Study of Efgartigimod to Replace IVIG in Adults with Stable Myasthenia Gravis Evaluating Effectiveness and Safety Over 26 Weeks

What this Trial Is About

This research evaluates efgartigimod as a replacement for intravenous immunoglobulin IVIG therapy in adults with stable, acetylcholine receptor antibody positive myasthenia gravis who depend on IVIG. The study aims to compare the effectiveness of efgartigimod with IVIG, assess patient treatment preferences, and monitor safety and tolerability over six months. It is an open-label, single-center prospective study lasting 26 weeks. Participants will stop IVIG one week before starting efgartigimod. Efgartigimod is administered as a one-hour intravenous infusion at a dose of 10 mgkg up to 1200 mg once weekly for four weeks, followed by a four-week break. This cycle repeats four times until week 24, with a final observation visit at week 26. Other myasthenia gravis medications remain unchanged during the study. Throughout the 26 weeks, weekly assessments using the Myasthenia Gravis Activities of Daily Living MG-ADL and Myasthenia Gravis Quality of Life MGQOL questionnaires will be conducted. Researchers will look for sustained improvements in MG-ADL scores lasting at least four consecutive weeks. Safety and continuation of efgartigimod treatment will also be monitored. Participants are involved in regular evaluations to track their symptoms and quality of life during and shortly after treatment.

Efgartigimod in IVIG Dependent Myasthenia Gravis Patients