Combination therapy of sutimlimab and rituximab can lead to stable remission in autoimmune hemolytic anemia: a case series

Abstract Autoimmune hemolytic anemia (AIHA) is associated with a significant impairment of quality of life for affected patients and can lead to life-threating hemolytic crises. Complement-mediated destruction of antibody-opsonized erythrocytes is a central pathomechanism in many cases of AIHA. Complement inhibition is therefore a promising and logical therapeutic strategy. Sutimlimab, a monoclonal antibody that targets complement factor C1s was approved in 2022 and can effectively inhibit hemolysis. However, this therapy must be administered as a permanent treatment and is only approved for the specific subtype cold agglutinin disease. In this case series, we report on a novel combination therapy of sutimlimab and rituximab, which led to rapid and durable remission in three patients suffering from severe autoimmune hemolytic anemia (two patients with cold agglutinin syndrome and one patient with primary warm AIHA). In two of these patients, treatment with sutimlimab could be discontinued without any recurrence to date. The other patient is also in remission but with ongoing therapy. This highly informative case series reports on an innovative therapeutic concept and may form the basis for further clinical studies in AIHA.