Johnson & Johnson: DAHLIAS Phase 2 finds mouth dryness is top-priority symptom for Sjögren’s patients

Patient‑reported priorities from DAHLIAS exit interviews

Of 163 randomized DAHLIAS participants, 49 (30.1%) completed blinded, 60‑minute semi‑structured exit interviews within two weeks after the 24‑week treatment period. Five core symptoms were most frequently reported: mouth dryness (96%), fatigue (92%), eye dryness (90%), joint pain (73%) and, among women, vaginal dryness (49%). Patients identified mouth dryness as both the most frequently reported symptom and the one most often prioritized for improvement.

Symptom change linked to daily functioning

Participants reported improvements across many core symptoms during the treatment phase. Those improvements were associated with better physical functioning, reduced need for disease management, and less interference with family, work and social commitments. Nearly 73.5% of interviewed participants said they were satisfied or very satisfied with study treatment.

Clinical context and next steps

Earlier DAHLIAS data showed objective unstimulated salivary flow (an exploratory endpoint) with at least a 50% increase from baseline in 33% of patients receiving 15 mg/kg nipocalimab versus 16% on placebo at Week 24. These patient experience findings helped inform the ongoing Phase 3 DAFFODIL study in adults with moderate‑to‑severe Sjögren’s disease, which evaluates disease activity alongside dryness, pain, fatigue, quality of life and patient‑perceived improvement.