New Drug Shows Promise in Treating Sjogren's Disease

By Pat Anson, PNN Editor

Sjogren's disease – also known as Sjogren's syndrome – is one of the most frustrating and painful autoimmune conditions. Often accompanied by rheumatoid arthritis, lupus and other immune system disorders, Sjogren's usually begins with dry eyes and a dry mouth, and then slowly progresses to a chronic illness that causes fatigue, muscle and joint pain, and organ damage.

Most frustrating of all is that there are few ways to stop Sjogren's progression and complications that can result in an early death. Eyes drops, anti-inflammatory drugs and pain medication only mask the symptoms temporarily.

“There are currently no disease-modifying therapies for Sjogren's, so current treatment is usually aimed at reducing symptoms," says E. William St. Clair, MD, a Professor in the Division of Rheumatology and Immunology at Duke University School of Medicine.

That could be changing, thanks to a new drug being developed by Amgen and an international research team. In a Phase 2 randomized clinical trial, 183 adult patients with moderate-to-severe Sjogren's received intravenous infusions of dazodalibep (DAZ), a drug that blocks the signals that drive the autoimmune reaction to Sjogren's.

The study findings, published this month in the journal Nature Medicine, show that patients who received DAZ therapy had a significant reduction in disease activity. They also had reduced symptoms of dryness, fatigue and pain.

"This is hopeful news for people with Sjögren's," says Clair, the study’s lead author. "DAZ is the first new drug under development for the treatment of Sjögren's to reduce both systemic disease activity and an unacceptable symptom burden.”

DAZ therapy was generally safe and well tolerated, with mild adverse events such as diarrhea, dizziness, respiratory tract infection, fatigue and hypertension.

Phase 2 studies are only meant to test a drug’s safety and efficacy. Amgen is currently recruiting about 1,000 patients with moderate-to-severe Sjögren's for two larger Phase 3 studies of DAZ therapy. Both are expected to take about two years to complete.  

Dazodalibep is also binge studied as a therapy for rheumatoid arthritis and glomerulosclerosis, a rare kidney disease. The drug was originally developed by Horizon Therapeutics, which Amgen purchased last year for $27.8 billion.