Nipocalimab在第二阶段试验中大幅降低Sjögren的疾病症状, Nipocalimab significantly reduced Sjögren’s disease symptoms in Phase 2 trial, meeting primary endpoint with improved salivary flow and lower autoantibodies.

Johnson & Johnson宣布对调查FcRn阻塞器Nipocalimab的DAHLIAS试验结果为积极阶段2, 显示中度至严重Sjögren病患者的疾病活动显著减少。 Johnson & Johnson announced positive Phase 2 DAHLIAS trial results for nipocalimab, an investigational FcRn blocker, showing significant reduction in disease activity among patients with moderate-to-severe Sjögren’s disease. 在高剂量患者中,治疗达到主要终点,在24周改善了ClinESSDAI得分与安慰剂相比,显着减轻了症状,减少了自身抗体,并且在33%的患者中增加了50%以上的唾液流量. The treatment met its primary endpoint, improving ClinESSDAI scores at Week 24 versus placebo, with notable symptom relief, reduced autoantibodies, and over 50% increased salivary flow in 33% of high-dose patients. 这种药物已经被批准用于一些肌痛性肌痛症病例, 拥有FDA的SjögrenS突破和快速指标, 正在第三期试验中进行研究. The drug, already approved for some myasthenia gravis cases, holds FDA Breakthrough and Fast Track designations for Sjögren’s and is being studied in a Phase 3 trial.