Sindhu Ramchandren, MD, Executive Medical Director of Neuroscience at Johnson & Johnson, discusses long-term efficacy of nipocalimab in 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 neonatal Fc receptor-binding monoclonal antibody that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of gMG in adult and pediatric patients 12 years of age and older who are anti-AChR or anti-MuSK antibody positive.
Analysis of Long-Term Efficacy of Nipocalimab in Myasthenia Gravis: Open-Label Extension of the Vivacity-MG3 Trial
The Vivacity-MG3 (NCT04951622) clinical trial was a phase 3 double-blind, 24-week study that demonstrated statistically significant and clinically meaningful improvements in MG Activities of Daily Living (MG-ADL) and Quantitative MG (QMG) scores with nipocalimab plus standard of care. Patients on nipocalimab plus standard of care in the double-blind phase had the option of continuing treatment in the open-label extension phase assessing long-term efficacy.
A total of 98 patients rolled over into the extension phase where data was collected up to week 48. At Week 48, 84.6% of patients achieved minimal clinical improvement (MCI) in MG-ADL. Mean time to earliest MCI was 4.0 weeks and sustained MCI for 8 weeks or greater was observed in 77.6% of patients. The mean percentage of time with MCI up to Week 48 was 71.6% and 50% or greater study time with MCI was observed in 73.9% of patients. 75% or greater study time with MCI was observed in 67.0% of patients.
At Week 48, 26.9% of patients achieved minimal symptom expression (MSE) in MG-ADL. Mean time to earliest MSE was 14.5 weeks and sustained MSE for 8 weeks or greater was observed in 23.5% of patients. Mean percentage of time with MSE up to Week 48 was 30.21% and 50% or greater study time with MSE was observed in 17.0% of patients while 75% or greater study time with MSE was observed in 12.5% of patients.
Efficacy of Nipocalimab in Adult Patients with Moderate-to-Severe Ocular Manifestations of gMG in Phase 3 VIVACITY-MG3
In gMG, 15–50% of patients present with ocular manifestations such as ptosis or diplopia. The objective of this post-hoc analysis was to evaluate the efficacy of nipocalimab versus placebo in the subgroup of patients with moderate-to-severe ocular manifestations (MSOM).
At baseline, within the MSOM subgroup, nipocalimab and placebo arms were comparable in mean age, BMI and mean (SD) MG-ADL-ocular and MG-ADL-total scores. At week 24, the change from baseline LS mean difference in MG-ADL scores was significantly greater with nipocalimab than placebo. The mean difference MG-ADL-total for nipocalimab vs placebo was −1.35. Additionally, at week 24, the change from baseline LS mean difference in MG-ADL-ocular scores was greater with nipocalimab than placebo. 51% of participants achieved meaningful within-person improvement at week 24 on MG-ADL-ocular domain with nipocalimab, comnpared to 24% in the placebo group.
To learn more about gMG and other rare neurological conditions, visit https://checkrare.com/diseases/neurology-nervous-system-diseases/