Johnson & Johnson has reported late‑breaking phase 2 results showing that nipocalimab met the primary endpoint of reducing disease activity at 24 weeks in adults with moderate to severe systemic lupus erythematosus, with improvements sustained through week 52 in the JASMINE study.
The company said: “Nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SRI‑4b 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 LLDAS.c”.
It added that greater responses were seen in participants who tested positive for lupus‑associated autoantibodies, representing around 80% of people with SLE.
Nipocalimab is designed to selectively block the neonatal Fc receptor, reducing circulating pathogenic immunoglobulin G autoantibodies and immune complexes associated with inflammation. Johnson & Johnson stated that JASMINE is the first clinical study to show efficacy of FcRn blockade in SLE and provides evidence supporting continued investigation of the therapy.
Richard Furie, Chief of the Division of Rheumatology at Northwell, said: “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 SLE.”
He added that the findings “support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody‑positive adult patients living with moderate‑to‑severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage.”
The study met its primary endpoint at week 24, with 53.5 % of patients receiving nipocalimab 15 mg/kg achieving an SRI‑4b response compared with 46.7% for placebo. At week 52, 53.6 percent of patients on nipocalimab achieved an SRI‑4b response versus 39.7% for placebo. More patients also achieved Lupus Low Disease Activity State at week 52.
Johnson & Johnson said nipocalimab had a safety profile consistent with previous studies, with no new safety signals identified.
Mark Graham, Therapeutic Area Head, Immunology, Europe, Middle East and Africa, said: “Findings from the JASMINE study mark an important step in advancing research in systemic lupus erythematosus, a complex autoantibody disease that can have profound impact on daily life for people living with moderate to severe disease.”
