Data from the phase 3 Cardinal and Cadenza studies have shown that the response to coronavirus disease 2019 (COVID-19) vaccinations was not impaired in patients with cold agglutinin disease (CAD) who were undergoing treatment with sutimlimab. The study, published in Blood, also noted that sutimlimab treatment was effective and well tolerated among the patients.

“In the phase 3 Cardinal and Cadenza studies, [sutimlimab] treatment led to rapid and sustained increases in hemoglobin and clinically meaningful improvements in fatigue and was generally well tolerated – reported adverse events (AE) were consistent with elderly populations,” the authors wrote.

“However, the impact of sutimlimab on immune response to COVID-19 vaccination is unknown.”

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The rationale for the study was that the commonly used anti-CD20 treatments for CAD can increase the risk of serious infection by SARS-CoV-2 as well as potentially reduce the COVID-19 vaccine immune response. Furthermore, patients with CAD are typically elderly with comorbidities and will need ongoing boosters as the pandemic progresses.

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The research team analyzed data from the 61 patients in the open-label extensions of the Cardinal and Cadenza phase 3 studies, including COVID-19 cases, AE reports, immunogenicity, and immunoglobulin G (IgG) titers. All participants were similar in terms of clinical and demographic characteristics.

Forty-seven participants received at least 1 vaccination, 11 had a booster, and 14 were not vaccinated.

There were no cases of COVID-19 reported during the open-label extensions, and no instances of hemolytic exacerbation were found. All participants developed a postvaccination immune response and, based on IgG titers, no patients had previous asymptomatic COVID-19 infections. Ten AEs were reported during the week after vaccination, but none were serious.


Fattizzo B, Roeth A, Broome CM, et al. Concomitant use of sutimlimab and COVID-19 vaccines in patients with cold agglutinin disease from the phase 3 Cardinal and Cadenza studies. Blood. 2022;140(Suppl 1):2839-2841. doi:10.1182/blood-2022-159988