Use of the investigational therapy sutimlimab results in substantial reductions in patient hospitalizations and blood transfusions among adults with primary cold agglutinin disease (CAD), a post hoc analysis of the CARDINAL trial found.
The results of the analysis point to a decreased use of healthcare resources with sutimlimab, which may reduce CAD’s economic burden on patients and providers.
The research, “Effect of Sutimlimab Treatment on Healthcare Resource Utilization in Patients with Cold Agglutinin Disease,” was presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, held virtually Dec. 5-8.
CAD is an autoimmune disorder caused by overactivation of the classical complement pathway that results in hemolysis, or the premature rupturing of red blood cells. Symptoms of CAD 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 that selectively binds and blocks the activity of the complement protein C1, and is expected to reduce the symptoms of this disease.
The CARDINAL Phase 3 clinical trial (NCT03347396) was designed to investigate sutimlimab in 24 CAD adults who had required at least one blood transfusion in the prior six months.
The treatment raised hemoglobin levels and eliminated the need for blood transfusions in most patients, while also leading to meaningful reductions in fatigue scores and other measures of quality of life.
Based on these positive results, Sanofi filed an application with the U.S. Food and Drug Administration requesting the approval of sutimlimab to treat hemolysis in adults with CAD. If approved, the medication will be the first hemolysis treatment for adults with CAD.
This request was granted priority review earlier this year, but the agency later issued a complete response to the application, claiming there were issues with a third-party manufacturing facility that must be resolved before sutimlimab gains approval in the U.S.
The post-hoc analysis of the CARDINAL trial — an analysis that was specified after the data were seen — aimed to examine patient use of healthcare resources, such as hospitalization and blood transfusions, in the six months before and after sutimlimab treatment.
Sutimlimab reduced the number of hospitalizations by more than threefold, the team found. While 41.7% of participants had been hospitalized prior to taking sutimlimab, that rate dropped to 12.5% following treatment.
Hospital admissions before sutimlimab were mainly due to CAD-related symptoms or blood transfusions; the reasons for hospitalization after treatment included sepsis, infection, and blood transfusion.
While the average number of hospitalizations per patient decreased following sutimlimab, the duration of hospitalizations per patient remained similar. There were nine patients (37.5%), however, who required fewer and shorter hospital stays after initiating treatment.
Blood transfusions were similarly reduced, with only 41.7% of patients needing one in the six months after starting the therapy. The number of transfusions also decreased from 105 before treatment to 25 after treatment.
Sanofi also is conducting Cadenza (NCT03347422), a placebo-controlled Phase 3 trial of sutimlimab in adults with primary CAD who have not received recent blood transfusions. Top-line results from the study are expected by the end of next year.
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