Key TakeawaysThe 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.

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 severesystemic lupus erythematosusin 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.”

Lupus Support Groups

What Is Lupus?

Lupusis 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 Verywell that the symptoms of lupus can range from relatively mild to life-threatening. Manzi says that lups symptoms may include:

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 abiologic therapy, meaning that it’s derived from a living organism and is a particularly targeted type of treatment.

“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?

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.

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.

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.

How Is Lupus Treated?

Known Side Effects

How Lupus Affects the Kidneys

Saphnelo and COVID-19People 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.

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.

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.

What Doctors Treat Lupus?

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 YouIf 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.

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.

2 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Saphnelo label. July 2021.Bengtsson AA, Rönnblom L.Role of interferons in SLE.Best Pract Res Clin Rheumatol. 2017 Jun;31(3):415-428. doi:10.1016/j.berh.2017.10.003

2 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Saphnelo label. July 2021.Bengtsson AA, Rönnblom L.Role of interferons in SLE.Best Pract Res Clin Rheumatol. 2017 Jun;31(3):415-428. doi:10.1016/j.berh.2017.10.003

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Food and Drug Administration.Saphnelo label. July 2021.Bengtsson AA, Rönnblom L.Role of interferons in SLE.Best Pract Res Clin Rheumatol. 2017 Jun;31(3):415-428. doi:10.1016/j.berh.2017.10.003

Food and Drug Administration.Saphnelo label. July 2021.

Bengtsson AA, Rönnblom L.Role of interferons in SLE.Best Pract Res Clin Rheumatol. 2017 Jun;31(3):415-428. doi:10.1016/j.berh.2017.10.003

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