NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced results from the Phase 2 DAHLIAS study, published in The Lancet, demonstrating that nipocalimab-an investigational FcRn-targeting therapy for Sjögren's disease (SjD)-significantly reduced disease activity and severity in patients with moderate-to-severe SjD.
The study met its primary endpoint, showing a statistically significant improvement in ClinESSDAI scores at Week 24 in the nipocalimab 15 mg/kg Q2W group versus placebo. These reductions were supported by favorable biomarker changes, including lower rheumatoid factor levels, fewer circulating immune complexes, and decreased inflammatory markers.
Patients receiving nipocalimab reported symptom relief, with numerical improvements over placebo in hallmark SjD symptoms such as dryness (mouth, eyes, and/or vagina), fatigue, and joint pain. Notably, objective salivary flow improved in more than twice as many patients in the high-dose group compared to placebo at Week 24. Nipocalimab was well tolerated, with no new safety signals observed during the 24-week treatment period.
IMAAVY is approved by the U.S. Food and Drug Administration for adult and pediatric patients (12 years of age and older) with AChR or MuSK antibody positive gMG, in Brazil by ANVISA for anti-AChR, anti-MuSK or anti-LRP4 antibody positive adults and pediatric patients aged 12 and older, and in Japan by the?Pharmaceuticals and Medical Devices Agency for the treatment of all patients living with gMG.
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