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Published in The Lancet: Nipocalimab significantly decreased Sjögren's disease (SjD) activity and severity through substantial reduction in Sjögren's-related autoantibodies

  • Nipocalimab met its primary endpoint by showing statistically significant improvement in the ClinESSDAI score at Week 24 compared to placebo, as detailed in the Phase 2 DAHLIAS study.
  • Patients receiving nipocalimab experienced greater improvements in critical Sjögren's disease symptoms, including dryness, pain, and fatigue, as reported in the study findings.
  • Nipocalimab demonstrated a tolerable safety profile with no new safety signals observed during the 24-week treatment period.
  • There is a significant unmet need for effective treatments for Sjögren's disease, as 9 out of 10 patients are women experiencing persistent symptoms with no approved therapies available.
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Published in The Lancet: Nipocalimab significantly decreased Sjögren's disease (SjD) activity and severity through substantial reduction in Sjögren's-related autoantibodies

Nipocalimab, a first-in-class FcRn blocker being investigated for SjD, met its primary endpoint in the Phase 2 DAHLIAS study with statistically significant improvement in ClinESSDAI score , which is based on 11 key systemic disease domains, at Week 24 versus…

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PR Newswire broke the news in United States on Friday, October 24, 2025.
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