Johnson & Johnson has announced new patient experience findings 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.
The results show that mouth dryness is the symptom improvement that matters most to patients, complementing previously reported phase 2 study results on increased saliva production in patients who received nipocalimab. This was also the most frequently reported symptom, with 96% of patients surveyed citing mouth dryness. 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.
Interviews were conducted with participants following the phase 2 study’s treatment period. Five core symptoms were most frequently reported by patients: mouth dryness (96%), fatigue (92%), eye dryness (90%), joint pain (73%) and, in women, vaginal dryness (49%). Patients who participated in the interviews reported improvements across many of the core symptoms during the treatment phase of the study.
“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,” said Ghaith Noaiseh, associate professor, allergy, clinical immunology, and rheumatology at The University of Kansas Medical Center.
“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.”
Patients described the core symptoms of SjD as having far-reaching effects on physical, social and emotional well-being, with improvements in these symptoms reported to have tangible benefits in day-to-day life. These improvements are associated with positive changes in physical functioning, less need for disease management, and less interference in family, work and social commitments. Nearly three-quarters of participants (73.5%) reported being satisfied or very satisfied with study treatment.
“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,” said Leonard L. Dragone, disease area leader, autoantibody and rheumatology at Johnson & Johnson.
“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.”
Following the phase 2 DAHLIAS results, which showed nipocalimab significantly reduced disease activity and severity in patients with moderate-to-severe disease, Johnson & Johnson initiated the phase 3 DAFFODIL study in adults with moderate-to-severe SjD. The DAFFODIL study design reflects the need to address both the systemic nature of SjD and the outcomes patients value most by assessing 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. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe SjD.