Jonathan Strober, MD, pediatric neurologist and neuromuscular specialist at the University of California at San Francisco, discusses the use of nipocalimab in adolescent patients with generalized myasthenia gravis (gMG).
gMG is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. Common symptoms include weakness of the muscles that control the eye and eyelid, facial expressions, chewing, talking, and swallowing. The condition results from a defect in the transmission of nerve impulses to muscles, which is due to the presence of antibodies against acetylcholine. The exact reason this occurs is not known.
Nipocalimab is a fully human IgG monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and affinity, blocking its interaction with IgG. The treatment is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of both adult and adolescent patients 12 years and older with gMG.
The objective of the study is to evaluate the safety and efficacy of nipocalimab in adolescents aged 12 to 18 years with gMG who exhibit an insufficient clinical response to standard-of-care therapy. Vibrance-mg (NCT05265273) is a phase 2/3 global, multicenter, open-label study evaluating nipocalimab plus standard of care in adolescents and children with gMG.
In adolescents with gMG, nipocalimab demonstrated a rapid, substantial and sustained reduction in total serum IgG levels over 24 weeks, with effects maintained through week 72 in the long term extension. Clinically meaningful improvements in MG Activities of Daily Living and Quantitative MG scores were achieved over 24 weeks and sustained in most participants through week 72. Treatment was well-tolerated in adolescents with gMG, with a favorable safety profile observed throughout the study.
To learn more about gMG and other rare neurological disorders, visit https://checkrare.com/diseases/neurology-nervous-system-diseases/