Johnson & Johnson Reports Positive Phase 2 Results for Nipocalimab in Sjögren’s Disease

Johnson & Johnson (NYSE: JNJ) announced that nipocalimab, its first-in-class FcRn inhibitor, met the primary endpoint in the Phase 2 DAHLIAS study for adults with moderate-to-severe Sjögren’s disease (SjD). The investigational therapy significantly improved ClinESSDAI scores, a key systemic disease activity index, at Week 24 versus placebo.

Patients treated with nipocalimab also showed numerical improvements in hallmark SjD symptoms, including dryness, fatigue, and joint pain. Objective measures, such as salivary flow, improved in over twice as many patients in the high-dose group (15 mg/kg) compared to placebo (33% vs. 16%).

Key findings from DAHLIAS:

• ClinESSDAI reduction (LS mean difference –2.65; 90% CI –4.03 to –1.28; p=0.0018)
• Reductions in biomarkers: rheumatoid factor, circulating immune complexes, and inflammatory markers
• Favorable patient-reported outcomes in dryness, fatigue, and pain
• Tolerable safety profile with preserved immune function

“Nipocalimab’s ability to reduce IgG autoantibodies without broadly suppressing the immune system is consistent with FcRn inhibition and represents a promising therapeutic approach for Sjögren’s disease,” said Ghaith Noaiseh, M.D., Ph.D., University of Kansas Medical Center.

Nipocalimab is the only investigational therapy in SjD to receive Breakthrough Therapy Designation from the U.S. FDA (November 2024) and Fast Track designation (April 2025). Based on these results, J&J has launched the Phase 3 DAFFODIL study, which is currently enrolling patients.

About Sjögren’s Disease

SjD is a chronic autoimmune disorder affecting approximately 4 million people worldwide, primarily women. It is characterized by mucosal dryness, joint pain, fatigue, and systemic inflammation, with moderate-to-severe cases impacting quality of life and daily functioning.

About Nipocalimab / IMAAVY™
Nipocalimab is a monoclonal antibody that inhibits FcRn, reducing circulating IgG autoantibodies. It is marketed as IMAAVY™ for generalized myasthenia gravis (gMG) in adults and pediatric patients (≥12 years). The therapy is under investigation for multiple autoantibody-mediated conditions, including rare rheumatic, maternal-fetal, and autoimmune diseases.

Safety Profile

DAHLIAS confirmed a tolerable safety profile for nipocalimab, with no new safety signals. Immune function was maintained, and there was no increase in serious infections or need for IVIG/rescue therapy.

About Johnson & Johnson

Johnson & Johnson is a global healthcare leader dedicated to innovation across pharmaceuticals, MedTech, and consumer health, aiming to advance therapies for complex diseases worldwide.

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