Sutimlimab continues to inhibit the classical complement pathway at C1s and the effects of the treatment are sustained in patients with cold agglutinin disease (CAD), according to 1-year interim results from a phase 3 clinical trial.

“These data reinforce the positive risk-benefit profile of sutimlimab as an effective long-term therapy with an acceptable safety profile for management of patients with chronic CAD, particularly symptoms influenced predominantly by activation of the classical complement pathway,” Alexander Röth, PhD, and colleagues wrote in a report published in Haematologica.

The phase 3 clinical trial called the CARDINAL study was a pivotal, open-label, multicenter study that aimed to assess the safety and efficacy of sutimlimab in patients with primary CAD who had a recent history of blood transfusion. Here, the researchers presented data from the ongoing 2-year CARDINAL extension study.

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The 1-year interim results showed that sutimlimab demonstrated an acceptable safety profile with no new safety signals identified. There were also no treatment-emergent adverse events that suggested serious hypersensitivity or anaphylactic reactions associated with the drug.

One patient experienced device-related thrombosis, but there were no other vascular thromboembolic treatment-emergent adverse events. Sutimlimab treatment maintained mean hemoglobin levels at 11 g/dL or higher with a sustained improvement in quality of life.

“After sutimlimab treatment, the number of blood transfusions decreased with time and most patients remained transfusion-free from Weeks 5 to 53, which translates to reduced patient burden and utilization of healthcare resource,” the researchers wrote.

Sutimlimab is an investigational humanized monoclonal antibody that selectively blocks C1 in the complement pathway. It is the first treatment specifically designed for CAD that has been approved by the US Food and Drug Administration. C1 plays a key role in the classic complement pathway., therefore, blocking it addresses the underlying cause of hemolysis in CAD and can reduce disease burden by preventing hemolytic anemia.


Röth A, Barcellini W, D’Sa S, et al. Complement C1s inhibition with sutimlimab results in durable response in cold agglutinin disease: cardinal study 1-year interim follow-up results. Haematologica. Published online February 17, 2022. doi:10.3324/haematol.2021.279812

A study to assess the efficacy and safety of BIVV009 (sutimlimab) in participants with primary cold agglutinin disease who have a recent history of blood transfusion (Cardinal study). November 20, 2017. Updated October 5, 2021. Accessed February 22, 2022.