Results of phase II trial of nipocalimab in myasthenia gravis published

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 placeboLe placebo est un produit dont la présentation est identique à celle d’un médicament, mais qui ne contient pas de principe actif. Dans un essai clinique, un placebo est utilisé pour mesurer l’action réelle du médicament testé, en comparant les effets du médicament testé contenant le principe actif et ceux du 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.

Safety and efficacy of nipocalimab in patients with generalized myasthenia gravis: results from the randomized phase 2 Vivacity-MG study. Antozzi C, Guptill J, Bril V et al. Neurology. 2024 Jan 23;102(2):e207937.