Ustekinumab

• Ustekinumab is used to treat Crohn’s and Colitis.
• Ustekinumab can be given to adults. It can also be used to treat children who weigh 40kg or more.
• It can help get your symptoms under control and keep them under control. But it does not work for everyone.
• You have your first dose of ustekinumab through a drip into a vein. After this, you have it as an injection under your skin. You may be able to learn to do this yourself at home. You usually take it every 8 or 12 weeks.
• You may be more likely to get an infection while you are taking ustekinumab. Contact your IBD team straight away if you think you have an infection.

Your IBD team can help if you have any concerns about your ustekinumab treatment.

Ustekinumab is used to treat adults with moderate to severely active Crohn’s or Colitis. It can also be used to treat children who weigh at least 40kg.

It aims to get your Crohn’s or Colitis under control and keep it under control. 

Ustekinumab can only be prescribed by a specialist in a hospital. Your IBD team might suggest ustekinumab if standard treatments or another biologic medicine:

• Have not worked
• Have stopped working
• Have caused side effects that are severe or difficult to manage
• Are not suitable for you

Standard treatments include:

• Aminosalicylates, known as 5-ASAs
• Steroids
• Immunosuppressants, including
  • Azathioprine
  • Mercaptopurine
  • Methotrexate
• Biologics, including
  • Adalimumab
  • Golimumab
  • Guselkumab
  • Infliximab
  • Mirikizumab
  • Risankizumab
  • Ustekinumab
  • Vedolizumab

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 think about the possible benefits and risks, and the goals of your treatment together. Things to consider include:

• How you take it
• How well it works
• How quickly it’s likely to work
• Side effects you might get
• Whether you need ongoing tests or checks
• Other medicines you’re taking

Our appointment guide includes a list of questions you might want to ask a healthcare professional about this medicine. 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.

Understanding clinical trial results

The information below shows the results of clinical trials. These looked at how effective ustekinumab is. To find this out, scientists compared people who took ustekinumab with people who took a placebo. A placebo is something that looks the same as the treatment but does not have any medicine in it.

You can find out more about clinical trials in our information on talking about the effectiveness of medicines. 

Getting Crohn’s under control

Two large clinical trials have looked at how effective ustekinumab is at getting Crohn’s under control. These trials compared ustekinumab to a placebo in people with moderately to severely active Crohn’s. Some of these people had already been treated with other biologic medicines. Some had not.

After six weeks of treatment with ustekinumab, around 5 in every 20 people, or 24%, had their Crohn’s in remission. And around 4 in every 20 people, or 19%, improved but did not have their Crohn’s completely under control.

Of those who took a placebo, around 3 in 20 people, or 13% were in remission. And 2 in every 20 people, or 12% improved but did not have their Crohn’s completely under control.

The clinical trials showed that around twice as many people got their Crohn’s under control, compared with people taking a placebo. But ustekinumab did not work well for everyone. Some people who did not respond after six weeks may have responded with more doses of ustekinumab. 

The table below shows the data from these clinical trials. 

Click here to see a larger image of this table.

Keeping Crohn’s under control

Another clinical trial looked at how effective ustekinumab was at keeping Crohn’s under control. This trial used people who had responded to ustekinumab treatment and were in remission. In the trial, some of them carried on taking ustekinumab, while others were switched to a placebo. Some of these people had already been treated with other biologic medicines. Some had not.

After 44 weeks of treatment with ustekinumab, around 10 in every 20 people, or 51%, were still in remission. 

Of those who took a placebo, around 7 in every 20 people, or 36% were still in remission. 

The clinical trials showed that more people kept their Crohn’s under control with ustekinumab compared to a placebo. But ustekinumab did not carry on working for everyone. 

The table below shows the data from these clinical trials. 

Click here to see a larger image of this table.

Evidence from using ustekinumab in the real world, outside clinical trials, has shown similar results to this trial.

A long-term trial followed up people treated with ustekinumab for 5 years. Overall, around 10 in 20 people, or 45 to 55%, who responded to treatment with ustekinumab were still in remission after five years.

Perianal fistulas

Some small trials suggest ustekinumab might be effective at treating perianal fistulas in people with Crohn’s. A perianal fistula connects the very end of the bowel to the skin near the bottom, where poo leaves the body.

Most of the trials that looked at how well ustekinumab works in people with perianal fistulas were small and did not include a placebo group. It’s difficult to know for sure how effective it is, but it may be helpful for some people.

We have separate information on fistulas.

Ustekinumab can be effective at improving symptoms and keeping your Colitis under control. But it does not work for everyone. Different medicines work for different people, and it may take time to find the medicine that is right for you.

Understanding clinical trial results

The information below shows the results of clinical trials. These looked at how effective ustekinumab is. To find this out, scientists compared people who took ustekinumab with people who took a placebo. A placebo is a substance that looks the same as the treatment but does not have any medicine in it.

You can find out more about clinical trials in our information on talking about the effectiveness of medicines. 

Getting Colitis under control

One large clinical trial looked at how effective ustekinumab was at getting Colitis under control. This trial compared ustekinumab to a placebo in people with moderately to severely active Colitis.  Some of these people had already been treated with other biologic medicines. Some had not.

After eight weeks of treatment with ustekinumab, around 3 in every 20 people, or 16%, had their Colitis in remission. And around 8 in every 20 people, or 41%, improved but did not have their Colitis completely under control.

Of those who took a placebo, around 1 in every 20 people, or 5% were in remission. And around 5 in every 20 people, or 26%, improved but did not have their Colitis completely under control.

The clinical trial showed that around three times as many people had their Colitis under control with ustekinumab, compared to a placebo. But ustekinumab did not work well for everyone. Some people who did not respond after eight weeks may have responded with more doses of ustekinumab. 

The table below shows the data from these clinical trials. 

Click here to see a larger image of this table.

Keeping Colitis under control with ustekinumab

In the same clinical trial as above, researchers asked those people who were in remission after eight weeks of taking ustekinumab to carry on the trial. This next stage of the trial looked at how effective ustekinumab was at keeping Colitis under control. In the trial, some people carried on taking ustekinumab, while others were switched to a placebo. Some of these people had already been treated with other biologic medicines. Some had not.

After 44 weeks of treatment with ustekinumab, around 12 in every 20 people, or 62%, were still in remission. 

Of those who took a placebo, around 8 in 20 people, or 38% were still in remission. 

The clinical trial showed that more people kept their Colitis under control with ustekinumab, compared to a placebo. But the ustekinumab did not carry on working for everyone. 

The table below shows the data from these clinical trials. 

Click here to see a larger image of this table.

A longer-term trial followed up on people treated with ustekinumab for two years. Overall, around 14 in 20 people, or 65 to 68%, who responded to treatment with ustekinumab were still in remission after two years.

Your first dose

You have your first dose of ustekinumab through a drip into a vein. This is called an intravenous infusion. You go to hospital to have this infusion. It takes about one hour to have the dose.

The doctor or nurse should flush your drip through with a solution of saline. Saline is a mix of salt and water. This is to make sure that all the ustekinumab goes into your vein, and none is left in the drip. The flush should not be painful, but it may feel a bit cold. 

You will be monitored for a while after your infusion to make sure you do not have a reaction to the medicine. 

Your second dose

You have your second dose eight weeks later. This is called a subcutaneous injection. A doctor or nurse will give you the injection. They usually come to your home to do it.

Ongoing treatment

After your second dose, you will usually have an injection under your skin every eight or twelve weeks, depending on how well you respond to treatment. Your IBD team will tell you how often you need it. 

Depending on your symptoms, your IBD team may suggest another infusion of ustekinumab or a shorter time between your doses. This may be shortened to every six or four weeks.

Once you are used to having ustekinumab, your doctor or nurse will agree for you to be trained on how to inject it yourself at home. This training may be given by your homecare medicines service. This is the company that will deliver your medicine. If you’re not comfortable injecting yourself, tell them. They could teach a friend or family member to do it for you. Or they might be able to arrange for a nurse to give you your injection at home.

Taking ustekinumab at home

Ustekinumab injections are available as a pre-filled syringe or a pre-filled injection pen. Currently, only the pre-filled syringes are available for children.

You have your ustekinumab injections delivered directly to your home. They come in a box containing either one pre-filled syringe or one pre-filled injection pen. Each syringe or pen contains one dose of medicine. Ustekinumab is free for people who are entitled to NHS care.

Storing your medicine

For both the pre-filled syringe and the pre-filled pen:

• You must keep ustekinumab in the fridge at a temperature of 2°C to 8°C.
• Do not freeze it.
• If you need to, you can keep this medicine out of the fridge at room temperature, up to 30°C, for a short time. The number of days that you can keep it out of the fridge will depend on the brand of ustekinumab you use. Check the package insert that comes with your medicine for how long you can store it outside the fridge.
• If you store your ustekinumab out of the fridge, keep it in its box to protect it from light. Write the date you took it out of the fridge on the box.
• Once ustekinumab has been out of the fridge at room temperature, do not put it back in the fridge.
• Do not shake the medicine as this may damage it.

Tips on injecting

You will be given training on how to inject yourself with ustekinumab. The patient information leaflet also contains detailed instructions on what to do. This can be found in the box your medicine comes in. It is sometimes called a package leaflet. You can also get it online at the Electronic Medicines Compendium website.

One of the most common side effects of ustekinumab is pain and redness at the injection site. These tips can help:

• Allow your medicine to come up to room temperature
  It can be uncomfortable if you inject yourself with ustekinumab straight from the fridge. Take your injection out of the fridge about 30 minutes before you inject. This means it can warm to room temperature. Do not warm the injection in any other way, such as in hot water or a microwave.
• Apply an ice pack before you inject
  You might find it helpful to apply an ice pack to the injection area for two to three minutes before you inject. If you do this, put a thin towel under the ice pack or wrap it in a cloth so it does not damage your skin.
• Choose your injection site
  The upper thigh or tummy, away from the belly button, are good places for the injection. Avoid any areas where the skin is red, scarred, bruised or hard. Do not use the same place every time.
• Wash your hands and clean the skin at the injection site
  Wash your hands with soap and water. Make sure the skin at the injection site is also clean before you inject. You can use an alcohol wipe to do this. This helps to lower the risk of infection.
• If using a pre-filled syringe, use a good injection technique
  Gently pinch the skin at the injection site between your thumb and finger. Use a quick, dart-like motion to insert the needle into the skin. Push the plunger slowly and evenly to inject all of the medicine, keeping the skin pinched.
• Apply an ice pack after you inject
  Some people recommend applying an ice pack or cold, damp towel to the area for 10 to 15 minutes after you have injected. This can help with pain at the injection site. Remember to put a thin towel under the ice pack or wrap it in a cloth.
• Wear loose clothing
  Wear loose clothing to avoid rubbing or pressure on the injection site

If you have problems injecting your ustekinumab, ask your IBD team for help

Your IBD team will review your treatment regularly to check whether it is still the best option for you.

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 Colitis is under control
  If your Crohn’s or Colitis stays under control for a year or more, you might be able to stop taking ustekinumab. If this is the case, you and your IBD team will make the decision together. If you stop ustekinumab and you become unwell again, you should have the option to start ustekinumab treatment again.
• Ustekinumab has not worked
  Your IBD team may suggest that you stop taking ustekinumab if it has not worked by:
  o    16 weeks after your first infusion, or
  o    16 weeks after switching to eight-weekly injections.
• Ustekinumab stops working well
  Some people make antibodies that stick to ustekinumab and stop it working. This happens to around 5 in 100 people over two to five years of treatment.
• You have side effects
  If you have side effects that are serious or hard to manage, stopping ustekinumab might be the best option for you.
• Difficulty injecting yourself
  If you are struggling with the injections, you might prefer to try a treatment you can take by mouth or have through a drip in hospital. Or you could ask your IBD team if there is an option for you to be given injections at home.

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

In theory, some immunosuppressants, such as ustekinumab, may slightly increase your risk of getting cancer. This risk is very small.

Clinical trials of ustekinumab found that people taking ustekinumab had a similar rate of cancer to the general population.

Another study looked at the effect of ustekinumab on the risk of cancer among people who had a history of cancer. The study found that the risk of cancer was the same for people taking ustekinumab, compared to people who had not.

However, if you have cancer or have had cancer in the past, ustekinumab might not be the right choice for you. 

To lower your risk of skin cancer, your doctor may carry out regular checks of your skin.

To lower your own risk of cancer, it is a good idea to:

• Go to any routine cancer screening you’re invited to.
• Contact your GP if you notice any changes to your body that you are worried about. The NHS website has information on symptoms to watch out for.
• Practice good sun safety. This includes:
  o    Wearing a hat
  o    Using high-factor sunscreen
  o    Staying in the shade
  o    Avoiding sunbeds

The NHS website has more tips for staying safe in the sun.

Very rarely, people taking ustekinumab may develop a condition similar to lupus. Contact your GP, IBD team or NHS 111 straightaway if: 

• You get a skin rash, especially if it’s on a part of your skin that’s exposed to the sun, and
• You also have joint pains. 

If you develop a condition related to lupus, your IBD team might advise you to stop taking ustekinumab. Tell your IBD team if you have had lupus in the past before starting ustekinumab.

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.

Possible serious side effects

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.

Allergic reactions

Up to 1 in every 100 people taking ustekinumab might have an allergic reaction. But serious allergic reactions are rare. Less than 1 in every 1,000 people taking ustekinumab get them.

After the allergic reaction has been treated, contact your IBD team to let them know what has happened.

Infections

Ustekinumab alters your immune system. This means 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.
Up to 1 in every 10 people taking ustekinumab might get: 

• A cold
• A cough
• A throat infection
• A sinus infection

Up to 1 in every 100 people taking ustekinumab might get more serious infections, like:

• A chest infection
• A skin infection
• Shingles

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

To lower your risk of getting an infection, try to:

• Avoid close contact with people who have infections
• Wash your hands often, especially before meals and after using the toilet
• Take care to store and prepare food safely

Find out more about immunosuppressant precautions.

Most common side effects

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

• Common cold, sore throat or sinus infection
• Feeling dizzy
• Headache
• Diarrhoea
• Feeling sick or being sick
• Itching
• Back pain, muscle pain or joint pain
• Feeling tired
• Pain or redness where the injection went in

This is not a full list of side effects. There is information about less common side effects of ustekinumab 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 on the Electronic Medicines Compendium website.

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 biologic medicine should have the flu jab 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 they are safe to have when you are taking ustekinumab.

We have not found any clinical trials that looked at the best time to have vaccinations in relation to your ustekinumab dose. But in general, people taking ustekinumab for Crohn’s or Colitis respond well to vaccination.

Contraception

Drug manufacturers advise you to use effective contraception while taking ustekinumab and for at least 15 weeks after you stop treatment. This is to prevent pregnancy.

Pregnancy

Ustekinumab did not have harmful effects on pregnancy during studies in animals. Studies in humans have not found any sign that ustekinumab causes problems during pregnancy or to babies exposed during pregnancy. But the number of people who have taken ustekinumab while they were pregnant is fairly small.  For this reason, manufacturers suggest not to take it during pregnancy. However, experts agree that taking ustekinumab while you’re pregnant is probably a low risk. 

Speak to your IBD team if you are offered or are taking ustekinumab and want to start a family. They can help you make an informed decision about your care and your baby's safety. 

If you take ustekinumab during pregnancy, always make sure you go to any scheduled prenatal scans.

Unplanned pregnancy

Contact your IBD team straight away if you take ustekinumab and find out you are pregnant. If you cannot contact your IBD team, speak to your GP. Your GP may be able to help you contact your IBD team. 

Do not stop taking your medicine until you have spoken to your healthcare professional.

If you have taken ustekinumab during the early part of your pregnancy, always make sure you go to any scheduled prenatal scans.

Find out more about pregnancy and birth with Crohn’s or Colitis.

Your baby and live vaccines

Tell your baby’s healthcare team if you took ustekinumab during your pregnancy. If you did, you may be told that your baby should not have live vaccines until they are a bit older. This includes the rotavirus vaccine and the BCG vaccine for tuberculosis. 

The BCG vaccine is not routinely given as part of the NHS vaccination schedule but is sometimes recommended. For these vaccinations, you may need to wait until your baby is between six and 12 months old or until ustekinumab cannot be found in your baby’s blood. But sometimes the benefit of giving a live vaccine earlier may be greater than the potential risk.

Taking ustekinumab during pregnancy should not affect the rest of your baby’s vaccination schedule. You might want to discuss this with your IBD team and your baby’s healthcare team. Decisions on what vaccines your baby should have, and when, will be made on an individual basis. Your IBD team and midwife or baby’s healthcare team should be able to help you make a decision.

If you take ustekinumab, you should take extra care if your baby has the rotavirus vaccine. Live virus can be found in the baby’s poo for a few weeks. Make sure you wash your hands or wear gloves when changing their nappy.
We have separate information about reproductive health and fertility and pregnancy and birth.

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

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.