Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients

Johnson & Johnson has reported new patient-experience findings from the Phase II DAHLIAS study of nipocalimab in Sjögren’s disease, highlighting the symptoms patients most want treatment to improve.

The findings, presented at ACR Convergence 2026, showed that mouth dryness was the most frequently reported symptom and the one most often prioritised for improvement.

Among patients interviewed, 96% reported mouth dryness, followed by fatigue in 92%, eye dryness in 90% and joint pain in 73%.

Among women participating in the interviews, 49% also reported vaginal dryness.

The patient-experience findings complement previously reported Phase II clinical results showing improved salivary flow with nipocalimab.

In the DAHLIAS study, at least a 50% improvement in objective salivary flow was observed in more than twice as many patients receiving nipocalimab 15 mg/kg compared with placebo.

Patients also reported improvements across several core Sjögren’s symptoms during the treatment period.

These changes were associated with better physical functioning, reduced need for disease management and less disruption to family, work and social activities.

Around 73.5% of participants said they were satisfied or very satisfied with the study treatment.

Ghaith Noaiseh, MD, Associate Professor of Allergy, Clinical Immunology and Rheumatology at the University of Kansas Medical Center, said the findings demonstrate how strongly Sjögren’s disease can affect daily life.

He noted that mouth dryness emerged as both one of the most common symptoms and one of the most important areas for improvement from the patient perspective.

Johnson & Johnson said the findings helped inform the design of its ongoing Phase III development programme.

The Phase III DAFFODIL study is evaluating nipocalimab in adults with moderate-to-severe Sjögren’s disease.

The trial includes measures of disease activity alongside outcomes related to dryness, pain, fatigue, quality of life and patient-perceived improvement.

Previous Phase II DAHLIAS results showed that nipocalimab significantly reduced disease activity and disease severity in patients with moderate-to-severe Sjögren’s disease.

Nipocalimab is an Fc neonatal receptor blocker designed to reduce circulating pathogenic IgG antibodies involved in autoantibody-driven diseases.

The therapy has received both Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration for adults with moderate-to-severe Sjögren’s disease.

Johnson & Johnson is presenting 23 abstracts on nipocalimab at ACR Convergence 2026.

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Related Topics and Keywords

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