Nipocalimab shows promise in Sjögren's disease

Treatment with nipocalimab is safe and helps improve clinical disease activity in patients with moderate-to-severe, active Sjögren's disease, according to the phase II DAHLIAS trial.

DAHLIAS included 163 adult patients (mean age 48.1 years, 93 percent female) with Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) of at least 6 and who were seropositive for anti-Ro IgG autoantibodies.

The patients were randomly assigned to receive nipocalimab at either 5 (n=53) or 15 mg/kg (n=54) or placebo (n=56). Treatment was administered intravenously every 2 weeks for 22 weeks. The primary endpoint was change from baseline in ClinESSDAI score at week 24.

Compared with placebo, nipocalimab 15 mg/kg was associated with a significant reduction in ClinESSDAI score at week 24 (least squares mean difference, –2.65, 90 percent confidence interval [CI], –4.03 to –1.28; p=0.0018). A reduction was also observed with nipocalimab 5 mg/kg group, although the change was not significantly different from that observed with placebo (least squares mean difference, –0.34, 95 percent CI, –1.71 to 1.03; p=0.68). IgG autoantibodies decreased in nipocalimab-treated patients.

In terms of safety, the rates of adverse events and serious adverse events were generally similar across the nipocalimab and placebo groups.

The findings underscore the potential role of drugs that target high levels of autoantibodies and associated pathways in the treatment of Sjögren's disease.