Catherine M. Broome, MD, Professor of Medicine and Director of Cellular Apheresis, Lombardi Cancer Center, MedStar Georgetown University, discusses real world safety data of Enjaymo (sutimlimab) in patients with cold agglutinin disease (CAD).
CAD is a rare type of autoimmune hemolytic anemia. When the affected individual’s blood is exposed to cold temperatures, IgM antibodies attach to red blood cells and create clumps (agglutination). This causes hemolysis leading to anemia and other associated signs and symptoms. Anemia may cause fatigue, weakness, and pale skin. CAD can be primary or secondary, due to an underlying condition such as an infection, another autoimmune disease, or certain cancers.
Sutimlimab is a humanized monoclonal antibody that specifically binds to complement protein C1s subcomponents in the C1 complement complex. This leads to inhibited activation of the classical complement pathway, preventing deposition of complement opsonins on red blood cells and resulting in inhibition of hemolysis. Sutimlimab is an FDA-approved therapy for hemolysis in adults with CAD.
Recently, real world data on the safety of sutimlimab, was presented at the 2025 American Society of Hematology (ASH) meeting. The data comes from an updated analysis from the CADENCE registry, a multinational, prospective, longitudinal registry for patients with CAD or cold agglutinin syndrome (CAS).
A total of 63 patients were enrolled in the CADENCE registry and treated with sutimlimab between December 12, 2019 and February 4, 2025. This included 58 patients diagnosed with CAD, four with CAS, and one with an unconfirmed diagnosis. At the time of data cut-off, the median and mean sutimlimab treatment duration was 22.7 and 25.1 months, respectively.
A total of 159 adverse events were reported in 52.4% of the sutimlimab-treated patients. 9.5% patients experienced adverse events that the investigator considered related to sutimlimab. Of the 37 serious adverse events reported in 17.5% patients, one serious adverse event, chest pain/stable angina, was considered unexpected and sutimlimab-related. There was one reported death in the cohort, due to low right lung pneumonia, and was considered unrelated to sutimlimab.
Adverse events of special interest in sutimlimab-treated patients included serious infections in three patients, and arterial hypertension in two patients; three patients who experienced adverse events of special interest had concomitantly used rituximab; none of these adverse events of special interest were considered related to sutimlimab. Non-serious adverse events of special interest of acrocyanosis were reported in eight patients, two of which were considered possibly related to sutimlimab.
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To learn more about CAD and other rare hematological conditions, visit https://checkrare.com/diseases/hematologic-disorders/
