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)
Source: Johnson & Johnson
Published by GSM · USA (original Chinese edition)
Photo: 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.
