- Nipocalimab, an investigational FcRn treatment, significantly decreased Sjögren’s disease activity in a Phase 2 study.
- The study showed improvements in ClinESSDAI score and key biomarkers at Week 24.
- Nipocalimab received Breakthrough Therapy and Fast Track Designations from the U.S. FDA.
- The Phase 3 DAFFODIL study is currently enrolling patients.
Study Findings
Johnson & Johnson announced results from the Phase 2 DAHLIAS study, published in The Lancet, indicating that nipocalimab significantly reduced Sjögren’s disease activity and severity in patients with moderate-to-severe conditions. The study met its primary endpoint, showing statistically significant improvement in the ClinESSDAI score at Week 24 for the nipocalimab group compared to placebo.
Biomarker Improvements
Reductions in disease activity were supported by favorable changes in key biomarkers, including lower levels of rheumatoid factor, fewer circulating immune complexes, and decreased inflammatory markers. Patients reported decreased symptoms, with improvements in dryness, fatigue, and joint pain. Objective salivary flow increased by at least 50% in more patients receiving high-dose nipocalimab compared to placebo.
Safety Profile
Nipocalimab demonstrated a tolerable safety profile with no new safety signals during the 24-week treatment period. Immune function was preserved, and there was no increase in serious infections. The safety data align with the overall profile of IMAAVY™, approved for generalized myasthenia gravis.
Regulatory Status
Nipocalimab is the only investigational treatment granted Breakthrough Therapy Designation by the U.S. FDA for Sjögren’s disease and received Fast Track Designation in April 2025. The Phase 3 DAFFODIL study is underway and actively enrolling patients.
