Vivacity-MG3
Trial question
What is the effect of nipocalimab in patients with generalized myasthenia gravis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 153
153 patients (92 female, 61 male).
Inclusion criteria: adult patients with generalized myasthenia gravis inadequately controlled with standard-of-care therapy.
Key exclusion criteria: clinical immunodeficiency syndrome not related to treatment of generalized myasthenia gravis or a family history of congenital or hereditary immunodeficiency unless confirmed absent in the patient; thymectomy in the past 12 months; allergies, hypersensitivity, or intolerance to nipocalimab or its excipients; MI, unstable ischemic heart disease, or stroke in the past 12 weeks.
Interventions
N=77 nipocalimab (nipocalimab 30 mg/kg loading dose, then 15 mg/kg every 2 weeks for maintenance plus standard-of-care therapy for 24 weeks).
N=76 placebo (matching placebo infusion every 2 weeks plus standard-of-care therapy for 24 weeks).
Primary outcome
Least-squares mean reduction in Myasthenia Gravis-Activities of Daily Living score over weeks 22-24 in antibody-positive patients
4.7 points
3.25 points
4.7 points
3.5 points
2.4 points
1.2 points
0.0 points
Nipocalimab
Placebo
Significant
increase ▲
Significantly greater reduction in least-squares mean Myasthenia Gravis-Activities of Daily Living score over weeks 22-24 in antibody-positive patients (4.7 points vs. 3.25 points; MD 1.45, 95% CI 0.52 to 2.38).
Secondary outcomes
Significantly greater reduction in least-squares mean Quantitative Myasthenia Gravis score over weeks 22-24 in antibody-positive patients (4.86 points vs. 2.05 points; MD 2.81, 95% CI 1.14 to 4.48).
Significant increase in Myasthenia Gravis-Activities of Daily Living responder rate at weeks 22-24 (68.8% vs. 52.6%; AD 16.2%, 95% CI 0.9 to 31.5).
Significant increase in ≥ 50% improvement in Myasthenia Gravis-Activities of Daily Living from weeks 22-24 (46.8% vs. 25%; AD 21.8%, 95% CI 7 to 36.6).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with generalized myasthenia gravis inadequately controlled with standard-of-care therapy, nipocalimab was superior to placebo with respect to a least-squares mean reduction in Myasthenia Gravis-Activities of Daily Living score over weeks 22-24 in antibody-positive patients.
Reference
Carlo Antozzi, Tuan Vu, Sindhu Ramchandren et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025 Feb;24(2):105-116.
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