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This research investigated sutimlimab in Japanese people suffering from cold agglutinin disease (chronic rare form of autoimmune hemolytic anemia) who accomplished a global phase 3 clinical trial (CARDINAL/CADENZA: 26-week therapy followed by 1–2 years of open-label extension [OLE]) and were later enrolled in the Japanese OLE trial.
In adult patients with cold agglutinin disease, sutimlimab maintains a favorable safety profile with sustained efficacy and no new concerns during extended use and retreatment.
This research investigated sutimlimab in Japanese people suffering from cold agglutinin disease (chronic rare form of autoimmune hemolytic anemia) who accomplished a global phase 3 clinical trial (CARDINAL/CADENZA: 26-week therapy followed by 1–2 years of open-label extension [OLE]) and were later enrolled in the Japanese OLE trial.
Patients with (CARDINAL, n = 3) and without (CADENZA, n = 4) a recent history of blood transfusion were analyzed (71.4% female; median age: 70 years). The median treatment duration was 140.9 weeks in CARDINAL/CADENZA and 47.1 weeks in the Japanese OLE study, with a cessation period of 70 weeks.
During CARDINAL/CADENZA, 42.9% of patients experienced treatment-related treatment-emergent adverse events (TEAEs), including bacterial cystitis, injection site erythema, viral infection, and raised blood pressure. In the Japanese OLE study, 1 person (14.3%) reported a treatment-linked TEAE (urinary tract infection).
A fatal case of kidney failure occurred due to hepatorenal syndrome secondary to liver cirrhosis and bacterial peritonitis, compounded by chronic kidney disease. However, this was not connected to sutimlimab. The levels of bilirubin and hemoglobin boosted with treatment, worsened after discontinuation, and rebounded upon retreatment. Over a median of 3.8 years, sutimlimab was well-tolerated, with no novel safety issues during retreatment.
Sutimlimab (humanized immunoglobulin G4 [IgG4] monoclonal antibody) was well-tolerated in Japanese patients suffering from cold agglutinin disease, with sustained efficacy over long-term treatment. Hemoglobin and bilirubin levels improved with treatment, dropped after cessation, and normalized upon reinitiation. No new safety concerns emerged.
International Journal of Hematology
Long-term safety profile of sutimlimab in adult Japanese patients with cold agglutinin disease
Yoshitaka Miyakawa et al.
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