Johnson & Johnson today announced results from additional analyses of the Phase 2 DAHLIAS study highlighting improvement in key measures of disease activity and significant IgG reduction by over 77% following treatment with investigational nipocalimab in adult patients with moderate-to-severe Sjögren’s disease (SjD). These data were included in a plenary session presentation and two posters and are among the Company’s 43 oral and poster presentations at the American College of Rheumatology (ACR) Convergence 2024.
Patients receiving nipocalimab, an investigational FcRn blocker, showed a significant improvement in the ClinESSDAI score at 24 weeks, achieving the primary endpoint. Additionally, key secondary endpoints were met, indicating reduced disease activity both systemically and across multiple organ systems, as well as improvements in physician assessments and composite SjD assessment tools.
Results also showed a significant reduction in IgG including autoantibody levels among patients receiving 15 mg/kg every two weeks, providing further evidence of nipocalimab’s mechanism of action through interaction with the FcRn. Moreover, improvements in ClinESSDAI were generally greatest in the participants with the highest baseline levels of anti-Ro and anti-La autoantibodies, associated with substantial nipocalimab-induced reductions in IgG and total IgG autoantibodies.
“These data highlight the relevance of autoantibodies in SjD pathogenesis. The observed reduction in IgG and pivotal autoantibodies, particularly the anti-Ro antibodies, in association with improvement in systemic disease activity and saliva production, represent an exciting advance in our understanding of the disease and how it may be treated effectively. I am also encouraged by the observed trend in many patient-reported measures as they are most important to patients. I look forward to future research to confirm these observations,” said Ghaith Noaiseh, M.D., Associate Professor, Allergy, Clinical Immunology, and Rheumatology, The University of Kansas Medical Center. “People living with SjD need targeted treatment options that can help address the underlying causes and alleviate the potentially serious health consequences of the disease.”
Many people living with SjD experience symptoms that interfere with daily activities and quality of life, including chronic and severe mucosal dryness.1,2 Extraglandular manifestations – more systemic symptoms of SjD – are also common and may impact multiple organ systems, including joints, lungs, kidneys, and nervous system. These patients with high activity in more than one organ or disease area have an increased mortality risk of up to five-fold.
In the Phase 2 study, patients reported a decrease in symptoms, with numerical improvements compared with placebo in the symptom categories most important to them, including mouth dryness, eye dryness, vaginal dryness, fatigue and joint pain. Additionally, an improvement in objective salivary flow (i.e., at least 50% increase from baseline) was observed in more than twice as many patients in the high dose nipocalimab group (15 mg/kg) compared to the placebo group (32.7% vs. 16%) at Week 24.
“No advanced therapies have been approved for SjD to date. A clear need exists for new immunoselective treatments with demonstrated safety profiles that can provide sustained relief from the heavy burden of the overall disease for patients living with SjD,” said Federico Zazzetti, Director, Rheumatology, Global Medical Affairs Lead, Johnson & Johnson Innovative Medicine. “Johnson & Johnson is committed to continued research to help address this unmet need, and the data presented at ACR demonstrate the potential of nipocalimab in a disease where patients have very few options.”
