FcRn blockade with nipocalimab reduces disease activity in moderate‑to‑severe Sjögren’s syndrome: positive phase 2 DAHLIAS results

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– In the phase 2 DAHLIAS trial, nipocalimab 15 mg/kg IV every 2 weeks for 22 weeks produced a statistically significant reduction in ClinESSDAI at week 24 versus placebo (LS mean difference -2.65; 90% CI -4.03 to -1.28; p=0.0018).

– The lower 5 mg/kg dose did not differ from placebo. Safety and serious adverse event rates were broadly similar across arms.

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