A new treatment, obinutuzumab, is being reviewed to see if it can be used in the NHS in England and Wales to treat lupus nephritis (lupus that affects the kidneys). Lupus UK will be submitting evidence to the review about the needs and experiences of people who have lupus nephritis. This article explains how the review process works, and you can find out how you can tell us what’s important to you at the end of the page.
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 the role of B Cells in Lupus Nephritis?
“B cells” are a type of white blood cell that normally help the body fight infections by making antibodies. But in lupus, B cells get confused and start making harmful antibodies that attack healthy parts of the body, like the kidneys. This causes inflammation and damage. So, B cells play a big role in the activity and worsening of lupus nephritis. Some treatments aim to reduce the number of B cells to help calm the disease and protect the kidneys.
What is obinutuzumab?
Obinutuzumab is a type of medicine called a monoclonal antibody. It’s made to target a specific protein called CD20, which is found on the surface of B cells, the white blood cells that cause problems in conditions like lupus. By attaching to CD20, obinutuzumab helps remove these B cells from the body. This means it could be useful for treating Lupus Nephritis. The medicine is given through a drip into a vein (called an intravenous infusion).
Obinutuzumab is licensed in the UK for some types of cancer. It is not currently licensed for lupus, but it has been used in the past for a small number of people with lupus who stopped responding to rituximab.
How does obinutuzumab compare to older anti-CD20 drugs like rituximab for lupus nephritis?
In the past, other medicines that target B cells, like rituximab, didn’t show much improvement when added to standard treatment for lupus nephritis. Obinutuzumab might be a better option. It’s a newer type of anti-CD20 medicine that is more similar to natural human proteins so the body is less likely to react against it. It’s also been specially designed to work more strongly by sticking better to immune cells and avoiding being broken down too quickly in the body.
What were the main findings of the clinical trial testing obinutuzumab for people with lupus nephritis?
A clinical trial was done to test how well this medicine works. In the trial, 271 adults with active lupus nephritis were randomly placed into two groups: one group received obinutuzumab along with standard treatment, and the other group received only standard medicines. Researchers wanted to see how many patients had a “complete kidney response” by week 76 of the study. This meant having low protein levels in the urine, keeping kidney function close to normal, and not having any serious problems like needing extra treatment, dropping out of the study, or dying. The results showed that roughly 4.5 out of 10 (46%) patients who received obinutuzumab had a complete kidney response, compared to roughly 3 out of 10 (33%) who got the standard treatment only.
How is a drug approved for use in NHS?
When a new medicine is developed, it doesn’t automatically get used in the NHS. First, the medicine must be reviewed to see if it is effective enough. This means the treatment must have evidence that it can improve someone’s health (“clinically effective”) and that is good value for money (“cost effective”). Usually the term “cost effective” is used to mean both “clinically and cost effective”. This review of a medicine is called an “appraisal”. The appraisal considers lots of different factors to decide whether a medicine is “cost effective”, including:
- How much a medicine costs
- What the benefits or risks are compared to treatments that are already available
- What impact the medicine could have on people’s quality of life
Different nations of the UK have different organisations that review medicines. In England and Wales, the group is called NICE (the National Institute for Health and Care Excellence), and in Scotland the group is called the SMC (Scottish Medicines Consortium). Northen Ireland doesn’t have a group that review medicines, so generally the NHS in Northern Ireland follows the recommendations from NICE.
The pharmaceutical company who makes the medicine decide if they want to ask NICE or the SMC to review it for use in the NHS. NICE and the SMC don’t usually review a medicine unless the pharmaceutical company asks them.
You can find out more information about how NICE makes decisions about which medicines to approve on their website here, and how the SMC makes decisions on their website here.
How is obinutuzumab being reviewed for approval in England and Wales?
NICE is reviewing obinutuzumab for treating lupus nephritis. They are carefully checking how well the medicine works and whether it gives good value for money. They will be considering evidence from a range of different people (called “stakeholders”), including the pharmaceutical company, doctors, NHS experts, academic experts, people living with lupus, and charities that work with people with lupus.
Lupus UK is a stakeholder for this appraisal so we will be submitting evidence about the needs and experiences of people living with lupus for NICE to consider.
This can be a long process. The next steps for this appraisal are:
- 23rd July 2025: This is the deadline for everyone to submit their evidence to NICE.
- Early December 2025: An expert committee meets to discuss all of the evidence. The committee includes expert doctors and expert patients.
- Early 2026 – NICE will publish a recommendation about whether obinutuzumab should be used in the NHS in England and Wales.
- If NICE decide it should not be used, they will first publish a “draft recommendation”. Stakeholders and the public, including Lupus UK, can then give more feedback and appeal the decision if we disagree.
- NICE then publishes “Final Guidance” which is their final decision. The current plan is that this will happen in March 2026.
- If NICE recommends a medicine be used, NHS England then has 90 to make it available, and NHS Wales has 60 days.
We will update you about what happens as the process moves forward.
Will obinutuzumab be reviewed for use in Scotland or Northern Ireland?
Obinutuzumab needs to be reviewed by the SMC for it be available in NHS Scotland, as the NICE appraisal only covers NHS England and Wales (and usually also Northern Ireland). We will keep you updated if there is an appraisal for use in NHS Scotland.
Northern Ireland doesn’t have an organisation like NICE or the SMC, but usually follows the recommendations that NICE makes. However, there is no set timeframe for the NHS in Northern Ireland to start making a new treatment available.
What will Lupus UK submit as evidence?
Lupus UK is involved in the NICE appraisal process for obinutuzumab as a stakeholder. We took part in the consultation stages, including reviewing the draft scope of the appraisal, which outlined who the treatment could help and what outcomes should be considered.
We will now be submitting evidence to the full appraisal, including information about the needs of people with lupus nephritis (and those that support them like partners, family, or carers), what their views are on current treatments, how well people can access treatments, and if there are any groups that might particularly benefit from obinutuzumab or a new treatment option.
How can I get involved?
If you have had lupus nephritis, or you support someone with lupus nephritis, you can complete our survey to share your experiences with us. All responses are anonymous, and we will use this information, alongside other research, so that we can submit evidence based on what’s most important to you.
You can find our anonymous survey here: https://forms.office.com/e/RqyZEtfGZr
The survey should take around 15-20 minutes to complete, and closes at 5pm on Tuesday 15th July.