Robert Hal Scofield, MD, Professor of Medicine, at the University of Oklahoma and Oklahoma Medical Research Foundation, discusses the DAHLIAS clinical trial evaluating nipocalimab in Sjögren’s disease (SjD).
SjD is an autoimmune disorder that largely impacts secretory glands, such as those that produce tears and saliva. It is also associated with rheumatic disorders such as rheumatoid arthritis or systemic lupus erythematosus. Hallmark symptoms include dry mouth and dry eyes, but the condition may cause skin, nose, and vaginal dryness. SjD may also affect other organs of the body including the kidneys, blood vessels, lungs, liver, pancreas, and brain.
Nipocalimab is a monoclonal antibody, designed to block FcRn and reduce levels of circulating IgG antibodies. It is currently approved for the treatment of generalized myasthenia gravis.
At the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress new biomarker exploratory analyses from the DAHLIAS phase 2 study (NCT04968912) evaluating nipocalimab in SjD was presented.
Results included clinical improvements observed across all patients. The most significant responses were observed in patients with elevated known disease-driving autoantibodies and IgG levels. Patients in the autoantibody-high subgroup who were treated with nipocalimab achieved higher response rates than the overall population, at 62.5% versus 51.9%. Previously reported results demonstrated statistically significant improvement in ClinESSDAI scores with nipocalimab versus placebo.
Nipocalimab is being further evaluated in patients with systemic SjD in the ongoing DAFFODIL phase 3 clinical trial (NCT06741969).
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To learn more about SjD and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-autoinflammatory-disorders/
