COVID‐19 vaccine safety and immunogenicity in patients with cold agglutinin disease receiving concomitant sutimlimab

Patients with cold agglutinin disease (CAD) are more vulnerable to infectious agents, thus the COVID‐19 pandemic has posed a particular risk to this population. Sutimlimab Phase 3 studies CARDINAL and CADENZA spanned the period before and during the pandemic; investigators were advised to vaccinate...

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Bibliographic Details
Published in:American journal of hematology 2024-04, Vol.99 (4), p.789-791
Main Authors: Fattizzo, Bruno, Röth, Alexander, Broome, Catherine M., Khan, Umer, Wardęcki, Marek, Cordoba, Matias, Barcellini, Wilma
Format: Article
Language:English
Subjects:
Cold agglutinin disease
COVID-19
Immune response
Immunogenicity
Immunoglobulin G
Monoclonal antibodies
Pandemics
Population studies
Vaccines
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Summary:Patients with cold agglutinin disease (CAD) are more vulnerable to infectious agents, thus the COVID‐19 pandemic has posed a particular risk to this population. Sutimlimab Phase 3 studies CARDINAL and CADENZA spanned the period before and during the pandemic; investigators were advised to vaccinate enrolled patients without stopping treatment. Of 61 completers from both studies, 47 received ≥1 dose of a COVID‐19 vaccine. In the immunogenicity analysis (n = 27) all patients developed an immune response post‐COVID‐19 vaccination, with detectable immunoglobulin G anti‐spike antibodies. Analysis of six patients with booster vaccinations demonstrated increased immune responses pre‐ to post‐booster. COVID‐19 vaccines were well tolerated in patients with CAD receiving sutimlimab treatment, and no signs of hemolytic exacerbations were observed post‐vaccination.
ISSN:0361-8609
1096-8652
1096-8652
DOI:10.1002/ajh.27234