AstraZeneca’s new lupus drug receives FDA approval


The US Food and Drug Administration on Monday approved a new drug for the treatment of adults with the most common type of lupus, moderate to severe.

AstraZeneca’s Saphnelo has fewer side effects than standard treatments and is effective for serious diseases. The approval of the drug has caused excitement in the lupus community.

Systemic lupus erythematosus It is an autoimmune disease that causes the immune system to malfunction, attacking organs and body systems instead of infection. The most commonly affected organs and systems are the skin, joints, kidneys and lungs.

Usually called Great imitator Because it mimics the similar symptoms of many other diseases, lupus is difficult to diagnose. It usually takes months or even years for patients to get an accurate diagnosis.

This The most common symptoms Lupus is fatigue; fever; joint pain, stiffness, and swelling; butterfly-shaped rash; rash and skin damage; shortness of breath; chest pain, headache; confusion; and memory loss.

“Currently, there are not many effective drugs for lupus, and many of the drugs used tend to have many side effects,” Say Mary K. “Peggy” Crow, Honorary Chief Physician at the Hospital of Special Surgery, Director of Autoimmune and Inflammation Research Projects, and Co-Director of the Mary Kirkland Lupus Research Center of the HSS Institute.

“I think the approval of this drug will make patients and doctors treating this disease very excited.”

In the early 2000s, special surgery hospitals played an important role in most of the basic work of this new drug. Anifrolumab is a monoclonal antibody that blocks type I interferon receptors.

Type I interferon is an important part of the body’s defense against viral infections. When these molecules detect foreign invaders, they bind to interferon receptors, thereby alerting the immune system to fight the infection.

However, in patients with lupus, when there is no infection that causes the body to attack itself, the recipient will sound an alarm. Decades of studies have shown that patients with lupus have high levels of type I interferon.

“There are observations dating back to the 1970s that interferon was elevated in certain autoimmune diseases, including lupus,” Krau said. “But it wasn’t until the advent of gene microarrays around 2000 that my laboratory was able to begin to figure out the exact role of interferon in disease.”

Crow and her team studied blood samples from lupus patients and found that one of the biggest differences between these blood samples and people without lupus was the genes regulated by type I interferon. Early studies in mice confirmed the role of type I interferon in lupus, indicating that it is a possible therapeutic target.

“Lupus is a very heterogeneous disease and it is difficult to control it,” said Kyriakos A. Kirou, an associate attending physician at the Special Surgery Hospital. He used to work in Dr. Crow’s laboratory and now leads clinical trials of lupus in the hospital. He is involved. Anifrolumab test was performed.

“One of the reasons anifrolumab is so promising is that it seems to be particularly effective for patients with more severe disease. It is particularly effective for the skin rashes that are common in patients with lupus.”

Kirou added that because the drug only targets type I interferon receptors, it has fewer side effects compared to existing treatments (such as steroids). However, the risk of developing upper respiratory tract infections and shingles is higher. Researchers said they might recommend that people get the shingles vaccine before taking the medicine.

AstraZeneca’s Saphnelo (anifrolumab)Intravenous administration is the third lupus treatment approved by the FDA since 2011. Vorosporin It is the first oral drug approved for the treatment of lupus-related kidney inflammation.

“After only one treatment for lupus was approved in the past 60 years, two new treatment options were approved in 2021 alone for the treatment of this life-threatening autoimmune disease that is estimated to affect 1.5 million Americans. This is worth celebrating.” Say Stevan W. Gibson, President and CEO of the Lupus Foundation of America.

Data from two phase III and one phase II clinical trials showed that patients who received anifrolumab in addition to standard treatment experienced greater improvement in symptoms compared to patients who received only standard treatment. More patients receiving new drugs can also reduce the need for oral corticosteroids.

TULIP-2 Phase II trial results were published in New England Journal of Medicine In January 2020, the results of the TULIP-1 phase III trial were published in Lancet Rheumatology In December 2019, the results of the MUSE Phase II trial were published in Arthritis and Rheumatology November 2016.



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