SUMMARY

• Nipocalimab is an investigational, fully human, high-affinity aglycosylated, effectorless immunoglobulin G1 (IgG1) anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody that is being studied for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients.^1-3 
• In a 24-week, phase 3, randomized, double-blind, placebo-controlled trial in adult patients with gMG, infusion-related reactions was reported in 10.2% and 11.2% of patients in the nipocalimab and placebo group, respectively.¹ 

CLINICAL DATA

VIVACITY-MG3

Vu et al (2024)¹ evaluated the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of nipocalimab in adults with gMG in a phase 3, randomized, multicenter, double-blind, placebo-controlled study.

Study Design/Methods

• Patients (≥18 years of age) with anti- acetylcholine receptor (AChR), muscle-specific tyrosine kinase (MuSK) or low-density lipoprotein receptor 4 (LRP4) antibody positive or seronegative (in all countries except France) gMG (Myasthenia Gravis Foundation of America [MGFA] Class IIa–IVb) were included in the study.
  • The safety analysis population included all randomized patients who received ≥1 dose (partial or complete) of any study treatment in the double-blind phase.
• The study consisted of a ≤4-week screening phase, followed by a 24-week, double-blind, placebo-controlled treatment phase, a variable-duration, open-label extension phase, and a safety follow-up at 8 weeks after the last infusion.
  • Patients who withdrew or discontinued after receiving any amount of the study intervention were required to complete a safety follow-up assessment at 8 weeks after the last dose.
• Eligible patients were randomized (1:1) to receive a loading dose of intravenous nipocalimab 30 mg/kg at week 0 followed by 15 mg/kg every 2 weeks or matching placebo through week 24 in addition to standard of care (SOC) therapy.

Results

• A total of 196 patients (nipocalimab, n=98; placebo, n=98) were included in the full analysis set.
• Infusion-related reactions were reported in 10.2% (10/98) of patients in the nipocalimab group and in 11.2% (11/98) of patients in the placebo group.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 October 2024.