Who can take ocrelizumab?
Ocrelizumab is used to treat ‘active’ relapsing MS. Its licence allows it to be used for early primary progressive MS too. At the moment it’s only available on the NHS for early primary progressive MS in England. We hope it will be available in the rest of the UK soon.
England, Scotland, Wales and Northern Ireland:
Ocrelizumab can now be given on the NHS to a small number of people with relapsing MS.
You must have ‘active’ relapsing MS. This means you’ve been having relapses or MRI scans of your brain or spinal cord show you have new lesions.
You’ll only be given ocrelizumab if you qualify to get alemtuzumab (Lemtrada) and that drug isn’t suitable for you.
So ocrelizumab is an alternative to alemtuzumab if you can’t take that drug for some reason, or you have worries about its side effects and risks.
Primary progressive MS
NICE decided in 2018 that ocrelizumab shouldn’t be available on the NHS in England to people with early primary progressive MS because it cost too much. In May 2019 NICE changed its decision after the drug’s makers, Roche, asked NICE to look at their decision again. You can take ocrelizumab for early primary progressive MS if you have:
- early active primary progressive MS
The following all also need to be true for you:
- your MRI scans show signs of inflammation. In particular, you need a T1 MRI scan to show that you have enhancing lesions, meaning that inflammation has occurred recently or you need two or more T2 MRI scans that who show you have new or growing lesions.
- you have a score on the Expanded Disability Status Scale (EDSS) between 3.0 and 6.5. A score over 6.5 means you use a wheelchair all the time. People aren’t given DMTs, including ocrelizumab, if they’ve been using a wheelchair for at least six months. This is because there’s not enough evidence at the moment that DMTs will make enough difference to their MS.
What is ‘early’ Primary Progressive MS?
If you have primary progressive MS, your neurologist will decide if it’s ‘early’ or not based on how long you’ve had symptoms, and how much disability it’s caused you.
For primary progressive MS to be classed as ‘early’ - and for you to qualify to get ocrelizumab - your neurologist will follow this rule:
- If your EDSS score is over 5, your MS symptoms must not have started longer than 15 years ago.
- If your score is 5 or under, your symptoms must not have started longer than 10 years ago.
The EDSS measures how much MS affects you, focussing on how well you can walk.
In Wales and Northern Ireland:
NICE make decisions for England but in most cases these are also soon followed by Wales. Northern Ireland also usually follows NICE recommendations, soon after a decision is made by NICE. So we hope that later in 2019 people with early primary progressive MS in Wales and Northern Ireland will also be able to access ocrelizumab on the NHS.
The Scottish Medicines Consortium (SMC) decides whether a drug should be available on the NHS in Scotland. The makers of ocrelizumab will be applying to the SMC in the near future to get the go ahead for the drug to be given to people with early primary progressive MS on the NHS there.
How does ocrelizumab work?
Your immune system makes special cells that attack and kill virus and bacteria. In MS these cells attack your nerves by mistake.
Ocrelizumab sticks to one type of these cells called B cells. This stops them getting into your brain and spinal cord where they would attack the myelin covering around your nerves. This stops inflammation and damage to the nerve.
You’re given this drug through a drip (an ‘infusion’) in hospital. You get the first dose as two separate infusions, two weeks apart. After that you have an infusion once every six months.
How well does ocrelizumab work?
MS drugs can be put into three groups based on how big their effect is against MS: ‘moderate, ‘good’ or ‘high’. Ocrelizumab is new, so it’s not yet certain how well it controls MS.
When this drug is used for relapsing MS it can be classed at the very least as ‘good’. Over time its effect may turn out to be ‘high’. This is based on how much it reduces relapses and slows down how fast people's disability gets worse.
Relapses dropped by:
46-47% compared to beta interferons
This means that in two trials, on average, people saw a 46-47% drop in the number of relapses they had. This was compared to people who took beta interferon, a standard treatment for MS.
Disability getting worse was slowed down by:
40% compared to beta interferons
This means that in two trials, on average, people saw a 40% drop in the risk of their disability getting worse. This was compared to people who took beta interferons.
Primary progressive MS
When ocrelizumab is used to treat primary progressive MS its effect is classed as ‘moderate’. This might not seem impressive but this the first drug to work at all against primary progressive MS.
Disability getting worse was slowed down by:
25% compared to a placebo
This means that in a trial, on average, people saw a drop of around 25% in the risk of their disability getting worse. This was compared to people who took a placebo, a dummy treatment with no drug in it.
The drug also helped people walk better, slowed down how fast their brains were shrinking and made lesions in the brain smaller.
What are the side effects of ocrelizumab?
Compared to other DMTs, the risk of side effects, especially serious ones, doesn’t seem high. Overall ocrelizumab is somewhere in the middle, between the drugs with the highest risk of serious side effects and those that are seen as the safest.
In trials side effects weren’t any more serious than what you get with beta interferons (among the safest DMTs).
Up to four in ten people had at least one fairly mild, short-lived reaction during or after their infusion. These included a skin rash, fever, sore throat, itching or flushing (going red in the face).
You’re more likely to get some infections when taking this drug. These include colds and infections of the chest and skin, cold sores and other herpes infections.
In trials there were no serious side effects like the ones you see with other, hard-hitting DMTs. In trials more people taking this drug got cancer, especially breast cancer. But the number was still within the normal range. So it’s not clear if this is actually a side effect of the drug. The drug’s makers are monitoring this risk.
There have been so far no definite cases in people with MS of this drug causing the brain infection progressive multifocal leukoencephalopathy (PML). But PML could be a risk because it’s happened in people taking this drug for other health problems.