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New drug in Duke-led clinical trial shows improvement in people with common autoimmune disease

A masked person holds an IV bag full of clear liquid
Mathurin Napoly
In the phase 2 study, patients were randomly assigned to either receive infusions of a new drug for Sjögren’s disease or a placebo drug.

A new drug has shown benefits in clinical trials for one of the most common autoimmune diseases.

Sjögren’s disease affects an estimated 1 to 4 million people in the United States. It can cause pain, fatigue, and dryness of the eyes and mouth.

“About a quarter of patients will have what we call systemic disease activity,” said Duke rheumatologist Dr. Bill St. Clair. “It can affect other organ systems. For example, the lungs. It can also affect the kidneys, the nervous system, and cause a variety of different types of rashes. And, interestingly, there's an increased risk for certain types of lymphoma.”

St. Clair said current treatments for Sjögren’s disease address symptoms, but not the disease itself.

“Sjögren’s disease for many years has been dismissed and largely ignored because many have assumed that these symptoms of dryness are more annoying than actually problematic,” St. Clair said. “But there are significant complications. A big unmet need of Sjögren’s disease is to find a therapy that actually modifies the disease itself and can affect long term outcomes.”

St. Clair led the phase 2 clinical trial for a new drug called dazodalibep, or DAZ. According to St. Clair, the medicine is believed to block the communication between certain cells in order to reduce the body’s inflammatory response.

Clinical trial participants who received the infusion treatment saw statistically significant improvements in both systemic disease activity and symptoms like dryness.

“It's a very promising result to see that both systemic disease activity and the cardinal symptoms of Sjögren’s disease — dryness and fatigue and pain — are both favorably impacted by this drug, at least in our phase two study,” St. Clair said. “If this holds together in phase three, I think we could end up with a very useful therapy.”

Phase 3 trials for the drug have begun, but St. Clair said it could be another four to five years before the treatment is available if approved by the Food and Drug Administration (FDA).

St. Clair added that DAZ and similar drugs may potentially be versatile treatments for other diseases involving inflammation, such as rheumatoid arthritis and multiple sclerosis. Additionally, while no evidence is available yet, St. Clair hypothesized that by slowing down an overactive immune system, DAZ may reduce the risk of lymphatic cancer associated with Sjögren’s disease.

Sophie Mallinson is a daily news intern with WUNC for summer 2023. She is a recent graduate from UNC-Chapel Hill, where she studied journalism. Sophie is from Greenville, N.C., but she enjoys the new experiences of the Triangle area. During her time as a Tar Heel, Sophie was a reporter and producer for Carolina Connection, UNC-Chapel Hill’s radio program. She currently is heavily involved in science education at Morehead Planetarium and Science Center.
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