FDA Approves New Lupus Treatment


Key Takeaways

  • The FDA has approved Saphnelo (anifrolumab) to treat moderate to severe lupus in individuals who are already receiving standard treatment for the disease.
  • The recommended dosage of Saphenelo is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.
  • Saphenlo is considered safe for most patients; however, it can increase the risk for viral respiratory infections and shingles.

Last month, the Food and Drug Administration (FDA) approved the AstraZeneca drug Saphnelo (anifrolumab) to treat moderate to severe systemic lupus erythematosus in patients who are already receiving standard treatment for the condition. Saphnelo is a prescription intravenous medication, administered once every four weeks over 30 minutes.

In an August 2 press release from the drugmaker, AstraZeneca, Richard Furie, MD, chief of the Division of Rheumatology at Northwell Health in New York and a principal investigator in the Saphnelo clinical development program, said that the goals of treatment for people with lupus are to “reduce disease activity, prevent organ damage from either the illness itself or the medications, especially steroids, and improve one’s quality of life.”

What Is Lupus?

Lupus is an autoimmune disorder that causes the immune system to overreact and attack healthy body cells. It tends to impact young women between 15 and 45, as well as women of color.

Susan Manzi, MD, MPH, a rheumatologist who was involved in Saphnelo clinical trials, tells Get Meds Info that the symptoms of lupus can range from relatively mild to life-threatening. Manzi says that lups symptoms may include:

  • Fevers
  • Weight loss
  • Hair loss
  • Profound fatigue
  • Skin rashes
  • Joint pain
  • Chest pain
  • Shortness of breath
  • Premature strokes or heart attacks
  • Kidney failure

What to Know About Saphnelo 

Saphnelo is for patients who have not been able to control their lupus symptoms through their current treatment. The drug is a biologic therapy, meaning that it’s derived from a living organism and is a particularly targeted type of treatment.

Saphnelo is the only drug that is designed to block the damaging effects of type 1 interferon, an immune system-regulating protein. Lupus can be triggered by high levels of type 1 interferon.

“If we base our recommendations on clinical trials, what we found was people with moderate to severe lupus were the best candidates for Saphnelo,” says Manzi, adding that the patients who benefit the most are those who experience “severe skin rashes, debilitating arthritis, and issues with the heart or lungs due to lupus.”

How Is It Administered?

Saphnelo is given in an outpatient setting. Patients receive a dosage of 300 miligrams by IV once a month for life.

If Saphnelo is effective at controlling lupus symptoms and is causing no side effects, it can be continued indefinitely. Manzi says that a patient who must stop taking Saphnelo will need to be placed on other potentially effective standard therapies.

How Does Saphnelo Work?

Saphenlo binds to the type 1 interferon receptors (IFNAR) on the surfaces of immune cells. When the receptor is blocked, type 1 interferon proteins are not able to cause the inflammation and tissue damage that is associated with lupus.

However, type 1 interferons are not the only proteins involved in lupus inflammation; therefore, additional therapies are needed to manage the condition.

Road to Approval

Researchers conducted Phase 3 trials for Saphnelo in multiple countries and included people of different ages and ethnicities. Manzi says that since 90% of patients with lupus are women, the trials incorporated a representative proportion of women to men.

Saphnelo was tested as an add-on to the standard of care for lupus. It will most often be used as an alternative to or in addition to traditional therapies.

Manzi says that until now, lupus treatment depended upon organ involvement and the severity of the disease.

  • For mild disease, patients can use over-the-counter (OTC) non-steroidal anti-inflammatory medications (NSAIDs) like ibuprofen (Motrin, Advil) and naproxen (Aleve).
  • Corticosteroids such as prednisone can be prescribed to target the inflammatory effects of lupus in many organ systems. Hydroxychloroquine is also a standard treatment for mild to moderate lupus.
  • For more severe cases, clinicians may prescribe more potent medications, including chemotherapy or transplant anti-rejection drugs that target the immune system.

Known Side Effects

Manzi says that most patients receiving Saphnelo do not have any allergic reactions or severe side effects. However, Saphnelo has not yet been tested in patients with severe neurologic or kidney impairment caused by lupus.

Saphnelo suppresses the immune system, which puts patients receiving it at a slightly higher risk for upper respiratory infections. Patients also have a slightly increased risk for developing shingles, which Manzi says can be mitigated by receiving a shingles vaccine.

Saphnelo and COVID-19

People taking Saphnelo have a higher risk for viral infections and need to take precautions against COVID-19.

“During the trial, researchers were carefully monitoring COVID-19 infection rates, and they did not see a signal suggesting higher rates of infection with the drug,” says Susan Manzi, MD, MPH, a rheumatologist who was involved in Saphnelo clinical trials. “But that will always be a concern with patients that are immune suppressed or have autoimmune conditions.”

Manzi strongly recommends that all patients with lupus receive a COVID-19 vaccine and adds that patients currently taking Saphnelo should receive a third mRNA vaccine “booster” dose.

How to Get Saphnelo If You Have Lupus

While many primary care providers treat lupus, Manzi says that rheumatologists are the specialists who are most familiar with the condition and the most comfortable prescribing biologic therapies.

Manzi says that there are plans for a trial testing a subcutaneous form of anifrolumab that patients could self-inject at home. In the future, Saphnelo might also be tested for use in other autoimmune disorders.

“Lupus patients have gone so long without effective therapies, and seeing these agents be approved is very encouraging,” says Manzi. “I’m grateful that we now have options for our patients.”

What This Means For You

If you have lupus and are not getting relief from your current treatment, ask your rheumatologist if Saphnelo might be something that you could try. AstraZeneca offers financial support to patients who have difficulty paying for Saphnelo. There are also other programs to help people with lupus pay for treatments.

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