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Published in The Lancet: Nipocalimab significantly decreased Sjögren's disease (SjD) activity and severity through substantial reduction in Sjögren's-related autoantibodies
Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 2 DAHLIAS study published in The Lancet showing that nipocalimab, an investigational FcRn treatment for Sjögren's disease (SjD), significantly decreased disease activity and severity in patients with moderate-to-severe disease.1
About this update from Johnson & Johnson
[{"type":"text","content":"Nipocalimab, a first-in-class FcRn blocker being investigated for SjD, met its primary endpoint in the Phase 2 DAHLIAS study with statistically significant improvement in ClinESSDAI score , which is based on 11 key systemic disease domains, at Week 24 versus placebo ","length":271,"tagName":"p"},{"type":"text","content":"Critical patient-reported SjD symptoms including dryness, pain and fatigue trended towards greater improvement in the nipocalimab-treated group compared to placebo-treated patients","length":180,"tagName":"p"},{"type":"text","content":"Nipocalimab is the only investigational treatment to be granted Breakthrough Therapy Designation (BTD) by U.S. FDA for the treatment of adults living with moderate-to-severe SjD, and the Phase 3 DAFFODIL study is currently enrolling patients","length":241,"tagName":"p"},{"type":"text","content":"SPRING HOUSE, Pa., Oct. 24, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 2 DAHLIAS study published in The Lancet showing that nipocalimab, an investigational FcRn treatment for Sjögren's disease (SjD), significantly decreased disease activity and severity in patients with moderate-to-severe disease.1","length":360,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Johnson & Johnson)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Johnson & Johnson)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":37,"url":"https://media.zenfs.com/en/prnewswire.com/388c9d27a537cc3a83771c29d6c3a86b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/YyQxtwHN0OWd0z9HyFy.lg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTY1O2NmPXdlYnA-/https://media.zenfs.com/en/prnewswire.com/388c9d27a537cc3a83771c29d6c3a86b","width":400,"height":37}},"href":"https://mma.prnewswire.com/media/2333578/Johnson_and_Johnson_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.1 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.1","length":427...