The humanised type II anti-CD20 monoclonal antibody obinutuzumab (brand name Gazyvaro) has been approved for the treatment of adults with lupus nephritis by the National Institute for Health and Care Excellence (NICE).
Obinutuzumab is recommended in final draft guidance as an option to treat active class 3 or 4 (with or without class 5) lupus nephritis in adults, in combination with the immunosuppressant mycophenolate mofetil.
This twice-yearly infusion works by targeting the CD20 protein on the surface of the white blood cells responsible for attacking the body in conditions such as systemic lupus erythematosus (SLE).
There are an estimated 3,000 new diagnoses of SLE in England and Wales each year, disproportionately affecting women and people from Asian and Black African or Caribbean backgrounds. Up to 60% will develop kidney involvement, with lupus nephritis causing fatigue, painful swelling, disrupted sleep and unpredictable flare-ups.
Helen Knight, NICE director of medicines evaluation said: ‘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.’
Obinutuzumab and kidney function decline in lupus nephritis
The NICE approval is based on the results of the phase 3, randomised, controlled Regency trial, which found people taking obinutuzumab were more likely to experience complete renal response than those receiving a placebo, which is linked with having better long-term outcomes.
A total of 271 adults with biopsy-proven active lupus nephritis were randomised (1:1) to receive obinutuzumab (n=135) in one of two dose schedules (1000 mg on day 1 and at weeks 2, 24, 26 and 52, with or without a dose at week 50) or placebo (n=136).
All patients received standard therapy with mycophenolate mofetil, plus oral prednisone at a target dose of 7.5 mg per day by week 12 and 5 mg per day by week 24.
At week 76, complete renal response was observed in 46.4% of patients in the obinutuzumab group and 33.1% of those in the placebo group (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 2.0 to 24.8; P=0.02).
No unexpected safety signals were identified and the authors concluded that obinutuzumab plus standard therapy was more efficacious than standard therapy alone in providing a complete renal response in adults with active lupus nephritis.
‘Encouraging to see more treatments for lupus’
Fiona Loud, policy director at the charity Kidney Care UK welcomed the NICE approval of obinutuzumab plus mycophenolate mofetil for the treatment of lupus nephritis, which will help approximately 12,000 people in England.
She added: ‘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.’
The final NICE guidance is expected to be published on 12 February 2026.
