Johnson & Johnson Shares New Insights on Nipocalimab for Sjögren’s Disease at EULAR 2026

New Data Highlights Potential Benefits for Patients With Higher Disease Activity

Johnson & Johnson has announced new exploratory biomarker findings from its Phase 2 DAHLIAS study evaluating nipocalimab in adults with moderate-to-severe Sjögren’s disease (SjD). The latest analysis suggests that patients with higher levels of disease-related autoantibodies and immunoglobulin G (IgG) may experience even greater clinical benefits from treatment.

The findings are being presented during an oral session at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress and provide additional insight into how nipocalimab may help address one of the key biological drivers of Sjögren’s disease.

Understanding Sjögren’s Disease

If you're not familiar with Sjögren’s disease, it is a chronic autoimmune condition where the immune system mistakenly attacks healthy tissues in the body. It commonly affects the glands responsible for producing moisture, leading to symptoms such as dry eyes and dry mouth.

However, the disease can go far beyond dryness. Many patients also experience fatigue, joint pain, organ involvement, and other systemic complications that can significantly affect daily life.

Despite its impact, treatment options for moderate-to-severe Sjögren’s disease remain limited, making new therapies an important area of research.

What Is Nipocalimab?

Nipocalimab is an investigational therapy designed to selectively block the neonatal Fc receptor (FcRn).

The treatment works by reducing harmful immunoglobulin G (IgG) autoantibodies that contribute to disease activity while preserving important immune system functions. This targeted approach aims to address the underlying cause of the disease rather than simply managing symptoms.

Researchers believe that by lowering disease-driving autoantibodies, nipocalimab may help reduce inflammation and improve overall disease control in patients with Sjögren’s disease.

What the New Biomarker Analysis Found

The latest exploratory analysis from the DAHLIAS study focused on the relationship between autoantibody levels, IgG levels, and treatment response.

According to the findings, patients who had elevated levels of disease-associated autoantibodies and immunoglobulin G showed stronger clinical responses when treated with nipocalimab.

These patients are often the ones who experience a higher disease burden and more severe disease activity. The results suggest that targeting pathogenic IgG autoantibodies may play an important role in improving outcomes for this group of patients.

The analysis also strengthens the scientific understanding of how nipocalimab works and supports its mechanism as a targeted immunoselective therapy.

Results From the DAHLIAS Phase 2 Study

The DAHLIAS trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate nipocalimab in adults with moderately-to-severely active primary Sjögren’s disease.

Participants enrolled in the study were positive for anti-Ro60 and/or anti-Ro52 IgG antibodies, which are commonly associated with the disease.

According to Johnson & Johnson, the study demonstrated clinical improvements across the overall patient population. However, the strongest responses were observed in patients with elevated disease-driving autoantibodies and higher IgG levels.

These findings support continued development of nipocalimab as a potential treatment option for systemic Sjögren’s disease.

Earlier Findings Showed Improvements in Symptoms

The new biomarker data build upon previously reported Phase 2 results.

Earlier analyses showed that nipocalimab helped reduce overall disease activity and disease severity in patients with Sjögren’s disease. Researchers also observed potential improvements in some of the most challenging symptoms reported by patients, including:

• Dryness

• Fatigue

• Pain

These symptoms often have a major impact on quality of life, making improvements particularly meaningful for patients living with the disease.

Expert Perspective on the Findings

Dr. R. Hal Scofield from the University of Oklahoma and Oklahoma Medical Research Foundation emphasized the importance of the new research.

According to Dr. Scofield, the analyses provide valuable insight into the role of pathogenic IgG autoantibodies in driving disease activity and help expand the understanding of the biological mechanisms behind Sjögren’s disease.

He noted that this type of research is critical for helping clinicians evaluate emerging therapies and better understand the evolving treatment landscape for patients living with this chronic and often underserved condition.

Johnson & Johnson Sees Continued Potential for Nipocalimab

Leonard L. Dragone, M.D., Ph.D., Disease Area Leader for Autoantibody and Rheumatology at Johnson & Johnson, stated that the biomarker findings are consistent with the expected mechanism of action of nipocalimab.

He explained that the data suggest meaningful responses across the broader study population while also indicating even greater benefits among patients with elevated disease-driving autoantibodies and immunoglobulin G levels.

The findings also contribute to a deeper understanding of the role these autoantibodies may play in the development and progression of Sjögren’s disease.

Moving Forward With the Phase 3 DAFFODIL Study

The encouraging results from DAHLIAS have helped support the continued clinical development of nipocalimab.

Johnson & Johnson is currently evaluating the therapy in the ongoing Phase 3 DAFFODIL study, which aims to further assess its safety and effectiveness in adults with moderate-to-severe Sjögren’s disease.

Nipocalimab has already received both Breakthrough Therapy Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe Sjögren’s disease. Notably, it is currently the only FcRn blocker to receive both designations in this indication.

What These Findings Mean for Patients

For people living with Sjögren’s disease, the latest results provide another reason for optimism.

The new biomarker analyses suggest that patients with higher levels of disease-driving autoantibodies may benefit the most from targeted FcRn blockade. At the same time, the overall study results continue to support the potential of nipocalimab as a new treatment approach designed to address the underlying biology of the disease.

As the Phase 3 DAFFODIL study progresses, researchers hope to further confirm whether this targeted strategy can offer meaningful and lasting improvements for patients living with moderate-to-severe Sjögren’s disease.

Conclusion

The latest data from Johnson & Johnson’s Phase 2 DAHLIAS study add to the growing body of evidence supporting nipocalimab as a promising investigational therapy for Sjögren’s disease.

By targeting pathogenic IgG autoantibodies while preserving broader immune function, nipocalimab offers a different approach to disease management. The stronger responses observed in patients with elevated autoantibody and IgG levels provide valuable insights into which patients may benefit most from treatment.

With the ongoing Phase 3 DAFFODIL study and continued regulatory support, nipocalimab remains one of the most closely watched emerging therapies in the Sjögren’s disease treatment landscape.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!