Lupus UK are really pleased than the SMC have decided that a new treatment, obinutuzumab, can be used to treat some patients with lupus nephritis in the NHS in Scotland.
We hope that having another treatment option will help more people affected by lupus nephritis to have better outcomes and live well with lupus.
You can read more about the announcement, lupus nephritis, and obinutuzumab in our FAQs below:
What is lupus nephritis?
Lupus nephritis is a type of kidney disease caused by lupus, which is an illness where the immune system attacks the body’s own tissues. When lupus affects the kidneys, it causes swelling and damage, making it hard for the kidneys to clean the blood properly or get rid of waste. This can lead to symptoms like swelling in the legs, high blood pressure, and protein in the urine. If not treated, it can lead to serious kidney problems.
What is obinutuzumab?
Obinutuzumab is also called “Gazyvaro”. It is given through a drip in the arm (called an “intravenous infusion” or IV). It is usually given more often at first, and then every six months.
- Dose 1: first dose
- Dose 2: week 2 (two weeks after dose 1)
- Dose 3: week 24
- Dose 4: week 26 (two weeks after dose 3)
- Dose 6: six months after dose 4
- Doses in future: every six months
Obinutuzumab is a biological medicine (sometimes called a “biologic”). It works by targeting a type of cell in the immune system called a B cell, signalling to the immune system to destroy them. Destroying these B cells can help to reduce the inflammation caused by the overactive immune system in people with lupus.
Obinutuzumab is used together with another treatment called mycophenolate mofetil (MMF).
You can find more information in the patient leaflet for obinutuzumab. This leaflet includes information for people with lupus nephritis and for people with certain types of blood cancer, which it is also used to treat.
Who are the SMC?
The SMC, or “Scottish Medicines Consortium” assess new treatments to decide if they can be used in NHS Scotland. You can find out more about the SMC on their website.
Why did the SMC decide NHS Scotland can use obinutuzumab with MMF for lupus nephritis?
- The SMC gathered evidence from people living with lupus nephritis, clinical experts, economics experts, the company who makes it, and the results of clinical trials and other research. The main reasons they decided to approve it were:
- The research showed that obinutuzumab with MMF was more effective than MMF alone in increasing the chance of “Complete Renal Response” (CRR). CRR means an improvement in how well the kidney is working, measured by having results within a certain level on kidney function tests. Having a CRR is linked with having better outcomes longer-term.
- The research also showed it was more effective in increasing the time before someone has another flare.
- Obinutuzumab was found to be cost-effective. This means that the balance between how much it costs and the benefits was positive.
You can read the recommendation, including the evidence the SMC considered, on the SMC website.
Who can have obinutuzumab?
The SMC recommended that obinutuzumab can be used (with mycophenolate mofetil; MMF) for adults with class 3 or 4, with or without class 5, lupus nephritis.
Doctors use a classification system to divide lupus nephritis into six stages, from least severe (class 1) to most severe (class 6). A description of the different classes is given below:
| Class | Description |
| 1 | Minimal damage (often only viewable under a special microscope) |
| 2 | Some inflammation in the kidney |
| 3 | Damage to less than 50% of the blood vessels of the kidney |
| 4 | Damage to more than 50% of the blood vessels of the kidney |
| 5 | Thickening of kidney structures and immune deposits in the blood vessels |
| 6 | Damage to more than 90% of the blood vessels in the kidney |
Will obinutuzumab be available for children and young people with lupus nephritis?
The recommendation only applies to adults.
All medicines have to get an approval about who they can be given to, which is called a “marketing authorisation”. Obinutuzumab has a marketing authorisation for adults with lupus nephritis, and not for children. However, there is currently research investigating how effective obinutuzumab might be to treat young people with lupus nephritis. Depending on the results of that research, it is possible that it becomes available to young people in the future.
When will obinutuzumab become available in Scotland?
Scotland’s 14 NHS health boards have 90 days (about 3 months) after the SMC has approved a treatment to decide whether to make the treatment available in their area.
Will obinutuzumab be available in England, Wales, and Northern Ireland?
Obinutuzumab for lupus nephritis has already been approved for use in England and Wales, by their approval system called NICE. Northern Ireland doesn’t have an approval system like NICE or the SMC, but in practice usually follows decisions made by NICE. This should mean that obinutuzumab will become available, but the time it takes is not clear and it is not guaranteed. We will provide updates whenever we have information about access to obinutuzumab in Northern Ireland.
What was Lupus UK’s role in the SMC decision?
Lupus UK sent evidence to the SMC about the experiences and needs of people living with lupus and their carers and family members. We based this on two surveys about lupus nephritis and obinutuzumab that we ran, as well as our past surveys, conversations, and focus group work with people living with lupus nephritis and those that care for them. Our main points were:
- Lupus nephritis can have a large impact on the lives of people living with it
- There is a serious need for more effective treatments, especially because there is no single treatment that works for everyone, some people have no treatments that work for them, and we need more treatments that can reduce the use of steroids.
- Reducing and preventing flares and limiting long-term damage are important treatment priorities for people living with lupus nephritis.
- There are some groups of people who might be more likely to have severe lupus nephritis, or people who find having lots of tablets difficult, who might benefit from medication in a drip. But there are other people who live further from infusion centers who might not get a benefit if their access is not considered after approval.
- If the SMC finds the treatment to be good at treating people but too expensive to use, they should still make it available to people who don’t have other treatment options.
We also included stories and quotes from people who gave their permission.
We share evidence to help the SMC to understand the needs of the lupus community when they make their decision.