PeopleImages/Shutterstock.com
A combination treatment that can restore normal or near normal kidney function in patients with lupus nephritis has been recommended for use on the NHS in England by the National Institute for Health and Care Excellence (NICE).
In final draft guidance published on 22 January 2026, NICE approved obinutuzumab (Gazyvaro; Roche), a twice-yearly infusion, combined with daily immunosuppressant tablet mycophenolate mofetil (CellCept; Roche), as an option to treat active class 3 or 4 — with or without class 5 — lupus nephritis in adults.
The combination treatment, which could benefit nearly 12,000 people in England, was found to “significantly outperform the usual treatments for the disease”, NICE said.
Results from clinical trials showed that 46% of patients who were on obinutuzumab achieved normal or near normal kidney function — sometimes known as ‘complete renal response’ — compared with 33% of patients on existing treatment alone, which is usually an immunosuppressant tablet.
NICE estimates that around 60,000 people in England and Wales live with lupus, which causes joint pain, skin rashes and extreme tiredness, with approximately 3,000 new diagnoses each year.
Up to 60% of patients will develop lupus nephritis — the most severe form of lupus — where the immune system turns on the kidneys and causes inflammation, which can lead to permanent scarring, kidney failure and, ultimately, the need for dialysis or transplant, NICE said.
The condition disproportionately affects women and people from Asian and black African or Caribbean backgrounds.
Obinutuzumab works by targeting CD20, a protein on the surface of the white blood cells responsible for attacking the body in conditions such as lupus.
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.”
Debbie Kinsey, health information, policy and research manager at Lupus UK, said: “We are very pleased that another treatment option has been approved for lupus nephritis. Lupus nephritis is challenging to manage and current treatments don’t work well for everyone, which can lead to long-term kidney damage. We hope that this decision will support more people to have an improved quality of life and live well with lupus nephritis.”
Fiona Loud, policy director at Kidney Care UK, said: “It’s encouraging to see more treatments for lupus, which affects many younger people and is a difficult condition to manage. Recent studies found people who received this treatment were less likely to have a deterioration in their kidney function by the end of the trial than those receiving a placebo.”
NHS England will make obinutuzumab available within three months of the publication of the final guidance, which is expected in March 2026.
