Johnson & Johnson (NYSE: JNJ) announced new exploratory analyses from its Phase 2 DAHLIAS study showing that patients with elevated autoantibodies and immunoglobulin G levels had higher clinical response rates when treated with nipocalimab for moderate-to-severe Sjögren's disease.

The biomarker analysis found that participants in the autoantibody-high subgroup treated with nipocalimab achieved response rates of 62.5% compared to 51.9% in the overall study population. The subgroup included patients with the highest baseline levels of three disease-associated autoantibodies: anti-Ro60, anti-Ro52 and anti-La.

The data will be presented at the 2026 European Alliance of Associations for Rheumatology Congress. Previously reported results from the Phase 2 study demonstrated statistically significant improvement in ClinESSDAI scores with nipocalimab versus placebo.

Nipocalimab is an investigational immunoselective treatment designed to target and block neonatal Fc receptor, reducing circulating immunoglobulin antibodies while preserving immune functions. The drug has received both Breakthrough Therapy Designation and Fast Track Designation from the U.S. FDA for treating adults with moderate-to-severe Sjögren's disease.

The DAHLIAS study enrolled 163 adults aged 18-75 who were randomized to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every two weeks through Week 22. Johnson & Johnson is continuing investigation of nipocalimab in the ongoing Phase 3 DAFFODIL study.

Sjögren's disease is a chronic autoimmune condition estimated to affect approximately four million people worldwide and is nine times more common in women than men. The disease is characterized by autoantibody production, chronic inflammation and affects exocrine glands, causing symptoms including dryness, joint pain and fatigue.