Healthcare company Johnson & Johnson (NYSE:JNJ) on Saturday reported 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.
Following the positive 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 company says that 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.
According to Johnson & Johnson, nipocalimab is the only Fc receptor (FcRn) blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe SjD.
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