommended dose for long-term treatment is 15mg once a day.
• If you have not responded well to the first 12 weeks of treatment, your IBD team might suggest taking 30mg once a day for another 12 weeks. If you still do not respond well, you will probably need to stop upadacitinib and try a different treatment option.

If you respond to upadacitinib and have no serious side effects, you usually carry on taking it for at least a year. Every year, your IBD team should assess you to check whether continuing upadacitinib is the best option. If you, or your IBD team, feel that it is no longer right for you, you should discuss other treatment options together.

Stopping or changing treatment

There are a few reasons why you or your IBD team might think about stopping or changing your treatment:

• Your Crohn's or Ulcerative Colitis is under control
  If your Crohn's or Ulcerative Colitis stays under control for a year or more, you might be able to stop taking upadacitinib. If this is the case, your IBD team will discuss it with you and you’ll make the decision together. You can tell them if you have any concerns about stopping. If you stop upadacitinib and you become unwell again, you should have the option to start upadacitinib treatment again.
• Upadacitinib has not worked
  If your condition has not got better after 16 weeks (for Ulcerative Colitis) or 24 weeks (for Crohn’s) of upadacitinib, your IBD team are likely to suggest stopping upadacitinib and trying a different treatment option.
• Upadacitinib stops working well
  It is possible that upadacitinib could stop working for you over time. If this happens, your IBD team might suggest stopping upadacitinib and trying another treatment.
• You have side effects
  If you have side effects that are serious or hard to manage, stopping upadacitinib might be the best option for you.

If upadacitinib is no longer the best treatment for you, your IBD team should discuss other treatment options with you. You should consider the potential benefits, possible risks, and the goals of your treatment together.

It is safe to take upadacitinib alongside steroids or aminosalicylates (5-ASAs). Clinical trials have not looked at whether it is safe to take it alongside other immunosuppressants, biologic medicines or other JAK inhibitors. Your IBD team will talk to you about whether you need to take other medicines. Most people are unlikely to take upadacitinib alongside other immunosuppressant or biologic medicines.

If you are on steroids when you start upadacitinib, you should be able to gradually stop them if you respond well to treatment. Your IBD team will advise you about this.

Like all medicines for Crohn’s or Colitis, upadacitinib alters your immune system. So you may not be able to fight off infections as well as you used to. Because of this, any inactive viruses you have in your body, like the viruses that cause chicken pox or cold sores, could become active again. Before you start upadacitinib, your IBD team will ask you some questions and do some tests to make sure it’s suitable for you. They are likely to:

• Check if you’ve ever had chicken pox, shingles, TB (tuberculosis), cold sores or genital herpes
• Ask if you’ve ever travelled to or lived in a place where TB is very common or if you live with anybody who’s had TB
• Make sure all your vaccinations are up-to-date
• Take blood tests to check for hepatitis viruses, the chicken pox or shingles virus, and HIV
• Take blood tests to measure your red blood cell count, white blood cell count, liver function and cholesterol level
• Do a chest X-ray and blood test to check for TB

If you have an infection, you might need to delay starting upadacitinib until it’s been treated. If you get lots of infections or you have a long-term infection, upadacitinib might not be suitable for you.

You should not take upadacitinib if you have active TB. If you have underlying, inactive TB, it needs to be treated before you start upadacitinib.

After you start upadacitinib, you should have regular checks to see how well it is working. Your IBD team will ask about your symptoms and any side effects you’re getting. They will also check for any signs of infection.

Upadacitinib can sometimes cause a low red or white blood cell count. You usually have blood tests every 3 months during treatment to check your level of white blood cells and test for anaemia (low red blood cells). You also have blood tests from time-to-time to check your liver function, cholesterol and levels of a protein called creatine kinase. Upadacitinib can sometimes affect these. Creatine kinase levels also increase after heavy exercise so try to avoid exercising heavily before having your blood tests.

Your IBD team should tell you what tests you’ll have and when you need them.

Once you’ve got used to upadacitinib, you should have a check-up with your IBD team at least every year. This is to check if you are still responding to upadacitinib or whether you need to change the dose or stop treatment.

There are some things that might mean upadacitinib is not right for you, or could have a higher risk of causing serious side effects.

If you are taking upadacitinib, your doctor might give you a patient card that tells you important safety information.

Infections

Upadacitinib alters your immune system, so your body might not fight off infections as well as other people. You might get more infections than you used to. Or they might last longer or be more serious than usual.

More than 10 in every 100 people taking upadacitinib might get a cold, a cough or a throat or sinus infection. Up to 1 in every 100 people taking upadacitinib might get shingles, cold sores, chest infections, skin infections, flu or urine (pee) infections.

Less than 1 in every 100 people taking upadacitinib might get a more serious infection, like pneumonia, sepsis or a skin infection called cellulitis.

If you have an infection, you may need urgent treatment. Your IBD team might advise you to stop taking upadacitinib until you are better.

To reduce your risk of getting an infection, try to avoid close contact with people who have infections. It’s sensible to wash your hands often, especially before meals and after using the toilet. And take care to store and prepare food safely.

Risk of cancer

In theory, there is a risk that upadacitinib might slightly increase your risk of getting some cancers. This is because of the way it affects your immune system. But there is not enough evidence yet to know for sure. In clinical trials of upadacitinib, cancers were rare, but longer term studies are needed to understand this fully. If you have cancer, or you’ve had cancer in the past, upadacitinib might not be the right choice for you.

Certain types of skin cancer (non-melanoma skin cancer) have been seen in people taking upadacitinib. Your doctor should carry out regular skin examinations to check for any signs.

To be safe, it’s a good idea to:

• Go to any routine cancer screening you’re invited to
• Contact your GP if you have any skin growths, new moles or moles that have changed
• Protect your skin from the sun – cover up, use sunscreen and stay in the shade if you can
• Stop smoking

Blood clots

Some medicines that work in a similar way to upadacitinib have been linked to an increased risk of getting blood clots in your legs or lungs. Most of the evidence comes from people with rheumatoid arthritis who were over 50 and had other risk factors for heart disease. We do not know whether the risk is the same for people with Crohn’s or Colitis. In clinical trials of upadacitinib for Crohn's and Colitis, blood clots were rare.

Your chance of getting blood clots during treatment is higher if you also have other factors that increase your risk, like:

• You’re over 65
• You’re obese
• You smoke
• You’ve had a blood clot before
• You’ve had major surgery
• You don’t move around much
• You’re taking the combined oral contraceptive pill

Having active Crohn’s or Colitis also increases your risk of getting blood clots. Effective treatment that gets your condition under control may help reduce the risk, so it’s a balance between the risks and benefits.

To be safe, if you have any of these factors, upadacitinib might not be the best treatment option for you.

The NHS has more information about blood clots.

Diverticulitis

Diverticula are small bulges or pouches in the bowel wall. They are very common, especially in people over 60. Most of the time, they do not cause any symptoms. If they do, it’s called diverticular disease. Sometimes, diverticula can get inflamed. This is called diverticulitis. It can be serious. Rarely, it can cause a hole in the bowel.

Between 1 and 10 in every 1000 people taking upadacitinib might get diverticulitis. But in clinical trials, nobody taking upadacitinib got a hole in their bowel.

To be safe, upadacitinib might not be the best treatment option for you if:

• You have diverticular disease
• You’re on long-term treatment with other medicines that increase your risk of getting diverticulitis

All medicines can have side effects, but not everyone gets them. Some side effects can happen right away, others might happen later.

Some side effects are mild and may go away on their own or after you stop taking upadacitinib. Others may be more serious and could need treatment. Some side effects might mean that upadacitinib is not right for you.

In most clinical trials, the risk of getting side effects was similar in people taking upadacitinib to people not taking upadacitinib (the placebo group).

We also encourage you to report any side effects to the Medicines and Healthcare Products Regulatory Agency (MHRA). You can do this through the Yellow Card scheme online or by downloading the MHRA Yellow Card app. This helps collect important safety information about medicines.

Some people might get serious side effects that need urgent treatment. These do not happen often, but it is important to know what to look out for.

Between 1 and 10 in every 1000 people taking upadacitinib might have a serious allergic reaction.

Most common side effects

Here, we list the most common side effects of upadacitinib. These might affect up to 1 in every 10 people taking upadacitinib.

• Common cold, sore throat or sinus infection (these may affect more than 1 in every 10 people taking upadacitinib)
• Spots (acne - this may affect more than 1 in every 10 people taking upadacitinib)
• Infections
• Cough
• Headache
• Feeling sick
• Tummy pain
• Fatigue
• Rash
• Itching
• High temperature
• Non-melanoma skin cancer
• Low red blood cell count or white blood cell count
• High level of cholesterol or other fats in your blood
• Changes to your liver or kidney function on blood tests

This is not a full list of side effects. There is information about less common side effects of upadacitinib in the Patient Information Leaflet. This is also called a Package Leaflet. It should be in the box with your medicine. You can also get it online: Patient Information Leaflet for upadacitinib.

Some medicines can affect how upadacitinib works. These include:

• Some antibiotics, like rifampicin and clarithromycin
• Medicines used to treat fungal infections, like ketoconazole, itraconazole, posaconazole, voriconazole
• Phenytoin, a medicine used to treat epilepsy

This is not a full list. Speak to your doctor or pharmacist if you’re taking, or plan to take, any other medicines. This includes medicines you buy from a pharmacy or supermarket, as well as herbal, complementary, or alternative medicines.

We do not know if it is safe to have live vaccines when you are taking upadacitinib.

Live vaccines are made using weakened versions of living viruses or bacteria. If you have a lowered immune system, there is a possibility they might cause infections. Live vaccines routinely used in the UK include:

• TB vaccine
• Some shingles vaccines – but a non-live version is also available for some at-risk people
• Chickenpox vaccine
• Measles, mumps and rubella vaccines
• Nasal flu vaccine used in children – but the injected flu vaccine used in adults is not live
• Rotavirus vaccine
• Yellow fever vaccine
• Oral typhoid vaccine – but the injected typhoid vaccine is not live

If someone you live with is due to have a live vaccine, ask your IBD team if you need to take any precautions.

Everyone with Crohn's or Colitis taking a medicine that alters the immune system should be invited to have the flu vaccine every year. You may be advised to have the pneumococcal vaccine. You are also eligible for all doses of COVID-19 vaccination. These are not live vaccines and it is safe to have them while you are taking upadacitinib.

There is very little information about the use of upadacitinib in pregnancy. But studies in animals suggest that it may harm unborn babies. Talk to your IBD team if you're pregnant or planning to get pregnant. They can discuss your treatment options with you.

We do not know if upadacitinib affects fertility. Studies in animals indicate that it does not, but this has not been tested in humans.

We have separate information about Reproductive health, Pregnancy and breastfeeding.

In studies on animals, upadacitinib passed into breastmilk. But this has not been tested in humans so we do not know whether this is true in humans too.

If you are thinking about breastfeeding, talk to your IBD team. They can help you decide whether to:

• Stop upadacitinib while you are breastfeeding
• Not breastfeed so you can carry on taking upadacitinib

We have separate information about Pregnancy and breastfeeding.

There is no evidence that drinking alcohol affects the way your body deals with upadacitinib. But to keep the health risks from alcohol low, it is best to keep to recommended limits.

Taking medicines and managing side effects can be difficult – we understand and we’re here to help. Our Helpline can answer general questions about treatment options and can help you find support from others with the conditions.

Your IBD team are also there to help. You can talk to them about your medicine, how they’ll be monitoring you and what other options there might be. You should also get in touch with your IBD team if you have any new symptoms or side effects.

It can take time to find the medicine that’s right for you. Don’t be afraid to ask questions and seek out extra support when you need it.

This information is general and does not replace specific advice from your health professional. Talk to your GP or IBD team for information that’s specific to you.

We follow strict processes to make sure our information is based on up-to-date evidence and easy to understand.

Please email us at evidence@crohnsandcolitis.org.uk if:

• You have any comments or suggestions for improvements
• You would like more information about the sources of 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 contact us through our Helpline: 0300 222 5700