Following an initial presentation at the 2021 American Academy of Neurology meeting, the final (and more moderate) results of the Vivacity-MG trial were published in the journal Neurology in January 2024 :
- 57 of the 68 participants completed 57 days of treatment with placebo or nipocalimab 5, 30 or 60 mg;
- the incidence of side-effects was comparable between nipocalimab (83.3%) and placebo (78.6%), including infections;
- There was a statistically significant dose-response effect for improvement in MG-ADL score at D57 with nipocalimab, but no significant difference between nipocalimab and placebo;
- nipocalimab produced a rapid (D7) and substantial (up to 83%) reduction in total IgG levels.
A phase III trial is now evaluating nipocalimab, an anti-FcRn agent like efgartigfimod or rozanolixizumab, in several countries including France. It is due to finish in mid-2026.
