What is lupus?
Also known as systemic lupus erythematosus (SLE), lupus reprograms immune cells so they attack the body itself, resulting in chronic inflammation. It can affect the kidneys, joints, skin, brain, and the lining of the heart and lungs. Lupus can be mild or life-threatening.
Risk factors for developing lupus
The triggers for lupus are poorly understood. Some factors that are associated with developing lupus are:
- Being female: 90 per cent of Australians with lupus are women.
- Early adulthood: most cases of lupus are detected in people aged between 15 and 40.
- Genetic susceptibility: lupus is more prevalent in some families and some racial groups. Lupus is more prevalent and more severe in Aboriginal Australians than in the wider Australian population.
- Sunlight exposure can be a trigger in susceptible people.
1 in 1,000
Lupus is estimated to affect more than 25,000 (1 in 1,000) people in Australia
Onset usually occurs between 15 and 45 years
90% of those affected are women
GSK’s Benlysta® (belimumab) is First Lupus Nephritis Treatment Approved by FDA
The U.S. Food and Drug Administration (FDA) in late December 2020 approved Benlysta® to treat lupus nephritis (lupus-related kidney disease) in adults. The decision makes Benlysta the first lupus therapy authorized to treat this potentially life-threatening complication of the disease.
Another milestone, this new indication is the only FDA approval of a new lupus treatment since belimumab was first approved for systemic lupus erythematosus in 2011.
One of the most common and serious complications of systemic lupus erythematosus, lupus nephritis is inflammation in the kidneys. Too often, this damage necessitates regular dialysis or a transplanted organ to do the work of the kidneys in filtering wastes from the body.
“The FDA’s approval of Benlysta for lupus nephritis represents an important milestone in treating one of the most serious consequences of lupus,” said Stevan W. Gibson, president and CEO, Lupus Foundation of America. “Between 10 and 30 percent percent of people with lupus nephritis will develop end-stage renal disease or kidney failure. Effective treatment can greatly improve health outcomes and reduce the long-term costs associated with managing lupus-related kidney disease.”
The recent approval by the FDA follows on from the Pharmaceutical Benefits Advisory Committee (PBAC) decision in October 2020 to reject Benlysta being included on the Pharmaceutical Benefits Scheme. This is the second submission to the PBAC that has been rejected despite attempts put forward to mitigate the uncertainties identified.
Lupus Australia remains disappointed by the PBAC’s decision not to recommend Benlysta® (belimumab) administered subcutaneously for the treatment of patients with systemic lupus erythematosus (SLE), given this is the only new therapy to be approved by the Therapeutic Goods Administration for this indication in 50 years.