NEW BRUNSWICK, N.J. – November 07, 2026 -- Johnson & Johnson reported that 96% of Sjögren's disease patients interviewed after its Phase 2 DAHLIAS study cited mouth dryness as a symptom, making it both the most frequent complaint and the improvement patients prioritized most. The company will present the findings among 23 nipocalimab abstracts at the American College of Rheumatology (ACR) Convergence 2026.
Four core symptoms reported by more than 70% of interviewed patients
Besides mouth dryness (96%), patients most often reported fatigue (92%), eye dryness (90%) and joint pain (73%). Among women, 49% reported vaginal dryness. Patients said they saw improvements across many of these symptoms during the treatment phase.
Sjögren's disease is a chronic, systemic, autoantibody-driven condition affecting approximately four million people worldwide. It is nine times more common in women than in men.
Only 49 of 163 DAHLIAS participants completed exit interviews
The analysis rests on a limited sample. Of 163 participants, 49 (30.1%) completed 60-minute, one-to-one semi-structured interviews within two weeks after the 24-week treatment period. Their treatment assignments remain blinded and pooled across arms. Independent, blinded researchers used thematic analysis.
Nearly three-quarters of interviewees (73.5%) said they were satisfied or very satisfied with study treatment. Patients linked symptom improvements to better physical functioning, less need for disease management and less interference with family, work and social commitments.
Saliva production doubled in responder share at the 15 mg/kg dose
The patient feedback complements previously reported Phase 2 results on objective unstimulated salivary flow, an exploratory endpoint. At Week 24, 33% of patients on 15 mg/kg nipocalimab achieved at least a 50% increase from baseline, versus 16% on placebo, or more than twice as many.
DAHLIAS randomized 163 adults aged 18-75 1:1:1 to intravenous nipocalimab at 5 or 15 mg/kg or placebo every two weeks through Week 22. The primary endpoint was change from baseline in ClinESSDAI score at Week 24. Johnson & Johnson says nipocalimab significantly reduced disease activity and severity in patients with moderate-to-severe disease.
Phase 3 DAFFODIL trial adds dryness, pain and fatigue to disease-activity measures
Johnson & Johnson started the Phase 3 DAFFODIL study in adults with moderate-to-severe Sjögren's disease after the Phase 2 results. It assesses disease activity alongside dryness, pain, fatigue, quality of life and patient-perceived improvement. The company says the interview findings helped shape this design.
Leonard L. Dragone, Disease Area Leader for Autoantibody and Rheumatology at Johnson & Johnson, described nipocalimab as a potential targeted approach addressing the underlying biology of the disease. Ghaith Noaiseh of the University of Kansas Medical Center, a paid J&J consultant, said he awaits the Phase 3 results.
FDA has granted nipocalimab Breakthrough Therapy and Fast Track status in Sjögren's
The U.S. Food and Drug Administration granted Breakthrough Therapy designation for Sjögren's disease in November 2024 and Fast Track designation in March 2025. Johnson & Johnson states nipocalimab is the only FcRn blocker with both designations for adults with moderate-to-severe disease.
Nipocalimab is investigational. It blocks the neonatal Fc receptor to reduce circulating IgG antibodies while preserving B-cell function, based on in vitro and/or in vivo studies. The company says no currently approved therapies treat the underlying, systemic nature of Sjögren's disease.