France was one of the investigating countries in a trio of international trials designed to evaluate immunomodulating monoclonal antibodies or antibody fractions in myasthenia gravis in cases of resistance or intolerance to the usual drugs:
- the open-label extension of the Champion-MG trial of ravulizumab, an intravenous anti-C5 agent,
- the MycarinG trial of rozanolixizumab, an anti-Fc-Rn injected subcutaneously,
- the Raise trial of zilucoplan, a self-administered subcutaneous anti-C5 agent.
All three trials demonstrated rapid efficacy and good tolerability. Ravulizumab and zilucoplan now benefit from early access authorisation in France, and rozanolixizumab from compassionate access authorisation.
Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. Meisel A, Annane D, Vu T et al. J Neurol. 2023 Apr 27:1–14.
Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Bril V, Drużdż A, Grosskreutz J et al. Lancet Neurol. 2023 May;22(5):383-394.
Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Howard JF Jr, Bresch S, Genge A et al. Lancet Neurol. 2023 May;22(5):395-406.The results of three phase III trials in myasthenia gravis have been published!
