Johnson & Johnson announcedpatients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa score versus 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.
These data represent the first positive results in SjD for nipocalimab. The study results were featured in a late-breaking presentation (LBA0010) and are among 30 abstracts that the Company is presenting at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress.
“These data establish proof of concept for nipocalimab in Sjögren’s disease and support further clinical development, which is welcome news for the approximately 4 million people worldwide living with this chronic, debilitating disease,” said Prof. Jacques-Eric Gottenberg, MD, PhD, Department of Rheumatology, Strasbourg University Hospital, National Centre for Rare Systemic Autoimmune Diseases and study investigator.b,1,2 “SjD patients need approved advanced therapies that can help address the serious health consequences of the disease, and I am encouraged by these results and the positive impact on disease measures that are clinically meaningful.”
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 (DALc), physician assessments (PhGAd), and composite tools for clinical trial endpoints (STARe, CRESSf)
- Improvement trends in important SjD symptoms including mouth dryness, eye dryness, and vaginal dryness
- Safety and tolerability consistent with other nipocalimab clinical studies
Furthermore, lowering levels of total IgG and autoantibodies associated with SjD (e.g. anti-Ro60 and -La/SSB) are highly consistent with the nipocalimab mechanism of action, exhibiting reductions similar to those observed in prior nipocalimab clinical studies.
“A clear need exists for patients living with Sjögren’s disease to have advanced therapies that target the underlying cause and systemic nature of this disease, as none have been approved to date,” said Terence Rooney, vice president, Rheumatology, Immunology Disease Area leader, Johnson & Johnson Innovative Medicine. “Johnson & Johnson is committed to delivering innovative and transformational approaches for autoantibody-mediated diseases like SjD, and the data presented at EULAR demonstrate the potential of nipocalimab in a disease where patients have very few options.”