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Johnson & Johnson announces new Phase 2 nipocalimab study data in Sjögren's disease that reveal insights on importance of symptom improvements most valued by patients

JNJ
  • New patient experience data from the Phase 2 DAHLIAS study of nipocalimab will be presented at ACR 2026.
  • Mouth dryness was reported as the most important symptom to improve by patients, followed by eye dryness, fatigue, and joint pain.
  • 96% of surveyed patients cited mouth dryness as the most frequently reported symptom of Sjögren's disease.
  • Phase 2 results demonstrated a 50% increase in saliva production in more than twice as many patients receiving nipocalimab compared to placebo.
  • Two ongoing Phase 3 studies are evaluating nipocalimab in Sjögren's disease, incorporating patient-reported outcomes critical to the disease.
  • Five core symptoms were identified in patient interviews: mouth dryness (96%), fatigue (92%), eye dryness (90%), joint pain (73%), and vaginal dryness (49% among women).
  • Patients reported that symptom improvements led to tangible benefits in physical functioning, reduced disease management needs, and less interference with work, family, and social commitments.
  • 73.5% of participants reported being satisfied or very satisfied with the study treatment.
  • Johnson & Johnson initiated the Phase 3 DAFFODIL study to assess disease activity alongside dryness, pain, fatigue, quality of life, and patient-perceived improvement.
  • Nipocalimab is the only Fc receptor (FcRn) blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA for moderate-to-severe Sjögren's disease.
  • The drug targets the neonatal Fc receptor to reduce circulating IgG antibodies while preserving B-cell function.
  • Sjögren's disease is estimated to affect approximately four million people worldwide, with nine times more cases in women than men.
Company
Johnson & Johnson
Keywords
Johnson & Johnson