Johnson & Johnson issued a press release on November 7, 2026, announcing new patient experience findings from the Phase 2 DAHLIAS study of nipocalimab in Sjogren's disease, to be presented at the American College of Rheumatology Convergence 2026.

Key Highlights

  • Most important symptom: Mouth dryness was identified by patients as the most important symptom to improve, and was also the most frequently reported, cited by 96% of patients surveyed.
  • Five core symptoms: Patients most frequently reported mouth dryness (96%), fatigue (92%), eye dryness (90%), joint pain (73%), and, among women, vaginal dryness (49%).
  • Salivary flow data: At least a 50% increase from baseline in objective salivary flow was observed in more than twice as many patients in the 15 mg/kg nipocalimab group compared with placebo (33% versus 16%, respectively) at Week 24.
  • Patient satisfaction: Nearly three-quarters of participants (73.5%) reported being satisfied or very satisfied with study treatment.
  • Interview scope: Of 163 DAHLIAS participants, 49 (30.1%), still blinded and pooled across treatment arms, completed 60-minute, one-to-one semi-structured qualitative exit interviews.
  • Regulatory designations: Nipocalimab holds both Breakthrough Therapy Designation and Fast Track Designation from the U.S. FDA for the treatment of adults with moderate-to-severe Sjogren's disease.
  • Phase 3 program: Two Phase 3 studies are ongoing, including the DAFFODIL study in adults with moderate-to-severe Sjogren's disease.

DAHLIAS Patient Experience Findings and Phase 3 Context for Nipocalimab in Sjogren's Disease

According to the filing, Johnson & Johnson (NYSE:JNJ) disclosed patient experience findings from the Phase 2 DAHLIAS study (NCT04968912), a multicenter, randomized, placebo-controlled, double-blind, dose-ranging study. The DAHLIAS study enrolled 163 adults aged 18-75 who were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg or placebo every two weeks through Week 22. Exit interviews were conducted within two weeks after the 24-week treatment period using blinded, independent researchers and thematic analysis. The filing notes that nipocalimab is described as an investigational treatment.

The filing reports that patients described Sjogren's disease as affecting nearly every aspect of daily life. Improvements in core symptoms were reported by interview participants to be associated with positive changes in physical functioning, reduced need for disease management, and less interference in family, work, and social commitments. The company disclosed that these patient insights helped inform the design of the ongoing Phase 3 DAFFODIL study, which assesses disease activity alongside dryness, pain, fatigue, quality of life, and patient-perceived improvement.

The filing notes that Sjogren's disease is estimated to affect approximately four million people worldwide and is nine times more common in women than men, with no therapies currently approved that treat the underlying and systemic nature of the disease. The findings on nipocalimab are among 23 abstracts on the therapy to be presented at ACR Convergence 2026. The press release contains forward-looking statements, which the filing cautions readers not to rely upon, noting they are based on current expectations and subject to risks if underlying assumptions prove inaccurate.

What Was Disclosed

Johnson & Johnson disclosed new patient experience data from the Phase 2 DAHLIAS study of investigational nipocalimab in Sjogren's disease, including symptom prioritization findings, treatment satisfaction rates, and salivary flow results, alongside details on two ongoing Phase 3 studies.