Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD).
[3] In two phase 3 studies (n=66), 29% of patients experienced infusion-related reactions, including shortness of breath, rapid heartbeat, nausea, flushing, headache, hypotension, chest discomfort, pruritis, rash, injection site reaction, and dizziness.
[11] The effectiveness of sutimlimab was assessed in a study of 24 adults with cold agglutinin disease who had a blood transfusion within the past six months.
[3] All participants received sutimlimab for up to six months and could choose to continue therapy in a second part of the trial.
[3] The response was defined in the study as an increase in hemoglobin (an indirect measurement of the amount of red blood cells that are not destroyed) of 2 g/dL or greater (or to 12 g/dL or greater), and no red blood cell transfusions after the first five weeks of treatment; and no other therapies for cold agglutinin disease as defined in the study.