Last updateWed, 20 Sep 2017 9am

Your Health

FDA approves first new lupus medication in 50 years


In March, the U.S. Food and Drug Administration approved a new lupus medication called Benlysta. This is significant because it’s the first treatment approved in more than 50 years for this autoimmune disorder.

Between 300,000 and 1.5 million Americans suffer from systemic lupus erythematosus, or lupus, a sometimes serious and potentially fatal disease. Lupus mainly affects young women, with African-American, Asian-American and Hispanic-American women several times more likely to develop the condition than American women of European descent. The typical age of onset is between 15 and 45.

Lupus is an autoimmune disorder in which the body misidentifies its own tissues and organs as foreign. Consequently, the immune system attacks the body’s own tissues, potentially causing damage to joints, skin, kidneys, nerves and even sometimes the heart and brain. Common lupus symptoms include joint pain and swelling, which may occur in combination with fevers, facial rash and severe fatigue.

Benlysta, an immunosuppressive medicine administered as an intravenous infusion, reduces the effect of a specific subset of abnormal immune cells called “B lymphocytes,” which are important in causing lupus. This new medication is exciting to the medical community because it carries new hope for treating the disorder, but we still have much to learn about its effectiveness.

For example, the clinical trials for the drug were small, and it’s not yet clear how much benefit Benlysta offers to lupus patients with the most serious manifestations of the condition.

The most common side effects of the drug are nausea, diarrhea and fever. Rarer, more serious side effects include allergic reactions, depression and infection.

While Benlysta is the latest addition, several other lupus drugs are commonly used.

Nonsteroidal anti-inflammatory drugs – ibuprofen, naproxen and aspirin – have been used to treat relatively minor lupus symptoms since the 1940s. Other lupus drugs, including steroids and antimalarial agents, have been approved for the treatment of lupus since the 1950s. These treatments also come with potential side effects. Specifically, steroids can cause high blood pressure, bone loss, weight gain and diabetes. Antimalarials can cause upset stomach and vision problems.

Other stronger immunosuppressives are used in the most serious cases of lupus, but these carry the risk of infection and cancer.

Even with these risks, the medical treatments for lupus have improved the lives of people living with the disease. Most patients live much longer and more comfortably than they did 30 years ago.

While Benlysta isn’t a miracle cure, and it does carry risks like all the other lupus medications, it has been shown to benefit certain patients with the disease. It’s a welcome addition to the set of tools we can use to improve the quality of life of our patients with lupus.

Dr. Andrew Rozelle is a rheumatologist at the Palo Alto Medical Foundation. PAMF and column editor Arian Dasmalchi provide this column.

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