After the 24-week double-blind phase of the study, patients entered the ongoing OLE phase, with the latest results reflecting a total of 120 weeks of observation – among the longest follow-up periods reported for any FcRn blocker study in gMG. At 96 weeks in the OLE, IMAAVY demonstrated:
- Sustained improvements in MG-ADLd and QMGe scores over time, with mean reductions of 6.47f points on the total MG-ADL and 5.97f points on the total QMG scales – measures of MG symptom impact on daily living and muscle strength.
- Half of patients achieved MSE and nearly one-third (32%) achieved sustained MSE for at least 8 weeks on IMAAVY treatment.
- Incremental reduction of corticosteroid use was also observed through the OLE, with 57% of patients reaching low doses of ≤10 or ≤5 mg/day.
- Greater than 64%f reduction in total immunoglobulin G (IgG), including pathogenic IgG autoantibodies, the underlying driver of disease.
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