Nipocalimab patient interviews identify mouth dryness as the most important symptom to improve in phase 2 Sjögren’s disease data

1. In unpeer-reviewed phase 2 data to be presented at American College of Rheumatology (ACR) Convergence 2026, mouth dryness was the symptom patients most often prioritized for improvement.

2. At least 50% improvement in objective salivary flow occurred in 33% of patients receiving 15 mg/kg nipocalimab versus 16% receiving placebo at Week 24.

Evidence Rating Level: 2 (Good)

2MM Brief: Johnson & Johnson reported new patient experience findings from the phase 2 DAHLIAS study of nipocalimab in Sjögren’s disease (SjD), with the results scheduled for presentation at ACR Convergence 2026. The findings have not been peer reviewed. DAHLIAS was a multicenter, randomized, placebo-controlled, double-blind, dose-ranging study of 163 adults aged 18-75 years with moderately to severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies. Participants were randomized to intravenous nipocalimab at 5 or 15 mg/kg, or placebo, every 2 weeks through Week 22, with protocol-permitted background standard of care; safety assessments continued through Week 30. The primary endpoint was change from baseline in the Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ClinESSDAI) score at Week 24. After the 24-week treatment period, 49 participants completed 60-minute, one-to-one exit interviews conducted within two weeks by blinded, independent researchers. Mouth dryness was the most frequently reported symptom, cited by 96% of surveyed participants, and was the symptom most often prioritized for improvement, followed by eye dryness, fatigue and joint pain. Participants reported improvements across several symptoms and associated benefits in physical functioning, disease management, and family, work and social commitments; 73.5% reported being satisfied or very satisfied with study treatment. In an exploratory endpoint analysis, at least 50% improvement from baseline in objective unstimulated salivary flow at Week 24 occurred in 33% of participants receiving 15 mg/kg nipocalimab and 16% receiving placebo. The patient interview analysis was limited by its qualitative design, the small interview sample, and pooled, blinded treatment groups; the broader findings remain unpeer reviewed. These results suggest that symptom priorities identified by patients may complement objective salivary-flow and disease-activity assessments in ongoing phase 3 studies, but this single phase 2 study cannot establish clinical benefit.

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