强生干燥综合征二期研究：96%患者最盼改善口干 高剂量组唾液流量显著改善者比例为安慰剂两倍
强生公司11月7日公布其在研药nipocalimab治疗干燥综合征（Sjögren's disease）的二期DAHLIAS研究患者体验数据：受访患者中，口干既是最常见的症状，也是他们最希望改善的症状，提及比例达96%；其后依次为眼干、疲劳与关节痛。相关发现将在2026年美国风湿病学会（ACR）年会上公布，是该药在该年会上的23篇摘要之一。
干燥综合征是一种慢性、全身性、由自身抗体驱动的疾病，全球患者约400万人。DAHLIAS研究共163名参与者，其中49人在24周治疗期结束后接受了约60分钟的一对一退出访谈：报告口干者占96%、疲劳92%、眼干90%、关节痛73%，女性受访者中另有49%报告阴道干涩。受访患者表示，治疗期间上述多项核心症状均有改善。
此次公布的是患者体验发现，与此前公布的二期临床数据相互印证：第24周时，接受高剂量（15 mg/kg）nipocalimab的患者中，客观唾液流量较基线改善至少50%者占33%，是安慰剂组16%的两倍多。强生已根据二期阳性结果启动三期DAFFODIL研究。
Nipocalimab是目前唯一同时获得美国食品药品管理局（FDA）突破性疗法认定与快速通道资格、用于中重度干燥综合征成人患者的FcRn阻断剂。强生称，这批患者体验发现已用于完善三期研究设计，把患者最看重的症状改善纳入评估。
（来源：强生公司）
In J&J's Sjögren's Study, 96% of Patients Ranked Dry Mouth the Symptom They Most Want Improved; Saliva Gains Doubled Placebo at High Dose
Johnson & Johnson on November 7 released patient-experience findings from the Phase 2 DAHLIAS study of its investigational drug nipocalimab in Sjögren's disease: mouth dryness was both the most frequently reported symptom and the improvement patients valued most, cited by 96% of those interviewed, followed by eye dryness, fatigue and joint pain. The findings are among 23 nipocalimab abstracts to be presented at the American College of Rheumatology (ACR) Convergence 2026.
Sjögren's disease is a chronic, systemic, autoantibody-driven disease affecting about four million people worldwide. Of 163 DAHLIAS participants, 49 completed roughly 60-minute exit interviews after the 24-week treatment period: 96% reported mouth dryness, 92% fatigue, 90% eye dryness and 73% joint pain, and 49% of women reported vaginal dryness. Interviewees reported improvements across many of these core symptoms during treatment.
The patient-experience results complement previously reported Phase 2 clinical data: at Week 24, 33% of patients receiving high-dose nipocalimab (15 mg/kg) achieved at least a 50% improvement in objective salivary flow, more than double the 16% on placebo. Following the positive Phase 2 results, Johnson & Johnson initiated the Phase 3 DAFFODIL study.
Nipocalimab is the only FcRn blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the U.S. Food and Drug Administration for adults with moderate-to-severe Sjögren's disease. Johnson & Johnson said the patient-experience findings helped inform the design of the ongoing Phase 3 study, incorporating the symptom improvements patients value most.
(Source: Johnson & Johnson)
来源：强生公司
发布：GSM·美国（发布链接）
图片来源：图：强生公司位于新泽西州New Brunswick的总部大楼。ekem摄，公共领域，经Wikimedia Commons。 / Photo: Johnson & Johnson headquarters building in New Brunswick, New Jersey. Photo by ekem, public domain, via Wikimedia Commons.
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