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
Key Highlights
- ➤Mouth dryness ranked most important symptom; 96% of surveyed patients reported it
- ➤Saliva improved at least 50% in 33% receiving nipocalimab versus 16% placebo
- ➤Two Phase 3 studies are ongoing evaluating nipocalimab in Sjögren's disease
- ➤73.5% of participants were satisfied or very satisfied with study treatment
- ➤FDA granted nipocalimab Breakthrough Therapy and Fast Track designations for Sjögren's disease
Expert Statements
Ghaith Noaiseh, Associate Professor, Allergy, Clinical Immunology, and Rheumatology, The University of Kansas Medical Center
“Patients told us that Sjögren's disease affects nearly every aspect of daily life, with mouth dryness emerging as both the most frequently reported symptom and the symptom most often prioritized, among those asked, for improvement. Notably, in the previously published clinical data, at least 50% improvement in objective salivary flow was observed in more than twice as many patients receiving 15 mg/kg nipocalimab compared with placebo. I look forward to the Phase 3 results and what they may tell us about the potential of nipocalimab to deliver meaningful benefit for patients.”
Leonard L. Dragone, Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson
“These patient insights reinforce the broad, systemic nature of Sjögren's disease and the importance of recognizing and addressing the symptoms and outcomes that matter most to patients. Together, these findings alongside the positive Phase 2 clinical results provide important context as we advance nipocalimab as a potential targeted approach designed to address the underlying biology of this serious autoantibody-driven disease.”
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 PR Newswire
* New patient experience data(a) to be presented at ACR 2026 show mouth dryness was reported as the most important symptom to improve, followed by eye dryness, fatigue and joint pain * Patient insights complement Phase 2 study results demonstrating a 50% increase in saliva production(b) in more than twice as many patients on nipocalimab compared to placebo(c) * Two Phase 3 studies are ongoing, evaluating nipocalimab in Sjögren's disease including these measures critical to patients NEW BRUNSWICK, N.J., Nov. 7, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new patient experience findings(a) from the Phase 2 DAHLIAS study of nipocalimab in Sjögren's disease (SjD), a chronic, systemic autoantibody-driven disease affecting approximately four million people worldwide.(1) The results show that mouth dryness is the symptom improvement that matters most to patients,(2) complementing previously reported Phase 2 study results on increased saliva production in patients who received nipocalimab.(3) This was also the most frequently reported symptom, with 96% of patients surveyed citing mouth dryness.(2) These findings helped to inform the design of the ongoing Phase 3 study of nipocalimab in SjD, and are among 23 abstracts on nipocalimab to be presented at the American College of Rheumatology (ACR) Convergence 2026.
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