sutimlimab

08/01/2023 - "This approval was based on the phase III CARDINAL trial, which evaluated sutimlimab in patients with CAD-associated hemolysis. "
05/01/2022 - "In February 2022, sutimlimab received its first approval in the USA to decrease the need for RBC transfusion due to haemolysis in adults with CAD. "
01/01/2020 - "When a patient's laboratory data showed signs of breakthrough hemolysis, the dose of sutimlimab was increased. "
01/01/2023 - "Results of the CARDINAL study Part B (2-year extension) study, described herein, demonstrated that sutimlimab sustains improvements in hemolysis, anemia, and quality of life over a median of 144 weeks of treatment. "
01/01/2023 - "In Part A (26 weeks) of the open-label, single-arm, Phase 3 CARDINAL study in patients with CAD and a recent history of transfusion, sutimlimab demonstrated rapid effects on hemolysis and anemia. "

03/01/2023 - "Least-squares (LS) mean change in FACIT-Fatigue score from baseline to treatment assessment timepoint was 10.8 vs. 1.9 points (sutimlimab vs. placebo; p < 0.001). "
01/01/2023 - "In the 9-week follow-up period after sutimlimab cessation, CP inhibition was reversed, and hemolytic markers and fatigue scores approached pre-sutimlimab values. "
10/01/2022 - "Sutimlimab treatment resulted in sustained improvements in symptoms of fatigue and overall quality of life in patients with CAD. "
10/01/2022 - "Clinical trials have shown that most patients with CAD respond well to treatment with sutimlimab, with rapid improvement in anemia and fatigue. "
07/01/2023 - "The beneficial effects of sutimlimab go beyond rapid inhibition of hemolysis and include sustained meaningful improvements in fatigue and quality-of-life measures. "

10/01/2022 - "Clinical trials have shown that most patients with CAD respond well to treatment with sutimlimab, with rapid improvement in anemia and fatigue. "
01/01/2023 - "Results of the CARDINAL study Part B (2-year extension) study, described herein, demonstrated that sutimlimab sustains improvements in hemolysis, anemia, and quality of life over a median of 144 weeks of treatment. "
01/01/2023 - "In Part A (26 weeks) of the open-label, single-arm, Phase 3 CARDINAL study in patients with CAD and a recent history of transfusion, sutimlimab demonstrated rapid effects on hemolysis and anemia. "
08/01/2023 - "Sutimlimab provides an additional therapeutic option in the treatment of CAD-associated hemolysis that can lead to rapid improvement in hemoglobin and anemia-related symptoms."

01/01/2023 - "Sustained hematologic remission after discontinuation of sutimlimab treatment in patients with cold agglutinin disease."
03/01/2023 - "Sutimlimab provides clinically meaningful improvements in patient-reported outcomes in patients with cold agglutinin disease: Results from the randomised, placebo-controlled, Phase 3 CADENZA study."
10/01/2022 - "Sutimlimab improves quality of life in patients with cold agglutinin disease: results of patient-reported outcomes from the CARDINAL study."
01/01/2022 - "Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial."
01/01/2022 - "Sustained sutimlimab response for 3 years in patients with cold agglutinin disease: A phase I, open-label, extension trial."

01/01/2019 - "Hemolytic anemia recurred when drug levels were cleared from the circulation 3 to 4 weeks after the last dose of sutimlimab. "
01/01/2019 - "This trial tested the hypothesis that the anti-C1s antibody sutimlimab would ameliorate hemolytic anemia. "
01/01/2019 - "Reexposure to sutimlimab in a named patient program recapitulated the control of hemolytic anemia. "
01/01/2022 - "Sutimlimab, an investigational C1s inhibitor, effectively prevents exacerbation of hemolytic anemia in a patient with cold agglutinin disease undergoing major surgery."
01/01/2023 - "Sutimlimab, a humanized monoclonal antibody targeting the classic complement pathway, is approved in the United States, Japan, and the European Union for the treatment of hemolytic anemia in adults with cold agglutinin disease. "