By Amy Norton
HealthDay reporter
THURSDAY, May 27, 2021 (HealthDay News) – Experimental antibody therapy may help relieve skin symptoms of the autoimmune disease lupus, a small preliminary study suggests.
The researchers found that a higher-dose version of the drug induced “clinically meaningful” improvement in symptoms in 87% of patients after one month.
However, they also emphasized that the results are based on a small “phase 1” study – a type of study primarily designed to measure the safety of a treatment.
The safety results were “encouraging” and there was “some evidence of clinical benefit,” said lead researcher Jodi Karnell, senior director of research at Horizon Therapeutics, the company developing the drug.
Now, she said, larger studies are needed to confirm the therapy is working.
The drug, currently known as VIB7734, is a monoclonal antibody – a laboratory-made protein that acts like an antibody made by the immune system. Such antibodies can be directed against certain substances in the body that are involved in a disease process.
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Lupus is caused by an autoimmune reaction in which the immune system mistakenly attacks the body’s own tissues.
The most common form is systemic lupus, which can cause inflammation throughout the body, including the skin, joints, kidneys, blood vessels, and the brain.
Another form, called skin lupus, affects only the skin and causes rashes and sores, often on the face and scalp.
There are treatments for these skin symptoms, including anti-inflammatory corticosteroids; Antimalarial drugs that alter the immune response; and immunosuppressive drugs like methotrexate.
But these treatments can have significant side effects and do not always work, emphasized Karnell.
“There is a great unmet need,” she said.
In the United States alone, about 1.5 million people have lupus, according to the Lupus Foundation of America.
A monoclonal antibody, Benlysta (belimumab), is approved for systemic lupus. It blocks a protein in the immune system that is involved in the formation of autoantibodies (antibodies that attack tissue in the body).
The new monoclonal antibody works differently, explained Karnell. It depletes the cells of the immune system called plasmacytoid dendritic cells.
These cells usually fight infection by releasing inflammatory chemicals, including type 1 interferons. However, it is believed that uncontrolled activities in cells that are expressing too much interferon contribute to autoimmune diseases.
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For the Phase 1 study, Karnell’s team recruited 31 patients with at least one of several autoimmune diseases, including systemic and cutaneous lupus. They were randomly selected to receive injections of either the monoclonal antibody at different doses or a placebo. The injections were given every four weeks for a total of three.
After one month, the group with the highest dose of antibody showed the greatest benefit: Seven out of eight (87.5%) showed a “clinically meaningful” reduction in skin symptoms, compared with about 37% of patients on the lower dose and 28% of placebo Patient.
The results were published in the journal Science Translational Medicine on May 26th.
Dr. Donald Thomas, a rheumatologist who was not involved in the study, commented cautiously: Over the years, various lupus therapies have initially only shown promises to disappoint in late-stage studies.
Even so, these early results are encouraging, he noted.
“If they make it into Phase 2 and 3 studies, that would be a cornerstone,” said Thomas of the Uniformed Services University of Health Sciences and Arthritis and Pain Associates of PG County, Maryland.
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Skin lupus can affect patients’ quality of life, Thomas said. Some have hair loss and scars from skin lesions.
Unlike therapies that have a broad target for the immune system, monoclonal antibodies target specific components of the immune response, Thomas said. That means they may have fewer side effects and be more effective.
Thomas found that the side effects of Benlysta, the antibody approved for SLE, were “remarkably minimal” overall.
Karnell emphasized that the experimental drug worked as intended – breaking down dendritic cells and type 1 interferon activity in both the blood and skin lesions of the patients. The next step will be a larger phase 2 study, she added.
The researchers also found that patients with high interferon activity initially were the ones whose symptoms improved with the antibody. One question for the future, therefore, said Karnell, is whether measuring patient interferon activity can help identify those who are most likely to benefit from treatment.
If doctors were able to do this, Thomas said it would be a step forward.
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Right now, he said, lupus treatment often involves trial and error trying to figure out which therapy works – a frustrating fact for patients.
More information
The Lupus Foundation of America offers more options for treating lupus.
SOURCES: Jodi Karnell, PhD, Senior Director, Research Group, Horizon Therapeutics, Dublin, Ireland / Deerfield, IL; Donald Thomas Jr., Associate Professor, Medicine, Uniformed Services University of Health Sciences, Bethesda, Md., And Rheumatologist, Arthritis and Pain Associates, PG County, Greenbelt, Md .; Scientific translational medicine, May 26, 2021, online
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