Johnson & Johnson has announced results from the Phase 2 DAHLIAS study, published in The Lancet, indicating that nipocalimab, an investigational FcRn inhibitor, significantly reduced disease activity and severity in patients with moderate-to-severe Sjögren’s disease (SjD). The study met its primary endpoint by showing a statistically significant improvement in the ClinESSDAI score—a key measure of SjD activity—at week 24 for patients receiving nipocalimab compared to those on placebo.
The trial found that reductions in disease activity were supported by favorable changes in biomarkers such as lower rheumatoid factor levels, fewer circulating immune complexes, and decreased inflammatory markers. Patients treated with nipocalimab reported improvements in hallmark symptoms of SjD, including dryness of the mouth, eyes, or vagina, fatigue, and joint pain. Additionally, more than twice as many patients in the high-dose group (15 mg/kg) experienced at least a 50% increase in salivary flow compared to placebo at week 24.
Ghaith Noaiseh, M.D., Associate Professor at The University of Kansas Medical Center and paid consultant for Johnson & Johnson, commented: “The DAHLIAS Phase 2 study represents an important step forward in the understanding of FcRn inhibition as a potential therapeutic approach in Sjögren’s disease. By demonstrating clinically meaningful improvements in disease activity and reductions in key biological indicators, nipocalimab may offer an avenue for addressing the autoantibody-driven pathology of this complex condition. The ability of nipocalimab to potentially lower IgG autoantibody levels rapidly and reversibly is consistent with the mechanism of FcRn inhibition and does so without broadly suppressing the immune system.”
Safety data from the study indicated that nipocalimab had a tolerable safety profile over 24 weeks. There were no new safety signals observed; immune function was preserved even among patients with significant reductions in immunoglobulin G (IgG) levels. There was no increased risk of serious infections and no participants required intravenous immunoglobulin or rescue therapy. These findings are consistent with the overall safety profile of IMAAVYTM (nipocalimab-aahu), which is already approved for generalized myasthenia gravis (gMG).
Leonard L. Dragone, M.D., Ph.D., Disease Area Leader at Johnson & Johnson Innovative Medicine stated: “A significant unmet need exists in the treatment of Sjögren’s disease, a condition in which patients, 9 out of 10 of which are women, live with persistent and often debilitating symptoms, yet there are no approved therapies available. These data published in The Lancet add to the growing body of evidence supporting the potential of nipocalimab in Sjögren’s disease. This publication not only underscores the scientific merit of the findings but also reflects our commitment to advancing research in autoantibody-mediated diseases and delivering innovative therapies for patients with few alternatives.”
Nipocalimab is currently under further investigation through a Phase 3 DAFFODIL study that is actively enrolling participants. It has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for SjD as well as Fast Track Designation earlier this year.
IMAAVY is approved by regulatory agencies including the U.S. FDA for adults and pediatric patients aged 12 years or older with anti-AChR or anti-MuSK antibody positive gMG; it also holds approvals from ANVISA in Brazil and Japan's Pharmaceuticals and Medical Devices Agency for similar indications.
Sjögren’s disease affects about four million people worldwide—predominantly women—and is characterized by chronic inflammation resulting from autoantibody production targeting exocrine glands. Most patients experience mucosal dryness along with joint pain and fatigue; over half have moderate-to-severe forms that can severely impact quality of life.
Nipocalimab continues to be studied across several areas involving autoantibody-mediated diseases—including rare autoimmune conditions, maternal-fetal diseases mediated by maternal alloantibodies, and rheumatic diseases—with multiple ongoing clinical trials listed on ClinicalTrials.gov.
Further information about Johnson & Johnson can be found at https://www.jnj.com/ or https://innovativemedicine.jnj.com/.
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