The use of the experimental treatment sutimlimab results in a substantial reduction patient hospitalizations and blood transfusions in adults with primary cold agglutinin disease (CAD), a post hoc analysis of CARDINAL test found.
The results of the analysis indicate a decrease in the use of healthcare resources with sutimlimab, which may reduce the economic burden of coronary artery disease on patients and providers.
The research, “Effect of Sutimlimab Treatment on Health Resource Utilization in Patients with Cold Agglutinin Disease», Was presented to American Society of Hematology (ASH) 62nd Annual Meeting and Exhibition, which was held practically from December 5 to 8.
Coronary artery disease is an autoimmune disease caused by overactivation of the classical complement pathway which results in hemolysis, or premature rupture of red blood cells. Symptoms of coronary artery disease include fatigue, joint pain, jaundice, and heart problems, which impact quality of life and create a significant economic burden for patients.
Sutimlimab, developed by Sanofi, is an antibody which binds and selectively blocks the activity of the complement protein C1, and should reduce the symptoms of this disease.
The CARDINAL Phase 3 the clinical trial (NCT03347396) was designed to study sutimlimab in 24 adults with coronary artery disease who had required at least one blood transfusion within the previous six months.
The treatment increased hemoglobin levels and eliminated the need for blood transfusions in most patients, while also leading to significant reductions in fatigue scores and other measures of quality of life.
Based on these positive results, Sanofi filed an application with the US Food and Drug Administration requesting the approval of sutimlimab to treat hemolysis in adults with coronary artery disease. If approved, the drug will be the first hemolysis treatment for adults with coronary artery disease.
This application received priority review earlier this year, but tThe agency then released a full response to the request, saying there were issues with a third-party manufacturing facility. that must be resolved before sutimlimab is approved in the United States
The post-hoc analysis of the CARDINAL trial – an analysis that was specified after viewing the data – aimed to examine patient use of healthcare resources, such as hospitalization and blood transfusions, during the six months before and after treatment with sutimlimab.
Sutimlimab has reduced the number of hospitalizations by more than three times, according to the team. While 41.7% of participants had been hospitalized before taking sutimlimab, this rate fell to 12.5% after treatment.
Hospital admissions prior to sutimlimab were primarily due to symptoms related to coronary artery disease or blood transfusions; reasons for hospitalization after treatment included sepsis, infection and blood transfusion.
While the average number of hospitalizations per patient decreased after sutimlimab, the length of hospitalizations per patient remained similar. However, nine patients (37.5%) required fewer and shorter hospital stays after starting treatment.
Blood transfusions were similarly reduced, with only 41.7% of patients needing one within six months of starting treatment. The number of transfusions also decreased from 105 before treatment to 25 after treatment.
Sanofi also manages Cadenza (NCT03347422), a phase 3 placebo-controlled trial of sutimlimab in adults with primary coronary artery disease who have not received recent blood transfusions. The main results of the study are expected by the end of next year.