Effects of Nipocalimab on Sjögren's Disease

Important Clinical Findings

Nipocalimab, classified for the first time as an FcRn blocker investigated for Sjögren's disease (SjD), achieved significant success in a Phase 2 study called DAHLIAS. The study showed a statistically significant improvement in the ClinESSDAI score, which is based on 11 core domains of systemic disease, with a notable advancement in patients receiving nipocalimab treatment compared to placebo at week 24.

Critical patient reports indicate that symptoms associated with SjD (such as dryness, pain, and fatigue) improved more in the group receiving nipocalimab compared to those receiving placebo. Nipocalimab has become the only investigational therapy to receive Breakthrough Therapy Designation approval from the U.S. Food and Drug Administration (FDA) for adults with moderate to severe SjD, and patient enrollment is currently ongoing in a Phase 3 study called DAFFODIL.

Contribution of Nipocalimab to Clinical Improvements

Pennsylvania, SPRING HOUSE – October 24, 2025 /PRNewswire/ – Johnson & Johnson (NYSE: JNJ) announced the results of the DAHLIAS study published in The Lancet. This study demonstrates that nipocalimab treatment significantly reduces disease activity and severity in patients with moderate to severe SjD. The study revealed a statistically significant improvement in the ClinESSDAI score at week 24 when comparing the nipocalimab 15 mg/kg Q2W group to placebo. Reductions in disease activity in patients were supported by lower rheumatoid factor, decreased circulating immune complexes, and declining inflammatory markers compared to placebo.

Patients receiving nipocalimab reported numerical improvements in significant symptoms of SjD, such as oral, eye, and/or vaginal dryness, compared to the placebo group. Additionally, the high-dose nipocalimab group observed improvements in saliva flow (% over 50% increase), while the placebo group had a %16 increase and the nipocalimab group had a %33 increase. These data suggest that nipocalimab may reduce the symptom burden of SjD.

Safety and Efficacy Profile

Nipocalimab has an acceptable safety profile during the 24-week treatment period, with no new safety signals observed. Immune function was preserved during treatment, with no significant increase in serious infections observed even in patients with substantial decreases in circulating immunoglobulin G (IgG) levels. The improvements provided by nipocalimab are consistent with the overall safety profile for IMAAVY™ (nipocalimab-aahu), which is also used in approved treatment for generalized myasthenia gravis (gMG).

Leonard L. Dragone, M.D., Ph.D., from the Johnson & Johnson Innovative Medicines Department, stated, "There is a significant unmet need in the treatment of Sjögren's disease. These research findings are among the growing body of evidence supporting the potential of nipocalimab in Sjögren's disease and reflect our commitment to providing innovative treatments that offer alternatives for patients."

Nipocalimab is the only investigational treatment approved by the FDA with Breakthrough Therapy Designation for Sjögren's disease, and a Phase 3 study called DAFFODIL is currently underway with patient enrollments ongoing.