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An expert opinion on the (good) results of rozanolixizumab in myasthenia gravis
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Three neurologists from Toronto’s Centre for Neuromuscular Diseases have analyzed the findings of various trials of rozanolixizumab (Rystiggo®), a monoclonal antibody directed against neonatal Fc receptors (anti-FcRn), in autoimmune myasthenia with anti-RACh or anti-MuSK antibodies. They conclude that :
- rozanolixizumab is effective, reducing pathogenic IgG by up to -78%, similar to plasma exchange;
- it also improves various clinical parameters such as MG-ADL, QMG, MGC and MG-PRO scores (phase IIIAu cours d’un essai clinique de phase III, un médicament, pour lequel on a déterminé lors d’essais antérieurs l’innocuité et le dosage optimum (essais de phase I et II), est administré à un grand groupe de malades, sur une longue durée, dans le but d’évaluer son efficacité thérapeutique en la comparant à celle d’un traitement de référence ou un placebo. Il permet aussi de mettre en évidence les interactions indésirables et les effets secondaires du traitement à moyen terme. Au terme de cet essai, le médicament peut obtenir une autorisation de mise sur le marché. trial);
- it is well tolerated, with fewer side effects than many other myasthenia treatments, the most frequent being headaches;
- it is easier and quicker to administer (subcutaneous route) than other anti-FcRn drugs (intravenous route), and an open-label self-administration trial is currently underway.
For the Canadian experts, these good results have yet to be confirmed in real life, since rozanolixizumab already has marketing authorization in the US (June 2023) and Europe (January 2024).