JNJ · News · 20261107N

Nipocalimab Sjögren’s Disease Program

JOHNSON & JOHNSON · 2026-11-07 · Importance 17 · Surprise 24

Johnson & Johnson reported Phase 2 DAHLIAS study findings on patient-valued symptoms in Sjögren's disease, identifying mouth dryness as the symptom patients most want improved. The findings complement prior Phase 2 results showing increased saliva production with nipocalimab and are intended to inform ongoing Phase 3 studies. The development program aims to address systemic disease activity as well as dryness, pain, and fatigue; nipocalimab has FDA Breakthrough Therapy and Fast Track designations for Sjögren's disease.

Key facts

• Johnson & Johnson's Phase 2 DAHLIAS study findings identified mouth dryness as the most critical symptom for Sjögren's disease patients to improve. source
• The patient experience findings will inform ongoing Phase 3 studies of nipocalimab, which aim to address systemic disease activity and patient-valued outcomes including dryness, pain, and fatigue. source
• Nipocalimab is described as the only FcRn blocker with both Breakthrough Therapy and Fast Track Designations from the FDA for Sjögren's disease. source
• Previous Phase 2 results showed increased saliva production with nipocalimab. source