Switching Patients with Generalized Myasthenia Gravis from Intravenous Immunoglobulin to IMAAVY

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for information on the appropriate use of IMAAVY in patients with generalized myasthenia gravis (gMG).
• In the VIVACITY-MG3 clinical study, patients were excluded from the study if they had received intravenous immunoglobulin (IVIG) within 6 weeks prior to baseline.¹
  • Patients who received IVIG as a rescue treatment during the double-blind (DB) placebo (PBO)-controlled phase were required to wait at least 4 weeks before receiving a subsequent dose of IMAAVY in the open-label extension (OLE) phase.²

CLINICAL DATA

VIVACITY-MG3 Study

Antozzi et al (2025)¹ conducted a phase 3, randomized, multicenter, DB, PBO-controlled study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMAAVY in adults with generalized gMG.

Exclusion Criteria

• Patients who had received IVIG within 6 weeks prior to baseline of the DB study were excluded.¹

Rescue Therapy

• Patients who experienced clinical deterioration requiring rescue therapy were treated with either IVIG or plasmapheresis.¹
• If rescue therapy was needed during the DB phase, the patient was discontinued from the DB phase and could enter into the OLE phase.¹
  • Patients who received IVIG as rescue therapy during the DB phase were required to complete an end of phase visit and undergo a minimum 4-week washout period before becoming eligible to receive a subsequent dose of IMAAVY in the OLE.^1,2
• Patients receiving IVIG rescue therapy did not receive study intervention (IMAAVY or PBO) concomitantly due to the potential for IMAAVY to reduce the efficacy of IVIG as rescue therapy.²

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 15 June 2026.