Monoclonal antibody sutimlimab did not interfere with COVID-19 vaccination response in Phase 3 studies

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The pandemic has complicated the treatment of cold agglutinin disease (CAD), a rare autoimmune hemolytic anemia accounting for roughly 20% of all autoimmune hemolytic anemia. It affects older adults primarily. The anti-CD20 therapies commonly used off-label to treat the disease increase the risk of serious COVID-19 infections and interfere with the immune response to COVID-19 vaccines. Furthermore, COVID-19 infections and vaccines appear to be correlated with CAD exacerbations. Multiple publications suggest that CAD patients exposed to the anti-CD20 therapy rituximab, for instance, do not mount a strong antibody response to COVID-19 vaccines. 

A study published in Blood focused on CAD patients receiving Enjaymo (sutimlimab-jome) from Sanofi (Nasdaq:SNY) and at least one COVID-19 vaccine dose. Drawing on data from the Phase 3 CARDINAL and CADENZA studies conducted during the pandemic, the ad h…

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