Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study

Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune function Results demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg/kg groupa The ongoing Phase 3 study of nipocalimab is currently recruiting people living with systemic lupus erythematosus – a debilitating autoantibody-driven disease which can lead to systemic organ damage LONDON, June 3, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SLE Responder Index 4 (SRI-4)b and continued to demonstrate sustained reduction in disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE)a through 52 weeks in the Phase 2 JASMINE study as measured by both SRI-4b and Lupus Low Disease Activity State (LLDAS).c In addition, the study results showed greater response versus placebo plus background medicationd in participants who tested positive for lupus-associated autoantibodies, which represents the vast majority (~80%) of people living with SLE.e,1 These findings will be featured in a late-breaking presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London and are among the 38 abstracts the Company is presenting across its Rheumatology portfolio. Nipocalimab is designed to selectively block the neonatal Fc receptor (FcRn), reducing levels of circulating pathogenic immunoglobulin (IgG) autoantibodies and immune complexes associated with inflammation in SLE.2,3 By reducing circulating IgG, including autoantibodies, nipocalimab is designed to target the underlying cause of disease while preserving critical immune functions.4 JASMINE is the first clinical study to demonstrate efficacy of FcRn blockade in SLE and provides clinical, biomarker and pharmacodynamic evidence supporting the continued investigation of nipocalimab as a potential treatment option for this disease.5 A healthcare professional's perspective "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 Richard Furie, M.D.
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