FDA Approves the First New Lupus Drug in 50 Years

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[Post updated March 10] For the first time in half a century, lupus sufferers have a new drug that could help control their disease, and it’s the first medication that works directly on the immune cells responsible for the condition’s worst symptoms. On Wednesday, the Food and Drug Administration approved belimumab, or Benlysta, which targets the production of certain immune cells in the body.

An estimated 1.5 million Americans and 5 million patients worldwide suffer from the autoimmune disease, which causes the body’s virus- and bacteria-fighting cells to mistakenly see its own healthy cells as foreign and begin to attack them. The result is a lifetime of flareups and remissions that can lead to painful and swollen joints, fever, rashes, abnormal blood clotting and problems in the kidneys, lungs, heart and brain. Until Benlysta’s approval, doctors treated lupus a variety of ways, from anti-inflammatory drugs, such as NSAIDs or aspirin, to strong steroids to dampen immune activity, to immune-suppressing medications and even antimalaria drugs to inhibit antibody production.

Benlysta operates on a population of immune cells known as B cells, which normally churn out the antibodies that bind and mark bacteria and viruses for destruction by other immune cells. In lupus patients, these B cells somehow get overstimulated and misguided, and are trained to target healthy body cells instead. Benlysta is designed to interfere with a protein critical to B cell activity, thus suppressing its search-and-destroy mission in the body.

“Benlysta is very much more targeted than the other therapies we have now for treating lupus,” says Dr. Gary Gilkeson, chair of the medical and scientific advisory committee of the Lupus Foundation of America and a professor of medicine at the Medical University of South Carolina.

In approving the drug, which is administered intravenously, the FDA analyzed two trials involving 1,684 patients with lupus, some of whom were given the medication along with their current therapy, and others who were given a placebo infusion. The treated patients recorded fewer episodes of disease activity than those on placebo, and some were able to lower the does of steroids they needed to control their disease. These patients did, however, also show slightly higher rates of infections and death than the group that didn’t receive Benlysta.

Patients and doctors welcomed the long-awaited addition to their treatment arsenal. As Dr. Anca Askanase of New York University told Reuters: “This is a major change, a new player in the field of lupus. I think it’s extraordinary.”

Despite the excitement over the approval, Gilkeson says that Benlysta likely will not be the first drug doctors use when they diagnose their patients with lupus. In order to do that, more studies will need to  show how Benlysta controls symptoms compared to steroids, anti-inflammatory medications, and other drugs that currently help some patients to treat their disease. Benlysta is also far more expensive than these therapies, with a predicted tally of about $35,000 a year compared to the several hundreds of dollars that patients now spend. But once patients become tolerant to their current drug regimen, and if they don’t respond as well to their medication, Benlysta could provide a therapeutic boost and relieve them of some of their symptoms.

“This is an incredibly important milestone, not just because it’s the first in class for a new agent, but it’s also the first drug approved specifically for lupus,” says Gilkeson, noting that current treatments were not designed initially to treat lupus, but turned out to have important benefits for lupus patients. Now, with Benlysta, lupus patients have a drug developed with their symptoms and disease in mind, and hopefully it won’t be the last.

This post has been updated with comments from Dr. Gary Gilkeson of the Lupus Foundation of America.

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