ACR Convergence 2023: New Data Shared on Dazodalibep for Sjögren’s Syndrome

The American College of Rheumatology (ACR) held its annual scientific meeting — ACR Convergence 2023 — from November 10 to 15. During the meeting, stakeholders throughout the field shared insights into the latest rheumatology advances, research, and breakthroughs. According to reporting from Drugs.com, biopharmaceutical company Amgen presented new data from a Phase 2 clinical study that explored the use of dazodalibep for people living with Sjögren’s syndrome.

Dazodalibep is a CD40 ligand antagonist. It works by stopping T cells from interacting with B cells that express CD40. Since multiple autoimmune diseases are associated with an overactive CD40 ligand co-stimulatory pathway, this therapy has the potential to be used or applied over a broad spectrum of disease. This is especially interesting given that there are no approved disease-modifying therapis for Sjögren’s syndrome. Therefore, dazodalibep could potentially fill a huge unmet need for people with this condition.

During ACR Convergence 2023, Amgen shared data into a Phase 2 study with two sub-groups. The first group of patients had moderate-to-severe systemic Sjögren’s disease activity; the other had moderate-to-severe symptoms even though they didn’t have a lot of organ involvement. Findings from the study show that:

  • After first starting with a placebo and later moving to active treatment, patients with moderate-to-severe disease activity saw an improvement in symptoms such as dry eyes and fatigue.
  • In the second group, dazodalibep treatment improved disease measure scores, as well as fatigue, dry eyes and mouth, and pain.
  • Dazodalibep was both safe and well-tolerated in both groups.

Moving forward, the company hopes to advance dazodalibep into Phase 3 studies.

What to Know about Sjögren’s Syndrome

First described by Dr. Henrik Sjögren in the 1900s, Sjögren’s syndrome is an autoimmune condition in which the immune system mistakenly attacks someone’s moisture-producing glands. In particular, the immune system attacks the lacrimal glands (which produce tears) and salivary glands (which produce saliva). However, this condition is multi-systemic and affects different parts of the body such as the lungs, liver, pancreas, brain, and kidneys. Autoimmune conditions typically affect females more than males. This is true also for Sjögren’s syndrome, which affects 10x as many females. Sjögren’s syndrome is also considered primary (occuring with no other rheumatic diseases) or secondary (occurring alongside other autoimmune connective tissue disease).

Symptoms, which often appear between ages 45 and 55, may include:

  • Dry mouth
  • Increased dental decay and/or gingival inflammation
  • Dry, peeling lips
  • Recurrent sinusitis and/or nosebleeds
  • Difficulty chewing, speaking, or swallowing
  • Swollen glands around the face and neck
  • Joint pain and stiffness
  • Excessive fatigue
  • Peripheral neuropathy
  • Changes in taste or smell
  • Acid reflux
  • Dry nasal passages, throat, vagina, and/or skin
  • Irritated, painful, burning, or gritty eyes
  • Increased risk of eye infections and corneal damage

Do you have Sjögren’s syndrome? Find a support group here.