NICE is the organisation that decides whether treatments should be available on the NHS in England. Wales and Northern Ireland usually follow NICE decisions too. This recommendation is based on the Final draft guidance. The final guidance will be published in May.

The Scottish Medicines Consortium (SMC) is the organisation that decides for Scotland. They are currently considering Risankizumab. But there is no date yet for a decision.

What is risankizumab?

Risankizumab is a type of biologic medicine. It sticks to a protein called IL-23. Your immune system makes IL-23 to help you fight infections. But it can also cause inflammation. Risankizumab blocks the effects of IL-23. This reduces gut inflammation.

The brand name for risankizumab is Skyrizi.

Who can have risankizumab?

NICE has recommended risankizumab as a treatment option for people over 16 years with moderately or severely active Crohn's Disease who:

• Did not respond well enough to another biologic medicine.
• Have stopped responding to another biologic medicine.
• Have tried a biologic medicine but had to stop it because of bad side effects.
• Are not suitable for treatment with an anti-TNF medicine (such as infliximab or adalimumab).

How do you have it?

You have your first three doses of risankizumab through a drip into a vein. You have one dose every 4 weeks. This aims to get your Crohn’s under control (induction treatment).

After this, you have risankizumab as an injection under your skin. You have the injection every 8 weeks. The injections aim to keep your Crohn’s under control (maintenance treatment).

How effective is it?

Two clinical trials looked at how well risankizumab works as induction treatment for Crohn’s. The trials compared risankizumab to dummy treatment (placebo).

• In the first trial, after 12 weeks of treatment, 45 in every 100 people who had risankizumab were in remission. Only 25 in every 100 people who had placebo were in remission.
• In the second trial, after 12 weeks of treatment, 42 in every 100 people who had risankizumab were in remission. Only 20 in every 100 people who had placebo were in remission.

People who responded to risankizumab in the two trials of induction treatment either carried on taking it or switched to placebo.

• After another year of treatment, 52 in every 100 people who carried on taking risankizumab were in remission. This compared to 41 in every 100 people who switched to placebo.
• The rate of side effects was similar in people taking risankizumab compared with those taking placebo.

When will it be available?

When NICE recommends a treatment option, it should be available on the NHS within 3 months. But the device used to inject risankizumab at home requires a CE mark, which has not been granted yet. Risankizumab will only be available in the UK for treating moderately to severely active Crohn's disease after this CE mark is granted.

How do I get it?

Risankizumab is not suitable for everyone with Crohn’s. If you think risankizumab might be suitable for you, talk to your IBD team. Together, you can talk about your treatment options and decide what is right for you.