DATA from the DAHLIAS Phase II was presented at ACR Convergence 2024 in Washington, D.C., as part of an abstract plenary session, sharing efficacy and safety of nipocalimab in treating primary Sjögren’s disease. Nipocalimab, an anti-FcRn monoclonal antibody, works by selectively blocking FcRn-IgG interactions, reducing pathogenic autoantibodies implicated in Sjögren’s disease.
The multicenter, randomized, placebo-controlled, double-blind study enrolled 163 patients aged 18-75 years with moderately-to-severely active primary Sjögren’s disease. Participants were randomized to receive intravenous nipocalimab (5 or 15 mg/kg) or placebo every 2 weeks through 24 weeks. The primary endpoint of change from baseline in clinESSDAI score at W24 was chosen to avoid mechanistic bias with IgG levels.
Patients receiving 15 mg/kg of nipocalimab demonstrated a statistically significant improvement compared to placebo. Improvements were seen in most secondary/exploratory endpoints, including changes from baseline at W24 in Physician Global Assessment of Disease Severity and ESSDAI score, treatment response according to Sjögren’s Tool for Assessing Response, Composite of Relevant Endpoints for Sjogren’s Syndrome, and disease activity level response (decrease in ≥1 clinESSDAI domain).
Safety profile:
Nipocalimab was generally well-tolerated, with adverse events comparable across treatment groups. Serious adverse events occurred in 7.5% of patients receiving 5 mg/kg, 7.4% in the 15 mg/kg group, and 5.4% in the placebo group. No opportunistic infections, severe hypoalbuminemia, or deaths were reported.
Implications for practice:
These findings establish the mechanistic relevance of FcRn inhibition in Sjögren’s disease and underscore nipocalimab’s potential as a novel treatment for moderate-to-severe cases. Researchers emphasized that further studies are warranted to confirm these promising results and explore long-term outcomes.
Reference: Gottenberg JE et al. Efficacy and Safety of Nipocalimab, an Anti-FcRn Monoclonal Antibody, in Primary Sjogren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study (DAHLIAS). Abstract 2527. ACR Convergence 2024, November 16-19, 2024.
