Late-breaking data presented at EULAR 2026 showed sustained reductions in systemic lupus erythematosus disease activity through 52 weeks, with the strongest responses seen in patients who tested positive for lupus-associated autoantibodies.
Johnson & Johnson has reported that its investigational drug nipocalimab significantly reduced disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE) in the Phase 2 JASMINE study, with benefits sustained through 52 weeks.
The findings, presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London, could strengthen the case for a new targeted treatment approach for SLE, an autoimmune condition that can lead to progressive organ damage.
The study is particularly notable because nipocalimab is the first neonatal Fc receptor (FcRn) blocker to be investigated in systemic lupus erythematosus. The therapy is designed to reduce pathogenic immunoglobulin G (IgG) autoantibodies and immune complexes that drive inflammation, while preserving critical immune functions.
Why the findings matter
Systemic lupus erythematosus is an autoantibody-driven disease in which the immune system attacks the body’s own tissues. Many patients continue to experience disease activity despite existing treatments and remain at risk of irreversible organ damage.
According to Johnson & Johnson, approximately 80% of people living with SLE test positive for lupus-associated autoantibodies. In the JASMINE study, this subgroup showed greater responses to nipocalimab compared with placebo when added to background medication.
The company said the results provide the first clinical evidence that FcRn blockade may be an effective therapeutic strategy in SLE.
Key results from the JASMINE study
The Phase 2 trial met its primary endpoint at Week 24.
Among patients receiving nipocalimab 15 mg/kg plus background medication, 53.5% achieved an SLE Responder Index-4 (SRI-4) response, compared with 46.7% of those receiving placebo plus background medication.
The benefits were maintained through one year of follow-up:
- At Week 52, 53.6% of patients receiving nipocalimab achieved an SRI-4 response, compared with 39.7% in the placebo group.
- More patients treated with nipocalimab achieved Lupus Low Disease Activity State (LLDAS), with rates of 37.5% versus 20.5% for placebo at Week 52.
- In the predefined autoantibody-positive population, SRI-4 response rates at Week 52 were 58.2% for nipocalimab versus 36.1% for placebo.
- In the same subgroup, 38.9% of patients achieved LLDAS compared with 18.0% in the placebo group.
LLDAS is a measure used to assess whether patients have achieved sustained low disease activity and is increasingly used in treat-to-target approaches in lupus care.
Experts highlight potential of targeted treatment
“The consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus,” said Dr Richard Furie, Chief of the Division of Rheumatology at Northwell.
Dr Furie said the 52-week findings support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody-positive adults with moderate-to-severe SLE, a disease in which many patients continue to experience active symptoms and face the risk of irreversible organ damage.
The study also generated clinical, biomarker and pharmacodynamic evidence supporting further development of the therapy, according to the company.
How nipocalimab works
Nipocalimab is an investigational monoclonal antibody designed to selectively block the neonatal Fc receptor (FcRn).
FcRn is involved in maintaining circulating levels of immunoglobulin G antibodies. By blocking this receptor, nipocalimab reduces circulating IgG, including disease-causing autoantibodies associated with lupus.
The approach is intended to target an underlying driver of disease activity while preserving broader immune function.
Johnson & Johnson said JASMINE is the first clinical study to demonstrate efficacy of FcRn blockade in systemic lupus erythematosus.
“We are especially encouraged by the responses observed in autoantibody-positive study participants,” said Dr Leonard L. Dragone, Disease Area Leader, Autoantibody and Rheumatology at Johnson & Johnson.
“These findings support the potential of nipocalimab as a targeted, immunoselective treatment designed to address underlying drivers of systemic lupus erythematosus.”
Safety profile and next steps
The company said nipocalimab’s safety profile was consistent with previous studies, and no new safety signals were identified.
The most common adverse reactions reported in patients with SLE receiving the drug were nasopharyngitis, headache, urinary tract infection and nausea.
Johnson & Johnson is currently recruiting participants for an ongoing Phase 3 trial of nipocalimab in systemic lupus erythematosus. The larger study will determine whether the efficacy and safety signals observed in JASMINE can be confirmed in a broader patient population.
For people living with moderate-to-severe SLE, particularly those with lupus-associated autoantibodies, the Phase 2 findings suggest that FcRn blockade could emerge as a new therapeutic strategy aimed at reducing disease activity and maintaining longer-term disease control.
