FDA: Lupus Therapies Continue to Evolve


Lupus can be a difficult disease to diagnose and to treat. Scientists continue to work to understand the genetic basis of this disease and develop new and more targeted therapies to treat it.

Each year, as many as 16,000 people in the U.S. are diagnosed with lupus, an autoimmune disease that can be fatal. (An autoimmune disease is an illness that makes your body attack itself.)

Although people of all races and ethnicities can have the disease, African American women are three times more likely than white, non-Hispanic women to have lupus. African American women also tend to develop the disease at a younger age and have more serious and life-threatening complications than white, non-Hispanic women. Lupus is also more common in women of Hispanic, Asian, and Native American descent.

Lupus is a chronic disease, meaning that treatment may help control it but that the illness never goes away. Someone with lupus will have good phases and bad phases. People with lupus have a range of symptoms, which can include extreme tiredness, pain or swelling in the joints, and headaches.

The root cause of lupus is not fully known, and there are many types of the disease. The most common form, called systemic lupus erythematosus, may cause mouth sores, rashes, fatigue, joint pain and swelling. This form also affects the kidneys.

Who Is Affected by Lupus

About 200,000 people in the U.S. are living with systemic lupus. According to the U.S. Centers for Disease Control and Prevention, 10 times more women than men have lupus, and the disease often starts between ages 15 and 44.

What makes lupus so hard to diagnose? The symptoms of lupus are different from person to person. The signs of lupus can show up in various ways and are often mistaken for symptoms of other diseases. Also, people with lupus can have different problems with their immune systems.

There is still a great need for better treatments, and scientists may be close to developing more refined therapies to help control symptoms and foster remission. The U.S. Food and Drug Administration’s Office of Women’s Health has funded several studies related to lupus and other autoimmune diseases. The FDA’s Office of Minority Health and Health Equity also has funded a study on lupus.

Because lupus has a disproportionate impact on racial and ethnic minority communities, it is critical to advance research into therapeutic treatments and increase diversity in clinical research to help ensure that the medical products being developed work for the people they are intended to help.

Targeted Therapies for Treating Lupus

Lupus can damage many parts of the body, including the joints, skin, kidneys, heart, lungs, blood vessels and brain. Treatment for lupus depends on the part of the body being affected by the disease and the severity of the symptoms.

Part of what makes lupus research such a challenge is that the precise problem with the immune system is so different among patients, which is also true for how the disease presents itself. New research is trying to zero in on what the best targets might be.

Older medicines, such as corticosteroids, tend to suppress the whole immune system, which can be an effective but an unnecessarily excessive measure with many undesirable side effects. As the understanding of the disease has evolved in recent years, so too has the development of medicines that target the specific molecule (or molecules) in the immune system that may be causing the problem.

The FDA approved Benlysta (belimumab) – the first targeted therapy for lupus – in 2011 to treat systemic lupus in adults. The FDA later approved Benlysta to treat children as young as 5 years old. In 2020, Benlysta became the first FDA approved targeted therapy to treat adults who have lupus with kidney involvement, one of the more severe forms of this disease. In 2021, the FDA approved Saphnelo (anifrolumab-fnia), a targeted therapy to treat adults with systemic lupus.

Advances in the understanding and treatment of lupus over the last several decades have resulted in people with the disease living longer and better lives. Still, many people with lupus need more treatment options.

Source: https://www.fda.gov/consumers/consumer-updates/lupus-therapies-continue-evolve