Johnson & Johnson (J&J) has announced positive results from its Phase II DAHLIAS study, evaluating nipocalimab, an FcRn blocker, for the treatment of moderate-to-severe Sjögren's disease (SjD). The multicenter, double-blind, placebo-controlled trial assessed nipocalimab's efficacy and safety in adult patients with primary SjD.
The study involved 163 participants aged 18 to 75 years, who were administered either nipocalimab or a placebo in addition to standard care. The trial's primary endpoint was the change from baseline in the ClinESSDAI score at week 24.
Significant Reduction in Autoantibodies
The trial met its primary endpoint, with patients showing a statistically significant improvement in their ClinESSDAI scores. Notably, individuals with higher baseline levels of anti-Ro and anti-La autoantibodies experienced the most substantial improvements. These patients also demonstrated a significant 77% reduction in IgG and total IgG autoantibodies, supporting nipocalimab's mechanism of action through FcRn interaction.
Broad Symptom Relief and Improved Salivary Flow
Secondary endpoints were also met, indicating benefits across multiple organ systems and in physician assessments. Patients reported alleviation of key SjD symptoms, including mouth dryness, eye dryness, vaginal dryness, fatigue, and joint pain. Objective improvements in salivary flow were observed in more than twice as many patients in the high-dose nipocalimab arm compared to the placebo arm at week 24.
Expert Commentary
Federico Zazzetti, Global Medical Affairs Lead and Rheumatology Director at J&J Innovative Medicine, emphasized the unmet need for new treatments for SjD: "No advanced therapies have been approved for SjD to date. A clear need exists for new immunoselective treatments with demonstrated safety profiles that can provide sustained relief from the heavy burden of the overall disease for patients living with SjD."
Zazzetti added, "Johnson & Johnson is committed to continued research to help address this unmet need, and the data presented at ACR demonstrate the potential of nipocalimab in a disease where patients have very few options."
FDA Breakthrough Therapy Designation
Based on the promising results from the DAHLIAS study, the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to nipocalimab for the treatment of adults with moderate-to-severe Sjögren's disease. The breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
The study revealed that patients receiving a 15mg/kg dose of nipocalimab every two weeks experienced a notable reduction in IgG, including autoantibody levels supporting its proposed mechanism of action through its interaction with FcRn.
