In this article, we use “lupus” instead of “SLE” (systemic lupus erythematosus).
In England and Wales, doctors can use a medicine called obinutuzumab to treat kidney disease caused by lupus. You might know this as lupus nephritis. Research has shown that obinutuzumab could also be helpful for treating lupus generally. However, it must be approved through a process called review before the NHS can use it in this way.
This review of obinutuzumab is now taking place. It’s important that the people doing the review understand what living with lupus is like. That’s why we’re sharing your experiences to help them make a decision.
In this article, we explain:
- what obinutuzumab is and how it works
- the research looking at whether obinutuzumab could be used for lupus
- what happens during a review
- how you can share your experience of being affected by lupus
If you would like to share your experience, you can find more information at the end of the article.
What is obinutuzumab and how does it work?
Obinutuzumab is also called “Gazyvaro”. Obinutuzumab is part of a group of medicines called monoclonal antibodies. It works by getting rid of B cells, which are a type of white blood cell. B cells usually keep us healthy by fighting germs. However, if someone has lupus, their B cells attack their body by mistake. This causes inflammation and damage to their organs.
Obinutuzumab can get rid of B cells by sticking to an area on their surface called CD20. This helps to destroy the B cell and reduce inflammation. Because obinutuzumab works like this, it is useful for treating the kidney damage caused in lupus nephritis. It also means it could be a good option for treating lupus more generally.
How does someone take obinutuzumab?
Obinutuzumab is given through a drip into a vein. This is called intravenous infusion.
Obinutuzumab is given more often in the first year of treatment. It is then given every six months.
- Dose 1: first dose
- Dose 2: week 2 (two weeks after dose 1)
- Dose 3: week 24 (about 5 months after dose 2)
- Dose 4: week 26 (two weeks after dose 3)
- Dose 5: six months after dose 4
- Doses in future: every six months
What research has been done to see if obinutuzumab could help treat lupus?
A clinical trial has taken place where 303 adults with lupus were split randomly into two groups. One group was given obinutuzumab along with their usual medicines. The other group had just their usual medicines, and no obinutuzumab.
After one year, the research found that:
- more people taking obinutuzumab had an improvement in their lupus than people taking just their usual treatments
- the people taking obinutuzumab were less likely to have a flare than the people on just their usual treatments
Who reviews obinutuzumab to decide if it can be used by the NHS?
Before a medicine can be used by the NHS, it must be approved by a group called the MHRA (Medicines and Healthcare products Regulatory Agency). The MHRA look at evidence from clinical trials to make sure a medicine like obinutuzumab is safe and that it does what it’s supposed to. They also think about whether it will have greater benefits, or fewer side effects, compared with medicines already being used.
If the MHRA is happy with the evidence, the medicine receives a license. This means it can be used legally in the UK. However, this doesn’t mean the medicine will automatically be used by the NHS. This must be approved by a second group.
The second group is different depending on where the medicine is going to be used in the UK. In England and Wales, the group is called NICE (the National Institute for Health and Care Excellence). In Scotland, it is called the SMC (Scottish Medicines Consortium). Northern Ireland doesn’t have a group that reviews medicines, so the NHS there usually follows the decision from NICE.
What do NICE do when they review a medicine like obinutuzumab for England and Wales?
NICE look at results from clinical trials as well as the cost of the medicine. They do this to work out if it will be good value for money for the NHS. NICE also talk to different groups of people who are interested in whether a medicine will be approved, called stakeholders. Stakeholders include the pharmaceutical company who make the medicine, doctors and expert scientists. It also includes people living with lupus and charities that work with them.
Lupus UK is a stakeholder for this review of obinutuzumab. This means we can give evidence to NICE about the needs of people living with lupus that are important for their decision.
You can find out more about how NICE decides which medicines to approve on their website here, and how the SMC makes decisions on their website here.
How long will the review of obinutuzumab take?
A review can take a long time. The next steps for the obinutuzumab review are listed below:
- 15 July 2026: This is the deadline for evidence to be given to NICE
- 2 December 2026: A group of experts will meet to discuss all the evidence. The expert group includes both doctors and patients
- Date TBC: NICE will publish their decision about whether obinutuzumab can be used by the NHS for lupus in England and Wales
- If NICE decide that obinutuzumab should not be used for treating lupus, they will publish a “draft recommendation”. If the stakeholders disagree with their decision, we can give NICE more evidence and ask them to reconsider
- NICE then release their final decision. This is called “Final Guidance”. It is planned to be ready in May 2027
- If NICE say that a medicine can be used, NHS England has to make it available in 90 days. NHS Wales must do the same in 60 days
We will update you on what happens.
Will obinutuzumab be reviewed for treating lupus in Scotland or Northern Ireland too?
Obinutuzumab needs to be reviewed by the SMC for it to be used in Scotland. We will keep you updated on whether a review will happen in Scotland.
Northern Ireland doesn’t have an organisation like NICE or the SMC, but usually follows the advice given by NICE. However, there is no set time for the NHS in Northern Ireland to make a new treatment available.
What will Lupus UK give to NICE as evidence for the review?
We will share the information below with NICE:
- The needs of people with lupus (and those that support them — like partners, family, or carers)
- What people affected by lupus think about current treatments and how well they can access them
- Whether there are any groups of people affected by lupus that might particularly benefit from either obinutuzumab, or a new treatment option
If you have lupus, or you support someone with lupus, you can share your experiences with us through our online survey. We will use this information to let NICE know what’s most important to you. All responses are anonymous.
The survey should take around 15 to 20 minutes to complete and closes on Thursday 25 June 2026.