DAHLIAS study - Nipocalimab in Sjögren's Disease Save
Nipocalimab, a neonatal Fc receptor blocker that reduces circulating IgG and autoantibodies, was shown to be effective in a phase 2 trial in patients with severe Sjögren's disease.
A phase 2, double-blind, multicentre trial enrolled individuals with moderate-to-severe, active, Ro positive, Sjögren's disease (with a ClinESSDAI of at least 6). This multicenter, multinational trial randomized (1:1:1) 163 Sjogren's patients to receive intravenous nipocalimab 5 mg/kg, intravenous nipocalimab 15 mg/kg, or placebo every 2 weeks for 22 weeks. The primary endpoint was the change in ClinESSDAI score at week 24.
The mean age of participants was 48 years and 93% were female. The nipocalimab 15 mg/kg group was superior to placebo with:
- Significant ClinESSDAI score reduction at week 24 (least squares mean difference –2·65, 90% CI –4·03 to –1·28; p=0·0018)
- Nipocalimab 5 mg/kg group had a non-significant reduction versus placebo (–0·34, –1·71 to 1·03; p=0·68).
- Similar rates of adverse events and serious adverse events across groups.
Fc receptor blockade with nipocalimab significantly improved clinical disease activity and was safe and well tolerated in patients with moderate-to-severe, active Sjögren's disease. Reductions in IgG autoantibodies during nipocalimab treatment support their contribution to Sjögren's disease pathogenesis.
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