Johnson & Johnson (NYSE: JNJ), a global leader in healthcare, announced significant progress in the treatment of Sjögren’s disease (SjD) with its drug, nipocalimab. In a recent Phase 2 DAHLIAS study, patients treated with nipocalimab exhibited a statistically significant improvement in their ClinESSDAI score compared to placebo at 24 weeks (P=0.002), marking a major advancement in SjD treatment.

Statistical and Clinical Improvements Demonstrated

The primary endpoint of the study was met with considerable improvements noted from as early as Week 4, which continued to rise throughout the 24-week treatment period. This represents the first positive outcome for nipocalimab in treating SjD, setting a potential new standard in therapy for the disease.

Details from the Phase 2 DAHLIAS Study

The DAHLIAS study is a Phase 2 multicenter, randomized, placebo-controlled double-blind trial aimed at evaluating the effects of nipocalimab in participants with primary Sjögren’s disease. This dose-ranging study included adults who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. A total of 163 adults aged 18-75 were randomized to receive intravenous nipocalimab at doses of 5 or 15 mg/kg, or placebo every two weeks up to Week 22, alongside a background standard of care. The study highlighted not only primary but also several secondary endpoint improvements, including multiple organ assessments and symptoms such as mouth, eye, and vaginal dryness.

Safety and Mechanism of Action

Nipocalimab’s safety and tolerability profiles were consistent with previous studies. It operates by targeting and blocking FcRn to reduce levels of circulating immunoglobulin G (IgG) antibodies, including autoantibodies, without causing broad immunosuppression, an approach that underpins its potential across various autoimmune conditions.

Regulatory Milestones and Future Prospects

Nipocalimab has received multiple designations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), including Fast Track designation for several indications and Orphan Drug status. These endorsements highlight the therapeutic’s potential and Johnson & Johnson’s commitment to addressing autoantibody-mediated diseases.

Industry and Expert Reactions

“Johnson & Johnson is committed to delivering innovative and transformational approaches for autoantibody-mediated diseases like SjD, and the data presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress demonstrate the potential of nipocalimab in a disease where patients have very few options,” stated Terence Rooney, Vice President, Rheumatology, Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine.

Professor Jacques-Eric Gottenberg, M.D., Ph.D., a key study investigator, also reflected on the findings: “These data establish proof of concept for nipocalimab in Sjögren’s disease and support further clinical development, which is welcome news for the approximately four million people worldwide living with this chronic, debilitating disease.”

The positive outcomes from the DAHLIAS study pave the way for further clinical trials and potential regulatory approval, offering hope to millions suffering from this challenging autoimmune disease. Johnson & Johnson continues to lead in the innovation of treatments that significantly improve patient outcomes in the realm of rheumatology and beyond.

  autoimmune disease treatment, Johnson & Johnson, Nipocalimab, Phase 2 DAHLIAS Study, Sjögren’s Disease Treatment