New Drug Benefits Patients with Sjögren’s Disease in Phase 2 Clinical Trial
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DURHAM, N.C. – In a phase clinical trial, a new drug under development significantly reduced both the symptoms and disease process of a condition called Sjӧgren’s disease (SjD).
SJD is marked by eye and mouth dryness, fatigue, and pain and often occurs in association with rheumatoid arthritis and systemic lupus, but it can also be its own primary disease.
The international study was led by E. William St. Clair, M.D., the W. Lester Brooks Jr. Professor of Medicine in the Division of Rheumatology and Immunology at Duke University School of Medicine. Results appear June 5 in the journal Nature Medicine.
“This is hopeful news for people with Sjögren’s,” St. Clair said. “There are currently no disease-modifying therapies for SjD, so current treatment is usually aimed at reducing symptoms.”
Among the most common autoimmune diseases, SjD affects mostly women. It typically develops in middle-age but can affect people of all ages. Systemic disease can cause inflammation, leading to arthritis, skin rashes, lung disease, kidney disease, nervous system disease, and vasculitis.
A new drug -- Dazodalibep or DAZ -- blocks the signals that drive autoimmunity in SjD. In this phase two study, two different study populations of SjD patients were enrolled and randomly assigned to either receive DAZ therapy or a placebo drug.
The first group of participants included 74 patients with moderate to severe systemic disease activity, and the second group consisted of 109 patients with severe symptoms but limited serious organ system involvement.
After 169 days, the moderate to severe group showed DAZ therapy produced significant improvement using a multi-dimensional index measuring systemic disease activity. In the second population, DAZ therapy also reduced symptoms over the same timeframe using a scale that evaluates the degree of dryness, fatigue, and pain.
“DAZ is the first new drug under development for the treatment of SjD to reduce both systemic disease activity and an unacceptable symptom burden,” St. Clair said. “These findings need confirmation in larger clinical trials.”
In addition to St. Clair, study authors include Alan N. Baer, Wan-Fai Ng, Ghaith Noaiseh, Chiara Baldini, Teresa K. Tarrant, Athena Papas, Valerie Devauchelle- Pensec, Liangwei Wang, Wenjing Xu, Tuyet-Hang Pham, Keith Sikora, William A. Rees, and Ilias Alevizos.
The was funded by Horizon Therapeutics (now Amgen Inc.), which is developing DAZ.