Nipocalimab for the treatment of moderate-to-severe Sjögren’s disease: a plain language summary of the DAHLIAS study

Plain Language SummaryWhat is this summary about?This is a plain language summary of an article published in the Lancet in 2025. It describes results from the phase 2 DAHLIAS study.The DAHLIAS study measured the efficacy and safety of an investigational medicine called nipocalimab to treat moderate-to-severe Sjögren’s disease. Nipocalimab is a type of biologic treatment called a monoclonal antibody. Scientists designed nipocalimab to reduce harmful immunoglobulin G (IgG) autoantibodies by blocking the neonatal fragment crystallizable receptor (FcRn). IgG autoantibodies called anti-Ro and anti-La are elevated in the majority of patients with Sjögren’s disease. DAHLIAS is the first controlled clinical trial of an FcRn blocker in Sjögren’s disease.What were the results?The DAHLIAS study included 163 participants who had moderate-to-severe, active Sjögren’s disease and a positive blood test for anti-Ro IgG autoantibodies. Of these, 53 participants received intravenous nipocalimab 5 mg/kg, 54 participants received intravenous nipocalimab 15 mg/kg, and 56 participants received intravenous placebo every 2 weeks for 22 weeks.At Week 24, on average, participants who received nipocalimab 15 mg/kg every 2 weeks had greater improvements in their Sjögren’s disease signs and symptoms than those who received placebo. Blood tests showed treatment with nipocalimab also reduced levels of IgG autoantibodies. The safety of nipocalimab was comparable to placebo. The most common side effects with both nipocalimab and placebo were infections, including COVID-19, the common cold, urinary tract infections, and conjunctivitis (pink eye).What do the results mean and why do they matter?This is the first study to show that nipocalimab has beneficial effects in patients with Sjögren’s disease. Based on these results, nipocalimab will be studied in larger, phase 3 studies in patients with Sjögren’s disease. If those studies are successful, nipocalimab could become the first treatment for Sjögren’s disease that may slow down or stop disease progression by reducing the harmful IgG autoantibodies.