Rozanolixizumab Improves in Activities of Daily Living in Individuals with Generalized Myasthenia Gravis
In the phase 3 MycarinG study1 (NCT03971422), adults with generalized myasthenia gravis (gMG) treated with 1 of 2 doses of rozanolixizumab (UCB7665; Creative Biolabs, Shirley, NY) vs placebo had mean score improvements from baseline to day 43 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL). A higher proportion of individuals treated with rozanolixizumab vs placebo had improved MG-ADL scores as well.
Improvements were also seen on the Myasthenia Gravis-Composite (MG-C) score and the Quantitative Myasthenia Gravis (QMG) score at day 43 compared to baseline. Using the patient-reported outcomes of muscle weakness fatigability, overall physical fatigue, and bulbar symptoms, improvements were also seen with rozanolixizumab vs placebo.
“Today’s encouraging findings from the MycarinG study show the potential of rozanolixizumab in the treatment of myasthenia gravis, and further reinforce the suggestion that FcRn inhibition may be a promising approach for this disease,” explained Professor Vera Bril, MycarinG study Lead Investigator, professor of Medicine (Neurology), University of Toronto, and Director of the Neuromuscular Section, Division of Neurology, University of Toronto and University Health Network, Toronto, Canada.
“For the many thousands of people living with myasthenia gravis around the world, current treatment options can be very limited,” said Samantha Masterson, chief executive officer of the Myasthenia Gravis Foundation of America (MGFA). “Given that this disease causes a wide range of symptoms, some of which can require urgent intervention or hospitalization, there is a critical need for new treatment options that could address the unmet needs of patients living with myasthenia gravis.”
Overall, rozanolixizumab was well tolerated and no new safety signals were identified. The most common adverse event in period 1 of the prior phase 2 trial was headache (rozanolixizumab 57%, placebo 14%)