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Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study
Autoantibody-high participants had a 62.5% response rate, compared with 51.9% overall, supporting continued Phase 3 testing of the therapy.
Johnson & Johnson announced on Wednesday that its Phase 2 JASMINE study showed nipocalimab sustained reductions in systemic lupus erythematosus disease activity through 52 weeks, measured by both SRI-4b and LLDAS endpoints.
Designed to target the neonatal Fc receptor , nipocalimab reduces circulating pathogenic immunoglobulin G autoantibodies while preserving key immune functions, addressing the underlying cause of SLE.
At Week 52, 53.6% of patients receiving nipocalimab 15 mg/kg achieved an SRI-4 response compared with 39.7% on placebo plus background medication; more patients also achieved Lupus Low Disease Activity State .
Richard Furie, Chief of the Division of Rheumatology at Northwell, said "consistent improvements across established disease activity measures" support nipocalimab as a targeted approach for SLE patients.
A Phase 3 study is currently underway to evaluate nipocalimab's potential to provide sustained disease control for adults with moderate-to-severe SLE, a debilitating autoantibody-driven disease.