The Vivacity-MG3 phase III trial included 153 adults with generalised myasthenia to evaluate nipocalimab, a monoclonal antibody targeting the neonatal Fc receptor (FcRn).
- Of all the patients, 88% had anti-RACh autoantibodies, 11% had anti-MuSK autoantibodies and 2% had anti-LRP4 autoantibodies.
- Patients were randomised into two groups: 77 received nipocalimab and 76 a placebo, every fortnight for six months. All patients received additional care as usual.
- A significantly greater reduction in the MG-ADL score compared with baseline (primary endpoint) was observed at six months in the nipocalimab group than in the placebo group.
- A significantly greater reduction in the Quantitative Myasthenia Gravis (QMG) score at six months compared to baseline was also observed with nipocalimab.
- A rapid and sustained reduction in IgG, correlated with a greater improvement in symptoms, was observed with nipocalimab.
- Nipocalimab was well tolerated, with mostly mild to moderate adverse events.
The open-label extension phase of the Vivacity-MG3 trial will provide longer-term efficacy and safety data.
