Johnson & Johnson nipocalimab achieves 53.5% SRI-4 response at 24 weeks
JNJ•Johnson & Johnson’s nipocalimab reduced SLE disease activity, achieving a 53.5% SRI-4 response at 24 weeks versus 46.7% on placebo. Efficacy was sustained through 52 weeks with 53.6% SRI-4 and 37.5% LLDAS rates versus 39.7% and 20.5% on placebo in autoantibody-positive adults.
1. Phase 2 JASMINE study results
The Phase 2 JASMINE trial met its primary endpoint at 24 weeks, with 53.5% of patients receiving nipocalimab 15 mg/kg achieving an SRI-4 response versus 46.7% on placebo. Efficacy persisted through Week 52, yielding 53.6% SRI-4 and 37.5% LLDAS rates compared with 39.7% and 20.5% for placebo.
2. Novel FcRn-blocking mechanism
Nipocalimab is a neonatal Fc receptor blocker designed to selectively reduce pathogenic IgG autoantibodies while preserving overall immune function, marking the first proof-of-concept of FcRn-mediated therapy in systemic lupus erythematosus.
3. Safety profile
Safety outcomes aligned with previous studies, showing no new safety signals; the most common adverse reactions (≥10%) were nasopharyngitis, headache, urinary tract infection and nausea in treated patients.
4. Next steps and regulatory status
Nipocalimab received FDA Fast Track designation for SLE and is advancing into the Phase 3 GARDENIA study, which is currently recruiting adults with moderate-to-severe systemic lupus erythematosus.
