Johnson & Johnson's nipocalimab shows promise in Sjögren's disease

Johnson & Johnson (J&J) has announced encouraging outcomes from its phase 2 trial of the investigational antibody nipocalimab in treating Sjögren’s disease (SjD), a chronic autoimmune condition. The DAHLIAS dose-ranging study assessed the impact of nipocalimab in 163 adults with primary SjD, including those with moderate to severe disease activity who tested positive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies.

Sjögren’s disease, which affects around four million people globally, is an autoantibody-driven condition marked by persistent inflammation and lymphocytic infiltration of exocrine glandular systems. Despite its prevalence, there are currently no approved therapies for SjD. Terence Rooney, Vice President of Rheumatology, Immunology, and Disease Area Leader at J&J Innovative Medicine, emphasized the urgent need for advanced treatments that address the systemic nature and underlying causes of SjD.

The DAHLIAS study results are the first positive findings for nipocalimab in SjD, showing that the investigational antibody met both its primary and secondary endpoints in patients compared to a placebo. The antibody led to a statistically significant and clinically meaningful improvement in the ClinESSDAI score, which evaluates disease activity across 11 organ systems. Patients treated with nipocalimab also exhibited symptom improvements at 24 weeks, consistent with the safety and tolerability seen in other clinical studies.

Professor Jacques-Eric Gottenberg, a study investigator from the Department of Rheumatology at Strasbourg University Hospital and the National Centre for Rare Systemic Autoimmune Diseases, stated that the data provides proof of concept for nipocalimab in SjD and supports further clinical development.

J&J's nipocalimab program includes multiple clinical trials, such as phase 3 studies investigating the antibody’s efficacy in treating generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy, and warm autoimmune hemolytic anemia. In February, J&J reported positive top-line results from the phase 3 VIVACITY study of nipocalimab in adults with gMG, a chronic autoimmune disorder affecting approximately 700,000 people worldwide.

The VIVACITY study revealed that nipocalimab achieved its primary endpoint by showing a statistically significant reduction in the MG-ADL score, which measures symptoms affecting patients' daily lives, from baseline over weeks 22 to 24 compared to a placebo.

Overall, the promising phase 2 results from the DAHLIAS study represent a significant step forward in the potential treatment of Sjögren’s disease with nipocalimab. These findings not only highlight the antibody’s potential efficacy and safety but also pave the way for further clinical trials and development, offering hope to millions of patients who currently have limited treatment options.