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.
The Scottish Medicines Consortium (SMC) is the organisation that decides for Scotland. The SMC has not yet assessed mirikizumab to decide if it should be available on the NHS in Scotland. We do not know when this might happen.
What is mirikizumab?
Mirikizumab 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. Mirikizumab blocks the effects of IL-23. This reduces gut inflammation.
The brand name for mirikizumab is Omvoh.
Who can have mirikizumab?
NICE has recommended mirikizumab as an option for adults with moderate or severe active Ulcerative Colitis who:
- Have not responded to an anti-TNF medicine (such as infliximab or adalimumab).
- Have stopped responding to an anti-TNF medicine.
- Have tried an anti-TNF medicine but had to stop it because of side effects.
- Are not suitable for treatment with an anti-TNF medicine.
How do you have it?
You have your first three doses of mirikizumab through a drip into a vein. You have one dose (300mg) every 4 weeks. This aims to get your Colitis under control (induction treatment).
After this, you have mirikizumab as an injection under your skin. You have one dose (200mg) every 4 weeks. The injections aim to keep your Colitis under control (maintenance treatment).
How well does it work?
One large trial has looked at how well mirikizumab works as induction and maintenance treatment for Colitis. The trial compared mirikizumab to dummy treatment (placebo).
- After 12 weeks of treatment, 24 in every 100 people who had mirikizumab were in clinical remission. Only 13 in every 100 people who had placebo were in remission.
People who responded to mirikizumab after 12 weeks went on to the maintenance phase of the trial. They either carried on taking mirikizumab or switched to placebo.
- After 40 weeks of maintenance treatment, 50 in every 100 people who carried on taking mirikizumab were in clinical remission. Only 25 in every 100 people who switched to placebo were in remission.
The rate of side effects was similar in people taking mirikizumab compared with those taking placebo.
- Common side effects included nose and throat infections, joint pain, and headache.
- Opportunistic infections and cancer occurred in a small number of people treated with mirikizumab. An opportunistic infection is one that does not normally cause disease but may be harmful if you have a weakened immune system.
When will it be available?
When NICE recommends a treatment option, it should be available on the NHS within 3 months.
How do you get it?
Mirikizumab is not suitable for everyone with Colitis. If you think mirikizumab might an option for you, talk to your IBD team. Together, you can talk about your treatment options and decide what is right for you.