• Risankizumab is used to treat Crohn’s. It can help get your symptoms under control and keep them under control. But it does not work for everyone.
• Risankizumab is free throughout the UK for people who are entitled to NHS care.
• You have your first three doses of risankizumab through a drip into a vein. You have one dose every 4 weeks.
• After this, you have it as an injection under your skin. You can learn to do this at home using a special on-body injector. You have one injection every 8 weeks.
• Risankizumab alters your immune system, so your body might not be able to fight off infections as well as it used to. Contact your IBD team straight away if you think you have an infection.
• If you could get pregnant, you are advised to use effective contraception while you are on risankizumab and for at least 21 weeks after you stop treatment.
• If you're taking risankizumab and you’re pregnant or planning to get pregnant, talk to your IBD team. They can discuss your treatment options with you.
• You should not have live vaccines when you are taking risankizumab and for at least 21 weeks after you stop treatment.

If you have any concerns about risankizumab treatment, contact your IBD team.

The brand name for risankizumab is Skyrizi.

Risankizumab is an antibody that’s made by living cells in a lab. It is a type of biologic medicine.

Antibodies are proteins that recognise and stick to specific targets. Risankizumab sticks to a target called IL-23. Your immune system naturally makes IL-23 to help you fight infections. But in people with Crohn’s, it can also cause inflammation. Risankizumab blocks the effects of IL-23. This reduces gut inflammation. But, like many other treatments for Crohn’s, it also alters your immune system.

Risankizumab is used to treat over 16s in England and Wales with moderate to severely active Crohn’s. In Northern Ireland it is used to treat over 18s, although it can sometimes be given to 16- and 17-year-olds if biologic medicines are not suitable. It aims to get your Crohn’s under control and keep it under control.

Risankizumab can only be prescribed by a specialist in a hospital. Your IBD team might suggest it for you if you have Crohn’s and:

• You did not respond well enough to another biologic medicine or
• You stopped responding to another biologic medicine or
• You had to stop another biologic medicine because you had bad side effects or
• Biologic medicines called TNF-alpha inhibitors (adalimumab or infliximab) are not suitable for you

Risankizumab is available to treat Crohn’s on the NHS throughout the UK.

Risankizumab is also used to treat a skin condition called psoriasis, and arthritis linked to psoriasis.

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

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

Risankizumab can be effective at improving symptoms and keeping your Crohn’s under control. But it does not work for everyone.

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

Getting Crohn’s under control with risankizumab

These results come from two large clinical trials of risankizumab induction treatment. The trials compared risankizumab to dummy treatment (placebo) in people with moderate to severely active Crohn’s. Everybody in the trials had already been treated with Crohn’s medicines that had not worked or had stopped working. Some of them had already been treated with biologic medicines. Some had not.

The table below shows how well the recommended dose of risankizumab got Crohn’s under control after 12 weeks of treatment.

How well risankizumab got Crohn’s under control

More people had their Crohn’s under control after 12 weeks of risankizumab treatment than 12 weeks of dummy treatment. But not everyone responded to risankizumab.

People taking the recommended dose of risankizumab were also more likely than people taking dummy treatment to have an improvement in:

• Diarrhoea
• Tummy (abdominal) pain
• Fatigue

Keeping Crohn’s under control with risankizumab

In clinical trials of risankizumab, people whose Crohn’s improved after 12 weeks of treatment either carried on taking risankizumab or switched to dummy treatment for maintenance treatment. The trials looked at how well risankizumab kept Crohn’s under control in people whose Crohn’s had improved on induction treatment. It’s important to know that not everyone in these trials had their Crohn’s completely under control at the start of maintenance treatment. Overall 59 in every 100 people in the trial did, and 41 out of every 100 did not. This was the same in both treatment groups.

The table below shows how many people had their Crohn’s completely under control after a year of maintenance treatment.

How well risankizumab kept Crohn’s under control

More people had their Crohn’s completely under control after taking risankizumab maintenance treatment than after taking dummy maintenance treatment. This included people who had not responded to biologic medicines in the past. But not everyone carried on responding to risankizumab.

Everyone responds differently to a new medicine. Most people who respond to risankizumab start feeling better within 4 to 12 weeks. In some people it could take longer. Some people might not respond at all.

You cannot take risankizumab by mouth because it is broken down by the gut, which stops it working. Instead, you have it through an intravenous infusion (drip) for your first three doses, and then as an injection under your skin.

• You have your first three doses of risankizumab through a drip into a vein. This is called an intravenous infusion. You go to hospital to have it. It takes about 1 hour to have the infusion. You have one infusion every 4 weeks.
• After three infusions, you switch to having risankizumab as an injection under your skin. You have it through a special injector that you stick to your skin, called an on-body injector. Your doctor or nurse will teach you how to use it yourself at home. 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.
• You have your first injection 12 weeks after your first dose of risankizumab. This will be 4 weeks after your last infusion.
• After this, you have an injection every 8 weeks.

Taking risankizumab at home

Risankizumab comes in a box containing one cartridge of medicine and one on-body injector. The cartridge and injector are single-use only.

You must keep risankizumab in the fridge at a temperature of 2°C to 8°C. Do not freeze it. You can keep it out of the fridge for up to 24 hours, but at no more than 25°C. Keep it in its box to protect it from light.

Do not use any doses that are past their expiry date or have ever been frozen, even if they have thawed. Your pharmacist can tell you how to dispose of them.

Tips on injecting

Your doctor or nurse will teach you how to inject yourself with risankizumab. The Patient Information Leaflet also contains detailed instructions on what to do. This is in the box. It is sometimes called a Package Leaflet. You can also get it online: Patient Information Leaflet for risankizumab injection.

Using the on-body injector might seem a bit daunting at first. But in clinical trials, over 9 in 10 people who used it said it was easy or very easy to use from the first dose.

One of the common side effects of risankizumab 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 risankizumab straight from the fridge. Take it out of the fridge around 45 to 90 minutes before you inject it. Leave it in its box and let it come up to room temperature naturally. You should not warm it in any other way, such as in hot water, in a microwave or by rubbing or rolling it in your hands.
• Choose your injection site
  The upper thigh or tummy (away from the belly button) are good places for the injection. Avoid any areas where your skin is red, scarred, bruised or hard. Do not use the same place every time.

• Wash your injection site
  Make sure the skin is clean before you inject yourself. This is to help prevent infections.
• Make sure the on-body injector sticks well
  Let your skin dry completely and choose a place where the on-body injector will stick well. If you’re injecting your tummy, pull your skin gently to create a firm, flat surface. Avoid skin folds and bulges. Do not move the on-body injector once you have stuck it on.
• Try not to move around too much
  Once you’ve started the on-body injector, it takes around 5 minutes for the whole dose of medicine to go in. You can walk around, bend and reach but try not to be too active.

Check your skin afterwards
When you remove the on-body injector, there might be a few drops of liquid on your skin and the injection site might bleed slightly. Press a cotton wool ball or pad over the injection site for about 10 seconds.

For your first three doses, you have 600mg of risankizumab every 4 weeks. These are the doses you have in hospital through a drip.

After this, all the rest of your doses are 360mg. This is one cartridge of medicine that you have through an on-body injector every 8 weeks. If you miss a dose, take it as soon as you remember.

How long to take risankizumab

If you respond to risankizumab and have no serious side effects, you are likely to carry on taking it for at least a year. Every year, your IBD team should assess you to check whether continuing risankizumab 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 is under control
  Your IBD team will review how well you are responding to risankizumab at regular intervals during your maintenance treatment. If your Crohn’s stays under control for a prolonged period (usually a year or more), you might be able to stop taking risankizumab. If this is the case, your IBD team will discuss it with you and make the decision together. You can tell them if you have any concerns about stopping. If you stop risankizumab and you become unwell again, you should have the option to start risankizumab treatment again.
• Risankizumab has not worked
  Your IBD team will review your response to risankizumab during the induction period. If your Crohn’s does not get better when you’re taking risankizumab, they might suggest stopping risankizumab and trying a different treatment option.
• Risankizumab stops working well
  Some people make antibodies that stick to risankizumab. This happens to up to 4 in every 100 people after 1 year of treatment. It does not seem to stop risankizumab working, but it is possible that it could stop working over time. If this happens, your IBD team might suggest stopping risankizumab and trying another treatment.
• You have side effects
  If you have side effects that are serious or hard to manage, stopping risankizumab 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 they can arrange for a nurse to give you your injections at home, although this may not be possible.

If risankizumab 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.

Taking risankizumab with other Crohn’s treatments

In clinical trials, it was safe to take risankizumab alongside steroids. The clinical trials did not look at whether it was safe to take it alongside other immunosuppressants or biologic medicines. Your IBD team will talk to you about whether you need to take other medicines.

Having treatment that alters your immune system makes you more likely to get infections. And it may cause any inactive infections you have in your body to become active again. Before you start risankizumab, your IBD team will do thorough checks to make sure it’s suitable for you. They may:

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

If you have an infection, you might need to delay starting risankizumab until it’s been treated.

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

You should wait 4 weeks after having any live vaccines before you can start risankizumab. You should not have any live vaccines until at least 21 weeks after your last dose of risankizumab.

After you start risankizumab, you should have regular checks to see how well it is working. Your IBD team will ask about your symptoms, any side effects you may be getting, and how you’re managing with the injections. They will also check for any signs of infection. You might have blood tests and faecal calprotectin testing. Your IBD team will tell you what checks you need and how often.

Once you’ve got used to risankizumab, you should have a check-up every year. This is to check if you are still responding to risankizumab or whether you need to change the dose or stop treatment.

Risankizumab 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.

Up to 1 in every 10 people taking risankizumab might get a cold, a cough or a throat or sinus infection. Up to 1 in every 100 people taking risankizumab might get skin infections.

If you have an infection, you may need urgent treatment. Your IBD team might advise you to stop taking risankizumab 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.

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 risankizumab. Others may be more serious and could need treatment. Some side effects might mean that the risankizumab is not right for you.

In clinical trials, the risk of getting side effects was similar in people taking risankizumab to people taking dummy treatment.

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

Rarely, people taking risankizumab might have an allergic reaction. In clinical trials, this happened to less than 1 in every 100 people taking risankizumab.

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

Most common side effects

Here, we list the most common side effects of risankizumab. These might affect 1 to 10 in every 100 people taking risankizumab:

• Common cold, sore throat or sinus infections (this might affect more than 10 in every 100 people taking risankizumab)
• Headache
• Tiredness
• Itching
• Pain and redness where the injection went in
• Fungal skin infections

This is not a full list of side effects. There is information about less common side effects of risankizumab 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 risankizumab injection.

There is no evidence that risankizumab interacts with other medicines. But it’s always best to check first.

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.

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 used in the UK include:

• TB vaccine
• Shingles vaccine – but a non-live version is also available and the live version is gradually being phased out
• 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 taking a biologic medicine 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.

We have not found any clinical trials that looked at the best time to have vaccinations in relation to your risankizumab dose.

Risankizumab did not have harmful effects on pregnancy or fertility during studies on animals. But we do not know how it affects pregnancy or fertility in humans.

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

We do not know if risankizumab passes into breastmilk.

In theory, it is likely to pass into breastmilk in very low levels. It is also likely to be destroyed in your baby’s gut so most of it will not be absorbed into their bloodstream. But this has not been tested so we do not know for sure.

If you are thinking about breastfeeding while you’re taking risankizumab, talk to your IBD team. They can help you weigh up the benefits of breastfeeding during treatment against the possible risks.

We have separate information about Pregnancy and breastfeeding.

There is no evidence that drinking alcohol affects the way your body deals with risankizumab. 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 dosage, 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.