SUMMARY

• In a 24-week, phase 3, randomized, double-blind, placebo (PBO)-controlled trial in adult patients with generalized myasthenia gravis (gMG), peripheral edema was reported as  an adverse reaction in 12% (12/98) of patients in the IMAAVY group and 2% (2/98) of patients in the PBO group.^1,2
  • Adverse events of peripheral edema were not considered serious or severe and none led to study discontinuation.^1,3 
• In a phase 2, randomized, double-blind, PBO-controlled trial in adult patients with gMG, peripheral edema was reported as a treatment-emergent adverse event (TEAE) in 1 patient in the IMAAVY 60 mg/kg single dose group and in 2 patients in the IMAAVY 60 mg/kg every 2 weeks (Q2W) group through day 113.^4,5 There were no reports of peripheral edema in the IMAAVY 5 mg/kg every 4 weeks (Q4W), IMAAVY 30 mg/kg Q4W, or PBO groups.

CLINICAL DATA

VIVACITY-MG3

Antozzi et al (2025)¹ evaluated the efficacy and safety of IMAAVY in adults with gMG in a phase 3, randomized, multicenter, double-blind, PBO-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.^1,6 
  • 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, PBO-controlled treatment phase, a variable-duration, open-label extension phase, and a safety follow-up at 8 weeks after the last infusion.^1,3 
  • 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.⁶ 
• Eligible patients were randomized (1:1) to receive a loading dose of intravenous IMAAVY 30 mg/kg at week 0, followed by 15 mg/kg Q2W, or matching PBO through week 24 in addition to standard of care (SOC) therapy.¹ 

Results

• A total of 196 patients (IMAAVY, n=98; PBO, n=98) were included in the safety analysis set.
• Peripheral edema (including peripheral edema, edema and peripheral swelling) was reported as an adverse reaction in 12% (12/98) of patients in the IMAAVY group and 2% (2/98) of patients in the PBO group.²  
  • Adverse events of peripheral edema were not considered serious or severe and none led to study discontinuation.^1,3 

Phase 2 VIVACITY-MG Study

Antozzi et al (2024)⁴ conducted a phase 2, randomized, multicenter, double-blind, PBO-controlled clinical trial to evaluate the safety, efficacy, PK, and PD of IMAAVY in adult patients with gMG who had an insufficient response to ongoing, stable SOC therapy.

Study Design/Methods

• Patients (≥18 years of age) with anti-AChR or anti-MuSK antibody positive gMG (MGFA Class II, III, or IVa) were included in the study.
• The study included a 4-week screening period, followed by an 8-week double-blind treatment period. Posttreatment follow-up assessment was performed for a period of 8 weeks.
• In addition to SOC therapy, eligible patients were randomized (1:1:1:1:1) to receive intravenous infusions of IMAAVY 5 mg/kg once Q4W, 30 mg/kg Q4W, 60 mg/kg single dose, or 60 mg/kg Q2W or PBO Q2W (5% dextrose in water).

Results

• A total of 68 patients (IMAAVY, n=54; PBO, n=14) were randomized to treatment.
• Through day 113, peripheral edema was reported as a TEAE in 7.7% (1/13) of patients in the IMAAVY 60 mg/kg single dose group and in 14.3% (2/14) of patients in the IMAAVY 60 mg/kg Q2W group.^4,5 
  • There were no reports of peripheral edema in the IMAAVY 5 mg/kg Q4W (n=14), IMAAVY 30 mg/kg Q4W (n=13) or PBO (n=14) groups.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 30 January 2025.