Johnson & Johnson reports Phase 2 nipocalimab findings in Sjögren’s disease, highlighting patient priorities for mouth dryness, fatigue and eye dryness.
Written By: Mayuri Vaja, PharmD
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson has reported new patient-experience findings from the Phase 2 DAHLIAS study of nipocalimab in Sjögren’s disease (SjD), highlighting the symptoms patients most want improved. Mouth dryness emerged as the highest-priority symptom, followed by eye dryness, fatigue and joint pain. The findings are being presented at the American College of Rheumatology (ACR) Convergence 2026.
Mouth Dryness Identified as the Most Important Symptom
The patient-experience analysis was based on 60-minute, one-to-one semi-structured exit interviews conducted after the 24-week treatment period. Of the 163 participants enrolled in DAHLIAS, 49 (30.1%) completed interviews within two weeks of treatment completion. Blinded, independent researchers conducted the interviews, and thematic analysis was used to assess patient experiences and perceived symptom changes.
Mouth dryness was the most frequently reported symptom, cited by 96% of interview participants, and was also identified as the symptom patients most wanted to improve. Other frequently reported symptoms included fatigue (92%), eye dryness (90%), joint pain (73%) and vaginal dryness (49%) among women.
Participants described how these symptoms affected physical functioning, emotional well-being, social interactions and daily activities. Reported symptom improvements were associated with better everyday functioning, reduced disease-management demands and less interference with family, work and social commitments.
The ACR abstract also reported that 36 of the 49 participants (73.5%) highlighted the four core symptoms of mouth dryness, eye dryness, fatigue and joint pain as important or impactful to their quality of life. Separately, 73.5% of participants reported being satisfied or very satisfied with the study treatment.
Importantly, participants remained blinded to treatment allocation, and interview findings were pooled across treatment groups. Therefore, these results describe patient experiences during the trial and should not be interpreted as evidence that nipocalimab specifically caused the reported symptom improvements.
Patient Insights Complement Phase 2 Clinical Findings
The interview findings complement previously published clinical results from DAHLIAS (NCT04968912), a randomized, double-blind, placebo-controlled Phase 2 study evaluating nipocalimab in adults with moderately-to-severely active primary Sjögren’s disease.
The study enrolled 163 adults who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. Participants were randomized to intravenous nipocalimab at 5 mg/kg, nipocalimab at 15 mg/kg or placebo, administered every two weeks through Week 22. The primary endpoint was change from baseline in the Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ClinESSDAI) score at Week 24.
Previously published results showed a significant reduction in ClinESSDAI disease activity with the 15 mg/kg dose compared with placebo, while the 5 mg/kg dose did not demonstrate a statistically significant difference.
An exploratory endpoint also evaluated objective unstimulated salivary flow. At Week 24, at least a 50% increase from baseline was observed in 33% of patients receiving high-dose nipocalimab, compared with 16% receiving placebo.
Although this exploratory finding provides an objective measure relevant to impaired saliva production, it does not establish a corresponding improvement in patients’ overall dryness symptoms. Together, the clinical and interview findings highlight the importance of evaluating both disease activity and patient-relevant outcomes.
Phase 3 Development Underway
Following the Phase 2 results, Johnson & Johnson initiated the Phase 3 DAFFODIL study in adults with moderate-to-severe Sjögren’s disease. Its design evaluates disease activity alongside patient-relevant outcomes, including dryness, pain, fatigue, quality of life and patient-perceived improvement.
A second Phase 3 study (NCT06741969) is also evaluating nipocalimab in moderate-to-severe Sjögren’s disease. Its outcome measures include ClinESSDAI, stimulated salivary flow, dryness, joint pain and fatigue.
The two Phase 3 studies will provide further evidence on whether nipocalimab can address both systemic disease activity and symptoms that substantially affect patients’ daily lives.
About Sjögren’s Disease and Nipocalimab
Sjögren’s disease is a chronic, systemic autoantibody-driven condition affecting approximately four million people worldwide and is around nine times more common in women than men. It involves autoantibody production, chronic inflammation and lymphocytic infiltration of exocrine glands. Common manifestations include eye and mouth dryness, vaginal dryness, joint pain and fatigue. No therapies are currently approved to treat the underlying systemic nature of the disease.
Nipocalimab is an investigational immunoselective therapy designed to block the neonatal Fc receptor (FcRn), thereby reducing circulating immunoglobulin G (IgG) antibodies involved in autoantibody-mediated diseases while preserving B-cell function, based on preclinical studies. The US Food and Drug Administration (FDA) has granted nipocalimab both Breakthrough Therapy Designation and Fast Track Designation for adults with moderate-to-severe Sjögren’s disease.
What the Findings Mean
The DAHLIAS patient interviews reinforce that improvements in disease activity alone may not fully capture treatment benefits in Sjögren’s disease. Mouth dryness, fatigue and eye dryness remain major patient priorities. The Phase 3 programme will be important in determining whether nipocalimab can translate its Phase 2 clinical findings into meaningful improvements across systemic disease activity and patient-reported symptoms.
Reference
Johnson & Johnson announces new Phase 2 nipocalimab study data in Sjögren’s disease that reveal insights on importance of symptom improvements most valued by patients, Johnson & Johnson, 07 November 2026
A Study of Nipocalimab in Adults with Primary Sjogren’s Syndrome (pSS), ClinicalTrials.gov ID NCT04968912
About the Writer
Mayuri Vaja (Linkedin) is a Pharm.D professional with a strong interest in clinical research, pharmacovigilance, and medical writing, supported by certifications in pharmacovigilance and academic projects exploring AI in healthcare and drug safety.
With a growing focus on evidence-based healthcare and scientific communication, she is developing expertise in clinical research and translating healthcare evidence into clear, meaningful content.
As a Pharmacally healthcare writer, Mayuri is committed to creating accurate, research-driven, and clinically relevant healthcare content while continuously strengthening her professional skills.