- NICE approves breakthrough combination treatment that
restores normal kidney function in almost half of patients with
lupus nephritis
A treatment that can restore normal kidney function in almost
half of patients has been approved for NHS use, offering new hope
to the nearly 12,000 people in England living with lupus
nephritis.
NICE has given the green light to obinutuzumab (Gazyvaro), a
twice-yearly infusion that, combined with daily immunosuppressant
tablets, significantly outperforms the usual treatments for the
disease.
Obinutuzumab works by targeting CD20, a protein on the surface of
the white blood cells responsible for attacking the body in
conditions like lupus.
Clinical trials showed 46% of patients achieved normal or near
normal kidney function*, compared with just 33% on existing
treatment alone, which is usually an immunosuppressant tablet.
Lupus nephritis is a disease where the immune system turns on the
kidneys, causing inflammation that can lead to permanent
scarring, kidney failure and, ultimately, the need for dialysis
or transplant. The condition disproportionately affects women and
people from Asian and Black African or Caribbean backgrounds.
Patients told NICE's independent committee that the disease
dominates their lives with crushing fatigue, painful swelling,
disrupted sleep, and the constant anxiety of unpredictable
flare-ups that can derail work, relationships and daily routines.
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.”
Debbie Kinsey, Health Information, Policy, & 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 final guidance publication, supported by a confidential
commercial arrangement that ensures value for money.
Around 60,000 people in England and Wales live with systemic
lupus erythematosus (SLE), with approximately 3,000 new diagnoses
each year. Up to 60% will develop kidney involvement.
ENDS
Notes to editors
- Read the full final draft guidance obinutuzumab with
immunosuppressive therapies for treating lupus nephritis.
- Obinutuzumab, also known as Gazyvaro and made by Roche, plus
mycophenolate mofetil, 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, the most severe forms of the disease.
- *This is sometimes known as ‘complete renal response'.
- An embargoed copy of NICE's final draft guidance on
obinutuzumab with immunosuppressive therapies for treating lupus
nephritis can be downloaded here: ID6420 obinutuzumab
FDG.docx.
