NICE approves obinutuzumab to treat lupus nephritis in England and Wales

NICE have recommended that a new treatment, obinutuzumab, can be used in combination with mycophenolate mofetil (MMF) to treat some patients with lupus nephritis in the NHS in England and Wales.

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.

You can find more information in the patient leaflet for obinutuzumab. This leaflet also includes information for people with lupus nephritis and for people with certain types of blood cancer, which it is also used to treat.

Why did NICE decide the NHS can use obinutuzumab with MMF for lupus nephritis?

NICE 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 NICE considered, on the NICE website.

Who can have obinutuzumab?

NICE 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 NICE 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 for lupus nephritis in England and Wales?

NICE published their draft recommendation for this treatment on 22nd January 2026. The final guidance will likely be published in March. Each NHS system has a different amount of time to make the treatment available. Once it is available, doctors will be able to use it to treat patients if they think it might be the best option for them.

England
NHS England will be making obinutuzumab for lupus nephritis available on the NHS from today via the “Innovative Medicines Fund”.

Wales
NHS Wales must usually fund and make the treatment available within 60 days (2 months) of the final recommendation being published.

Will obinutuzumab be available in Scotland and Northern Ireland?

Scotland
Scotland has its own appraisal system, separate from NICE, called the Scottish Medicines Consortium (SMC). Obinutuzumab has been submitted to the SMC, but there are currently no dates for when this appraisal will begin. We will give an update when the SMC considers whether to approve obinutuzumab.

Northern Ireland
Northern Ireland does not have an appraisal system like NICE or the SMC. In practice, Northern Ireland 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 NICE decision?

Lupus UK gave evidence to NICE about the experiences and needs of people living with lupus and their carers and family members. We based this on a specific survey we ran for the consultation, as well as our past surveys, conversations, and focus group work with people living with lupus nephritis and those that care for them. We also nominated expert speakers (a clinical expert and someone with lupus nephritis) who spoke at the decision-making meeting to give their opinion. These things help NICE to understand the needs of the lupus community and make their decision.