Apr 8, 2021 Treatment increased hemoglobin, decreased fatigue Results from a small open-label trial suggested that treatment with an investigational humanized monoclonal antibody may be an effective treatment for cold agglutinin disease, a rare autoimmune hemolytic anemia for which there are no approved therapies. The 26-week, single-group trial tested intravenous sutimlimab in 24 cold agglutinin patients who had recently undergone transfusions and found infusions of the antibody halted hemolysis, increased hemoglobin levels, and reduced fatigue in more than half of patients. The composite primary endpoint was a “normalization of hemoglobin level to 12 g or more per deciliter or an increase in hemoglobin level of 2 g or more per deciliter from baseline, without red-cell transfusion or medications prohibited by protocol,” Alexander Röth, MD, of the West German Cancer Center, University Hospital Essen, University of Duisburg-Essen in Essen, Germany, and colleagues reported.