What should people with lupus know about the FDA approved lupus nephritis drugs?
By Dr. Robert Katz, Chair Lupus Society of Illinois Board of Directors and Medical Advisory Board
There are now two FDA approved drugs to treat lupus nephritis. Kidney damage is one of the more common health problems caused by lupus. In adults who have lupus, as many as 5 out of 10 will have kidney disease – knowing the available drugs is important.
Benlysta has been FDA approved to treat lupus for several years, recently Benlysta was FDA approved for use in active lupus kidney disease (nephritis). There is approved intravenous dosing as well as self-administered subcutaneous dosing.
The other FDA approved drug is Lupkynis. Lupkynis is a pill which has also been approved for treating lupus nephritis.
Lupkynis has been found to play a helpful role in treating lupus kidney disease and avoiding high doses of prednisone. It is given as a pill twice a day along with mycophenolate and steroids such as prednisone. Patients usually take three pills twice a day, and treatment is given for at least 24 weeks. Lupkynis has a generic name, voclosporin. The mechanism of action is thought to be that the drug inhibits T lymphocyte activation in this autoimmune process of lupus.
So, a new pill to treat lupus kidney disease is welcome because relatively few drugs have been approved for lupus in quite a while.
About Lupus Kidney Disease (Lupus Nephritis)
To determine if a lupus patient has kidney involvement, there are three test doctors will evaluate: urine test, blood test and kidney biopsy. Urine tests will look for protein and/or red blood cells in the urine. Both the presence and the prevalence are indicators of kidney damage. Blood tests look at the creatinine level of your blood. Creatinine is a waste product from the normal breakdown of muscles in your body. Your kidneys remove creatinine from your blood. As kidney disease gets worse, creatinine levels go up. A kidney biopsy is a procedure that removes tissue from your kidney. The tissue is examined and provides doctors with information on how lupus nephritis has progressed and will inform treatment.
Lupus kidney disease is divided into different categories based on the extent and type of involvement. Class I is almost no microscopic abnormalities on kidney biopsy, but on electron microscopy we can see some changes in a part of the kidney called the mesangium. Class II is associated with minimal changes under a microscope. Class III and class IV are different types of what is called proliferative lupus nephritis in which there are a lot of white blood cells, more in class IV than class III. Class V is called membranous, and it has to do with thickening of the membranes of the kidney that are seen under the microscope.
Prior to the FDA approved Benlysta and Lukynsis, the drugs used to treat lupus nephritis were off-label drugs, meaning not FDA approved for lupus specifically.