Advanced Lupus Treatment Clinical Trials: People with autoimmune lupus disease may soon have a new drug to use, a clinical trial suggests.

Anifrolumab is a laboratory-created antibody that blocks type 1 interferon, a biochemist that activates an immune response in humans, said lead researcher Eric Morand, director of Monash's School of Health Clinical Sciences in Melbourne, Australia.

The new drug caused a significant reduction in lupus symptoms in 48% of patients after one year, compared with 32% of patients receiving a placebo.

Advanced treatment lupus clinical trials

"We have long known that about 80% of lupus patients have a detectable signature in their blood that shows they have too much interferon in their system," said Morand.

Anifrolumab, which blocks the type 1 interferon receptor that all immune cells share, shows that overproduction of this biochemical really plays a major role in lupus, he said.

"This medicine, which does only one thing, was associated with a dramatic improvement in patient outcomes compared to placebo," said Morand.

According to the results of this and previous tests, the AstraZeneca pharmaceutical company intends to seek U.S. approval of anifrolumab sometime in the first half of the year, Morand said.

"They are optimistic that in all three rehearsals, virtually all of the measures stack up and look the same," he said.

AstraZeneca funded this trial.

About 1.5 million people in the United States have lupus, and more than 5 million worldwide have it, researchers said in the background notes. Nine out of 10 lupus patients are women.

Lupus causes the immune system to turn against the body, causing inflammation and pain. People most commonly suffer from rash, sore or swollen joints, headaches, extreme fatigue, anemia, fever and swelling in the feet, legs and hands, according to the Lupus Foundation of America.

Lupus also causes sustained inflammation in the internal organs, and about 10% of people diagnosed with the disease die within a decade, the researchers said.

In this three-year international clinical trial, half of 362 patients received anifrolumab and the other half received a placebo.

A previous clinical trial of anifrolumab did not deliver positive results because doctors had set a goal of total improvement in at least one organ system affected by lupus, Morand said.

That test changed the goalposts, instead of pointing to a partial but significant improvement in all lupus-damaged organ systems, he said.

Researchers said the drug met that goal. For example, many patients with a lupus rash discovered that their skin was clear after starting anifrolumab.

"The most obvious improvements were in severe lupus skin disease. It's obvious because you and the patient can see it," said Morand. "There are many reports of skin disease researchers that they almost disappear quickly."

Patients also needed less dose of steroids to treat the symptoms and experienced less frequent symptom outbreaks.

No one had to stop taking anifrolumab because of the side effects, which were primarily caused by inhibiting the drug's immune response against viral infections, said Morand. About 7% of patients suffered an outbreak of shingles and 12% contracted bronchitis.

However, there was one death from pneumonia in the group that took anifrolumab. The findings were published on December 18 in the New England Journal of Medicine.

"There has been very little good news about lupus for a very long, long time," said Morand, saying that the results of the trial show "we are learning how to do better and we expect more drugs to succeed. for years to come. "

An editorial published with the study noted that in three clinical trials, results for most primary and secondary goals showed that anifrolumab performed better than a placebo.

"Given the need for medication for patients with SLE [systemic lupus erythematosus], the lupus community has urged regulators to consider trial designs that allow for more flexibility in defining success," wrote the editorialists. Jane Salmon of Weill Cornell Medicine and Dr. Timothy Niewold of NYU School of Medicine, both in New York City.

An editorial published with the study noted that in three clinical trials, results for most primary and secondary goals showed that anifrolumab performed better than a placebo.

"Given the need for medication to patients with SLE [systemic lupus erythematosus], the lupus community has urged regulators to consider trial designs that allow for more flexibility in defining success," wrote the editorialists. Jane Salmon of Weill Cornell Medicine and Dr. Timothy Niewold of NYU School of Medicine, both in New York City.

"These strategies could accelerate drug development in lupus until universally accepted response measures are available."