New immunotherapy has the potential to reduce the need for dialysis and transplantation for people with severe kidney inflammation
One in ten kidney patients undergoing dialysis in the Western world has an underlying kidney inflammation of the IgA nephritis type. A new type of immunotherapy that stabilizes kidney function has now been permanently approved by the FDA. It is the first drug ever approved for the indication of IgA nephritis. Regulatory authorities in the EU, UK, China and Japan are expected to follow suit. The treatment is based on research that originated at Uppsala University Hospital.
Bengt Fellström, Senior Consultant and Senior Professor in Renal Medicine at Uppsala University Hospital.
"A new immunotherapy for severe kidney disease with IgA nephritis is highly anticipated and valuable. The drug treatment has been shown to reduce egg white excretion from the kidneys and protect kidney function in the long term. In addition to improved quality of life for affected patients, the treatment can lead to a real and significant delay in dialysis and kidney transplantation," says Bengt Fellström, Senior Consultant and Senior Professor of Renal Medicine at Uppsala University Hospital.
The new immunotherapy suppresses the immunological overactivity of the intestinal immune system. Egg white excretion in the urine is reduced, while the activity of the antibodies is suppressed and kidney function is stabilized.
In Sweden, kidney inflammation causes about a quarter of all cases of chronic kidney failure, often requiring dialysis or kidney transplantation. For a certain type of kidney inflammation (IgA nephritis) there is an overactivity of the intestinal immune system that is of great importance. Globally, IgA nephritis is the most common form of kidney inflammation.
"The symptoms of this type of kidney inflammation are often insidious. Eventually, however, the immunological reaction causes antibodies to bind to an antigen and form so-called immune complexes, which are deposited in the kidney's vascular network. This can lead to blood and egg white in the urine and deterioration of kidney function. The deterioration is gradual and almost half of the patients develop chronic kidney failure over time and need dialysis or kidney transplantation," explains Bengt Fellström.
He has coordinated the Swedish participation, and also been the international coordinating investigator, in a recently completed international phase III study, the so-called NefIgArd study, published in The Lancet.The study was conducted at 132 hospital-based renal clinics in 20 countries around the world, including at Uppsala University Hospital. It is a randomized, placebo-controlled study in which 364 patients with primary kidney inflammation of the type IgA nephritis were randomized into two groups, one receiving treatment that affects the immune cells of the gut, the other a placebo.
Thanks to the good results of this and other clinical trials, the drug treatment has had temporary approval in the EU and the US for just over a year. The immunotherapy has now received permanent approval from the FDA in the US. According to Fellström, all indications are that the EU, UK, China, Japan and others will follow suit.