Johnson & Johnson Reports Phase 3 Results for Nipocalimab in Sjögren's Syndrome

Johnson & Johnson today announced results from the Phase 3 DAHLIAS trial evaluating nipocalimab, an anti-FcRn monoclonal antibody, in patients with moderate-to-severe Sjögren's syndrome. Nipocalimab demonstrated a statistically significant improvement in ESSDAI score at week 24 compared to placebo, with 52% of patients achieving a clinically meaningful response. The safety profile was consistent with previous observations. These results support nipocalimab as a potential new treatment option for Sjögren's syndrome and J&J plans to submit for regulatory approval.