Absolutely, thank you for the opportunity to discuss and share our results from the EAN 2026 Congress. I’ll be presenting this year the Myasthenia Gravis Inebilizumab trial or MINT, specifically the adverse events of special interest during the randomized controlled period. So, it’s important to kind of take a step back and understand that generalized myasthenia gravis is driven by CD19-positive B-cells, which generate autoantibodies that target muscle specific kinase or acetylcholine receptors on the surface of the motor end plate...
Absolutely, thank you for the opportunity to discuss and share our results from the EAN 2026 Congress. I’ll be presenting this year the Myasthenia Gravis Inebilizumab trial or MINT, specifically the adverse events of special interest during the randomized controlled period. So, it’s important to kind of take a step back and understand that generalized myasthenia gravis is driven by CD19-positive B-cells, which generate autoantibodies that target muscle specific kinase or acetylcholine receptors on the surface of the motor end plate. Inebilizumab is a humanized monoclonal antibody that targets and depletes these CD19-positive B-cells. However, it has been shown that B-cell depleting therapies may impair humoral responses and increase the risk of infections. The current study evaluated the incidence of investigator-reported adverse events of special interests or AESIs followed in the randomized controlled period or RCP of the Phase III Myasthenia Gravis Inebilizumab trial, also called MINT. In MINT, participants were randomized one to one to inebilizumab or placebo in the RCP. And participants that were eligible to enroll were either AChR antibody-positive generalized myasthenia gravis patients, which were followed for 52 weeks, or individuals with MuSK antibody-positive generalized myasthenia gravis, which were followed for 26 weeks. In this analysis, adverse event subsets relevant to the mechanism of action of inebilizumab were designated as AESIs. These included anaphylaxis and infusion-related reactions, immune complex disease, cytopenias, and serious and or opportunistic infections. Of the 238 randomized participants included in the safety analysis set, the incidence of AESIs was 10% in participants in participants treated with inebilizumab compared to 16% in those that were treated with placebo. Most AESIs were mild in severity and classified as either grade one or two. The incidence of cytopenias was 6.7% lower in participants with inebilizumab than those treated with placebo. The most common cytopenia related AESI included anemia, cytopenia, and neutropenia. Infusion-related reactions occurred in about 5% of inebilizumab and in 2. 5% of placebo-treated participants. Serious and/or opportunistic infections were infrequent, occurring in 3.4% of inebilizumab and 5% of placebo-treated participants. The study was done during the COVID-19 pandemic. COVID-19 was the most common occurring in two participants treated with inebilizumab and in three participants with placebo assignment. No instances of a progressive multifocal leukoencephalopathy were observed in the RCP. In conclusion, inebilizumab was associated with a low incidence of AESIs, 10%, which was comparable to the incidence observed with placebo. Most AESIs were grade one or two in severity and included cytopenia, infusion-related reactions, and serious and or opportunistic infections with no instances of PML. Overall, this analysis of meant the RCP specifically demonstrated favorable safety profile for inebilizumab administered for 26 or 52 weeks in participants with generalized myasthenia gravis.
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