JNJ · News · 20261108N

Nipocalimab Sjögren’s Disease Program

JOHNSON & JOHNSON · 2026-11-08 · Importance 23 · Surprise 24

Johnson & Johnson reported Phase 2 DAHLIAS patient-experience findings for nipocalimab in Sjögren’s disease, identifying mouth dryness as the symptom patients most valued improving. The findings complement earlier results showing increased saliva production and have informed the design of ongoing Phase 3 studies. Nipocalimab has FDA Breakthrough Therapy and Fast Track designations for the disease. Separately reported interviews pooled participants receiving nipocalimab and placebo, so they do not establish that the drug caused the reported symptom improvements.

Key facts

• The DAHLIAS patient-experience findings complement previous results showing increased saliva production with nipocalimab and have informed the design of ongoing Phase 3 studies. source
• Johnson & Johnson is advancing two late-stage studies of nipocalimab for Sjögren’s disease. source
• Johnson & Johnson released patient-experience data from the Phase 2 DAHLIAS study of nipocalimab in Sjögren's disease; patients identified mouth dryness as the most crucial symptom to improve. source
• Interviews with participants in a midstage nipocalimab study identified mouth dryness as their leading priority for symptom improvement in Sjögren’s disease. source
• The interviews pooled patients receiving nipocalimab and placebo, so they cannot establish whether the drug caused reported symptom improvements. source