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Sutimlimab for primary cold agglutinin disease


Haematology and Blood Products

November 2018

Sutimlimab is a first-in-class monoclonal antibody in development for the treatment of cold agglutinin disease, a rare form of autoimmune haemolytic anaemia, caused by cold-reacting autoantibodies. These antibodies bind to red blood cell membranes and destroy them, leading to anaemia. Symptoms include chronic debilitating fatigue, acrocyanosis, shortness of breath and other anaemia-related symptoms, leading to a poor quality of life and increased health resource utilization. In chronic cold agglutinin disease, the patient is more symptomatic during winter months. Therapeutic options may range from using warm clothing and avoiding exposure to cold weather to blood transfusions and chemotherapy.
Sutimlimab takes a novel approach by binding to the cold-reacting autoantibodies and preventing them from attacking the red blood cells. Sutimlimab acts by selectively inhibiting one of the three complement pathways in the immune system leaving the other two pathways intact. This potentially preserves some of complement’s immune functions although it is unclear whether this would provide a clinical benefit and data from the clinical trials will be needed to better understand this. If approved, sutimlimab has the potential to become the first treatment option for cold agglutinin disease.

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