en.Wedoany.com Reported - On June 3, Johnson & Johnson announced new exploratory biomarker analyses from the Phase 2 DAHLIAS study of nipocalimab in adult patients with moderate-to-severe Sjögren's syndrome. Results showed that in a patient subgroup with higher levels of autoantibodies and immunoglobulin G (IgG), the clinical response rate after nipocalimab treatment reached 62.5%, higher than the 51.9% observed in the overall nipocalimab-treated population. These data will be presented in an oral session at the 2026 European Congress of Rheumatology.
Nipocalimab is an immunoselective blocker targeting the neonatal Fc receptor (FcRn), designed to reduce pathogenic IgG autoantibodies associated with disease activity while largely preserving broader immune function. The DAHLIAS study is a Phase 2, multicenter, randomized, placebo-controlled, double-blind, dose-finding study that enrolled 163 adult patients aged 18 to 75 years with moderate-to-severe active primary Sjögren's syndrome, all positive for anti-Ro60 or anti-Ro52 IgG antibodies. Participants were randomized 1:1:1 to receive 5 mg/kg nipocalimab, 15 mg/kg nipocalimab, or placebo intravenously every two weeks through Week 22, with safety assessments completed at Week 30. The primary endpoint was the change from baseline in the ClinESSDAI score at Week 24, which covers 11 systemic domains including skin, lung, kidney, joints, muscles, peripheral nerves, central nervous system, blood, glands, constitutional symptoms, and lymphadenopathy/lymphoma.
This exploratory analysis further aligned autoantibody levels with clinical response. The high autoantibody subgroup consisted of moderate-to-severe Sjögren's syndrome patients with the highest baseline levels of three disease-related autoantibodies: anti-Ro60, anti-Ro52, and anti-La. These results provide clearer biomarker insights for subsequent patient stratification, efficacy prediction, and Phase 3 study design.
Sjögren's syndrome is a chronic autoimmune disease driven by autoantibodies, with common manifestations including dryness of the eyes and mouth, joint pain, and fatigue, and may also involve multiple systems. Johnson & Johnson disclosed that approximately 4 million people worldwide are affected by the disease, with a significantly higher prevalence in women, and over half of patients have moderate-to-severe forms. Due to the disease's high heterogeneity and complex systemic manifestations, drug development has long faced challenges such as endpoint selection, patient stratification, and consistency of symptom improvement. Previous Phase 2 data for nipocalimab showed improvement in ClinESSDAI scores compared to placebo at Week 24. This biomarker analysis further focuses treatment response on the high autoantibody and high IgG population, making the research rationale for the FcRn pathway in autoantibody-related diseases more specific. The drug has not yet been approved for the treatment of Sjögren's syndrome, and subsequent validation will continue to rely on the ongoing DAFFODIL Phase 3 study.
Johnson & Johnson also emphasized that nipocalimab is currently the only FcRn blocker that has simultaneously received both Breakthrough Therapy designation and Fast Track designation from the U.S. FDA for adult patients with moderate-to-severe Sjögren's syndrome. If subsequent Phase 3 studies continue in the direction of the Phase 2 and biomarker analyses, the development of treatments for Sjögren's syndrome may move from simply observing symptom improvement toward a precision stratification pathway supported jointly by autoantibodies, IgG levels, and systemic disease activity.
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