The National Institute for Health and Care Excellence has approved a breakthrough combination treatment for lupus nephritis, offering new hope to nearly 12,000 people in England living with the serious autoimmune condition.
The approved treatment combines obinutuzumab (Gazyvaro) - a twice‑yearly infusion – with daily immunosuppressant tablets, and has been shown to significantly outperform existing treatment options in clinical trials.
Clinical evidence submitted to NICE showed that 46% of patients receiving the combination treatment achieved normal or near‑normal kidney function, compared with 33% of patients on standard treatment alone, which typically consists of immunosuppressant tablets.
By improving kidney function outcomes, the treatment represents the most significant advance in lupus nephritis care available on the NHS to date.
Obinutuzumab is a monoclonal antibody that targets CD20, a protein found on the surface of certain white blood cells that play a central role in autoimmune diseases such as lupus. By reducing the activity of these cells, the treatment helps prevent the immune system from attacking healthy kidney tissue.
The therapy is administered as an infusion twice a year, reducing treatment burden compared with more frequent dosing regimens.
Lupus nephritis occurs when the immune system attacks the kidneys, causing inflammation that can lead to permanent scarring, kidney failure, and ultimately the need for dialysis or a kidney transplant.
The condition disproportionately affects women, as well as people from Asian and Black African or Caribbean backgrounds, contributing to unequal health outcomes.
Patients who gave evidence to NICE’s independent committee described how the disease dominates their lives, causing severe fatigue, painful swelling, disrupted sleep, and constant anxiety about unpredictable flare‑ups that can disrupt work, relationships and daily routines.
Helen Knight, Director of Medicines Evaluation at NICE, commented:
“This combination treatment has been shown to significantly improve the quality of life for people living with lupus nephritis. The evidence shows obinutuzumab improves outcomes, helping to restore normal kidney function, prevent long-term organ damage and reduce the risk of kidney failure.”
Following NICE’s approval, NHS England will make obinutuzumab available within three months of the publication of final guidance. Access will be supported by a confidential commercial arrangement to ensure value for money for the health service.
This rapid rollout means eligible patients across England could begin benefiting from the treatment later this year.
Around 60,000 people in England and Wales live with systemic lupus erythematosus, with approximately 3,000 new diagnoses each year. Up to 60% of people with SLE will go on to develop kidney involvement, making lupus nephritis a common and serious complication.
NICE’s decision marks a major step forward in improving outcomes for people with lupus, helping to prevent long‑term kidney damage and significantly improve quality of life.
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