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Johnson & Johnson announced new biomarker analyses from the Phase 2 DAHLIAS study evaluating nipocalimab in adults with moderate-to-severe Sjögren’s disease (SjD). The findings indicate that participants with elevated autoantibody and immunoglobulin G (IgG) levels—often linked to greater disease severity—exhibited higher clinical response rates compared to the overall study population. These results will be presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. The data suggest that nipocalimab may address key biological drivers of SjD in specific patient subgroups.

Dr. R. Hal Scofield, a researcher at the University of Oklahoma and Oklahoma Medical Research Foundation, emphasized the heterogeneity of SjD and the challenges in developing targeted therapies. He noted that the analyses provide insight into the role of pathogenic IgG autoantibodies in disease activity, supporting clinicians in evaluating emerging treatment options for this chronic and underserved condition. The findings highlight the need for further research to refine therapeutic approaches in SjD.

Clinical improvements were observed across all patients in the DAHLIAS Phase 2 study, with the most significant responses in participants with elevated disease-driving autoantibodies and IgG levels. Previously reported results showed statistically significant improvements in ClinESSDAI scores for nipocalimab compared to placebo. In the autoantibody-high subgroup, 62.5% of patients treated with nipocalimab achieved higher response rates than the overall population (51.9%), reinforcing its potential as an immunoselective treatment for systemic SjD management.

Biomarker analyses further support nipocalimab’s mechanism of action, which targets pathogenic IgG autoantibodies while preserving broader immune function. Dr. Leonard L. Dragone, Disease Area Leader at Johnson & Johnson, stated that the data align with the hypothesized role of nipocalimab in reducing disease activity in SjD. The findings underscore the importance of understanding pathogenic IgG autoantibodies in this heterogeneous disease as the Phase 3 DAFFODIL study continues.