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 Verywell that the symptoms of lupus can range from relatively mild to life-threatening. Manzi says that lups symptoms may include:
FeversWeight lossHair lossProfound fatigueSkin rashesJoint painChest painShortness of breathPremature strokes or heart attacksKidney 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.
“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.
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.
However, type 1 interferons are not the only proteins involved in lupus inflammation; therefore, additional therapies are needed to manage the condition.
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.
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.
“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.
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."
