Johnson & Johnson (NYSE:JNJ) today announced new biomarker exploratory analyses from the Phase 2 DAHLIAS study evaluating nipocalimab in adults with moderate-to-severe Sjögren's disease (SjD)a showing that participants with elevated autoantibody and immunoglobulin G (IgG) levelsb, who are often those who experience more substantial disease burden, showed greater clinical response rates.1 These data will be presented in an oral session at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.
A healthcare professional's perspective
"Sjögren's disease is a highly heterogeneous condition that has historically posed significant challenges for therapeutic development, leaving gaps in patient care," said R. Hal Scofield, M.D., the University of Oklahoma and Oklahoma Medical Research Foundation.c "These analyses provide important insight into the potential role of pathogenic immunoglobulin G autoantibodies in disease activity and help expand our understanding of the biological drivers of Sjögren's disease for certain patients. This research is critical for helping clinicians evaluate emerging evidence and the evolving treatment landscape in this chronic, underserved disease."
New DAHLIAS Phase 2 clinical and biomarker findings
Clinical improvements were observed across all patients, with the greatest responses observed in participants with elevated known disease-driving autoantibodies and IgG levels – factors associated with more severe SjD activity and outcomes.1 Previously reported positive Phase 2 study results demonstrated statistically significant improvement in ClinESSDAId scores with nipocalimab versus placebo.2 In the current analysis, patients in the autoantibody-high subgroupb treated with nipocalimab achieved higher response rates than observed in the overall participant population (62.5% versus 51.9%).1 These data support the continued investigation of nipocalimab as a potential immunoselective approach for systemic SjD management in the ongoing Phase 3 DAFFODIL study.
Biomarker analyses reveal autoantibody and immune function insights
These findings further support the underlying mechanism of action of nipocalimab as a targeted, immunoselective approach designed to reduce pathogenic IgG autoantibodies associated with SjD disease activity while preserving broader immune function.3
"The biomarker analyses are consistent with the hypothesized mechanism of nipocalimab in Sjögren's disease. These findings suggest greater response in the broad study population of adults with moderate-to-severe Sjögren's disease, plus a greater response observed among patients with elevated disease-driving autoantibodies and immunoglobulin G levels," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "The data also furthers our understanding of the role pathogenic IgG autoantibodies may play in this heterogenous disease as we continue to investigate nipocalimab in Sjögren's."