Scientists are currently exploring whether the experimental medication litifilimab can help treat lupus symptoms.
In a recent study, researchers tested litifilimab to see if the drug could reduce swollen and tender joints in people with lupus.
Litifilimab is a lab-produced monoclonal antibody. It was developed to target a protein on certain immune cells that are associated with inflammation in lupus.
The new study included 132 participants who had lupus as well as at least four tender and swollen joints.
They were randomized with 64 participants receiving 450 mg of litifilimab, 6 receiving 150 mg, 6 receiving 50 mg, and 56 receiving a placebo. The trial lasted 24 weeks, with participants receiving shots at the start of the trial and again at weeks 2, 4, 8, 12, 16, and 20.
At the end of the trial, researchers reported that the participants who received 450 mg shots had fewer swollen and tender joints than those taking a placebo.
The medication will now advance to phase 3 trials that will include a more significant number of participants.
Dr. Richard Alan Furie, the principal investigator in the study as well as the chief of the Division of Rheumatology at Northwell Health and a professor at the Feinstein Institutes for Medical Research in New York, said litifilimab performed well in the most recent trials, but more research is needed.
“The primary endpoint of this phase 2 study was improvement in arthritis, which was measured by assessing joint tenderness and swelling,” Furie told Healthline. “While the findings of improvement of arthritis were observed in this phase 2 study, there is a phase 3 study ongoing with a larger number of patients to confirm our initial results.”
The researchers did note that one of the side effects is an increased risk of shingles.
“Patients would be advised to be immunized with the shingles vaccine before starting this drug,” said Dr. Daniel Wallace, a rheumatologist and professor of medicine at Cedars-Sinai Medical Center in Los Angeles, in an editorial that accompanied the study results in the New England Journal of Medicine.
In addition to shingles, side effects of litifilimab also include:
“Clinicians always have to be concerned about potential side effects when a medicine is prescribed,” said Furie. “The safety profile of litifilimab was quite good. Phase 3 studies will further inform us of any safety signals.”
In an earlier study completed at Penn Medicine, researchers looked at the effects of litifilimab on lupus-related skin rashes.
They determined many people had reduced skin rash activity when taking the medication. Of the participants, three experienced hypersensitivities, three experienced oral herpes, and one developed herpes zoster (shingles).
“Some patients in our trial saw huge improvements within a month,” said Dr. Victoria Werth, the lead author of the study as well as a professor of dermatology at Penn and the chief of dermatology at the Corporal Michael J. Creszcenz Veterans Affairs Medical Center in Philadelphia, in a statement.
“Not only do the available drugs not always work, but they are also not always well tolerated,” Werth continued. “Sometimes, a patient may have to move up to immunosuppressants, which have many side effects like higher risk of infection. So being able to develop a different approach could be pivotal.”
One of the limitations of the study was the underrepresentation of minority groups.
“Even though Black patients make up one-third of the U.S. population with lupus, the response to litifilimab in this group is difficult to determine because few Black participants were enrolled in the study, two-thirds of the participants were outside the U.S., and race was not reported by sites in Europe,” explained Wallace.
Lupus is a chronic autoimmune disease that causes inflammation and pain anywhere in the body but most often affects the skin, joints, and internal organs, such as the kidney or the heart, according to the Lupus Foundation of America.
There are four types of lupus:
An estimated 1.5 million people in the United States have lupus.
People most at risk include:
About 90 percent of people with lupus are women.
Symptoms of lupus are varied and can differ from person to person, according to the
They can come and go. They are sometimes referred to as flares or remissions.
The goals of treatment are to reduce inflammation, prevent flares or treat them as they occur, and minimize damage to internal organs.
There are currently three main treatments:
“Lupus is associated with multiple complications and is one of the leading causes of death in young women,” said Wallace.
In addition to medication to treat the symptoms of lupus, doctors also prescribe treatments to help with complications. The medications include anticonvulsants, antibiotics, high blood pressure medication, statins for high cholesterol, drugs for osteoporosis, and vitamin D for kidneys.
“Other than taking medications, there are some strategies to reduce joint pain,” said Furie. “While those strategies depend on the origins and locations of the pain, a patient could consider working with a physical or occupational therapist.”