Practical Guidance on Initiating and Switching Targeted Immunotherapies in Generalised Myasthenia Gravis: A...

The therapeutic landscape of generalised myasthenia gravis (gMG) has evolved substantially with the approval of targeted immunotherapies, including complement C5 inhibitors (C5-I) and neonatal Fc receptor inhibitors (FcRn-I). While pivotal trials have demonstrated marked efficacy in defined subgroups, real-world experience reveals more heterogeneous outcomes and raises questions about optimal patient selection, therapy sequencing and integration into clinical practice. In Germany and Austria, early access following regulatory approval has facilitated clinical experience over recent years. This expert opinion paper aims to combine current evidence with clinical experience to guide the use of C5-I and FcRn-I in everyday care.

A panel of 18 neurologists from Germany and Austria, including two paediatric neurologists, evaluated study data and real-world experiences. Through structured discussion and a consensus process, they developed evidence- and experience-based recommendations on integrating targeted immunotherapies into existing treatment algorithms.

The panel provides practical recommendations for managing (highly) active gMG in adults, focusing on C5-I (eculizumab, ravulizumab, zilucoplan) and FcRn-I (efgartigimod, rozanolixizumab). The statements cover initiation criteria, sequencing and switching within and between drug classes and transitions to intensified immunomodulatory therapies (rituximab, apheresis, intravenous or subcutaneous immunoglobulin), as well as special considerations for juvenile MG.

This expert statement provides a practice-oriented framework integrating current evidence and clinical experience to support individualised therapeutic decision-making in gMG.