Ghaith Noaiseh, MD, Associate Professor of Allergy, Clinical Immunology, and Rheumatology at The University of Kansas Medical Center, discusses the development of nipocalimab for the treatment of Sjögren’s disease (SjD).
SjD is an autoimmune disorder in which immune cells attack and destroy the glands that produce tears and saliva. SjD is also associated with rheumatic disorders such as rheumatoid arthritis or systemic lupus erythematosus. The hallmark symptoms of SjD are dry mouth and dry eyes. In addition, SjD may cause skin, nose, and vaginal dryness. It also may 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 in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive. Nipocalimab is continuing to be investigated across three key segments including rare autoantibody diseases, maternal fetal diseases mediated by maternal alloantibodies, and rheumatic diseases.
DAHLIAS Clinical Trial
The phase 2 DAHLIAS clinical trial (NCT04968912) is a multicenter, randomized, placebo-controlled, double-blind, dose-ranging study evaluating the efficacy of nipocalimab in participants with moderate to severe active primary SjD who are anti-Ro60 and/or anti-Ro52 IgG antibody seropositive. Results were recently published in The Lancet.
The study met its primary endpoint with a statistically significant improvement in ClinESSDAI score at week 24 in the nipocalimab mg/kg Q2W group compared to placebo. Reductions in disease activity were supported by changes in key biomarkers such as lower levels of rheumatoid factor, fewer circulating immune complexes, and decreased inflammatory markers.
Patients receiving nipocalimab also reported a decrease in symptoms, with numerical improvements observed in dryness of mouth, eyes, and/or vagina, fatigue, and joint pain. An improvement in objective salivary flow of at least 50% increase from baseline was observed in 32.7% of patients versus 16% in the placebo group at week 24.
Additionally, no new safety signals were observed and immune function was preserved. The overall safety profile is consistent with the known safety profile of nipocalimab in myasthenia gravis.
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To learn more about SjD and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-and-auto-inflammatory-disorders/
