Efficacy and Safety of Nipocalimab in Patients with Generalised Myasthenia Gravis: Top Line Results from the Double-Blind, Placebo-Controlled, Randomised Phase III Vivacity-MG3 Study

Abstract

Nipocalimab, a high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody, has been developed as an add-on treatment for myasthenia gravis (MG). The agent, administered every 2 weeks, aims to selectively block neonatal Fc receptor (FcRn), in order to reduce levels of circulating immunoglobulin G (IgG) including autoantibodies and ameliorate disease manifestations, while preserving immune function. In this poster presentation, Carlo Antozzi outlined top-line results from the 24-week, double-blind, placebo-controlled, randomised Vivacity-MG3 Phase III study (NCT04951622).1 Nipocalimab, he explained, demonstrated efficacy and safety in a broad antibody-positive population, suggesting it could provide the first FcRn treatment option with a predictable dosing schedule in generalised MG (gMG).