Johnson & Johnson announces findings from Phase 2 DAHLIAS study

Johnson & Johnson announced findings from the Phase 2 DAHLIAS study published in The Lancet showing that nipocalimab, an investigational FcRn treatment for Sjogren’s disease, significantly decreased disease activity and severity in patients with moderate-to-severe disease. The study met its primary endpoint, with statistically significant improvement in ClinESSDAIa score, a key SjD activity index, at Week 24 in the nipocalimab 15 mg/kg Q2W group compared to placebob. Reductions in disease activity were supported by favorable changes in key biomarkers when compared to placebo, including lower levels of rheumatoid factor, fewer circulating immune complexes, and decreased inflammatory markers. This significant reduction in disease activity suggests nipocalimab may lessen the burden of SjD symptoms for patients impacted by the condition. Patients who received nipocalimab reported a decrease in symptoms, with numerical improvements compared with placebo in the hallmark symptoms of SjD including dryness of the mouth, eyes, and/or vagina, as well as fatigue and joint pain. Additionally, an improvement in objective salivary flow (i.e., at least 50% increase from baseline) was observed in more than twice as many patients in the high dose nipocalimab group (15 mg/kg) compared to the placebo group (33% vs. 16%, respectively) at Week 24.