An evaluation of rozanolixizumab-noli for the treatment of anti-AChR and anti-MuSK antibody-positive generalized myasthenia gravis.

INTRODUCTION: Myasthenia gravis (MG) is an auto-immune disease characterized by fluctuating symptoms of muscle weakness and fatigue. Corticosteroids and corticosteroid-sparing broad-spectrum immunosuppression play a great role in the treatment of myasthenia gravis. However, debilitating side effects and long time to treatment effect highlight the need for development of novel target-specific medications. Rozanolixizumab is a highly specific neonatal Fc receptor (FcRn) inhibitor that acts on immunoglobulin G (IgG) homeostasis. Results from the MycarinG Phase III randomized controlled trial demonstrated significant efficacy of rozanolixizumab in generalized MG in terms of primary outcome and all secondary endpoints, tolerability, and safety compared to placebo.

AREAS COVERED: We included different trials on myasthenia gravis and rozanolixizumab which include Phase II (NCT03052751) and Phase III MycarinG (NCT03971422) studies.

EXPERT OPINION: Clinical trials have demonstrated that rozanolixizumab has strong efficacy with a 78% reduction in pathogenic IgG like plasma exchange (PLEX) and has therapeutic benefits comparable with PLEX and IVIG. It has less treatment adverse events and is easily accessible through subcutaneous infusion. The safety and effectiveness of rozanolixizumab need to be assessed further in the real-world context in post-marketing studies. If current trial information holds true, rozanolixizumab may become a medication of choice for MG in succeeding years.