Johnson & Johnson announced patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAI score vs placebo at 24 weeks compared to baseline (primary endpoint) in the Phase 2 DAHLIAS dose-ranging study of nipocalimab in adult patients living with Sjögren’s disease (SjD). 

Response was demonstrated as early as Week 4 and continued to increase throughout the 24-week treatment period compared with patients receiving placebo, the company stated in a press release. These data represent the first positive results in SjD for nipocalimab, the company said. 

In addition to achieving the primary endpoint, the nipocalimab 15 mg/kg treatment group demonstrated:

• Clinically meaningful improvements in secondary endpoints at Week 24 including multiple organ assessments (Disease Activity Level), physician assessments (Physician Global Assessment of Disease Severity) and composite tools for clinical trial endpoints (Sjögren’s Tool for Assessing Response, Composite of Relevant Endpoints for Sjögren’s Syndrome)
• Improvement trends in important SjD symptoms including mouth dryness, eye dryness and vaginal dryness
• Safety and tolerability consistent with other nipocalimab clinical studies

The study results were featured in a late-breaking presentation (LBA0010) and are among 30 abstracts that the company presented at the European Alliance of Associations for Rheumatology 2024 Congress.